FERRING-PHARMACEUTICALS
30.10.2015 15:44:05 CET | Business Wire | Press release
Ferring Pharmaceuticals announced today that the filing for the Marketing Authorisation Application for REKOVELLE® (follitropin delta) has been accepted for review by the European Medicines Agency (EMA). REKOVELLE is a novel human recombinant follicle-stimulating hormone (rhFSH) intended for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) therapy such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).1-3 The submission is supported by comprehensive data from the Phase 3 ESTHER trials (E vidence-based S timulation T rial with H uman rFSH in E urope and R est of World) involving 1,326 patients from 37 fertility clinics in 11 countries.2,3
If approved, REKOVELLE would be administered in an individualised dosing regimen according to both the measurement of the woman’s serum anti-Müllerian hormone (AMH), a biomarker that assesses ovarian reserve and predicts ovarian response to stimulation, as well as her body weight. Fertility specialists would assess each patient’s biomarker profile and characteristics, and prescribe a precise fixed daily dose of REKOVELLE from the start of stimulation. This approach of controlled ovarian stimulation with an individualised REKOVELLE dosing regimen was prospectively studied in the ESTHER-1 trial.2 If approved, REKOVELLE would be paired with the recently launched fully-automated Elecsys® AMH immunoassay from Roche4 .
Personalised treatment is a new approach to the management of fertility treatment, with the ultimate goal of helping couples to conceive in an efficient and safe manner.1,5,6,7,8
“Ferring Pharmaceuticals has a long heritage in reproductive health and the acceptance of the Marketing Authorisation Application filing for REKOVELLE in controlled ovarian stimulation represents our commitment to innovation and advancing the role of personalised medicine in the area of fertility,” commented Per Falk, MD, PhD, Executive Vice President and Chief Scientific Officer, Ferring Pharmaceuticals.
- ENDS -
About REKOVELLE (follitropin delta)
REKOVELLE (also known as FE 999049) is the first human recombinant follicle stimulating hormone derived from a human cell line that has been developed for individualised dosing using a companion anti-Müllerian hormone (AMH) diagnostic immunoassay.2 REKOVELLE is a New Molecular Entity (NME) which is clinically distinct1,9 from other follitropins and is not a biosimilar.
About Ferring Pharmaceuticals
Headquartered in 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 nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com .
About the Elecsys ® AMH immunoassay from Roche
The Elecsys® AMH immunoassay from Roche has been shown to provide a precise, reliable and robust measurement of AMH levels.10-15 The fully automated Elecsys® AMH immunoassay determines AMH levels in 18 minutes, making it appropriate for routine clinical use and providing clinical confidence in the reliable assessment of ovarian reserve.10-15
REKOVELLE is a trade mark of Ferring B.V., registered in the European Union and under examination elsewhere.
ELECSYS® is a trademark of Roche. All other trademarks are the property of their respective owners.
References
1. Arce J-C, Nyboe Andersen A, Fernandez Sanchez M, et al. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone–stratified, dose–response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection Fertil Steril. 2014 Dec;102(6):1633-40.
2. ESTHER-1 trial. www.clintrials.gov Available at: https://clinicaltrials.gov/ct2/show/NCT01956110 . Last accessed: October 2015.
3. ESTHER-2 trial. www.clintrials.gov . Available at: https://clinicaltrials.gov/ct2/show/NCT01956123 . Last accessed: October 2015.
4. Deeks ED. Elecsys® AMH assay: a review in anti-Müllerian hormone quantification and assessment of ovarian reserve. Mol Diagn Ther 2015; 19: 245-249.
5. Leader B, Baker VL. Maximizing the clinical utility of antimullerian hormone testing in women’s health. Curr Opin Obstet Gynecol 2014;26:226–236.
6. Fleming R, Broekmans F, Calhaz-Jorge C, et al. Can anti-Mullerian hormone concentrations be used to determine gonadotropin dose and treatment protocol for ovarian stimulation? Reproductive BioMedicine Online 2013;26:431–439.
7. Nelson SM, Yates RW, Lyall H, et al. Anti-Müllerian hormone-based approach to controlled ovarian stimulation for assisted conception. Hum Reprod. 2009 Apr;24(4):867-75.
8. La Marca A, Sighinolfi G, Radi D, et al. Anti-Mullerian hormone (AMH) as a predictive marker in assisted reproductive technology (ART). Hum Reprod Update 2010; 16:113–130.
9. Olsson H, Sandström R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol 2014;54(11):1299-307.
10. Roche Diagnostics. Elecsys® AMH (anti-Mullerian hormone): Method sheet. 2015. https://pim-eservices.roche.com . Last accessed October 2015.
11. Gassner D, Jung R. First fully automated immunoassay for anti-Müllerian hormone. Clin Chem Lab Med. 2014;52(8):1143-52.
12. Anderson RA, Anckaert E, Bosch E, et al. Prospective study into the value of the automated Elecsys antimüllerian hormone assay for the assessment of the ovarian growing follicle pool. Fertil Steril. 2015;103(4):1074–80.e4.
13. Deeks, ED. Elecsys® AMH Assay: a review in anti-Müllerian hormone quantification and assessment of ovarian reserve. Mol Diagn Ther 2015; 19:245-249.
14. Nelson SM, Pastuszek E, Kloss G, et al. Two new automated, compared with two enzyme-linked immunosorbent antimüllerian hormone assays. Fertil Steril. 2015 Oct;104(4):1016-1021.e6.
15. Hyldgaard J, Bor P, Ingerslev HJ, et al. Comparison of two different methods for measuring anti-mullerian hormone in a clinical series. Reprod Biol Endocrinol. 2015 Sep 22;13(1):107.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151030005609/en/
Contact:
Ferring Pharmaceuticals
Nicole Barraud-Estoppey
Tel. +41 (0)
58 301 00 53
nicole.barraud-estoppey@ferring.com
or
Helen
Gallagher
Tel. +41 (0) 58 301 00 51
helen.gallagher@ferring.com
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Moody’s Corporation Elects Keith Demmings to Board of Directors12.8.2026 22:15:00 CEST | Press release
Moody’s Corporation (NYSE:MCO) today announced that Keith Demmings has been elected to the Company’s Board of Directors, effective November 1, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260812902420/en/ Mr. Demmings, 54, currently serves as President and Chief Executive Officer of Assurant, Inc., a publicly traded company that safeguards and services connected devices, homes, automobiles, and commercial equipment in partnership with the world’s leading brands, a position he has held since January 2022. He has also served on Assurant’s Board of Directors since that time. Prior to his appointment as Chief Executive Officer, Mr. Demmings served as President of Assurant from 2021 to 2022, overseeing all operating segments, including Global Lifestyle and Global Housing. Earlier, he served as Executive Vice President and President, Global Lifestyle from 2016 to 2021, Executive Vice President and President, Global Markets
Lattice to Deliver Keynote at 2026 OCP Global Summit12.8.2026 22:00:00 CEST | Press release
Lattice Semiconductor (NASDAQ: LSCC), the low power programmable and platform firmware leader, today announced that Lattice will deliver a keynote at the 2026 OCP Global Summit. Ford Tamer, President and CEO of Lattice Semiconductor, will take the stage with Sanjoy Maity, Senior Vice President, AMI Business Unit Leader, Lattice Semiconductor. Together, they will discuss the growing need for a common management and control model for AI and compute infrastructure, and how the OCP Community can work together to bring this vision to life with existing open technologies. The keynote will take place on Tuesday, Oct. 13, 2026, at 10 a.m. PT at the San Jose Convention Center (SJCC), South Hall, San Jose, California. The OCP Summit is the premier event uniting the most forward-thinking minds in open IT Ecosystem development. The Summit presents a unique platform for the OCP community from around the globe to share their insights, foster partnerships, and showcase cutting-edge advancements in op
BM3EAC Corp. 2026 Semi-Annual Report12.8.2026 17:51:00 CEST | Press release
BM3EAC Corp. (the “Company”), a special purpose acquisition company incorporated under the laws of the Cayman Islands as an exempted company with limited liability and listed on Euronext Amsterdam, the regulated market operated by Euronext Amsterdam N.V., today published its semi-annual report for the period 1 January 2026 to 30 June 2026. The semi-annual report can be downloaded from the Company’s website via the following link: https://www.BrigadeM3EAC.com/documents IMPORTANT INFORMATION This press release contains information that qualifies as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation. DISCLAIMER The Company’s semi-annual report referenced in this announcement may include forward-looking statements, which are based on the Company's current expectations and projections regarding a business combination, the business, the economy and other future conditions of the Company and speak only as of the date hereof. Forward-looking statements may
STL Selects Kinaxis Planning One to Strengthen Supply Chain Planning Across Global Operations12.8.2026 16:10:00 CEST | Press release
Deployment reflects Kinaxis' continued investment in India and expanding access through its growing partner ecosystem Kinaxis® Inc. (TSX:KXS), a global leader in supply chain orchestration, today announced that STL (NSE: STLTECH), a leading optical and digital solutions company, has selected Kinaxis Planning One to strengthen its supply chain planning capabilities and improve decision-making speed across its global operations. The deployment reflects Kinaxis' continued commitment to the Indian market and represents another milestone in expanding customer access through its growing network of value-added reseller (VAR) partners, and its first customer win through the company's Google Marketplace mid-market initiative. "Manufacturers are under increasing pressure to respond to volatility with faster, more coordinated decisions," said Ray Curbelo, SVP, Global Partner Organization at Kinaxis. "This engagement with STL reflects both the growing demand for modern supply chain planning in Ind
Azalea Vision Appoints Co-Founder Andrés Vasquez Quintero as Chief Executive Officer to Lead Next Phase of Clinical Development12.8.2026 16:00:00 CEST | Press release
Co-founder Andrés Vasquez Quintero assumes the CEO role while continuing as Chief Technology Officer, ensuring leadership continuity. Leadership transition positions Azalea Vision for clinical development of its smart contact lens platform, following selection for the EIC Accelerator. Co-founder Enrique Vega transitions to the Board of Directors, preserving founder continuity. Azalea Vision, a Belgian healthtech company, today announced that co-founder and CTO Andrés Vasquez Quintero will become Chief Executive Officer, effective immediately, while continuing as CTO. The transition marks the company’s next phase, advancing its smart contact lens platform into clinical development, following its selection for the European Innovation Council (EIC) Accelerator. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260812586109/en/ Andrés Vásquez Quintero, CEO & CTO of Azalea Vision As the inventor of Azalea Vision’s proprietary adapti
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom