Ferring strengthens growth hormone franchise Zomacton® through acquisition of ZomaJet™ needle-free injector device

• Ferring enters agreement with Antares Pharma Inc. for worldwide rights to ZomaJet™ needle-free injector device

• ZomaJet is used to deliver Ferring’s Zomacton^® (somatropin), indicated to treat Growth Hormone Deficiency in children and Turner Syndrome in girls

• ZomaJet helps increase adherence to treatment through its needle-free feature and the ability to self-administerm ^1,2,3

Saint-Prex, Switzerland – 10 October 2017 –

Ferring Pharmaceuticals announced today that it has entered into a definitive agreement with Antares Pharma, Inc. to acquire the worldwide rights for the ZomaJet™ needle-free auto injector device.

This transaction is subject to customary closing conditions. Antares will continue to manufacture and supply the ZomaJet device until completion of existing supply arrangements, expected by the end of 2018.

ZomaJet is used to deliver Ferring’s Zomacton^® (somatropin), a treatment indicated for the treatment of Growth Hormone Deficiency (GHD) in children and Turner Syndrome in girls.

“Through the acquisition of ZomaJet, we are consolidating our Zomacton franchise and commitment to improving quality of life and care for children with growth disorders,” said Michel Pettigrew, President of the Executive Board and Chief Operating Officer, Ferring Pharmaceuticals. “ZomaJet addresses the common problem of needle fear in children, lowering the burden for patients and care givers and leading to better adherence to treatment.”

Ferring is a recognised speciality player in endocrinology, with a commitment to addressing the unmet medical needs of patients with childhood growth disorders including GHD and Turner Syndrome.

– ENDS –

About ZomaJet™

ZomaJet devices are needle-free delivery systems for the administration of Zomacton® (somatropin) human growth hormone (hGH).

About Zomacton^®

Zomacton^® (somatropin) is a synthetic human growth hormone (hGH) produced by recombinant DNA technology. The main use for the product is to treat Growth Hormone Deficiency (GHD) in children and Turner Syndrome in girls.

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. A leader in reproductive and maternal health, Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative treatments to help mothers and babies, from conception to birth. The company also identifies, develops and markets innovative products in the areas of urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

For further information on Ferring or its products, visit www.ferring.com.

Ferring is on Twitter. Follow us @FerringNews at http://twitter.com/FerringNews

For more information, please contact

Lindsey Rodger
Senior Manager, Corporate Communications
+41 58 451 4023 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.com

Bhavin Vaid
Head of Corporate Communications
+41 58 301 0952 (direct)
+41 79 191 0632 (mobile)
bhavin.vaid@ferring.com

References

1. Haverkamp F. & Gasteyger G. Journal of Medical Economics 2011; 14(4): 448-457
2. Wickramasuriya B.P. et al, Horm Res 2006; 65(1): 18-22
3. Main K.M. et al, Acta Paediatr 1995; 84(3): 331-334

Ferring appoints Klaus Dugi as Executive Vice President and Chief Medical Officer

Saint-Prex, Switzerland – 2 October 2017 –

Ferring Pharmaceuticals announced today that Professor Klaus Dugi has been appointed Executive Vice President and Chief Medical Officer, effective immediately.

He will be responsible for Global Medical Affairs, Quality Assurance and Pharmacovigilance. In addition, he will also be a member of the Ferring Executive Board.

Prior to this role, Prof. Dugi held various leadership roles at Boehringer Ingelheim, including Vice President Global Medical Affairs, Chief Medical Officer, and, most recently, Managing Director UK & Ireland.

“Making the industry more patient-centric has always been a top priority for Professor Dugi, and this is perfectly aligned with our company philosophy and commitment to solving unmet patient needs, particularly in the area of reproductive and maternal health,” said Michel Pettigrew, President of the Executive Board and Chief Operating Officer, Ferring Pharmaceuticals.

A Professor of Medicine, with a speciality in Internal Medicine, Prof. Dugi continues to teach medicine at Heidelberg University, Germany. He also spent four years carrying out research at the US National Institutes of Health (NIH) and has published more than 70 manuscripts in peer-reviewed journals including The Lancet and Diabetes.

– ENDS –

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. A leader in reproductive and maternal health, Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative treatments to help mothers and babies, from conception to birth. The company also identifies, develops and markets innovative products in the areas of urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

For further information on Ferring or its products, visit www.ferring.com.

Ferring is on Twitter. Follow us @FerringNews at http://twitter.com/FerringNews

For more information, please contact

Ferring announces new analysis of Rekovelle® data relating to personalised medicine in fertility patients

• New analysis of Rekovelle® data presented at ESHRE showed similar cumulative live birth rates compared to conventional therapy

• New analysis of Rekovelle data also presented on safety profile in women undergoing IVF, including those with high AMH levels

Saint-Prex, Switzerland – 4 July, 2017

Ferring Pharmaceuticals announced today a new analysis of Rekovelle® (follitropin delta) data that showed cumulative live birth rates were similar between women receiving Rekovelle and conventional follitropin alfa treatment.¹ In addition, Rekovelle data from a separate new analysis showed a favourable safety profile in women with high anti-Müllerian hormone (AMH) levels.² These analyses of the ESTHER-1 and ESTHER-2 Phase III clinical trials^3,4 were presented today at the 33rd Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Geneva, Switzerland.

 “Rekovelle’s individualised dosing regimen, based on a patient’s AMH level and body weight, provides clinicians with a consistent, evidence-based approach to personalising treatment for their patients,” said Per Falk, Executive Vice President and Chief Scientific Officer, Ferring Pharmaceuticals. “These new Rekovelle analyses add further evidence for a personalised approach to fertility treatment for patients.”

A new analysis of the ESTHER-1 and ESTHER-2 trials showed that in women undergoing in vitro fertilisation (IVF), the cumulative live birth rate for fresh embryo transfers after three treatment cycles was 43.9% (292/665) with Rekovelle and 44.5% (294/661) with follitropin alfa.¹ In addition, ongoing pregnancy rate was 45.1% (300/665) and 45.7% (302/661), respectively.¹ The ESTHER trials^3,4were not powered for this analysis, so no confirmatory conclusions can be derived.

A separate new analysis of the ESTHER-1 trial was conducted to evaluate ongoing pregnancy rates, early ovarian hyperstimulation syndrome (OHSS) and preventive interventions for early OHSS in women with different AMH levels.² For women with high AMH ≥35 pmol/L (13% of the trial population) the incidence of early OHSS with Rekovelle was lower (4.7%, 4/86) compared with conventional follitropin alfa dosing (11.9%, 10/84). The number of patients requiring preventive interventions for early OHSS was also lower (4.7%, 4/86 and 23.8%, 20/84 respectively). In addition, patients maintained ongoing pregnancy rate.² The ESTHER trials^3,4 were not powered for this analysis, so no confirmatory conclusions can be derived.

– ENDS –

About Rekovelle^® (follitropin delta)

Rekovelle is the first recombinant follicle stimulating hormone (rFSH) derived from a human cell line (PER.C6® cell line).^3,5,6,7 It has been developed for individualised dosing based on a patient’s body weight and serum AMH level, as determined by a companion diagnostic, the Elecsys® AMH Plus immunoassay from Roche.^3,8,9 Rekovelle is structurally and biochemically distinct from other existing recombinant FSH treatments.^3,5,6,7

Rekovelle® received Marketing Authorisation from the European Commission (EC) in December 2016.

About the ESTHER trials

ESTHER-1 (Evidence-based Stimulation Trial with Human recombinant FSH in Europe and Rest of World) is a Phase 3, randomised, assessor-blind, controlled trial of 1326 patients in 11 countries undergoing their first ART cycle. Patients were randomized 1:1 to receive treatment with individualised Rekovelle, a fixed daily dose based on serum anti-Müllerian hormone (AMH) levels and body weight, or conventional follitropin alfa dosing. The co-primary endpoints of ongoing pregnancy rates and ongoing implantation rates were met and results showed no difference between the two treatment arms. Results of the ESTHER-1 trial were published in the February 2017 issue of Fertility & Sterility.³

ESTHER-2 is a Phase 3, assessor-blind, controlled trial evaluating the immunogenicity of Rekovelle in a subset of ESTHER-1 patients undergoing repeated cycles of controlled ovarian stimulation for ART. Data demonstrated no increased immunogenicity risk with Rekovelle after exposure in repeated cycles.⁴

About AMH and OHSS

AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response.¹⁰ Women with high AMH levels are at an increased risk of developing OHSS, a potential complication of IVF treatment.^11,12 Symptoms of early OHSS may include abdominal distension or discomfort, nausea and vomiting. In more severe cases OHSS can lead to large amounts of ascites (fluid accumulation in the abdominal cavity), shortness of breath, blood clots, dehydration and potentially, death.¹¹ 

The prevalence of OHSS in women undergoing IVF varies according to severity, with cases of OHSS experienced by 20–33% (mild), 3–6% (moderate) and 0.1–2% (severe) of women.¹³ A recent report suggested that OHSS is an underreported side effect of ovarian stimulation and the real world incidence may be higher.¹⁴ In addition to the impact on patients, the treatment of OHSS is associated with significant costs to the healthcare system.¹⁵ In the UK for example, the cost of treating moderate and severe cases of OHSS is estimated to be over £7 million every year.^15,16

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. A leader in reproductive and maternal health, Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative treatments to help mothers and babies, from conception to birth. The company also identifies, develops and markets innovative products in the areas of urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. For further information on Ferring or its products, visit www.ferring.com.

About the Elecsys^® AMH Plus immunoassay from Roche

The Elecsys^® AMH Plus immunoassay from Roche has been shown to provide a precise, reliable and robust measurement of AMH levels.^{8,9,17,18,19,20} This fully automated Elecsys^® AMH Plus immunoassay, run on the cobas^® e and Elecsys^® immunoassay analysers, determines AMH levels in 18 minutes, making it appropriate for routine clinical use. The Elecsys^® AMH Plus immunoassay is intended to be used for assessment of ovarian reserve, prediction of response to COS and establishment of the individual daily dose of Rekovelle in combination with body weight in COS for the development of multiple follicles in women undergoing an assisted reproductive technology programme.^{8,9,17,18,19,20}

For more information, please contact

Lindsey Rodger
Corporate Communications Manager
+41 58 451 40 23 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.com

Bhavin Vaid
Head of Corporate Communications
+41 58 301 09 52 (direct)
+41 79 191 06 32 (mobile)
bhavin.vaid@ferring.com

References

1. Havelock J, Bosch E, Sanchez F, et al. Cumulative ongoing pregnancy and live birth rates following repeated controlled ovarian stimulation (COS) cycles using individualised follitropin delta dosing compared to conventional follitropin alfa dosing [abstract] In: 33rd Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE); 2017; Geneva, Switzerland. Abstract no. 0-168
2. La Marca A, Nelson S, Gothberg M, et al. The impact of serum anti-Müllerian hormone (AMH) levels on clinical outcome of individualized follitropin delta dosing and conventional follitropin alfa dosing in controlled ovarian stimulation [abstract]. In: 33rd Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE); 2017; Geneva, Switzerland.  Abstract no. 0-174
3. Nyboe Andersen A, Nelson SM, Fauser BC, et al. Individualised versus conventional ovarian stimulation for an in vitro fertilization: a multicenter, randomized, controlled assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017: 107(2): 387-396
4. Buur Rasmussen A et al. Low immunogenicity potential of follitropin delta, a recombinant FSH preparation produced from a human cell line: Results from phase 3 trials (ESTHER-1 and ESTHER-2). Human Reproduction 2016; 31: 385
5. Rekovelle^® Summary of Product Characteristics (SmPC) – Available at: https://www.medicines.org.uk/emc/medicine/33324 [Last accessed: June 2017]
6. Arce JC, Andersen AN, Fernández-Sánchez 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;102(6):1633–1640
7. 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):1299–1307
8. Deeks ED. Elecsys^® AMH assay: a review in anti-Müllerian hormone quantification and assessment of ovarian reserve. Mol Diagn Ther. 2015; 19: 245-249
9. Roche Diagnostics. Elecsys^® AMH (anti-Mullerian hormone): Method sheet. 2015. https://pim-eservices.roche.com. [Last accessed June 2017]
10. 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(2):113-130
11. OHSS Symptoms and Causes. Patient Care and Health Information. Mayo Clinic. http://www.mayoclinic.org/diseases-conditions/ovarian-hyperstimulation-syndrome-ohss/symptoms-causes/dxc-20263586 [Last accessed: June 2017]
12. Salmassi A, Mettler L, et al.Cut-Off Levels of Anti-Mullerian Hormone for the Prediction of Ovarian Response, In Vitro Fertilization Outcome and Ovarian Hyperstimulation Syndrome. Int J Fertil Steril. 2015; 9(2): 157-167
13. Delvigne A, Rozenberg S, et al. Epidemiology and prevention of ovarian hyperstimulation syndrome (OHSS): a review. Hum Reprod Update. 2002; 8(6): 559-577
14. Thomsen L, Humaidan P, et al. Ovarian hyperstimulation syndrome in the 21^st century: the role of gonadotropin-releasing hormone agonist trigger and kisspeptin. Curr Opin Obstet Gynecol. 2015; 27(3): 210-214
15. Yates AP, Rustamov O, Roberts SA, et al. Anti-Mullerian hormone-tailored stimulation protocols improve outcomes whilst reducing adverse effects and costs of IVF. Hum Reprod. 2011; 26(9): 2353-2362
16. Fertility Treatment in 2014 Trends and Figures Report. Human Fertilisation and Embryology Authority. http://www.hfea.gov.uk/docs/HFEA_Fertility_treatment_Trends_and_figures_2014.pdf [Last accessed June 2017]
17. Gassner D, Jung R. First fully automated immunoassay for anti-Müllerian hormone. Clin Chem Lab Med. 2014;52(8):1143-1152
18. 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
19. Nelson SM, Pastuszek E, Kloss G, et al. Two new automated, compared with two enzyme-linked immunosorbent antimüllerian hormone assays. Fertil Steril. 2015;104(4):1016-1021.e6
20. 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;13(1):107

Ferring appoints Lars Peter Brunse to Executive Board

Saint-Prex, Switzerland – 3 July 2017 –

Ferring Pharmaceuticals announced today that Lars Peter Brunse has been appointed Executive Vice President and Chief Production Officer, and made a member of the Ferring Executive Board, effective immediately.

Lars Peter Brunse joined Ferring as Associate Director Technical Operations in 2000 and was rapidly promoted to Senior Vice President, Technical Operations and Logistics. He has led the expansion of Ferring’s manufacturing capability with the development of an additional nine state-of-the-art production sites, and extended the company’s product supply network from approximately 500 employees in the year 2000 to over 1,600 today.

“Lars Peter has been instrumental in expanding Ferring’s production capacity, most recently through the successful completion of new sites in the US and India,” said Michel Pettigrew, President of the Executive Board and Chief Operating Officer, Ferring Pharmaceuticals. “His team-focused leadership style has been extremely effective in building a strong product supply organisation, and his experience makes him uniquely qualified for this new role.”

Prior to joining Ferring, Brunse worked at Novo Nordisk in manufacturing, operational excellence, and quality assurance management.

– ENDS –

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. A leader in reproductive and maternal health, Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative treatments to help mothers and babies, from conception to birth. The company also identifies, develops and markets innovative products in the areas of urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. For further information on Ferring or its products, visit www.ferring.com.

Ferring is on Twitter. Follow us @FerringNews at http://twitter.com/FerringNews

For more information, please contact

Lindsey Rodger
Corporate Communications Manager
+41 58 451 40 23 (direct)
+41 79 191 0486 (mobile)
lindsey.rodger@ferring.com

Bhavin Vaid
Head of Corporate Communications
+41 58 301 09 52 (direct)
+41 79 191 06 32 (mobile)
bhavin.vaid@ferring.com

Paul Navarre joins Ferring Pharmaceuticals as Chief Executive Officer of Ferring Holding Inc.

Parsippany, N.J. – June 1, 2017 –

Ferring Pharmaceuticals announced today that Paul Navarre has been appointed Chief Executive Officer of Ferring Holding Inc. In this role Mr. Navarre assumes direct responsibility for all Ferring US activities including commercial operations, clinical development and manufacturing. He succeeds Aaron Graff, who has been appointed to a global role as Executive Vice President, Chief Commercial Officer and member of the Ferring Group Executive Board.

“Ferring is a fast growing pharmaceutical company with a unique culture centered on people and patients. I am very excited to lead this organization into the next phase of its development,” said Mr. Navarre.

Paul Navarre has more than 25 years’ experience in the pharmaceuticals and consumer goods industries. He joins Ferring from Allergan, where as President of Allergan International, he managed a $3 billion specialty care business covering dermatology, ophthalmology, urology and neurosciences. During 10 years at Allergan, Mr. Navarre built a strong track record, delivering solid business results and developing multiple successful organizations.

Before joining Allergan, Mr. Navarre spent 15 years at Procter & Gamble, starting in consumer goods before moving to the company’s pharmaceuticals division. During this time, he held positions of increasing responsibility in France, the USA, Switzerland, Italy and the UK.

As CEO, Mr. Navarre will report to the board of directors of Ferring Holding Inc., chaired by Michel Pettigrew, President of the Executive Board and Chief Operating Officer, Ferring Group.
“Paul’s extensive pharmaceutical specialty care experience and proven international leadership skills will help him take our successful US operations to the next level, pursuing our rapid expansion,” said Michel Pettigrew.

– ENDS –

About Ferring Pharmaceuticals Inc.

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, gastroenterology, infertility, obstetrics/gynecology, orthopaedics, and urology.

For more information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.

For more information, please contact

Patrick Gorman
+1-862-286-5035
patrick.gorman@ferring.com

Ferring appoints Aaron Graff to Executive Board

Saint-Prex, Switzerland – 1 June 2017 –

Ferring Pharmaceuticals announced today that Aaron Graff has been appointed Executive Vice President and Chief Commercial Officer and made a member of the Ferring Executive Board, effective immediately.

Aaron Graff joined Ferring in 2002 as Vice President Global Marketing, Business Development, and Medical Affairs, based in Copenhagen, Denmark. After leading the acquisition and integration of Israeli biopharmaceutical company BTG in 2005, he relocated his team to the newly established Ferring International Center in Saint-Prex, Switzerland, where he was promoted to Senior Vice President, Asia Region and Global Marketing. Since 2010, Graff has led Ferring’s U.S. operations from its U.S headquarters in New Jersey, first as Chief Operating Officer and since 2016 as Chief Executive Officer.

“Under Aaron’s leadership in the United States, our U.S. business grew at double-digit rates,” said Michel Pettigrew, President of the Executive Board and Chief Operating Officer, Ferring Pharmaceuticals. “His broad, global professional experience and track record make him uniquely qualified for this important role.”

Prior to joining Ferring, Graff worked at Bristol-Myers Squibb for over 17 years in a variety of sales, marketing and commercial operations management positions.

– ENDS –

About Ferring Pharmaceuticals

Headquartered in Saint-Prex, Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. A leader in reproductive and maternal health, Ferring has been developing treatments for mothers and babies for over 50 years. Today, over one third of the company’s research and development investment goes towards finding innovative treatments to help mothers and babies, from conception to birth. The company also identifies, develops and markets innovative products in the areas of urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

For further information on Ferring or its products, visit www.ferring.com.

For more information, please contact

Lindsey Rodger
+41 (0) 58 451 40 23
lindsey.rodger@ferring.com

Carine Julen
+41 58 301 01 78
carine.julen@ferring.com