Servier acquires non-Hodgkin B-cell lymphoma treatment PIXUVRI® (pixantrone) from CTI BioPharma, strengthening the Servier oncology portfolio

PARIS-Tuesday 1 October 2019 [ AETOS Wire ]

(BUSINESS WIRE) -- Servier, an independent international pharmaceutical company, today announced the acquisition of PIXUVRI® from CTI BioPharma. PIXUVRI is a treatment for adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma. Servier and CTI Biopharma completed an Asset Purchase Agreement which transferred worldwide rights of PIXUVRI to Servier. Servier commercialized PIXUVRI globally, in all countries where the drug was approved under an exclusive license from CTI BioPharma.

“The acquisition of PIXUVRI is an important step towards Servier’s long-term strategy to become a key player in oncology. Within oncology, one of our key focuses is hematology, and we now have two medicines that are marketed globally alongside a strong and innovative pipeline of drug candidates which includes CAR-T therapies,” said Claude Bertrand, Executive VP, Global Head of R&D at Servier. “As part of our strategy, we are committed to invest 50% of our R&D budget in oncology.”

Non-Hodgkin lymphoma (NHL) is a blood cancer that affects the lymphatic system, it can occur in different parts of the body from the lymph nodes in the neck to the liver or spleen, but also in other organs such as the stomach, small bowel, bones, brain, testicles or skin.1 Globally there are over 500,000 new cases of NHL a year; it is both the 11th most commonly diagnosed cancer and cause of cancer death.2

“We have a strong commitment to providing effective solutions for patients living with cancer. PIXUVRI is an effective treatment that received standard European marketing authorization in June, and today marks a new step towards achieving Servier’s long term goals. We will ensure that patients will continue to have access to PIXUVRI”, said Eric Falcand, VP, Global Head of Business Development & Licensing at Servier. “We are continuing to strengthen our oncology portfolio through our R&D efforts and strategic alliances.”



About PIXUVRI (pixantrone)

PIXUVRI is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells cannot divide and eventually die.3 PIXUVRI is indicated in the European Union as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma.3 PIXUVRI is also approved in Iceland, Israel, Liechtenstein, Myanmar, Norway, Pakistan, Russia and Ukraine.

PIXUVRI is mentioned in the ESMO guidelines as an anthracycline-like drug with reduced cardiotoxicity, which demonstrated some efficacy in heavily treated patients.4

More detail is available in the summary of the European public assessment report (EPAR) on the EMA website at www.ema.europa.eu.

About Servier

Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 149 countries and a turnover of 4.2 billion euros in 2018, Servier employs 22,000 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generics) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neurodegenerative diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development.

Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are twelve molecular entities in clinical development in this area, targeting gastro-intestinal and lung cancers and other solid tumors, as well as different types of leukemia and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics and immune targeted therapies, to deliver life-changing medicines to patients.

More information: www.servier.com

Follow us on Social Media: LinkedIn I Facebook I Twitter

1 Cancer Research UK. What is NHL cancer. Available at http://www.cancerresearchuk.org/about-cancer/type/non-hodgkins-lymphoma/about/what-is-lymphoma. Last accessed September 2019.
2 World Health Organisation. Globocan 2018. Non-Hodgkin lymphoma. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/34-Non-hodgkin-lymphoma-fact-sheet.pdf. Last accessed September 2019.
3 European Medicines Agency. Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/pixuvri-epar-product-information_en.pdf. Last accessed September 2019.
4 Tilly H et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology (2015). Volume 26 (suppl 5); v116-v125. Available at: http://www.esmo.org/Guidelines/Haematological-Malignancies/Diffuse-Large-B-Cell-Lymphoma. Last accessed September 2019.

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Contacts

Servier Media Relations
Sonia Marques
sonia.marques@servier.com
Tel. +33 (0)1 55 72 40 21 / + 33 (0) 7 84 28 76 13

Jean-Clément Vergeau
jean-clement.vergeau@servier.com
Tel. +33 (0)1 55 72 46 16 / + 33 (0) 6 79 56 75 96


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New data reinforces benefits of Spiolto® Respimat® in improving patient outcomes

• Data supports the efficacy and safety profile of Spiolto® Respimat®1

• Results from one study emphasise patient satisfaction and ease-of-use with Respimat® inhaler 2

• Two formative usability studies underscore the patient-centric design and enhanced usability of Respimat® re-usable inhaler3


INGELHEIM, Germany-Tuesday 1 October 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- Boehringer Ingelheim announced Spiolto® (tiotropium/olodaterol) Respimat® data being presented at the European Respiratory Society (ERS) 2019 Congress. The results show the benefits of tiotropium/olodaterol in improving symptoms and lung function as well as patients’ satisfaction when inhaling from and handling the tiotropium/olodaterol soft-mist inhaler.1,2,3,4 The results of these studies reinforce the importance of patient needs and preferences as well as patients’ ability to properly inhale when prescribing inhaler therapy for COPD management.

“The importance of matching a specific inhaled therapy with patients’ personal needs and preferences cannot be overstated in COPD management,” said Prof Paola Rogliani, Head of Clinical Respiratory Unit, Policlinico Tor Vergata, Rome, Italy. “A novel bidimensional, pooled analysis enabled us to directly compare six LAMA/LABA fixed-dose combinations and demonstrate that tiotropium/olodaterol improved patient outcomes more than the other treatments in the class. Varying efficacy and safety of combinations in the same class should be considered for a patient-centred approach in COPD.”

Data presented at ERS reinforces the benefits of tiotropium/olodaterol LAMA/LABA* therapy in improving patient outcomes, specifically:1,4

- A pooled analysis exploring the effect of step-up COPD treatment from tiotropium at baseline to tiotropium/olodaterol,4 showed that optimising bronchodilation with tiotropium/olodaterol led to clinically relevant improvements in lung function, health status and breathlessness.4
- A bidimensional comparative analysis looked at the efficacy and safety profile of six LAMA/LABA fixed-dose combinations and found tiotropium/olodaterol surpassed all others in-class in terms of efficacy, while also having fewer cardiovascular serious adverse events.1

Further data presented reinforce satisfaction, inhaleability and ease of use associated with the tiotropium/olodaterol inhaler:2,3

- An open-label, observational study evaluating patients’ general condition as well as treatment and device satisfaction in COPD patients treated with tiotropium/olodaterol, found improved general condition as well as high satisfaction with handling and inhaling from the tiotropium/olodaterol device as reported by patients.2
- To guide the development of an enhanced tiotropium/olodaterol inhaler, two formative studies evaluating COPD patients’ general handling of the tiotropium/olodaterol and the tiotropium/olodaterol re-usable inhalers confirmed that a patient-centric design led to an enhanced tiotropium/olodaterol re-usable inhaler with improved usability and easier-to-read dose indicator.3

These findings are significant because in addition to the importance of individualising treatment, the internationally-recognised GOLD‡ guidance document emphasises considering patient preferences and ability to use their inhaler when prescribing a specific COPD therapy.5 Studies suggest that up to 52% of COPD patients struggle to inhale from their device (including those with mild disease),6,7 and the ability to properly inhale medication plays a key role in COPD management.8,9

“As a company, we have been developing therapies and inhaler devices for people with respiratory conditions for almost a century,” said Dr Alberto de la Hoz, Global Head of Medical Affairs, Respiratory Franchise at Boehringer Ingelheim. “The data presented at ERS underscore the efficacy of tiotropium/olodaterol as a treatment for COPD patients with different clinical characteristics and needs, and how the Respimat® re-usable was enhanced based on HCP and patient feedback, addressing their evolving needs and preferences.”

Boehringer Ingelheim will present data from 11 abstracts relating to the COPD portfolio, host two scientific symposia and post daily podcasts featuring leading respiratory experts throughout the ERS Congress. To find out more, visit the Boehringer Ingelheim ERS webpage: https://congresscoverage.com/BI/congress/ers2019

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

For references and notes to editors, please visit: http://www.boehringer-ingelheim.com/press-release/spiolto-respimat-improves-patient-outcomes-copd

* Long-acting muscarinic antagonists/long-acting beta2 agonists
‡ Global Initiative for Chronic Obstructive Lung Disease (GOLD) Strategy for the Diagnosis, Management, and Prevention of COPD

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Contacts

Boehringer Ingelheim
Corporate Communications
Media + PR
Julia Gußmann
Boehringer Ingelheim
Email: julia.gussmann@boehringer-ingelheim.com
Phone: +49 (6132) 77-171244
Fax: +49 (6132) 72-171244
Email: press@boehringer-ingelheim.com

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U.S. Army Awards $35.1 Million Contract to FLIR Systems for New Chemical Agent Disclosure Spray

Innovative Spray Technology Changes Color when Chemical Warfare Agents like Sulfur Mustard, VX, or Sarin are Detected on Equipment, Surfaces, or Clothing; Enables Faster, More Effective Decontamination


ARLINGTON, Va.-Tuesday 1 October 2019 [ AETOS Wire ]

(BUSINESS WIRE) -- FLIR Systems, Inc. (NASDAQ: FLIR) announced it has won an indefinite-delivery/indefinite-quantity (IDIQ) contract worth up to $35.1 million with the United States Army to deliver a new version of the company’s Agentase™ C2 chemical agent disclosure spray to detect sulfur mustard, a highly toxic chemical warfare agent.

FLIR Agentase C2 spray quickly changes color on a surface if a chemical warfare agent is present. With faster and more targeted detection, military decontamination experts can locate trace levels of contamination on surfaces and precisely mitigate the threat.

“Blister agents like sulfur mustard and nerve agents such as VX and sarin are an ongoing concern to the military,” said David Ray, President of FLIR’s Government and Defense Business Unit. “Our Agentase C2 spray technology offers unprecedented performance, enabling rapid detection of highly toxic substances while reducing the lifecycle cost of decontamination operations. This new award underscores our strategy to provide mission-critical solutions that help protect personnel on the frontline and save lives.”

The contract will support the Army’s Contamination Indicator/Decontamination Assurance System (CIDAS) program, a “program of record” within the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). Work will be performed at FLIR’s Pittsburgh location.

The IDIQ award consists of a 30-month engineering and manufacturing development phase, followed by an 18-month low-rate initial production phase, and a 72-month full-rate production phase. Shipments are expected to begin in the first quarter of fiscal year 2020.

This is the second award issued to FLIR by JPEO-CBRND to support fielding of the Agentase C2 product line to the Joint Services under CIDAS. FLIR already is engaged on a $30 million contract to deliver its disclosure spray formulated for nerve agents such as VX and sarin. That effort is scheduled to enter full-rate production in first quarter of fiscal year 2020.

For more on FLIR’s chemical agent disclosure spray, visit www.flir.com/AgentaseC2.

About FLIR Systems, Inc.

Founded in 1978, FLIR Systems is a world-leading industrial technology company focused on intelligent sensing solutions for defense, industrial, and commercial applications. FLIR Systems’ vision is to be “The World’s Sixth Sense,” creating technologies to help professionals make more informed decisions that save lives and livelihoods. For more information, please visit www.flir.com and follow @flir.

Forward Looking Statements

The statements in this release by David Ray and the other statements in this release about the contract and order described above are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are based on current expectations, estimates, and projections about FLIR's business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements due to numerous factors, including the following: the ability to manufacture and deliver the systems referenced in this release, changes in pricing of FLIR's products, changing demand for FLIR's products, product mix, the impact of competitive products and pricing, constraints on supplies of critical components, excess or shortage of production capacity, the ability of FLIR to manufacture and ship products in a timely manner, FLIR's continuing compliance with U.S. export control laws and regulations, and other risks discussed from time to time in FLIR's Securities and Exchange Commission filings and reports. In addition, such statements could be affected by general industry and market conditions and growth rates, and general domestic and international economic conditions. Such forward-looking statements speak only as of the date on which they are made and FLIR does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of this release, or for changes made to this document by wire services or Internet service providers.

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Contacts

Media Contact:
Joe Ailinger
Phone: 978-769-9339
Email: joe.ailinger@flir.com

Investor Relations:
Lasse Glassen
Addo Investor Relations
Phone: 424-238-6249
Email: lglassen@addoir.com

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WeWork to Withdraw S-1 Registration Statement

NEW YORK-Tuesday 1 October 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- WeWork will file a request to withdraw the Registration Statement on Form S-1 that was initially filed with the Securities and Exchange Commission on August 14.

Co-CEOs Artie Minson and Sebastian Gunningham said, “We have decided to postpone our IPO to focus on our core business, the fundamentals of which remain strong. We are as committed as ever to serving our members, enterprise customers, landlord partners, employees and shareholders. We have every intention to operate WeWork as a public company and look forward to revisiting the public equity markets in the future.”

View source version on businesswire.com: https://www.businesswire.com/news/home/20190930005559/en/

Contacts

Jimmy Asci / Gwen Rocco
press@wework.com


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Bacardi Announces European Launch of Shake Your Future, a Life-changing Experience Giving the Unemployed a New Start in Mixology

 Young Adults Across the Region Offered Opportunity to Begin Career as Professional Mixologists

AMSTERDAM-Tuesday 1 October 2019 [ AETOS Wire ]

(BUSINESS WIRE)-- Bacardi, the largest privately held spirits company in the world, today announced the European launch of its initiative to help tackle youth unemployment. Shake Your Future is the company’s bartending and mixology training program that aims to secure the futures of young people within the hospitality industry.

After a successful pilot in 2018, the initiative will run in Italy, France and Spain over the coming months, rolling out to 12 major cities globally over the next three years, bringing this opportunity to thousands of young adults around the world.

Developed in partnership with the European Bartender School, Bacardi launched Shake Your Future as a pilot in 2018 to help address the youth unemployment crisis on the doorstep of its French office based in the Parisian suburb of Saint-Ouen. With youth unemployment at an all-time high (15% across the European Union) and an industry-wide shortage of skilled bartenders, the program aims to address both challenges.

Participants in the 10-week program will be trained in the art of bartending and mixology, as well as gaining invaluable work experience in some of the industry’s leading bars and restaurants. Graduates will receive an internationally recognised diploma and access to permanent employment opportunities within the sector, empowering them to transform their lives and build a brighter future.

The program will run annually in each of the cities where it is launched, with an ever-growing number of bar and restaurant partners pledging their support to Shake Your Future and to giving the trainees the all-important experience they need for a fresh start.

“This is only the beginning,” said Francis Debeuckelaere, Europe Regional President for Bacardi. “Shake Your Future will change the lives of potentially thousands of young adults around the world. Across Europe, our teams have witnessed first-hand the scale of unemployment among young adults and we are committed to making a difference. Through no fault of their own some people just don’t get the break they deserve. We want to give them that break. The skills participants will learn through the Shake Your Future program go far beyond just shaking and stirring cocktails; they will take away key transferable skills that will equip them for success, even if their future career paths lie outside the hospitality industry. With youth unemployment at an all-time high, we built Shake Your Future to empower and inspire all those who take part so that they can fulfil their true potential.”

About Bacardi Limited
Bacardi Limited, the largest privately held spirits company in the world, produces and markets internationally recognized spirits and wines. The Bacardi Limited brand portfolio comprises more than 200 brands and labels, including BACARDÍ® rum, GREY GOOSE® vodka, PATRÓN® tequila, DEWAR’S® Blended Scotch whisky, BOMBAY SAPPHIRE® gin, MARTINI® vermouth and sparkling wines, CAZADORES® 100% blue agave tequila, and other leading and emerging brands including WILLIAM LAWSON’S® Scotch whisky, ST-GERMAIN® elderflower liqueur, and ERISTOFF® vodka. Founded more than 157 years ago in Santiago de Cuba, family-owned Bacardi Limited currently employs more than 7,000, operates more than 20 production facilities in 11 countries, and sells its brands in more than 170 countries.

Bacardi Limited refers to the Bacardi group of companies, including Bacardi International Limited. Visit www.bacardilimited.com or follow us on Twitter @BacardiLimited or Instagram @BacardiLimited1862.

Enjoy Our Brands Responsibly

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190930005468/en/

Contacts

Andrew Carney | acarney@bacardi.com | M. +31 613 23 75 94

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INBUILD® meets primary endpoint - study evaluated nintedanib in patients across a range of progressive fibrosing interstitial lung diseases1

INGELHEIM, Germany -Monday 30 September 2019 [ AETOS Wire ]

    New data showed positive effect of nintedanib on slowing decline of lung function in a broad range of fibrosing interstitial lung diseases with a progressive phenotype1
    Phase III results published in the New England Journal of Medicine and to be presented at the European Respiratory Society (ERS) International Congress in Madrid, Spain
    Regulatory applications were recently submitted for this new indication with the FDA and EMA

(BUSINESS WIRE)-- Boehringer Ingelheim announced today that in the Phase III INBUILD® trial nintedanib slowed lung function decline by 57% across the overall study population, as assessed by the annual rate of decline in forced vital capacity (FVC)a over 52 weeks in patients with fibrosing interstitial lung disease (ILDs) with signs of progression.1 Just published in the New England Journal of Medicine and to be presented at the ERS Congress in Madrid, Spain, the study has met its primary endpoint and demonstrated the efficacy and safety of nintedanib in patients with a broad range of progressive fibrosing interstitial lung diseases other than idiopathic pulmonary fibrosis (IPF).1 Chronic hypersensitivity pneumonitis, autoimmune ILDs such as rheumatoid arthritis-associated ILD, systemic sclerosis-associated ILD (SSc-ILD), mixed connective tissues disease-associated ILD, sarcoidosis and idiopathic forms of interstitial pneumonias, i.e. non-specific interstitial pneumonia, and unclassified idiopathic interstitial pneumonia, are among these diseases. Nintedanib was shown to slow the rate of ILD progression independent of the fibrotic pattern seen on chest imaging.1 The side effect profile was consistent with previous studies of nintedanib in ILDs, with diarrhoea being the most common adverse event.1

About the study

INBUILD® is the first clinical trial in the field of ILDs to group patients based on the clinical behaviour of their disease, rather than the primary clinical diagnosis.1 ILDs encompass a large group of more than 200 disorders that may involve the threat of pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function.2 Patients with ILD can develop a progressive phenotype that causes pulmonary fibrosis, leading to lung function decline, deterioration in quality of life and early mortality similar to IPF, the most frequent form of idiopathic interstitial pneumonias.3 The course of the disease and the symptoms are similar in progressive fibrosis ILDs regardless of the underlying disease.4

In the INBUILD® trial, nintedanib slowed lung function decline by 57% across the overall study population, with an adjusted annual rate of decline over 52 weeks in FVC of -80.8 mL/year compared to -187.8 mL/year for placebo (difference, 107.0 mL/year [95% CI, 65.4 to 148.5]; p<0.001).1 Ofev demonstrated a consistent effort on lung function decline in patients with an usual interstitial pneumonia (UIP) like fibrotic pattern and those with other fibrotic patterns on HRCT.1 The most common adverse event was diarrhoea, reported in 66.9% and 23.9% of patients treated with nintedanib and placebo, respectively.1 The safety profile observed in INBUILD® was consistent to what has been seen in IPF and SSc-ILD patients treated with nintedanib previously.1

Implications for the ILD community

“Progressive fibrosis of the lung can have a devastating impact on patients with a range of conditions. Yet, except for IPF and the new approved therapy for use in SSc-ILD in the U.S., there are currently no medications approved for the treatment of progressive fibrosing ILDs,” explained Professor Kevin Flaherty, M.D., Professor of Medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan in Ann Arbor, Michigan, U.S., and lead investigator of the INBUILD® trial. “The results of INBUILD showed for the first time that nintedanib slowed the decline of lung function in patients with a range of fibrosing lung diseases, who demonstrate a progressive phenotype, across a spectrum of ILD diagnoses.”

“We are very proud to be presenting the results of this first ever clinical trial studying patients with different forms of progressive fibrosing ILDs, which are the basis of the regulatory applications that were recently submitted with the FDA and EMA,” commented Dr. Mehdi Shahidi, M.D., Chief Medical Officer, Boehringer Ingelheim. “We are absolutely committed to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need.”

a FVC is Forced Vital Capacity, an established measure of lung function

~ENDS~

Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/press-release/pfildinbuildtrialmeetsprimaryendpoint



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Contacts

Boehringer Ingelheim
Corporate Communications
Media + PR
Alexander Kurz
55216 Ingelheim/Germany
Tel.: +49 (6132) 77-184531
Mobile: +49 (151) 68948378
Email: press@boehringer-ingelheim.com

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Update of Summary of Product Characteristics for Nuwiq® includes data on effective bleed protection with twice-weekly dosing with personalised prophylaxis

LACHEN, Switzerland-Monday 30 September 2019 [ AETOS Wire ]

(BUSINESS WIRE) -- Octapharma announced today that the European Medicines Agency has authorised an updated Summary of Product Characteristics (SmPC) for Nuwiq® that includes information on personalised prophylaxis in patients with haemophilia A. The updated SmPC can be accessed at https://www.ema.europa.eu/en/medicines/human/EPAR/nuwiq

The new information in the updated SmPC is based on data from the NuPreviq study in which 66 previously treated adult patients were switched from a 1 to 3-month standard prophylaxis regimen to a 6-month personalised regimen based on their individual pharmacokinetic (PK) characteristics. Of the 66 patients reported in the study, 44 patients switched to a different prophylaxis regimen after PK assessment. Of these, 40 completed the 6 months of prophylaxis according to the assigned dosing and treatment scheme, and 34 patients (85%) were treated twice weekly or even less frequently. The mean annualised bleeding rate among the 40 patients was 1.2 ± 3.9, 90% of patients experienced no spontaneous bleeds, and 83% had no bleeds of any type. The mean ± SD dose was 52.2 ± 12.2 IU/kg per injection (99.7 ± 25.6 IU/kg per week), and there were no treatment-related adverse events.

Larisa Belyanskaya, Head of Octapharma’s IBU Haematology commented “we at Octapharma are delighted with the NuPreviq results and the update to the Nuwiq® Summary of Product Characteristics. The data show that personalised prophylaxis with Nuwiq® may enable twice weekly or less frequent dosing while maintaining effective bleed protection”.

Olaf Walter, Board Member at Octapharma, added “Understanding the benefits of using pharmacokinetic data to guide treatment will help further personalise the care of people with haemophilia A and we are proud to be driving efforts to achieve this important goal”.

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma AG is one of the largest manufacturers of human protein products in the world. For over 30 years, Octapharma has been committed to patient care and medical innovation. Its core business is the development, production and sale of human proteins from human plasma and human cell lines. Patients in over 100 countries are treated with Octapharma products in the following therapeutic areas:

    Haematology (coagulation disorders)
    Immunotherapy (immune disorders)
    Critical Care

Octapharma owns state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico.

About Haemophilia A

Haemophilia A is an X-linked hereditary bleeding disorder caused by a deficiency of factor VIII (FVIII) which, if left untreated, leads to haemorrhages in muscles and joints and consequently to arthropathy and severe morbidity. The disorder affects around one in every 10,000 males worldwide. Prophylaxis with replacement FVIII therapy reduces the number of bleeding episodes and the risk of permanent joint damage.

About Nuwiq®

Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein.1 Nuwiq® is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for the von Willebrand coagulation factor.1 Nuwiq® treatment has been assessed in seven completed clinical trials which included 201 previously treated patients (PTPs; 190 individuals) with severe haemophilia A, including 59 children.1 Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) across all age groups.2 Nuwiq® is available in 250 IU, 500 IU, 1000 IU, 2000 IU , 2500 IU, 3000 IU and 4000 IU presentations with all vial strengths in a 2.5 mL infusion volume and supplied with a pre-filled syringe.2

    Lissitchkov T et al. Ther Adv Hematol 2019; doi: 10.1177/2040620719858471.
    Nuwiq® Summary of Product Characteristics.



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Contacts

Octapharma AG
International Business Unit - Haematology
Olaf Walter
Olaf.Walter@octapharma.com

Larisa Belyanskaya
Larisa.Belyanskaya@octapharma.com
Tel: +41 55 4512121

Ivana Spotakova
Communications Manager
ivana.spotakova@octapharma.com
Tel.: +41793474607

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