Ferring announces the start of the PRONOUNCE Trial for patients with advanced prostate cancer and cardiovascular disease receiving degarelix or leuprolide

Saint-Prex, Switzerland – 8 February 2016 –

Ferring Pharmaceuticals announced today the commencement of the Phase 3b PRONOUNCE Trial. The trial will compare the occurrence of major adverse cardiovascular events (MACEs) in patients with prostate cancer and cardiovascular disease (CVD), receiving the GnRH receptor antagonist, degarelix, to patients receiving a GnRH receptor agonist, leuprolide.

Prostate cancer is the second most common form of cancer in men worldwide with 1.1 million cases diagnosed and over 300,000 deaths in 2012.¹ Androgen deprivation therapy (ADT) is considered the gold-standard treatment for patients with advanced prostate cancer.² However, ADT has shown to be associated with increased risk for CVD. This increase in risk is particularly apparent within the first year of treatment initiation.^3,4,5

A retrospective analysis of pooled data from six Phase 3 clinical trials suggests that there may be a difference in the risk of a major CV event when patients with prostate cancer and a history of CVD were treated with the GnRH antagonist, as compared to GnRH agonists.⁶ The PRONOUNCE Trial has been initiated to compare the cardiovascular safety profile of two types of ADT treatment, the GnRH antagonist (degarelix) and a GnRH agonist (leuprolide) over a one year treatment period. The primary endpoint of the PRONOUNCE Trial is time from patient randomization to the first confirmed occurrence of the composite MACE endpoint.

“Since increased risk of CVD is found among men at advanced age and with prostate cancer, it is critical that cardiovascular status is considered in the management of patients in which ADT is initiated” said Dr. Howard Scher, Chief of the Genitourinary Oncology Service at the Memorial Sloan-Kettering Cancer Center and co-principal investigator of the PRONOUNCE Trial. “The PRONOUNCE Trial could provide valuable insight into the cardiovascular safety profile of GnRH antagonists and GnRH agonists and contribute to informed clinical decision making.”

Ferring Pharmaceuticals is partnering with Duke Clinical Research Institute (DCRI), an institute of the Duke University School of Medicine, USA, to conduct the PRONOUNCE Trial. The DCRI will provide academic leadership with its world-renowned CVD clinical trial expertise.

“This eagerly anticipated trial represents the first cardiovascular outcomes trial conducted in patients with cancer and represents a unique collaboration among cardiologists, oncologists, and urologists who are involved in the care of patients with CVD and prostate cancer,” said Dr. Matthew Roe, Associate Professor of Medicine at Duke University Medical Center and the Duke Clinical Research Institute.

The PRONOUNCE Trial will enroll approximately 900 patients over 50 trial sites in the USA and Canada with the First Patient First Visit (FPFV) due to take place in February 2016.

Dr. Pascal Danglas, Chief Medical Officer, Ferring Pharmaceuticals, commented: “The start of the PRONOUNCE Trial marks another important milestone in Ferring’s long-standing commitment to improving the lives of men living with prostate cancer and addressing the unmet needs of patients with prostate cancer and pre-existing CVD.”

– ENDS –

About the CHAMPION trial

The PRONOUNCE Trial is a large, 1-year, randomised, controlled, prospective cardiovascular safety trial comparing the occurrence of independently adjudicated major adverse cardiovascular events (MACEs) in patients with prostate cancer and CVD receiving degarelix (GnRH antagonist) to patients receiving leuprolide (GnRH agonist). Further information on the PRONOUNCE trial is available at: https://clinicaltrials.gov/ct2/show/NCT02663908?term=pronounce&rank=1.

About degarelix

Degarelix is an antagonist form of androgen deprivation therapy that reversibly binds to the GnRH receptors, inhibiting the production of testosterone immediately. By suppressing the production of testosterone, tumour growth is inhibited.⁷ Degarelix was approved for the treatment of advanced hormone-dependent prostate cancer in the US in 2008, and in the EU in 2009. Today it is available in approximately 53 countries around the world, including Asia, Latin America and the Middle East.

About prostate cancer

Prostate cancer is the second most common form of cancer in men worldwide accounting for 15% of the cancers diagnosed in men. It is the fifth leading cause of death from cancer in men accounting for 6.6% of the total male deaths in 2012.¹ Prostate cancer develops from cells in the prostate gland that begin to grow out of control. In most cases, prostate cancer grows slowly and can remain undetected throughout a man’s life, although it can grow and spread quickly.⁸ The seven types of standard treatment are: watchful waiting or active surveillance, surgery, radiation therapy or radiopharmaceutical therapy, hormone therapy, chemotherapy, biologic therapy or bisphosphonate therapy.⁷

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.

For more information, please contact

Helen Gallagher
+41 58 301 00 51
helen.gallagher@ferring.com

Nicole Barraud-Estoppey
+41 58 301 00 53
nicole.barraud-estoppey@ferring.com

References

1. WHO GLOBOCAN 2012: http://globocan.iarc.fr/old/FactSheets/cancers/prostate-new.asp#MORTALITY [Last Accessed: January 2016]
2. Chowdhury S et al. Trends in Urology and Men’s Health. 2014:5: 26-27
3. Keating NL et al. J Clin Oncol. 2006 Sep 20;24(27):4448-56.
4. D’Amico AV et al. J Clin Oncol. 2007 Jun;25(17):2420-2425
5. Kintzel PE. Pharmacotherapy. 2008;28(12):1511-22.
6. Albertsen PC et al. Eur Urol. 2014 ;65:565-73
7. National Cancer Institute. Prostate Cancer (PDQ(R)): Treatment: Treatment Option Overview. http://www.cancer.gov/types/prostate/patient/prostate-treatment-pdq [Last Accessed: January 2016]
8. American Cancer Society. Cancer Reference Information, Overview: Prostate Cancer. http://www.cancer.org [Last Accessed: January 2016]

Ferring Pharmaceuticals and Karolinska Institutet sign collaboration agreement on the development of a Human Microbiome Translational Research Programme

Saint-Prex, Switzerland – 27 January 2016 –

Ferring Pharmaceuticals and Karolinska Institutet announce today that a collaboration agreement has been signed for the establishment of a research center exploiting the human microbiome. The programme will be fully funded by Ferring Pharmaceuticals and governed by a joint steering committee.

The proposed project focuses on therapeutic areas where Ferring has extensive expertise. Karolinska Institutet has a deep understanding of the human microbiome. Parts of the research will be carried out at the Science for Life Laboratory (SciLifeLab) that provides access to a broad technical platform for studying complex microbiological communities in well-defined human material.

The collaboration between the two partners form a solid foundation for the ambition of a better understanding of the contribution of the human microbiome to physiology and pathophysiology and opens opportunities for development of novel therapies. The research will be led by Professor Lars Engstrand, Karolinska Institutet, who will serve as director. The center will further establish an internationally competitive infrastructure with focus on translational research in the microbiome field set up to develop a comprehensive mapping of the human microbiome in health and disease.

“There is no question that the information coming from this field will lead to innovation in life sciences through improvements in diagnosis, prevention and therapy,” said Per Falk, MD, PhD, Executive Vice President and Chief Scientific Officer at Ferring. “This collaboration with Karolinska Institutet involving SciLifeLab will help to understand the role of the microflora in our key therapy areas and develop innovative treatments to better serve the needs of our patients.”

Anders Hamsten, president of Karolinska Institutet said: “This is yet another example of a strong collaborative research effort that Karolinska Institutet has set up with the pharmaceutical industry. The exploration of the human microbiome promises to provide new insights into its role in human physiology and pathology.”

“The strength of the center lies in its well-established network between scientists representing different competencies,” said Lars Engstrand, Professor at the Department of Microbiology, Tumor and Cell biology and Director of Clinical Genomics at SciLifeLab. “By acting together, contributing resources and skills, we will now get a great opportunity to sort out the hope from the hype in this exciting research field.”

– ENDS –

About Microbiota

The microbiota can be considered a “new organ” which actually constitutes 2 kg of our body and an estimated 80% of its components has not yet been cultivated. Biomarkers and novel drug candidates could potentially be found in the highly metabolically active bacteria. An example is the antibacterial molecule Lactocillin produced by Lactobacillus gasseri (a vaginal bacteria). The tools used to study the microbiota have benefitted greatly from the major advances in high throughput analysis of molecules at the DNA, RNA, protein and metabolite levels, usually collected under the terminology “omics-platforms”.

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 Karolinska Institutet

Karolinska Institutet is one of the world’s leading medical universities. It accounts for over 40% of the medical academic research conducted in Sweden and offers the country’s broadest range of education in medicine and health sciences. Since 1901 the Nobel Assembly at Karolinska Institutet has selected the Nobel laureates in Physiology or Medicine.

For more information please visit: www.ki.se

About SciLifeLab

SciLifeLab is a Swedish national center for molecular biosciences, with the mission to develop, use and provide advanced technologies for applications in health and environmental research. SciLifeLab is hosted by four universities; Karolinska Institutet, KTH Royal Institute of Technology, Stockholm University and Uppsala University.

For more information please visit: www.scilifelab.se

For more information, please contact

Targeted Immuno Therapies AB and Ferring Pharmaceuticals sign a strategic collaboration agreement for the treatment of IBD

Stockholm – 11 January 2016 –

Targeted Immuno Therapies (TLA) announced today that it has signed a strategic collaboration agreement with Ferring Pharmaceuticals, granting Ferring worldwide rights (excluding China) to its discovery of a new, novel treatment for IBD.

This collaboration aims to further develop the technology, created by TLA, for the treatment of IBD (Inflammatory Bowel Diseases, including Ulcerative Colitis, Crohn’s Disease, unclassified colitis as well as microscopic colitis).

The newly discovered and proprietary technology works by removing harmful cells from the patient’s blood, thereby re-establishing a positive balance of the patient’s immune system. Patients are referred to their hospital to be treated ambulatory with a modified version of leukapheresis (or blood-exchange). The patient’s own blood is pumped through a column containing a specifically designed and proprietary peptide chemokine that removes the specific cells that are known to cause damage in inflammatory diseases.

A proof-of-principle clinical study, completed in 2015, with severely affected ulcerative colitis patients gave some promising results. The inflamed gut mucosa healed in more than half of the patients and this was linked to a significant reduction of the circulating pro-inflammatory cells. A confirmatory clinical study in severe ulcerative colitis patients is now being planned as the next step.

Dr Hans Glise, CEO of TLA said “This is a very important step for us and an acknowledgement of our technology. Ferring is a leader within gastroenterology, and Ferring sees the potential of our technology platform”.

“TLA’s technology is very interesting to us, as it has the potential to help patients with severe inflammatory diseases, where other treatments are without effect, or have unacceptable side effects”, said Per Falk, EVP R&D and CSO of Ferring.

Starting in 2016, Ferring will now fund the further product development and clinical trial programme, in exchange for an exclusive, worldwide option (excluding China), and this will hopefully lead to a fulfilling potential of this technology in the treatment paradigm related to severe IBD patients.

– ENDS –

About Ulcerative Colitis

Ulcerative Colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms. For moderate to severe cases of ulcerative colitis, immunosuppressant drugs or biologic drugs may be prescribed. If the condition does not respond to pharmaceutical therapy and the symptoms are severe, the patient may be referred for surgery.

About TLA

Targeted Immuno Therapies AB (TLA) was founded at Karolinska Institutet in 2005 and has developed a flexible technology platform for the treatment of inflammatory diseases. TLA has won a number of prestigious awards, such as the Universal Biotech Innovation Prize and Sweden’s Athenapriset (the Athena Prize). A very successful study of IBD was conducted during 2014. The technology is based on a discovery of Professor Ola Winqvist at Karolinska University Hospital.

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

For more information, please contact

TLA
Hans Glise
CEO
+46-70-892-4824
hans.glise@ithgroup.se

Johan Järte
COO
46-70-652-4532
johan.jarte@ithgroup.se

Ferring Pharmaceuticals
Helen Gallagher
Corporate Communications
+41 58 301 00 51
helen.gallagher@ferring.com

Nicole Barraud-Estoppey
Corporate Communications
+41 58 301 00 53
nicole.barraud-estoppey@ferring.com

Cosmo & Ferring Pharmaceuticals enter into licensing agreement for CORTIMENT®MMX® (budesonide) in Japan

Luxembourg – 14 December, 2015 –

Cosmo Pharmaceuticals S.A. (SIX: COPN) announced today that it has signed a licensing agreement with Ferring Pharmaceuticals, granting Ferring the rights to CORTIMENT®^MMX® for Japan.

In Japan, it is believed that as many as 160’000 people suffer from ulcerative colitis, a form of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the colon. The inflammation can interfere with the normal function of the colon, often causing cramping, bloating, diarrhoea, bleeding, fatigue, weight loss and frequent bowel movements, which may also strongly affect quality of life.

If approved, CORTIMENT®^MMX® will offer a treatment with a novel formulation for active, mild-to-moderate ulcerative colitis. Its oral tablet formulation, which utilizes MMX® multi-matrix technology, is designed to result in a prolonged release and distribution of budesonide throughout the length of the colon.

Ferring already had the rights of CORTIMENT®^MMX® ex-US, ex-Japan and is currently launching in Europe and many territories.

“We are very pleased to have acquired rights to CORTIMENT®^MMX® for Japan. Ferring Pharmaceuticals is committed to building its gastroenterology franchise in Japan and to improving the quality of life and outcomes for Japanese patients suffering from Intestinal Bowel Disease. CORTIMENT®^MMX® is Ferring Japan’s second entry in the gastroenterology field¹”, said Michel Pettigrew, President of the Ferring Executive Board and COO.

Alessandro Della Cha, CEO of Cosmo Pharmaceuticals SA said: “We firmly believe that CORTIMENT®^MMX® will play an increasingly important role in treating ulcerative colitis patients in Japan. Ferring is one of the most experienced companies in inflammatory bowel disease world-wide and we are pleased to extend our collaboration to Japan.”

Under the terms of the agreement, Ferring will conduct, at its expense, the necessary clinical trials which are required for the submission of the registration in Japan. Ferring will commit to a payment of EUR 8 million and double digit royalties upon first sale of the product.

– ENDS –

About CORTIMENT®^MMX®

CORTIMENT is a locally acting corticosteroid in a novel, patented, oral tablet formulation, which utilizes MMX® multi-matrix technology and is designed to result in the prolonged release and distribution of budesonide throughout the length of the colon. Budesonide has mainly topical anti-inflammatory activity and due to its high first pass metabolism, it has low system bioavailability. Budesonide using MMX® technology may be marketed under another name in some countries.

About Ulcerative Colitis

Ulcerative Colitis is a chronic relapsing-remitting illness for which there is no known cure, but with appropriate treatment patients can manage their symptoms. However, it is estimated that up to 30% of patients with mild or moderate ulcerative colitis do not respond to aminosalicylate (5-ASA) drugs and require a different or add on therapy. Patients refractive to treatment with 5-ASA drugs typically receive a course of a systemically absorbed corticosteroid, the success of which may be limited by significant side effects. For moderate to severe cases of ulcerative colitis, immunosuppressant drugs or biologic drugs may be prescribed. If the condition does not respond to pharmaceutical therapy and the symptoms are severe, the patient may be referred for surgery.

About Cosmo Pharmaceuticals S.A.

Cosmo is a specialty pharmaceutical company that aims to become a global leader in the field of optimized therapies for selected Gastrointestinal and topically treated Skin Disorders. The company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as Ulcerative Colitis and Crohn’s Disease, and Colon Infections. In addition, the Company is developing a diagnostic for the detection of colon cancer and a medical device for polyp excision as well as new chemical entities that are being developed by the associate company Cassiopea SpA for the topical treatment of skin diseases.
Cosmo’s MMX® products that have reached the market are Lialda®/Mezavant®/Mesavancol®, a treatment for IBD that is licensed globally to Giuliani and Shire Limited and Uceris®, the first glucocorticosteroid indicated for the induction of remission in active, mild to moderate Ulcerative Colitis, licensed in US to Salix and in the Rest of the World except for Japan to Ferring as Cortiment®. Cosmo’s proprietary MMX® technology is at the core of the Company’s product pipeline and was developed from its expertise in formulating and manufacturing gastrointestinal drugs for international clients at its GMP (Good Manufacturing Practice) facilities in Lainate, Italy. The technology is designed to deliver active ingredients in a targeted manner in the colon. For further information on Cosmo, please visit the Company’s website: www.cosmopharma.com

Financial agenda
Results 2015: 7 March, 2016
AGM: 23 March, 2016

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.

FERRING, CORTIMENT and PICOPREP are trademarks of Ferring B.V. MMX is a trademark of Cosmo Pharmaceuticals SA. UCERIS in the USA is a trademark of Santarus Inc/Salix Pharmaceuticals Inc.

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.

For more information, please contact

Cosmo Pharmaceuticals S.A.
Dr. Chris Tanner
CFO and Head of Investor Relations
+352 2784 87 49
ctanner@cosmopharma.com

Ferring Pharmaceuticals
Helen Gallagher
Corporate Communications
+41 58 301 00 51
helen.gallagher@ferring.com

Nicole Barraud-Estoppey
Corporate Communications
+41 58 301 00 53
nicole.barraud-estoppey@ferring.com

References

1. First entry is the submission of PICOPREP® (sodium picosulphate, magnesium oxide, citric acid), an oral solution indicated for cleansing of the colon as a preparation for colonoscopy in adults.

Ferring Pharmaceuticals submits variation application to introduce new tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label

Saint-Prex, Switzerland – 11 December 2015 –

Ferring Pharmaceuticals announced today that it has submitted a variation application in the Mutual Recognition Procedure (MRP) (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Portugal, Romania, Slovak Republic, Spain, Sweden and United Kingdom) in Europe to introduce its new tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label.

If approved, the proposed variation would introduce a new tailored dosing regimen as supported by the results from the OPTIMA trial. The variation application has been submitted on 28 October 2015 in the MRP with the UK as a Reference Member State (RMS).

“Sufficient data have now been collected to enable Ferring to file for official registration of this new tailored dosing regimen in the PICOPREP® label in the MRP,” said Malin Carlsson, Acting Associate Vice President at IPC Copenhagen. “If approved, it will enable the label to become in line with the guideline recommendations of shorter time interval between the last dose of the bowel preparation and the colonoscopy procedure.”

The filing is based on data from the randomised, assessor-blinded, multi-centre OPTIMA clinical trial, assessing the efficacy, safety and tolerability of the PICOPREP® tailored dosing regimen¹, compared to the currently approved PICOPREP® day-before dosing regimen² for colon cleansing, in preparation for colonoscopy.

The OPTIMA trial, started in 2014, enrolled 204 patients in Germany, France and the Netherlands. Patients were randomised (2:1) to either the PICOPREP® tailored dosing regimen or PICOPREP® day-before dosing regimen for colon cleansing in preparation for colonoscopy. Primary endpoint was the overall colon cleansing efficacy based on total Ottawa Scale (OS) scores. Key secondary endpoint was the responder status for ascending colon based on OS. Other secondary endpoints were responder status for mid (transverse, descending) and recto-sigmoid colon. Convenience, satisfaction, impact on daily activities, safety and tolerability were also evaluated.

– ENDS –

About PICOPREP® (sodium picosulfate, magnesium oxide, citric acid)

PICOPREP® (sodium picosulfate 10mg, magnesium oxide 3.5mg, citric acid 12g), a dual action laxative medication, is used to clean the bowel prior to X-ray examination, endoscopy and surgery when judged clinically necessary. PICOPREP® has approved dosing for children as of 1 year old and adults. This product is sold in some countries under the trademarks PICO-SALAX®, PICOLAX® or PREPOPIK®.

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.

Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

For more information, please contact

Nicole Barraud-Estoppey
+41 (0) 58 301 00 53
nicole.barraud-estoppey@ferring.com

Helen Gallagher
+41 (0) 58 301 00 51
helen.gallagher@ferring.com

References

1. In the OPTIMA trial, the time of administration of the two sachets is set according to the time of the colonoscopy for a more tailored approach. The first sachet is to be taken 10-18h, and the second sachet 4-6h before the colonoscopy.
2. In the currently approved regimen, the first sachet is to be taken at 8am the day before the procedure. The second dose is then taken 6-8h later.

Ferring receives acceptance of Marketing Authorisation filing from EMA for personalised fertility treatment with REKOVELLE® (follitropin delta)

Saint-Prex, Switzerland – 30 October 2015 –

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 (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest 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.

– 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 distinct^1,9 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

For more information, please contact

Nicole Barraud-Estoppey
+41 (0) 58 301 00 53
nicole.barraud-estoppey@ferring.com

Helen Gallagher
+41 (0) 58 301 00 51
helen.gallagher@ferring.com

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 07 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.