Tuesday, May 31, 2022

Takeda Presents Latest Research from Oncology Portfolio and Pipeline at ASCO & EHA

CAMBRIDGE, Mass. & OSAKA, Japan-Tuesday 31 May 2022 [ AETOS Wire ]


Positive Results from the Phase 3 PARADIGM Study in Japanese Patients with Colorectal Cancer to be Presented During the Plenary Session at ASCO, in Collaboration with Amgen


Overall Survival Data to be Presented during Oral Sessions at both ASCO and EHA from the Phase 3 ECHELON-1 Trial in Patients with Previously Untreated Advanced Hodgkin Lymphoma, in Partnership with Seagen


Pipeline Presentations Highlight Progress with Programs Harnessing Innate Immunity to Outsmart Cancer and Improve Patients’ Lives


 


(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that it will present data at two upcoming scientific congresses this spring: the 58th Annual Meeting of the American Society of Clinical Oncology (ASCO), June 3-7 in Chicago, Ill. and the 30th Congress of the European Hematology Association (EHA), June 9-12 in Vienna, Austria. Takeda’s latest research in oncology focuses on enhancing and improving patient care while exploring novel approaches for patients with limited treatment options.


Data presentations span a range of cancers, including lymphoma, leukemia, multiple myeloma and non-small cell lung cancer, including early insights into investigational therapies that leverage the innate immune system.


“Our data at this spring’s medical congresses are indicative of our quest to outsmart cancer and our ability to work collaboratively with partners to further our research capabilities,” said Christopher Arendt, Ph.D., Head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda. “In addition to sharing data on currently approved therapies, we look forward to presenting early findings from our innate immunity clinical programs – many of which are exploring novel mechanisms of action – that we believe have the power to advance the field of oncology and recast current standards of care.”


A full list of company-sponsored abstracts are available for ASCO and EHA.


Takeda’s Commitment to Oncology


Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.


About Takeda Pharmaceutical Company Limited


Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.


View source version on businesswire.com: https://www.businesswire.com/news/home/20220531005140/en/


Contacts

Japanese Media

Ryoko Matsumoto

ryoko.matsumoto@takeda.com

+81 (0) 3-3278-3414


Oncology U.S. and International Media

Lauren Padovan

lauren.padovan@takeda.com

+1 (215) 859-2605

Takeda and Moderna Announce Plans to Transfer Marketing Authorization for Spikevax™ COVID-19 Vaccine in Japan to Moderna

 CAMBRIDGE, Mass. & OSAKA, Japan-Tuesday 31 May 2022 [ AETOS Wire ]


− Moderna to become marketing authorization holder in Japan and be responsible for all import, local regulatory, development, quality assurance and commercial activities for Spikevax™ from 1st August 2022


− Companies concluded memorandum of understanding that Takeda will continue to provide distribution support for the Moderna COVID-19 vaccines for a transitional period.


(BUSINESS WIRE) -- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Takeda (TSE:4502/NYSE:TAK) announced to transfer the marketing authorization in Japan for Moderna’s COVID-19 vaccine Spikevax™ (mRNA-1273) from Takeda to Moderna in Japan as of August 1, 2022.


Moderna will assume responsibility for all Spikevax™ activities, including import, local regulatory, development, quality assurance and commercialization. Takeda will continue to provide distribution support under the current national vaccination campaign for Moderna COVID-19 vaccines for a transitional period. Both companies will be responsible for ensuring proper implementation of operations associated with this transfer.


“We thank Takeda for their support and partnership in bringing our COVID-19 vaccine to Japan over the last two years, and for helping to play a key role in addressing the pandemic across the country,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We are happy to take this important step as we continue to build and strengthen our own commercial organization in Japan, and we look forward to continuing our partnership in 2022.”


“We are proud to have been able to support the early public health response to the COVID-19 pandemic by using the Takeda network to provide Moderna’s COVID-19 vaccine to the people of Japan,” said Gary Dubin, M.D., President, Global Vaccine Business Unit at Takeda. “Following transfer of the marketing authorization to Moderna, we will continue to provide transitional distribution support to ensure supply continuity."


Authorized Use


Moderna's COVID-19 vaccine Spikevax™ has been granted authorization for special approval by the Ministry of Health, Labour and Welfare of Japan. In Japan, it is indicated for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. A dose may be given to people aged 12 years or older. A second dose should be given as soon as possible if more than four weeks have passed since the first vaccination. A booster dose may be given at least five months after the second dose for people aged 18 years and older. A fourth dose may be given at least five months after the third dose for the elderly etc. considering the benefits and risks.


About Moderna


In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.


Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.


About Takeda


Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.


Takeda’s Commitment to Vaccines


Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For more than 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda’s global vaccine business is applying innovation to tackle some of the world’s most challenging infectious diseases, such as dengue, COVID-19, Zika and norovirus. Takeda’s team brings an outstanding track record and a wealth of knowledge in vaccine development and manufacturing to advance a pipeline of vaccines to address some of the world’s most pressing public health needs. For more information, visit www.TakedaVaccines.com.


Moderna Forward-Looking Statements


This post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the transfer of marketing authorization holder from Takeda to Moderna in Japan for the Spikevax COVID-19 vaccine (mRNA-1273) and the responsibilities undertaken by each company in association with the transfer. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this post in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.


Takeda Important Notice


For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.


The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.


Takeda Forward-Looking Statements


This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.


Medical information


This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.


View source version on businesswire.com: https://www.businesswire.com/news/home/20220530005448/en/


Contacts

Moderna Contacts


Media

Luke Mircea Willats

Director, Corporate Communications

Luke.Mirceawillats@modernatx.com


Investors

Lavina Talukdar

Senior Vice President & Head of Investor Relations

+1 617-209-5834

Lavina.Talukdar@modernatx.com


Takeda Contacts


Media

Mika Shirai

mika.shirai@takeda.com

+81332782407

Galderma to Present Extensive New Clinical Data Across Its Portfolio of Neuromodulators, Fillers and Biostimulators at the IMCAS World Congress 2022

 ZUG, Switzerland-Tuesday 31 May 2022 [ AETOS Wire ]


 Strong clinical data supporting Alluzience® (abobotulinumtoxinA, ABO), the first liquid, ready-to-use neuromodulator as an effective and well-tolerated treatment for glabellar (frown) lines, with a rapid onset and long duration of action of up to six months


Data confirming that Dysport® was consistently efficacious for the treatment of frown lines, was well tolerated and had a fast onset of effect across three trials with high patient satisfaction reported up to 6 months after injection in phase III trials


Phase IV data confirming the effectiveness and natural-looking effects with the Restylane® range of hyaluronic acid fillers, with all patients achieving the aim of their treatment, whether it was projection or contouring/volumization with results that were natural-looking with high subject satisfaction


Presentation of the latest extension study for Sculptra®, the original poly-L-lactic acid (PLLA) which demonstrated it to be well-tolerated and with long-lasting effectiveness until week 96 using reconstituted 8mL dilution.


 


(BUSINESS WIRE)-- Galderma will present a range of new clinical data and analyses across its portfolio during nine poster sessions and two symposia at the upcoming International Master Course on Aging Science (IMCAS) World Congress 2022 in Paris from June 3-5, 2022.


“At Galderma, we are committed to advancing dermatology for every skin story. The extensive series of oral and poster presentations with new data from across our portfolio demonstrates our drive for innovation across the industry. We will also be hosting two symposia with leading physicians, reinforcing our partnership with the aesthetics community as we present work completed with them to deliver holistic individualized treatments (HITs) for patients and the science and clinical experience behind our latest innovation Alluzience, the first ready-to-use neuromodulator”


Flemming Ørnskov, M.D., MPH


Chief Executive Officer


Galderma


Latest efficacy, safety & satisfaction data for neuromodulator portfolio


Alluzience


Two oral presentations and a poster will center on data for Alluzience, the first ready to use liquid (abobotulinumtoxinA), approved in June 2021 in Europe. Pooled data from two phase III studies (NCT02353871 and NCT02493946) demonstrated that Alluzience effectively improved frown line severity, with rapid onset of effect and up to 6 months improvement after a single treatment.1-3 Improvements in the severity of frown lines, satisfaction and psychological well-being were maintained over repeated treatment cycles.1 Additional post-hoc analyzes will be presented that confirm that the median time to return to baseline rating was nearly six months.3


The clinical data that will be presented are listed below:


 


Poster title


Authors


Number


Poster


presentation


Ready-to-use liquid abobotulinumtoxinA: An overview of available phase III clinical data for moderate-to-severe glabellar line treatment


 


Benjamin Ascher, et al.


#113846


Oral


Presentation


16:45 CET


June 4


Ready-to-use liquid abobotulinumtoxinA for moderate-to-severe glabellar lines: Pooling of two double-blind, randomized, controlled phase III studies


 


Inna Prygova, et al.


#114879


Oral


Presentation


16:30 CET


June 4


Liquid abobotulinumtoxinA for glabellar line treatment: Post hoc analysis of duration of effect and subject satisfaction phase III study data


 


Berthold Rzany, et al.


#114895


Delegates at IMCAS can also attend Galderma’s symposium, Alluzience: the first liquid neuromodulator – from theory to practice. During the session, an expert panel will take attendees on a journey through the science of the first ready-to-use neuromodulator and their clinical experience of the breakthrough treatment. The symposium is taking place on Saturday 4, 13:30 to 15:00 CET.


Dysport (also marketed as Azzalure® in the EU)


Clinical experience with Dysport (abobotulinumtoxinA) spans over three decades* and it has a well-established safety profile across multiple aesthetic indications including both frown lines and crow’s feet.4–14


Researchers will present three posters demonstrating that Dysport is efficacious and well tolerated, with subjects reporting natural results and high rates of satisfaction. A dose escalation study evaluated subject satisfaction using abobotulinumtoxinA doses up to 125U and demonstrated it was efficacious and well-tolerated across all doses from 50U to 125U with high satisfaction and improvement maintained for up to 9 months.15 Data was analyzed from three studies (NCT03736928, Phase 2; NCT03960957, Phase 3; NCT03687736, Phase 4) in which all subjects were treated with on-label 50 units. Subjects reported median onset of effect after two days in all three trials and high rates of subject satisfaction up to six months after injection in phase III and nine months in phase II trials.16 A post-hoc analysis of clinical trial NCT03687736 also found that while all age groups were satisfied with and experienced psychological benefits from treatment, millennials, known for their high expectations appeared to be particularly happy with two treatments a year of abobotulinumtoxinA.17


The clinical data that will be presented are listed below:


 


Poster title


Authors


Number


Poster


presentation


Assessment of subject satisfaction after glabellar line treatment with escalating doses of abobotulinumtoxinA in a randomized, double-blind study


 


Steven Dayan, et al..


#114887


Poster


presentation


Subject satisfaction and duration of effect of on-label 50U abobotulinumtoxinA treatment of glabellar lines - results from three individual trials


 


Steven Dayan, et al.


#114885


Poster


presentation


Subject satisfaction with twice-yearly treatment of glabellar lines with abobotulinumtoxinA in millennials


 


Inna Prygova, et al.


#114945


*Approved for therapeutic use in December 1990 and aesthetic use in April 2009


New data for Restylane range of hyaluronic acid fillers


Restylane


One of the oral presentations presented will report on phase IV data from the CHEEKY study which evaluated treatment outcome after providing investigators with a treatment guide to help choose the right treatment for their patient. The study demonstrated that all patients achieved the aim of their treatment, whether it was projection or contouring/volumization and that the results were natural-looking with high subject satisfaction.18


The clinical data that will be presented are listed below:


 


Poster title


Authors


Number


Oral


Presentation


16:00 CET


June 4


Effectiveness of cheek treatment after providing a treatment guide to help choose between hyaluronic acid filler HA-VOL or HA-LYF: the CHEEKY study


 


Andreas Nikolis, et al.


#114864


Poster presentation


Water uptake of hyaluronic acid fillers.


 


Åke Öhrlund


#114878


96 Week Data for Collagen Biostimulator


Sculptra


The latest long-term effectiveness and safety of Sculptra, the original and only poly-L-lactic acid (PLLA) approved by the FDA, will also be presented at IMCAS 2022. In this extension study for the correction of nasolabial folds, Sculptra, using the new constitution of 8 ml with 1 ml lidocaine, showed it to be well-tolerated and with long-lasting effectiveness until week 96.19


The clinical data that will be presented is shown below:


Oral


Presentation


16:15 CET


June 4


Extension study on safety and effectiveness of PLLA for correction of nasolabial folds after changes in reconstitution and injection procedures


 


Brenda LaTowsky,

set al.


#114971


Participants are also invited to attend the symposium, Restylane and Sculptra: Predictive Lessons from generations applied to facial rejuvenation, taking place on Saturday June 4, 08:30 to 10:00 CET. The symposium will see leading physicians offer their insights into how assessing people within the same family at different stages of their life can inform the design of holistic individualized treatments for patients.


For more information, the IMCAS 2022 program is available here.


About Galderma


Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market though Injectable Aesthetics, Dermo-cosmetics and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com


About Alluzience® (liquid botulinum toxin type A)


Alluzience (liquid botulinum toxin type A) is the first ready-to-use BoNT-A liquid neuromodulator formulation to be introduced in Europe. Alluzience should only be administered by a physician with appropriate qualifications and expertise in this treatment using the required equipment.20 Dosing and treatment intervals depend on assessment of the individual patient’s response.20 The treatment interval should be no more frequent than every three months.20 For more information, please see the Summary of Product Characteristics.20


Alluzience is a product under license from Ipsen. Alluzience is a registered trademark of Ipsen. Galderma has an exclusive license from Ipsen to develop, promote and distribute Alluzience in the approved indication in Europe (excluding Greece, Lithuania, Estonia, Latvia, Hungary).


About Dysport®


Dysport (abobotulinumtoxinA) is a prescription injection for temporary improvement in the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age. Dysport is also marketed as Azzalure in the EU for the treatment of glabellar lines and lateral canthal lines. Dysport has more than 30 years of clinical experience Globally for therapeutic indications and 13 years for aesthetics indications, with extensive clinical evidence of safety and efficacy. It is licensed for aesthetic indications in 85 markets worldwide, Dysport is one of the world’s leading brands of aesthetic neuromodulators with over 100 million treatments delivered in the aesthetics indications to date.


Dysport is a product under license from Ipsen and is manufactured by them. Since 2009, Galderma and Ipsen have had a strategic partnership under which Galderma has promoted and distributed Ipsen’s botulinum toxin type A products in aesthetic indications. The Ipsen-Galderma strategic partnership now covers China, the United States, Europe and the Middle East, Australia, South Korea, Canada, Brazil, Argentina and certain other countries. Ipsen continues to promote Dysport within certain therapeutic indications in countries around the world. For more information on Ipsen, visit www.ipsen.com.


About Galderma’s Restylane® portfolio


RESTYLANE is the original non-animal stabilized hyaluronic acid filler with over 25 years of achievement and over 50 million treatments worldwide. NASHA™ and OBT™ technologies make RESTYLANE the world’s most diverse range of fillers to deliver truly individualized results.21,22


The RESTYLANE® portfolio of products includes RESTYLANE®, RESTYLANE® LYFTTM, RESTYLANE® KYSSETM, RESTYLANE® VOLYMETM, RESTYLANE® DEFYNETM, RESTYLANE® REFYNETM, RESTYLANE® EYELIGHTTM and RESTYLANE® SKINBOOSTERS VITALTM.


About Sculptra®


SCULPTRA works to stimulate the skin’s own collagen production23 and is suitable for increasing the volume of depressed areas, particularly to correct skin depressions such as skin creases, wrinkles, folds, and scars, and for signs of skin aging.24 SCULPTRA is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).24


SCULPTRA is an injectable biostimulator containing microparticles of poly-L-lactic acid (PLLA) which gradually revitalizes the skin’s structural foundation, providing natural-looking, long-term results for up to 25 months.25 SCULPTRA was first approved in 1999 in Europe and it is currently available in more than 40 countries globally.


References:


Ascher B. Poster #113846 to be presented at IMCAS 2022.

Picaut, P. Oral Presentation #114879 to be presented at IMCAS 2022.

Rzany B. Oral Presentation #114895 to be presented at IMCAS 2022.

Kane AC et al. Plast Reconstr Surg 2009;124:1619–29.

Dysport Summary of Product Characteristics, Galderma, July 2018.

Brandt F et al. Dermatol Surg 2009;35:1893–1901.

Moy RM et al. Arch Facial Plast Surg 2009;11(2):77–83.

Rubin MG et al. J Drugs Dermatol 2009;8(5):439–444.

Schlessinger J et al. Dermatol Surg 2014;40(2):176–183.

Maas C et al. Aesthet Surg J 2012;32(1S):8S–29S.

Cohen JL and Scuderi N. Aesthet Surg J 2017;37(S1):S33–S44.

Hexsel D et al. Dermatol Surg 2018;44(12):1555-1564.

Rubin M et al. Aesthet Surg J 2009;29:S50–S56.

Cohen JL et al. Aesthet Surg J 2009;29(Suppl 1):S43–S49.

Dayan S et al. Poster #114887 to be presented at IMCAS 2022.

Dayan S et al. Poster #114885 to be presented at IMCAS 2022.

Prygova I et al. Poster #114945 to be presented at IMCAS 2022

Nikolis A et al. Oral Presentation #114864 to be presented at IMCAS 2022.

LaTowsky B et al. Oral Presentation #114971 to be presented at IMCAS 2022.

Summary of Product Characteristics, 10 June 2021.

Data on file (MA-33939).

Öhrlund A. Poster presented at AMWC 2019.

Bohnert K et al. Plast Reconstr Surg 2019;127(4):1684–92.

Sculptra IFU. 2018.

Brown SA et al. Plast Reconstr Surg 2011;127(4):1684–92.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220531005477/en/ 


Contacts

For further information:


Christian Marcoux, M.Sc.

Chief Communications Officer

christian.marcoux@galderma.com

+41 76 315 26 50


Rachel Mooney

Global Franchise Communications

rachel.mooney@galderma.com

+41 76 261 64 41


Tracy Krumme

Global Head of Investor Relations

tracy.krumme@galderma.com

+1 914 497 9073


Sébastien Cros

Corporate Communications Director

Sebastien.cros@galderma.com

+41 79 529 59 85



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On ‘International Mount Everest Day’ (29th May) ‘The Art Maze’, by Curator Marcus Schaefer, unveils Artist Sacha Jafri’s latest Masterpiece as a first time ever event at Mount Everest

 From the Burj Al Arab helipad to Mount Everest



KATMANDU, NEPAL-Tuesday 31 May 2022 [ AETOS Wire ]


‘The Art Maze’ World Tour, in partnership with UNESCO, is an unpresented collection of 50 UNESCO World Heritage Sites, created by celebrated Artist, Sacha Jafri, in celebration of UNESCO World Heritage Site’s 50th year anniversary and The Next 50, a year-long UNESCO campaign promoting interdisciplinary reflection on the future of the World’s Heritage.


Jafri, awarded by the UN for his humanitarian work raising over $140 million for charitable causes, is unveiling his ‘Sagarmatha National Park - Mount Everest’ painting, a spectacular 380cmx160cm three-canvas Triptych piece. With this project Jafri aims to reconnect humanity to our cultural heritage, our ancestral past and the beauty that surrounds us within our natural world, as well as shine a light on the important conversations and actions so desperately needed for the future of our world, in the areas of equality, sustainability & climate change.


Sacha Jafri, Artist & Philanthropist: “It is such an honour for me to partner with ‘The Art Maze’ and UNESCO using the power of art to reconnect with humanity in space and on earth.”


Marcus Schaefer, Art Visionary & Curator: “Feeling such a strong connection to this great country, we are so excited to unveil Sacha’s latest painting with the people of Nepal at the majestic Mount Everest.”


Michael Croft, Head of Office and Representative to Nepal at UNESCO: “As we listen to communities from the mountain regions and hear their perspective on tackling the dual challenges of climate change and sustainable tourism, we are at once motivated - and better informed - how best to fashion our own actions for change.” 


UNESCO’s partnership with ‘The Art Maze’ and Sacha Jafri reinforces its mission of promoting inclusive, interdisciplinary dialogues related to climate change, heritage conservation, sustainable tourism, and the challenges these sites face in the context of climate change. In Nepal, UNESCO is working to bring together mountain community leaders as part of The Next 50 dialogues.


Raza Beig, Chairman of BoredPuma: “So excited to be able to announce my purchase of this monumental painting - I now own a piece of a living Indian master, Sacha Jafri, but also, the artistic expression of the world’s largest natural beauty - Mount Everest.” 


In honour of this cause, Jafri is producing a signature print collection for art lovers who are keen to own a piece of his humanitarian journey. They can be found at: www.https://collection.theartmaze.com/


‘The Art Maze’ visits 18 countries across six continents of the world 2022-2024 with the next stop in Paris, September 2022, at UNESCO’s Headquarters commemorating the organisation’s 50th anniversary with all 50 of Jafri’s paintings on display.


Follow ‘The Art Maze’


WEBSITE: www.theartmaze.com


@sachajafri @the.artmaze


Download Images & Films HERE


Contacts

Leidar


Lejo Johnny


Lejo.johnny@leidar.com





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Andersen Global Adds Member Firm in the Netherlands

 SAN FRANCISCO-Tuesday 31 May 2022 [ AETOS Wire ]


(BUSINESS WIRE) -- Andersen Global further solidifies its platform in Northern Europe as Taxture, a collaborating firm since 2019, becomes a member of the global organization. Building on its commitment to delivering integrated client solutions in a seamless manner, Taxture is one of 11 collaborating firms that will formally join Andersen Global as member firms in 2022.


Founded in 2009, the Amsterdam-based firm is an international firm specializing in tax and legal advisory, compliance and transfer pricing services. Led by Office Managing Partner Ferruh Tarik Tigli, the firm’s team of more than 45 highly skilled professionals works closely with clients globally to provide comprehensive tax and legal services.


“Being an Arthur Andersen alumnus, our firm’s values and vision align well with the global organization’s, and we remain committed to delivering best-in-class solutions for our domestic and multinational clients’ business needs,” Ferruh said. “Becoming a member firm of Andersen Global is our firm’s next step to extend our global resources and maintain a strong foothold in the regional market.”


“The Taxture team consistently impresses clients and professionals through their dedication to quality service,” said Andersen Global Chairman and Andersen CEO Mark Vorsatz. “The firm’s high-end practice seamlessly mirrors our organization’s values, distinguishing them as a competitive firm in the region. Taxture’s addition as a member firm of our organization is key as we continue to build a benchmark organization with comprehensive global coverage.”


Andersen Global is an international association of legally separate, independent member firms comprised of tax and legal professionals around the world. Established in 2013 by U.S. member firm Andersen Tax LLC, Andersen Global now has more than 10,000 professionals worldwide and a presence in over 343 locations through its member firms and collaborating firms.


View source version on businesswire.com: https://www.businesswire.com/news/home/20220531005175/en/


Contacts

Megan Tsuei

Andersen Global

415-764-2700


Coliseo De Puerto Rico and ASM Global Recognize 10,000,000th Visitor at Tommy Torres Concert

 

SAN JUAN, Puerto Rico-Tuesday 24 May 2022 [ AETOS Wire ]

(BUSINESS WIRE) -- The Coliseo de Puerto Rico José Miguel Agrelot and ASM Global, the world’s largest producer of live entertainment experiences, surprised Melanie Biringer-Figueroa with the news of being the 10,000,000th visitor to the “Choli” as she made her entrance to the venue on Saturday to enjoy the Tommy Torres concert, “El Playlist de Anoche Live.”

 “We are overjoyed to be able to recognize our 10 millionth visitor and celebrate this historic and special moment with her,” said Jorge L. Pérez, CVE, regional manager of ASM Global. The winner received an array of gifts as part of this accolade, including a trip and holiday vacation in Punta Cana, Dominican Republic and gift baskets with a variety of products, among other surprises.

The Coliseo de Puerto Rico, recognized as one of the most successful arenas in the world, opened its doors on Sept. 4, 2004, and has been the stage of special events and memorable concerts ever since, including local and international artists who have toured its stage, delighting millions of visitors, sports fans, theater productions and events.

In December 2021, Coliseo de Puerto Rico was ranked among the highest ticket-selling venues globally, despite having been closed until August 2021 due to the COVID-19 pandemic.

Ron Bension, president and CEO of ASM Global, said, “We’re incredibly proud of this moment. Coliseo represents the best of what ASM offers its clients throughout the world—amazing content and the best and most seamless guest experience anywhere, leveraging technology, innovative culinary creations and a team dedicated to optimizing the fan journey.”

“We are deeply grateful of all our visitors for the love and solid patronage over the course of nearly 18 years. The people of Puerto Rico and our guests enjoy concerts, special events and sports to the fullest. After the challenges we have collectively faced due to the pandemic since 2020, we were able to reopen 11 months ago with great success. Today we honor one of our Choli fans and celebrate this historic moment with her,” said Mariela Vallines, executive director of the Puerto Rico Convention District Authority.

About ASM Global

ASM Global is the world’s leading producer of entertainment experiences. It is the global leader in venue and event strategy and management—delivering locally tailored solutions and cutting-edge technologies to achieve maximum results for venue owners. The company’s elite venue network spans five continents, with a portfolio of more than 350 of the world’s most prestigious arenas, stadiums, convention and exhibition centers, and performing arts venues. Follow us on Facebook, Instagram and Twitter or visit asmglobal.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220523005410/en/

Contacts

Karen Garnik, APR
787-502-2424

Jim Yeager
breakwhitelight (for ASM Global)
jim@breakwhitelight.com
Mobile: 818-264-6812

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Envision the Future and Take on the Power of Computing with GIGABYTE at COMPUTEX 2022

 

TAIPEI-Friday 20 May 2022 [ AETOS Wire ]

(BUSINESS WIRE) -- GIGABYTE, a world leader in computer technology, will be presenting “Power of Computing” as its theme of the year, and exhibiting its leading products and solutions designed for various industries and fields in the upcoming COMPUTEX Taipei.

GIGABYTE has curated its presentation around the theme “Power of Computing” to demonstrate that, everything from the cloud to the edge, from team collaboration to individual creation, from business applications to personal use, computing done by servers in data centers to process massive data and embedded systems in IoT and personal computers to render real-time information is the key behind groundbreaking innovations that appear in the fields of AI, cloud deployment, smart technologies, and digital content creation, etc.

Data Center is an integral part of making technological breakthroughs. GIGABYTE is a trusted pioneer in developing new server products for developers, and worked on software integrations to provide product solutions that are in line with the future of the digital age. GIGABYTE also works closely with vendors in early stages of HPC server platform development, so that system integration and optimization of SmartNICs and GPGPUs allow for heterogeneous architecture in servers to provide application-specific computing acceleration the higher computation and efficiency. In addition to supporting x86 applications using AMD and Intel processors, GIGABYTE also offers the choice of ARM servers that provide consistent data processing and encoding from the user’s terminal to edge, which not only enhances an agile response but also accelerates the development of innovations in the edge computing-piloted 5G era.

GIGABYTE is dedicated to use computing performance to accelerate innovation and advance quality of life, and has devoted effort into development of various cooling methods that includes launching products with direct liquid cooling and immersion cooling technologies to reduce the environmental impact of increased heat generated by data centers.

In the new digital age driven by AI-enabled applications, GIGABYTE has coupled its servers with MyelinTe's MLSteam platform to cluster all computing servers, storage and management nodes to facilitate resource allocation, monitoring and management, and effectively maximize resource utilization. GIGABYTE further expands its hardware experience and expertise by releasing embedded computers into everyday applications such as the fields of self-driving cars and the Internet of Vehicles. GIGABYTE's ADCU series can process massive data and make vehicle-control decisions on a real-time basis; and T-BOX can handle data and mutual communications between on-road vehicles, which is an ideal solution suitable for commercial fleet management.

Computing powers the engine for technological progression, not only to enabling successes in businesses, but also providing exhilarating personal experiences. GIGABYTE exhibits an NVIDIA Omniverse™ virtual collaboration scenario with a host-client setup using its high-performance W771-Z00 workstation and visual-spectacle BRIX mini PC; an awe-inspiring gaming showcase of flagship gaming solutions powered by Intel 12th gen processors, iF Design award-winning motherboards and monitor, and AMD Socket AM5 motherboards with advanced design and extensive features of PCIe 5.0 graphics slot and m.2 Gen5 interface; and GIGABYTE's creator/gaming laptops provide high performance with premium visual experience, with its newest flagship gaming laptop featuring the 12th Gen Intel® Core™ i9 HX series processor, offer a glimpse at the Metaverse potential.

From May 24th to 27th, GIGABYTE is primed, with an array of product solutions and applications, and ready to exhibit its hardware expertise and technology know-how, which possess the computing performance to accelerate technology innovations and uphold its vision to “Upgrade Your Life”

GIGABYTE @ COMPUTEX 2022 - https://gbte.tech/CX22

More About GIGABYTE enterprise: https://www.gigabyte.com/enterprise

View source version on businesswire.com: https://www.businesswire.com/news/home/20220519005640/en/

Contacts

Media: Michael Pao brand@gigabyte.com

Permalink : https://www.aetoswire.com/news/envision-the-future-and-take-on-the-power-of-computing-with-gigabyte-at-computex-2022/en

MAJOR BREAKTHROUGH IN SEARCH TO DEVELOP “CLEAN GAS” ENERGY SOURCE

 

Abu Dhabi -Monday 30 May 2022

NEW DISCOVERY WILL HELP TACKLE GLOBAL ENERGY CRISIS WITH ZERO CO2 EMISSIONS AND SIGNIFICANTLY CHEAPER GAS

 

KINETIC 7™ WILL ENABLE GLOBAL GAS INDEPENDENCE,

REDUCE CARBON EMISSIONS & MAINTAIN SECURITY OF SUPPLY

 

A disruptive technology company has today confirmed it has made a major breakthrough in its search to innovate a ground-breaking “clean gas” energy source that will not only provide an alternative supply to natural gas, but also boasts zero CO2 emissions and is estimated will be cheaper than current domestic household and business energy supplies by as much as 80%.

The clean gas, which is carbon neutral with net zero emissions, will give global economies access to a cheap, endless supply of clean energy. Importantly, it will allow countries to maintain security of their gas and energy supplies whilst also meeting their carbon-neutral net zero targets. This discovery could play a major role in reversing the global energy crisis, significantly reducing energy costs to the consumer and businesses sectors at a time when the cost-of-living crisis is worsening, and inflation has reached a 40-year high.

The scientific breakthrough, which is 10 years ahead of its time, has been made by a team from Voltage Enterprises, a disruptive tech company based in Abu Dhabi. The company, which has been funded by Aquarius Global, an investment company and tech incubator also based in Abu Dhabi, is also working on further innovations and disruptive technology projects.

Code-named KINETIC 7™ , the scientific breakthrough is a clean gas energy source that is a stable and an efficient gas derived solely from water. Whilst creating a gas from water such as hydrogen is not new, KINETIC 7™ has a unique molecular chemistry that is way more advanced than hydrogen gas. For example, hydrogen gas is obtained through electrolysis, where pure distilled water (H2O) is broken down into (H2) and (O2) gases. Not only does this use a huge amount of energy to create the molecular process; it requires high pressure storage and has a low flash point, making it very unstable.

KINETIC 7™ patented technology reconstructs and converts water into molecular clusters, which are electrically charged to create a constant oxidisation and friction. This makes the molecules more efficient, causing them to vibrate, which in turn creates a very reactive gas, providing a clean gas and flame.

Unlike hydrogen gas KINETIC 7™ is also inert, making it a safe and controllable gas for domestic and industrial supply. Most importantly, the cost savings by using KINETIC 7™ will be substantial against current gas and energy costs. The KINETIC 7™ generators which create the clean gas, will be manufactured to high standards in Europe. The current process of making the gas is both EU-approved and CE-certified.

The KINETIC 7™ discovery, which has taken more than eight years of research and development, will not only enable countries and global economies to maintain their own gas independence and sovereignty, but will also ensure global energy security, with an unlimited supply of carbon neutral gas to both domestic and industrial customers.

It comes at a time of global instability in the energy markets, fuelled by the Russian invasion of Ukraine, which has sent gas prices soaring. EU energy ministers have also held talks over recent weeks to tackle the energy crisis that has been negatively impacting 218 million households throughout the bloc. Households in the UK faced a record energy bill spike of 54% at the beginning of April and prices are set to rise again in October. Many engineering, industrial and manufacturing businesses have also been severely impacted by the energy crisis. Soaring gas costs have led to partial factory shutdowns, reductions in production and output, all of which has impacted on the supply chain.

It follows an unprecedented demand for energy and a perfect storm of war in Ukraine, a post-pandemic recovery in manufacturing and industrial production, coupled with an unusual downturn in wind power supply to national grids.

Rick Parish, Founder and Executive Chairman of investment incubator Aquarius Global, which has funded the research and development of Voltage Enterprises, said:

“KINETIC 7™ represents more than eight years of scientific research, development and tech innovation by a dedicated team of scientists and tech disruptors, all working to produce a clean energy source that is carbon-neutral, significantly cheaper, stable and efficient – but disruptive in every sense to the status quo.

“KINETIC 7™ is a major gamechanger in the global energy market. Just as we saw with the oil boom, the technologies and science  that we are innovating, developing and disrupting in the energy sector through Voltage Enterprises are truly ground-breaking – a world first for the energy sector!”

Governments around the world are desperately considering other options of energy supply and security, including the highly controversial fracking for shale gas, which is not only hugely damaging to the environment and public health, but has also been known to cause earthquakes.  Other options include the importing of gas from Iran and the building of further nuclear reactors, both of which carry huge risks and have inherent downsides attached. These include the geopolitical sanctions on Iran, with the US oil and gas ban and the huge cost of building nuclear reactors. Sizewell C in the United Kingdom is estimated to cost UK taxpayers £20 billion with costs set to increase. Construction time to build a nuclear reactor takes on average 10 years, coupled with the safety concerns and health issues that have long plagued nuclear energy.

Rick Parish added:

“In much the same way that solar power is currently being used in domestic housing, KINETIC 7™ will allow households to produce their own clean gas energy source, using water and a small amount of electricity. The cost to create the clean gas is minimal. The KINETIC 7™ generator unit will be retrofitted into homes. The plug-n-play product, which uses a small amount of AC or DC power and water, will allow the householder to enjoy the same natural gas/LPG benefits without the high costs, supply disruptions and dramatic price increases. An external wall unit can be fitted to a domestic household and used for stove cooktops and ovens, hot water systems, ambient heating and underfloor heating.”

KINETIC 7™ represents a significant breakthrough in providing an alternative and viable energy source of clean gas that has zero carbon emissions. KINETIC 7™ can then be utilised in three ways:

    The KINETIC 7™ flame can be used for domestic energy supply in ambient heating, cooking and hot water heating.

    KINETIC 7™ gas also has a major role to play in providing clean energy for industrial production. Large-scale manufacturing, engineering and industry are all hugely reliant on vast amounts of energy in their production and manufacturing processes. Food production, restaurants and hotels are also gas- and energy-intensive, and KINETIC 7™  can now provide a cleaner more efficient energy source that is carbon-neutral and significantly cheaper than existing natural gas supplies.

    KINETIC 7™ can also be used as a clean energy gas source for heating and cooking from portable stoves in remote locations and developing countries which do not have access to gas or energy.

 

Rick Parish said:

“With KINETIC 7™  we have the world’s first commercially viable clean gas energy source that can be used in domestic households. At the same time, KINETIC 7™ can power large-scale industrial production and manufacturing, providing clean energy that is carbon neutral from water. We anticipate KINETIC 7™ will be 80% cheaper than current energy supplies.

“This will not only help solve the global gas and energy crisis, but the innovation will allow countries and global economies to maintain stability in the energy sector, reduce costs and maintain security of supply.”

KINETIC 7™ will also bring efficient cooking and heating across Africa to developing nations, war-torn countries and places where poor infrastructure has inhibited or restricted access to clean energy. The company will be manufacturing miniaturised KINETIC 7™ portable cooking and heating stoves that will change the lives of millions for the better, providing low-cost energy and heat using clean or untreated water.

Ultimately, in developed countries, the cost of KINETIC 7™ gas will be cheaper than current energy providers. KINETIC 7™ is low-maintenance, safe, efficient and significantly reduces household energy costs.

Aquarius CEO, Rick Parish, added:

“As an investment incubator in disruptive industries, Aquarius Global has been supporting companies like Voltage Enterprises to work on a number of disruptive technologies and innovations in energy and healthcare. Our corporate objective is to support companies using science and technology in a disruptive manner, to develop and deliver beneficial innovations for mankind and the environment. We are currently working on ground-breaking projects to capture carbon emissions and reduce CO2, whilst also creating anti-microbial and immune-boosting water that can be used in a whole range of applications.

“The whole ethos of Voltage Enterprises is to innovate and disrupt using technology and science to change the lives of millions of people for the better, to arrest the environmental damage that has been caused by oil and gas exploration and leave a positive legacy for future generations.”

The founders of Voltage Enterprises both have a philanthropic desire to help change the world for the better. They will be donating 20% of their global profits from KINETIC 7™ to provide African nations and those in need with free clean energy.

A series of “real-world”  R&D trials are currently underway using KINETIC 7™ in residential properties for domestic cooking stoves, hot water systems and residential heating. A number of factories and engineering plants are also part of an R&D program to integrate the technology and use the clean gas in a number of commercial and industrial applications.

It is envisaged that after further R&D trials have been completed, a programme of rolling the technology and clean gas out into domestic households and commercial premises could feasibly start within 6-12 months’ time.  Voltage Enterprises has confirmed that it is around three months away from manufacturing the miniaturised portable cooking and heating stoves that it will be supplying to developing countries.

Further announcements are expected from the company over the coming months as it also looks for global energy partners to work with and assist in the rapid rollout and deployment of the clean gas technology.

NOTES TO EDITORS

VOLTAGE ENTERPRISES

Voltage Enterprises Limited was founded in 2021 under the Abu Dhabi Global Market, Abu Dhabi, United Arab Emirates.

The company was established as a technology and scientific disruptor in energy, healthcare and smart MedTech. It was established as an alliance with investment incubator Aquarius Global Limited, whose investments and interests span oil, gas, marine and offshore energy.

Voltage Enterprises is also partnered with one of the leading scientific research laboratories in disruptive technologies. The partnership has innovated a number of patented  solutions related to clean energy, human immune systems, water treatment and restructuring via antioxidants, proprietary technologies, hygiene disinfection and ecological solutions.

Voltage Enterprises Limited is also creating innovative, unique products for the water, health and cosmetic industries. Within its first year of formation, Voltage Enterprise secured UAE patents for a restructured drinking water and has a number of other disruptive tech patents approved.

AQUARIUS GLOBAL

Aquarius Global Limited is a proprietary investment incubator under Abu Dhabi Global Market, Abu Dhabi, the United Arab Emirates, established in 2018.

Aquarius Global Limited’s business investments include disruptive technology, scientific and technical activities, educational training and management, and business consulting services. Aquarius Global Limited provides consultancy in healthcare, oil  and gas, aviation and other heavy industries.

As a holding company, Aquarius has partnered with several industry experts to drive sales and distribute various products around the globe. In these challenging times, Aquarius Global Limited continues to play a role in sourcing and supplying vital medical products and PPE.

For more information on Aquarius Global and Voltage Enterprises

Please contact Gerard Franklin:

Global Head Of PR & Communications, Aquarius Global & Voltage Enterprises

e: kinetic7@i5media.co.uk +44 07376-604981

Consortium Led by Todd Boehly and Clearlake Capital Completes Acquisition of Chelsea Football Club

 New joint control owners are committed to growth and building on the tradition of unparalleled football excellence


LONDON-Tuesday 31 May 2022 [ AETOS Wire ]


(BUSINESS WIRE) -- The consortium led by Todd Boehly, chairman and CEO of Eldridge, and Clearlake Capital Group, L.P. (together with its affiliates, “Clearlake”), today announced completion of the ownership transfer of Chelsea Football Club (“Chelsea FC” or “the Club”). The consortium also includes Hansjörg Wyss, founder of the Wyss Foundation, and Mark Walter, co-founder and CEO of Guggenheim Capital. Walter and Boehly are owners of the Los Angeles Dodgers, the Los Angeles Lakers, and the Los Angeles Sparks. The transaction has received all necessary approvals from The Government of the United Kingdom, The Premier League, and other authorities.


Under the terms of the agreement, Boehly and Clearlake will share joint control and equal governance of the Club. Boehly will serve as Chairman of the holding company.


Boehly and Clearlake are committed to investing in key areas that will extend and enhance Chelsea’s competitiveness, including the redevelopment of Stamford Bridge, further investment in the Academy, the Women’s Team, and Kingsmeadow stadium. The owners will also continue the important work of the Chelsea Foundation.


“We are honoured to become the new custodians of Chelsea Football Club,” said Boehly. “We’re all in – 100% -- every minute of every match. Our vision as owners is clear: we want to make the fans proud. Along with our commitment to developing the youth squad and acquiring the best talent, our plan of action is to invest in the Club for the long-term and build on Chelsea’s remarkable history of success. I personally want to thank ministers and officials in the British government, and the Premier League, for all their work in making this happen.”


Behdad Eghbali and José E. Feliciano, Clearlake co-founders and managing partners, said, “We are excited to commit the resources to continue Chelsea’s leading role in English and global football, and as an engine for football talent development. We also want to thank the authorities for all their work throughout the process. As pioneers in sports and media investing, we are thrilled to partner with Todd and the rest of the consortium to meaningfully grow the Club as a global platform. Together, we will expand the Club’s investment across infrastructure, technology, and sports science to support the incredible Chelsea football and commercial teams – all with the goal of leveraging this growth to fuel even more on-pitch success.”


The new ownership group wishes to recognise the dedication and professionalism of the Department for Digital, Culture, Media and Sport, HM Treasury, and the Premier League in conducting their reviews of this historic and complex transaction.


Deutsche Bank, Goldman Sachs, Moelis & Company LLC, and Robey Warshaw LLP served as financial advisors to the new ownership group. Latham & Watkins LLP, Paul, Weiss, Rifkind, Wharton & Garrison LLP, and Sidley Austin LLP served as legal counsel.


The Raine Group served as exclusive financial advisor to Fordstam Limited and Chelsea FC. Northridge Law LLP, Simmons & Simmons LP, and Pillsbury, Winthrop, Shaw, Pittman LP served as legal counsel.


View source version on businesswire.com: https://www.businesswire.com/news/home/20220530005307/en/


Contacts

For Eldridge


Nadia Damouni

ndamouni@prosek.com

+1 646 818 9217


Aidan O’Connor

aoconnor@prosek.com

+1 646 818 9283


For Clearlake


Max Cherry

max.cherry@fgh.com

+1 201 803 3768


Winnie Lerner

Winnie.Lerner@fgh.com

+1 917 375 5652




Monday, May 30, 2022

Global Processing Services Names Jill Docherty as Director, Global Partnerships

 LONDON-Monday 30 May 2022 [ AETOS Wire ]


(BUSINESS WIRE) -- Global Processing Services (GPS), a leading global payment technology platform, has today announced the appointment of Jill Docherty as Director, Global Partnerships. Based in London, Jill sits on GPS’ global executive committee and is responsible for identifying, leading and managing all GPS ecosystem partners, facilitating collaboration to drive innovation and growth for GPS and its customers.


Prior to GPS, Jill spent fifteen years at Mastercard and Visa where she held a number of senior roles across Business Development, Customer Success, Product and Marketing. Jill also has extensive international experience having lived and worked across three continents, Africa, Asia-Pacific, and Europe.


Her most recent position was Head of Business Development UK & Ireland at Visa where she had end-to-end responsibility for delivering the full range of the Visa portfolio to different customers – including strategic growth issuers, commercial offerings, and the FinTech sector.


Joanne Dewar, Chief Executive Officer, GPS, said: “We are delighted to welcome Jill to our senior leadership team. Jill is someone we have collaborated with for many years through our long-standing partnerships with both Visa and Mastercard, both of whom are also investors of GPS. She is incredibly well connected and possesses an extraordinary wealth of knowledge of value to fintechs of all shapes and sizes. She is ideally placed to help accelerate our growth plans as we expand into new markets around the world and build out our global partner ecosystem.”


Jill Docherty, Director, Global Partnerships, GPS, added: “During my fifteen years at Mastercard and Visa I have helped innumerable fintechs launch new card programmes and navigate the payments ecosystem. I have always been drawn to working with entrepreneurial, courageous businesses who are keen to experiment and innovate, all with the goal to continue to advance and transform society for the better. GPS is exactly that type of company. I’m thrilled to be joining the leadership team and helping to establish GPS as the number one partner to call when launching a new card programme anywhere in the world.”


In January 2022, GPS announced a significant capital injection of over US$400 million, providing GPS with a bench of experienced global growth investors including Advent International – through Advent Tech and affiliate Sunley House Capital – Viking Global Investors; Temasek the global investment company headquartered in Singapore; and MissionOG, a US-based growth equity firm. In March 2022, GPS announced Mastercard had also made a strategic investment into the company.


GPS is investing strongly in its award-winning API-first payment technology platform, upgrading its infrastructure and diversifying its capabilities, with an eye on new and fast-growing verticals where adoption continues to rise, including digital banks, crypto, BNPL, open banking and cross border payments, and is expanding its international footprint worldwide.


View source version on businesswire.com: https://www.businesswire.com/news/home/20220530005042/en/


Contacts

Media:


Louisa Bartoszek

Marcom@globalprocessing.com

The Health Bank Presents A Pilot Study on Remote Health Monitoring for Diabetes at the MESPEN Congress

 Dubai, United Arab Emirates-Monday 30 May 2022 [ AETOS Wire ]


Globally, Chronic illnesses pose a major socioeconomic burden. Research indicates that one in every three adults worldwide lives with more than one form of chronic illness, incurring considerable costs for both the individual and on healthcare systems, at large.


Through their Connected Care Program, The Health Bank Global (THB)  have modernized remote health monitoring by making patients an active part of their healthcare journey. By harnessing such methods, patients facing chronic conditions are able to monitor their own symptoms and take control over their own health, with the guidance of licensed healthcare professionals.


The pilot study recruited 32 patients with chronic conditions for a three-month period to test the hypothesis that the program’s patient-centred approach to remote monitoring of health would provide better patient outcomes and increased adherence to treatment. In the traditional medical setup, these patients would often report low compliance to treatment, as appointments are spread apart over weeks to months.


THB’s remote monitor coupled with the development of a unique Patient Engagement Rating System (PERS) yielded a strong correlation between high patient engagement scores and improved blood glucose levels over the 3 month period. This is indicative that care management of diabetes can take place within the comfort of a patient’s home in a manner that is cost effective and proves to be a good alternative to the traditional medical setup of healthcare practices happening exclusively in hospitals or clinics.


The Health Bank was awarded a feature poster abstract at the 1st edition of the Middle Eastern Society of Parenteral and Enteral Nutrition (MESPEN) Congress hosted by SEHA. The two-day conference under the theme ‘Raising the Practices of Clinical Nutrition’ which took place in Abu Dhabi from the 13th to 15th of May.


By leveraging cutting edge technology and combining quality, patient-centered care in the comfort of your home, THB continues to prove its commitment to providing streamlined home health services. The mission is simple: to provide our clients with care in their own homes and enable them to successfully manage their own health.


Contacts

Mohammed Al Barazenjey 


+971557163727


mb@saharapr.com

Shipsy to Showcase Key Innovations to Achieve UAE’s Smart City and Sustainability Goals at Seamless 2022 As Sponsors

 At Seamless 2022, Shipsy will showcase how innovative AI solutions will help businesses build smarter logistics processes and ensure sustainable supply chain operations.

Dubai, United Arab Emirates-Monday 30 May 2022 [ AETOS Wire ]


The MEA Smart Cities market is set to double by this year. The UAE is one of the frontrunners in the race as it speeds towards achieving its Smart City status by fulfilling the goals highlighted in the Dubai 2040 Plan and the Abu Dhabi Economic Vision 2030.


Shipsy, a leading global smart logistics management platform provider, continues to assist the nation in achieving its Smart City and sustainability goals through its AI-driven smart logistics management solutions. At a time when UAE is poised to become a key driver of global trade with a 6% growth in exports annually, Shipsy's technology innovations will play a pivotal role in enabling the government here to balance social, environmental and financial progression.


In February this year, the Dubai Supreme Council of Energy updated its plans to reduce carbon emissions by 30% before 2030. This was an important move to support the UAE's efforts to achieve net-zero ambitions by 2050. The region's supply chain and logistics sectors will play an instrumental role in helping governments achieve this objective.


"A major goal the UAE wants to achieve by building smart cities is to further improve the livelihood of the country's local communities. One important aspect of this objective will be democratizing the availability of products, goods, and services in the fastest and the most efficient way possible — an area that depends on robust logistics operations. Shipsy is helping businesses leverage AI, Machine Learning, IoT, Predictive Intelligence, Automation, Big Data Analytics, Blockchain, and more to build resilient supply chain networks capable of responding to demand-supply fluctuations and absorbing unprecedented disruptions," says Soham Chokshi, CEO and Co-Founder Shipsy.


With demand for faster online deliveries ballooning, cross-border eCommerce activities are intensifying, and margins getting thinner, businesses in the region are posed with logistics challenges that can be transformed into novel opportunities when addressed using the right technology.


Shipsy is also among the key associate sponsors for Seamless Middle East 2022. The company will leverage this opportunity to showcase its technology and highlight how it's helping UAE achieve its Smart City goals, improve logistics operations, and drive logistics and business sustainability.


At Seamless 2022, Shipsy will exhibit how 170+ customers across the globe are using its platform to cost-efficiently scale deliveries, provide engaging and transparent delivery experiences, optimize cross-border logistics operations, mitigate transportation risks and achieve more. 


Seamless Middle East 2022 will be a two-day event, 31st May to 1st June, held in Dubai World Trade Center. The event will witness 10,000+ attendees, 350+ exhibitors, and 300+ speakers.


Businesses in the region use Shipsy's technology to monitor and reduce carbon emissions. Their technology ensures lesser trip volumes, reduces miles traveled and return volumes, and significantly eliminates chances of delivery failures and empty miles to counter CO2 emissions. Attendees of the Seamless event will have the opportunity to delve deeper into how these are being made possible.


"Shipsy is empowering businesses across the globe to expedite their logistics sustainability goals. It's curbing distance traveled by 5% and reducing trip volumes by 6%. It ensures 14% more deliveries per driver and drastically reduces failure rates by improving address accuracy," added Chokshi.


The organization also highlighted that it would be announcing the launch of its shipment tracking platform and demonstrating its innovations in the space at Seamless 2022. This will happen before the global launch in Orlando, Florida on 6th June.


To get instant access to Shipsy's shipment tracking platform, visit https://shipsy.io/shipment-tracking/.


About Shipsy


Shipsy enables businesses worldwide to build resilient, connected, agile, sustainable and autonomous supply chain and logistics operations. Our smart logistics management platform empowers businesses to significantly reduce operating costs, lower carbon footprint, enhance customer experiences, boost delivery productivity, and drive seamless cross-border freight movement. Our 220+ team based out of India, Dubai, and Indonesia serves 160+ customers across the globe, procuring 100 million+ freight every month and optimizing the movement of more than 2 million parcels every day. To know more about us, please visit www.shipsy.io.


Contacts

Ambika Jadeja - ambika@matrixdubai.com


Noura Tabbaa - noura@matrixdubai.com

PallyCon’s Distributor Watermark now Detects 30 Seconds Video Length for Post Production & Pre-release Workflow

 Its latest release supports the traceability of forensic watermarks in video clips as short as 30-seconds duration.


(BUSINESS WIRE) -- PallyCon, the leading content protection vendor, has launched an advanced version of its distributor watermarking solution—PallyCon Distributor Watermarking v2.0—that can detect piracy information from video clips as short as 30 seconds compared to previous version of 5min video length. This distributor watermarking service helps those film studios and production houses that are worried about their premium content leaking at the post-production & Pre-release stages.


The PallyCon Distributor Watermarking service inserts recipient information in the form of invisible metadata in video frames that helps track down the source of content leak when a video asset is distributed through multiple medium. The PallyCon Distributor Watermarking detection service extracts the watermark from the file and matches it against its unique watermark database to identify the source from where it got leaked.


Govindraj Basatwar, Managing Director APAC, says, “The pain of detecting watermark from short video clips was a challenge for a long time, this has been addressed in the new enhanced 30 sec video length detection version giving a revolutionary edge to the post production houses to safeguard their valuable content such as trailers, dailies, user generated content and pre-release leaks.”


The PallyCon Distributor Watermarking service supports pre-integration with Multi-DRM for enhanced protection, mezzanine file format, like AVC, HEVC, VP9, ProRes, and XDCAM, and delivery formats like MP4, MOV, and MXF.


It has an easy interface for smooth content distribution workflow. The watermarks are robust, imperceptible which stand secure against piracy attacks like re-encoding, resizing, cropping, and filtering. This tool also allows visible watermarking.


About PallyCon


PallyCon is a premium content protection service by INKA ENTWORKS trusted by 200+ customers globally, providing 360-degree, cloud-based end-to-end content security for OTT platforms, such as Multi DRM, Forensic Watermarking, Visible Watermarking, Distributor Watermarking, Anti-Piracy services and App Security with Quick and Simple integration. It is a ONE-IN-ALL solution for OTT owners.


View source version on businesswire.com: https://www.businesswire.com/news/home/20220528005006/en/


Contacts

Parag Manikpure

parag@inka.co.kr

INKA Entworks


Sunday, May 29, 2022

Takeda and Seagen to Highlight ADCETRIS® Combination Data Showing Statistically Significant Improvement in Overall Survival (OS) for Patients with Advanced Hodgkin Lymphoma

 

– Randomized Phase 3 Clinical Trial of ADCETRIS Combination Met Key Secondary OS Endpoint, Demonstrating a 41% Reduction in Risk of Death vs. Standard of Care in Patients With Advanced Hodgkin Lymphoma –

CAMBRIDGE, Mass. & OSAKA, Japan & BOTHELL, Wash.-Monday 30 May 2022 [ AETOS Wire ]

(BUSINESS WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502) and Seagen Inc., (NASDAQ:SGEN) today announced that overall survival (OS) data from the Phase 3 ECHELON-1 clinical trial of an ADCETRIS® (brentuximab vedotin) plus chemotherapy combination will be presented in an oral session at the 59th American Society of Clinical Oncology (ASCO) Annual Meeting on Friday, June 3, 2022, 1:00-4:00 PM CT, and at the 27th European Hematology Association (EHA) Annual Meeting on Friday, June 10, 2022, 11:30 – 12:45 CEST.

“The longer-term follow-up data from the ECHELON-1 trial have significant clinical importance, as this trial represents one of only two frontline randomized studies in advanced stage Hodgkin lymphoma that shows an overall survival advantage for the experimental arm,” said Stephen Ansell, M.D., Ph.D., Mayo Clinic, and ECHELON-1 study investigator. “These results clearly show that the addition of brentuximab vedotin to chemotherapy improves the long-term outcome of patients and the combination should be considered a standard of care.”

Data from the ECHELON-1 trial demonstrated a statistically significant improvement in OS in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma treated with ADCETRIS plus doxorubicin, vinblastine and dacarbazine (A+AVD) vs. doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD). With approximately six years median follow up (73 months), patients receiving A+AVD had a 41 percent reduction in the risk of death (hazard ratio [HR] 0.59; 95% confidence interval [CI]: 0.396 to 0.879), with an estimated OS rate (95% CI) of 93.9% (91.6, 95.5) at 6 years. The safety profile of ADCETRIS was consistent with previous studies, and no new safety signals were observed. Please see Important Safety Information, including a SPECIAL/BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

“Patients with advanced-stage Hodgkin lymphoma have not benefitted from an improvement in overall survival outcomes for far too long,” said Chris Arendt, Ph.D., Head of Oncology Cell Therapy and Therapeutic Area Unit, Research and Development, at Takeda. “We are extremely proud of the results of the ECHELON-1 trial, as these findings represent a transformative improvement in care that can profoundly impact the lives of patients with advanced-stage disease. We look forward to sharing the data with regulators around the world.”

“These data unequivocally demonstrate the ability of the ADCETRIS combination regimen to improve upon a current standard of care, ABVD, for people with Hodgkin lymphoma by delivering an unsurpassed overall survival benefit,” said Roger Dansey, M.D., Interim CEO and Chief Medical Officer, Seagen. “We continue to evaluate the potential of ADCETRIS in different patient populations and in combination with other approved and investigational medicines.”

ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma in combination with AVD in the United States and for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD in Europe.

First-line brentuximab vedotin plus chemotherapy to improve overall survival in patients with stage III/IV classical Hodgkin lymphoma: An updated analysis of ECHELON-1. (Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia on Friday, June 3, 2022, 1:00 PM-4:00 PM CT at McCormick Place, Hall A8)

Key findings, which will be presented by Dr. Ansell, include:

  • The trial achieved its key secondary endpoint with the combination of A+AVD, resulting in a statistically significant improvement in OS versus the control arm of ABVD as assessed by an Independent Review Facility (IRF) (HR 0.59; p-value=0.009). This corresponds to a 41 percent reduction in the risk of death.

    • At a median follow up of 73 months, 39 and 64 OS events occurred in the A+AVD and ABVD arms, respectively.

    • Estimated six-year OS rates (95% CI) were 93.9% (91.6, 95.5) with A+AVD vs. 89.4% (86.6, 91.7) with ABVD.

    • Subgroup analyses supported a consistent benefit for A+AVD vs. ABVD.

  • The six-year PFS estimate (95% CI) was 82.3% (79.1, 85.0) with A+AVD vs. 74.5% (70.8, 77.7) with ABVD.

  • A+AVD resulted in a manageable safety profile consistent with prior reports.

    • Treatment-emergent peripheral neuropathy continued to resolve or improve in both arms, with 86% (379/443) and 87% (249/286) of patients in the A+AVD and ABVD arms, respectively, either completely resolving (72% vs. 79%) or improving (14% vs. 8%) by last follow up.

    • Fewer patients reported second malignancies in the A+AVD vs. ABVD arm (23 vs. 32).

    • No new safety signals were identified.

About the ECHELON-1 Trial

The ECHELON-1 trial, which compared the use of ADCETRIS in combination with AVD to ABVD in 1,334 patients with previously untreated Stage III or IV classical Hodgkin lymphoma, had a primary endpoint of modified progression-free survival (PFS) per independent review facility (IRF). A key secondary endpoint was OS, which was an event-driven, pre-specified, alpha-controlled analysis in the intention-to-treat population.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system affecting a type of white blood cell called lymphocytes. There are two major categories of lymphoma: Hodgkin lymphoma (HL) and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell present in lymph nodes. Reed-Sternberg cells usually have a special protein on their surface called CD30, which is a key marker of HL. CD30 is present in approximately 95 percent of all cases of Hodgkin lymphoma.

According to the American Cancer Society, approximately 8,540 cases of Hodgkin lymphoma will be diagnosed in the United States during 2022 and more than 900 will die from the disease. According to the International Agency for Research on Cancer, as of 2020, over 83,000 people worldwide were diagnosed with Hodgkin lymphoma and approximately 23,000 people died from this cancer.i

About ADCETRIS® (brentuximab vedotin)

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seagen’s proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019, and for previously untreated adult patients with sALCL, peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS) or angioimmunoblastic T-cell lymphoma (AITL), whose tumors express CD30, in combination with cyclophosphamide, doxorubicin, prednisone in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine (AVD), (2) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (3) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (4) for the treatment of adult patients with relapsed or refractory sALCL, and (5) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in more than 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See Important Safety Information below.

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies.

Seagen and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seagen has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seagen and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

ADCETRIS (brentuximab vedotin) Important Safety Information (European Union)

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

CONTRAINDICATIONS

ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. In addition, combined use of ADCETRIS with bleomycin causes pulmonary toxicity.

SPECIAL WARNINGS & PRECAUTIONS

Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients treated with ADCETRIS. PML has been reported in patients who received ADCETRIS after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.

Closely monitor patients for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. A negative JCV PCR does not exclude PML. Additional follow up and evaluation may be warranted if no alternative diagnosis can be established. Hold dosing for any suspected case of PML and permanently discontinue ADCETRIS if a diagnosis of PML is confirmed.

Be alert to PML symptoms that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).

Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Closely monitor patients for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. Hold ADCETRIS for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.

Pulmonary Toxicity: Cases of pulmonary toxicity, some with fatal outcomes, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. Promptly evaluate and treat new or worsening pulmonary symptoms (e.g., cough, dyspnoea) appropriately. Consider holding dosing during evaluation and until symptomatic improvement.

Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, cytomegalovirus (CMV) (reactivation) and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Patients should be carefully monitored during treatment for the emergence of possible serious and opportunistic infections.

Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have been reported with ADCETRIS. Carefully monitor patients during and after an infusion. If anaphylaxis occurs, immediately and permanently discontinue administration of ADCETRIS and administer appropriate medical therapy. If an IRR occurs, interrupt the infusion and institute appropriate medical management. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. IRRs are more frequent and more severe in patients with antibodies to ADCETRIS.

Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS. Monitor these patients closely and manage according to best medical practice.

Peripheral neuropathy (PN): ADCETRIS treatment may cause PN, both sensory and motor. ADCETRIS-induced PN is typically an effect of cumulative exposure to ADCETRIS and is reversible in most cases. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay and a dose reduction or discontinuation of ADCETRIS.

Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Monitor complete blood counts prior to administration of each dose.

Febrile neutropenia: Febrile neutropenia has been reported with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose of treatment. Closely monitor patients for fever and manage according to best medical practice if febrile neutropenia develops.

When ADCETRIS is administered in combination with AVD or CHP, primary prophylaxis with G-CSF is recommended for all patients beginning with the first dose.

Severe cutaneous adverse reactions (SCARs): Cases of SCARs, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with ADCETRIS. Fatal outcomes have been reported for SJS and TEN. If SJS, TEN or DRESS occur, ADCETRIS should be discontinued and appropriate medical therapy should be administered.

Gastrointestinal (GI) Complications: GI complications, some with fatal outcomes, including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, have been reported with ADCETRIS. Promptly evaluate and treat patients if new or worsening GI symptoms occur.

Hepatotoxicity: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported with ADCETRIS. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk. Test liver function prior to treatment initiation and routinely monitor during treatment. Patients experiencing hepatotoxicity may require a delay, dose modification, or discontinuation of ADCETRIS.

Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. Closely monitor serum glucose for patients who experience an event of hyperglycemia. Administer anti-diabetic treatment as appropriate.

Infusion site extravasation: Extravasation during intravenous infusion has occurred. Given the possibility of extravasation, it is recommended to closely monitor the infusion site for possible infiltration during drug administration.

Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations.

CD30+ CTCL: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence. In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sézary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology. These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes. Carefully consider the benefit-risk per patient and use with caution in other CD30+ CTCL patient types.

Sodium content in excipients: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

Traceability: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

INTERACTIONS

Patients who are receiving a strong CYP3A4 and P-gp inhibitor, concomitantly with ADCETRIS may have an increased risk of neutropenia. If neutropenia develops, refer to dosing recommendations for neutropenia (see SmPC section 4.2). Co-administration of ADCETRIS with a CYP3A4 inducer did not alter the plasma exposure of ADCETRIS, but it appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. ADCETRIS is not expected to alter the exposure to drugs that are metabolized by CYP3A4 enzymes.

PREGNANCY: Advise women of childbearing potential to use two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. There are no data from the use of ADCETRIS in pregnant women, although studies in animals have shown reproductive toxicity. Do not use ADCETRIS during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus.

LACTATION (breast-feeding): There are no data as to whether ADCETRIS or its metabolites are excreted in human milk, therefore a risk to the newborn/infant cannot be excluded. With the potential risk, a decision should be made whether to discontinue breast-feeding or discontinue/abstain from therapy with ADCETRIS.

FERTILITY: In nonclinical studies, ADCETRIS treatment has resulted in testicular toxicity, and may alter male fertility. Advise men being treated with ADCETRIS not to father a child during treatment and for up to 6 months following the last dose.

Effects on ability to drive and use machines: ADCETRIS may have a moderate influence on the ability to drive and use machines.

UNDESIRABLE EFFECTS

Monotherapy: The most frequent adverse reactions (≥10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain. Serious adverse drug reactions occurred in 12% of patients. The frequency of unique serious adverse drug reactions was ≤1%. Adverse events led to treatment discontinuation in 24% of patients.

Combination Therapy: In the studies of ADCETRIS as combination therapy in 662 patients with previously untreated advanced HL and 223 patients with previously untreated CD30+ PTCL, the most common adverse reactions (≥ 10%) were: infections, neutropenia, peripheral sensory neuropathy, nausea, constipation, vomiting, diarrhoea, fatigue, pyrexia, alopecia, anaemia, weight decreased, stomatitis, febrile neutropenia, abdominal pain, decreased appetite, insomnia, bone pain, rash, cough, dyspnoea, arthralgia, myalgia, back pain, peripheral motor neuropathy, upper respiratory tract infection, and dizziness. Serious adverse reactions occurred in 34% of patients. Serious adverse reactions occurring in ≥ 3% of patients included febrile neutropenia (15%), pyrexia (5%), and neutropenia (3%). Adverse events led to treatment discontinuation in 10% of patients.

ADCETRIS (brentuximab vedotin) for injection U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

  • Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Institute dose modifications accordingly.

  • Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.

  • Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS.

Administer G-CSF primary prophylaxis beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

  • Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for bacterial, fungal, or viral infections.

  • Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor and high tumor burden.

  • Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment compared to patients with normal renal function. Avoid use in patients with severe renal impairment.

  • Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment compared to patients with normal hepatic function. Avoid use in patients with moderate or severe hepatic impairment.

  • Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.

  • PML: Fatal cases of JC virus infection resulting in PML have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS, with some cases occurring within 3 months of initial exposure. In addition to ADCETRIS therapy, other possible contributory factors include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.

  • Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement.

  • Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.

  • Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with preexisting GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, including severe abdominal pain, perform a prompt diagnostic evaluation and treat appropriately.

  • Hyperglycemia: Serious cases, such as new-onset hyperglycemia, exacerbation of pre-existing diabetes mellitus, and ketoacidosis (including fatal outcomes) have been reported with ADCETRIS. Hyperglycemia occurred more frequently in patients with high body mass index or diabetes. Monitor serum glucose and if hyperglycemia develops, administer anti-hyperglycemic medications as clinically indicated.

  • Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus, and to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Most Common (≥20% in any study) Adverse Reactions

Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use. Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

Please see the full Prescribing Information, including BOXED WARNING, for ADCETRIS here.

About Seagen

Seagen is a global biotechnology company that discovers, develops and commercializes transformative cancer medicines to make a meaningful difference in people’s lives. Seagen is headquartered in the Seattle, Washington area, and has locations in California, Canada, Switzerland and the European Union. For more information on our marketed products and robust pipeline, visit www.seagen.com and follow @SeagenGlobal on Twitter.

Forward-Looking Statements

Certain statements made in this press release are forward looking, such as those, among others, relating to the therapeutic potential of ADCETRIS, its safety, efficacy and therapeutic uses, plans to present and publish the specified data, and anticipated and ongoing development activities for ADCETRIS, including clinical trial activities. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include without limitation the level of utilization and adoption of the referenced treatment regimen by prescribing physicians, competitive conditions including the availability of alternative treatment regimens, the availability and extent of reimbursement, the risk of adverse events or safety signals, the possibility of adverse regulatory actions, and the potential for delays or setbacks in product development and the regulatory review process. More information about the risks and uncertainties faced by Seagen is contained under the caption “Risk Factors” included in Seagen’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, and Seagen’s subsequent reports, filed with the Securities and Exchange Commission. Seagen disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise except as required by applicable law.

About Takeda Oncology

At Takeda Oncology, we aspire to cure cancer, with inspiration from patients and innovation from everywhere. We ensure a tight connection from research to development to commercialization and rapidly meet the needs of the cancer community, optimizing our ability to bring transformative medicines to patients. Our demonstrated leadership in the treatment of hematologic cancers and solid tumors combined with cutting-edge science through multiple platforms, partnerships and therapeutic approaches enable us to bring novel medicines to patients worldwide.

For more information, visit www.takedaoncology.com.

About Takeda

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit https://www.takeda.com.

Important Notice

For the purposes of this notice, “press release” means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. No offering of securities shall be made in the United States except pursuant to registration under the U.S. Securities Act of 1933, as amended, or an exemption therefrom. This press release is being given (together with any further information which may be provided to the recipient) on the condition that it is for use by the recipient for information purposes only (and not for the evaluation of any investment, acquisition, disposal or any other transaction). Any failure to comply with these restrictions may constitute a violation of applicable securities laws.

The companies in which Takeda directly and indirectly owns investments are separate entities. In this press release, “Takeda” is sometimes used for convenience where references are made to Takeda and its subsidiaries in general. Likewise, the words “we”, “us” and “our” are also used to refer to subsidiaries in general or to those who work for them. These expressions are also used where no useful purpose is served by identifying the particular company or companies.

Forward-Looking Statements

This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda’s future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as “targets”, “plans”, “believes”, “hopes”, “continues”, “expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”, “would”, “could” “anticipates”, “estimates”, “projects” or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda’s global business, including general economic conditions in Japan and the United States; competitive pressures and developments; changes to applicable laws and regulations, including global health care reforms; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic, on Takeda and its customers and suppliers, including foreign governments in countries in which Takeda operates, or on other facets of its business; the timing and impact of post-merger integration efforts with acquired companies; the ability to divest assets that are not core to Takeda’s operations and the timing of any such divestment(s); and other factors identified in Takeda’s most recent Annual Report on Form 20-F and Takeda’s other reports filed with the U.S. Securities and Exchange Commission, available on Takeda’s website at: https://www.takeda.com/investors/sec-filings/ or at www.sec.gov. Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda’s future results.

Medical information

This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development.

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View source version on businesswire.com: https://www.businesswire.com/news/home/20220525005958/en/

Contacts

Takeda:
Japanese Media
Ryoko Matsumoto
ryoko.matsumoto@takeda.com
+81 (0) 3-3278-3414

Media outside Japan
Emy Gruppo
emy.gruppo@takeda.com
(215) 859-2605

Seagen:
Investors
Peggy Pinkston
ppinkston@seagen.com
(425) 527-4160

Media
David Caouette
dcaouette@seagen.com
(310) 430-3476

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