Ferring’s follicle-stimulating hormone is in development with a companion diagnostic test from Roche to help improve the clinical management of infertility treatment
SAINT-PREX & ROTKREUZ, Switzerland. - Tuesday, June 24th 2014 [ME NewsWire]
(BUSINESS WIRE) Ferring Pharmaceuticals and Roche have announced a collaboration to combine diagnostic testing technology from Roche with Ferring’s human cell line derived recombinant follicle-stimulating hormone (human rFSH), a gonadotrophin currently in phase III development. This combination is intended to make it possible for healthcare professionals to personalise infertility treatment to a woman’s specific needs.
Under the terms of the worldwide agreement, Roche will work with Ferring and its global phase III programme to qualify, validate, document and seek regulatory approval for a companion diagnostic test to be used in combination with Ferring’s human rFSH.
Currently under development with Ferring’s human rFSH, the fully-automated Elecsys® AMH assay from Roche aims to assess anti-Müllerian hormone (AMH) levels, a measure of a woman’s ovarian reserve and also of her ovarian response to infertility treatment with gonadotrophin. With this information, doctors will be better able to deliver a personalised dose of Ferring’s human rFSH based on the woman’s AMH level. Unlike manual AMH testing that can take up to several hours to produce results, the fully automated Elecsys AMH test determines hormone levels in 18 minutes, making it appropriate for routine clinical use.1
“The ability to tailor a specific dose of gonadotrophin based on a woman’s personal AMH level would represent a major step forward in fertility management,” said Pascal Danglas, MD, Executive Vice President, Clinical and Product Development at Ferring. “This collaboration demonstrates Ferring’s commitment to researching and developing innovative treatment options for infertility.”
Personalised dosing according to a woman’s AMH level, if successful, may improve the predictability of infertility treatment and, as a result, lower the potential burden of treatment for women seeking to conceive through assisted reproductive technology.
“As a leader in personalised healthcare we are expanding this approach to ever more areas of unmet medical need such as infertility and women’s health. In collaboration with Ferring, we are excited to play a pioneering role in individualising fertility management while continuing to invest in medically differentiated tests,” said Jean-Claude Gottraux, Head of Roche Professional Diagnostics.
This unique approach in personalised medicine may provide an improved option for couples seeking to conceive through in vitro fertilization.
About the phase III clinical study
A multinational clinical phase III comparative study is already underway to confirm the efficacy and safety of Ferring’s human cell line derived rFSH in a personalised treatment regimen based on the woman’s AMH levels. The ESTHER (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World) programme will enrol 1150 patients from 11 countries and from over 30 sites during 2014 and 2015. Additional studies are planned for US, Japan, China and other parts of Asia.
About Ferring Pharmaceuticals
Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in 55 countries and markets its products in more than 100 countries. To learn more about Ferring or its products please visit www.ferring.com.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the WHO Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
1 Gassner D, Jung R: First fully automated immunoassay for anti-Müllerian hormone. Clin Chem Lab Med. 2014 Mar 13. pii: /j/cclm.ahead-of-print/cclm-2014-0022/cclm-2014-0022.xml. doi: 10.1515/cclm-2014-0022. [Epub ahead of print]
For more information
Tel: +41 (0) 58 301 00 53
Dr Daniel Fleiter
Roche Diagnostics International Ltd
Tel: +41 (0) 41 798 5990