Ferring Pharmaceuticals and North Zealand University Hospital mark first milestone in innovative IBD collaboration

Saint-Prex, Switzerland – 31 August, 2016 –

Ferring Pharmaceuticals and North Zealand University Hospital (Nordsjællands Hospital) yesterday formally inaugurated a multi-year collaboration aimed at transforming the way in which patients with inflammatory bowel disease (IBD) and irritable bowel syndrome (IBS) manage their condition and receive medical care.

During the event, held at North Zealand University Hospital in Copenhagen, local doctors, researchers and IBD patients learned more about the eHealth-based programme and its potential to increase adherence to treatment and reduce time-to-remission.

“We have already implemented web-ward rounds in the eHealth out-patient clinic,” said Bente Ourø Rørth, Head of North Zealand University Hospital. “Our web-based application empowers patients to home-monitor, giving them the opportunity to detect a relapse sooner than in a standard care setting.”

The collaboration reflects Ferring’s long-term commitment to enhancing the quality of life and quality of care of IBD patients through the development of personalised, ‘beyond-the-pill’ solutions and innovative scientific research, including the exploration of the human microbiome.

Ferring’s collaboration with the hospital also evaluates the role of microbiota in IBD patient responses to different treatments in an eHealth setting. As the first test site, information and patient data generated from the programme will be used to refine the eHealth tool and provide more insights into treatment options before it is rolled out more widely.

“Research into the microbiome is changing our perspectives on health and disease, but there are still many factors that are not yet known or properly understood,” said Per Falk, Executive Vice President and Chief Scientific Officer, Ferring Pharmaceuticals. “Ferring is committing to advancing research in this area, with the ultimate goal of generating personalised treatment for IBD patients and early interventions for those at risk of developing the disease.”

– ENDS –

About Inflammatory Bowel Disease (IBD)

Inflammatory bowel disease (IBD) is a chronic relapsing idiopathic inflammation of the gastrointestinal tract (GIT). The two most common forms of IBD are Crohn’s disease and Ulcerative colitis which together affect over 3.6 million people worldwide. IBD is characterized by an aberrant mucosal immune response observed locally in the GIT leading to impaired epithelial barrier function and tissue destruction. Over the past decade IBD has emerged as one of the most studied human conditions linked to the gut microbiota.

About Irritable Bowel Syndrome (IBS)

Irritable bowel syndrome (IBS) on the other hand has no organic cause, however, has been linked to dysbiosis of the gut microbiota in many studies. IBS is the most common GI disorder affecting 10-15% in the industrialized world. Abdominal pain and altered bowel habits are the most bothersome symptoms for many IBS patients which greatly affect their quality of life. Treatment of IBS patients relies so far on symptom reduction. Many IBS patients have reported their symptoms to be triggered by meals or specific food. Food is also one of the most important environmental factors impacting the microbial composition in the gut.

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 have not yet been cultivated.

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

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

Ferring Pharmaceuticals Acquires Exclusive Licensing Rights to Condoliase from Seikagaku Corporation

Saint Prex, Switzerland – August 29, 2016 –

Ferring Pharmaceuticals announced today that it has signed an agreement with Seikagaku Corporation granting Ferring the exclusive worldwide rights (excluding Japan) to SI-6603 (condoliase), a chemonucleolytic product in Phase III development for the treatment of radicular leg pain (e.g. sciatica) due to lumbar disc herniation.

Seikagaku has been developing condoliase for the U.S. and Japan and has two on-going Phase III clinical trials (a pivotal double-blind study and an open-label safety study). Seikagaku is responsible for completing development and obtaining U.S. regulatory approval. Following approval from the Food and Drug Administration, Ferring will commercialize the product in the United States and has received further rights to develop, register and commercialize condoliase worldwide, excluding Japan. In consideration, Ferring will pay Seikagaku an upfront licensing fee, development and regulatory milestones and royalties.

“We believe condoliase may answer a substantial unmet need among those patients suffering from radicular leg pain due to lumbar disc herniation,” said Michel Pettigrew, President of the Ferring Executive Board and COO. “This is a significant opportunity to expand our global Orthopaedics franchise with a new innovative drug therapy.”

“Condoliase is an exciting product being developed with the potential to return a proven mechanism, chemonucleolysis, as a treatment alternative for radicular leg pain associated with lumbar disc herniation,” said Gunnar Andersson, MD, Professor and Chairman Emeritus of the Department of Orthopaedic Surgery at Rush University Medical Center in Chicago, U.S.A.

“Condoliase could offer a non-surgical alternative to patients for whom conservative therapy and/or corticosteroid injections have failed to provide durable relief, while maintaining the option for surgery should it later become medically necessary,” said Ray Baker, MD, past president, North American Spine Society.

– ENDS –

About radicular leg pain and Condoliase (SI-6603)

Lumbar disc herniation (LDH) is the result of a progressive and degenerative process within the intravertebral disc (IVD) that affects between 1.6% of the general population to 43% of individuals in selected working groups worldwide, with the majority of incidents occurring in the fourth and fifth decades of life^1,2. In the US, 3 to 5% of the population is symptomatic (i.e. sciatica)³. The IVD is made up of the nucleus pulposus and annulus fibrosis that together cushion and allow flexibility within the spine. The disc herniation may increase pressure on a surrounding root nerve resulting in lower back pain and radicular leg pain (e.g. sciatica).

Condoliase is being developed for use as a chemonucleolysis treatment to break down selected components of the IVD, primarily within the nucleus pulposus. This reduces its water content and volume, thereby relieving disc pressure and compression on the spinal nerve root. A Japanese Phase III study (163 patients) met its primary endpoint of significantly reducing worst leg pain at 13 weeks (vs. a saline placebo injection) with sustained relief at 52 weeks⁴.

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 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

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

Global
Lindsey Rodger
+41 58 451 40 23
lindsey.rodger@ferring.com

References

1. Konstantinou, K., Dunn, K.M. Spine (Phila Pa 1976) 2008, 33, 2464-2472
2. Ropper, A.H., Zafonte, R.D. New Engl J Med 2015, 372, 1240-1248
3. Tarulli, A, W et al. Neurol Clin 2007, 25, 387-405
4. Seikagaku (Study 6603/1031) Data on File)

Ferring announces Phase 3 data for investigational human recombinant FSH with individualised dosing regimen at the 32nd Annual Meeting of ESHRE®

Saint-Prex, Switzerland – 4 July 2016 –

Data from the Phase 3 ESTHER trials (Evidence-based Stimulation Trial with Human recombinant follicle-stimulating hormone (FSH) in Europe and Rest of World) were presented today at the 32^nd Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Helsinki, Finland.

ESTHER-1, a randomised, assessor-blind, controlled, multicentre trial in women aged 18–40 years undergoing their first cycle of in-vitro fertilisation (IVF) or intracytoplasmic injection (ICSI) assessed an individualised dosing regimen of follitropin delta compared to follitropin alfa (conventional dosing regimen).¹

The individualised dosing regimen for follitropin delta was based on the patient’s serum anti-Müllerian hormone (AMH) level (a parameter used to assess ovarian reserve) and body weight. This individualised dosing regimen was used from the first day of controlled ovarian stimulation to determine an appropriate dose of FSH with the aim of minimising the risk of poor and excessive ovarian response in IVF or ICSI.^1,2

Non-inferiority was demonstrated for the co-primary endpoints of ongoing pregnancy rate (30.7% vs 31.6%; LL 95% CI -5.9%) and ongoing implantation rate (35.2% vs 35.8%; LL 95% CI -6.1%) for follitropin delta compared to follitropin alfa.¹

Secondary endpoints, including the number of oocytes retrieved and number of blastocysts obtained, were comparable between both groups. In addition, ovarian hyperstimulation syndrome (OHSS) and/or OHSS preventive interventions occurred less frequently (p<0.05) in women receiving follitropin delta than in women in the follitropin alfa group.¹

“This trial is an integral part of Ferring’s commitment to help couples conceive by translating the practice of personalised medicine into reproductive health and fertility,” commented Joan-Carles Arce, M.D., Ph.D., Vice President Clinical Research & Development, Ferring. “We believe that by focusing on innovative and personalised approaches to treatment, we can continue to lead the way in assisted reproductive technology.”

Additional data from the ESTHER-2 trial presented at the meeting demonstrated no increased immunogenicity risk following controlled ovarian stimulation with follitropin delta after exposure in repeated cycles.³

– ENDS –

About the ESTHER trials

The ESTHER trials were randomised, assessor-blind, controlled, multicentre trials involving fertility clinics in Europe, Canada, Brazil and Russia.^4,5

ESTHER-1^1,4

The ESTHER-1 trial established non-inferiority for ongoing pregnancy rates and ongoing implantation rates for follitropin delta (individualised dosing regimen) compared to follitropin alfa (conventional dosing regimen), in women undergoing their first IVF/ICSI cycle. The trial randomised 1,326 women aged 18–40 years to either a daily, individualised dose of follitropin delta which was fixed throughout stimulation, or a daily follitropin alfa dose of 150 IU (11 µg) for the first five days, which could thereafter be adjusted by the investigator according to the patient’s response.

• Non-inferiority was established for ongoing pregnancy rate (30.7% vs 31.6%; LL 95% CI -5.9%) and ongoing implantation rate (35.2% vs 35.8%; LL 95% CI -6.1%) for follitropin delta compared to follitropin alfa.
• The number of oocytes retrieved was similar for follitropin delta and follitropin alfa in the overall population (10.0 and 10.4, respectively).
• More (p<0.05) patients using the fixed, individualised dosing regimen of follitropin delta obtained the target 8–14 oocytes, as compared to those using the conventional dosing regimen of follitropin alfa. This is despite dose adjustments in 36.8% of follitropin alfa patients. As requested by the protocol, there was no dose adjustment in the follitropin delta group.
• OHSS preventive interventions occurred less frequently (p<0.05) in patients receiving an individualised dose of follitropin delta than in patients in the follitropin alfa group.
• The number of blastocysts obtained was comparable between follitropin delta and follitropin alfa (3.3 and 3.5, respectively).

ESTHER-2^3,5

In the ESTHER-2 trial, a subset of women underwent additional assessor-blind stimulation cycles (a total of 513 in cycle 2, and 188 in cycle 3). In all treatment cycles, blood samples for anti-FSH antibody analyses were collected at stimulation day 1 (pre-dosing) as well as 7–10 days (first post-dosing) and 21–28 days (second post-dosing) after the last gonadotropin dose.

• No increased immunogenicity risk was found following COS with follitropin delta, neither in the first treatment cycle nor after exposure in repeated cycles.
• The incidence of anti-FSH antibodies prior to exposure to follitropin delta was 1.4% after treatment. With follitropin delta, the incidence of anti-FSH antibodies was 1.1% in cycle 1, 0.8% in cycle 2 and 1.1% in cycle 3.
• These incidences were similar to those observed for follitropin alfa.

About follitropin delta

Follitropin delta (also known as FE 999049) is the first recombinant FSH derived from a human cell line (human rFSH), and has been developed for individualised dosing based on serum AMH level and body weight.^1,6 Follitropin delta is structurally and clinically distinct from other existing recombinant follicle stimulating hormone treatments.^6,7

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

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

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

References

1. Nyboe Andersen A and Arce JC on behalf of the ESTHER-1 trial group. Efficacy and safety of follitropin delta in an individualised dosing regimen: A randomised, assessor-blind, controlled phase 3 trial in IVF/ICSI patients (ESTHER-1). Poster presented at 32nd Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Helsinki, 3–6 July 2016.
2. La Marca A and Sunkara SK. Individualization of controlled ovarian stimulation in IVF using ovarian reserve markers: from theory to practice. Hum Reprod Update 2014;20:124–140.
3. Buur Rasmussen A et al, on behalf of the ESTHER-1 and ESTHER-2 trial group.  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). Poster presented at 32nd Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Helsinki, 3–6 July 2016.
4. ESTHER-1 trial. www.clintrials.gov Available at: https://clinicaltrials.gov/ct2/show/NCT01956110. Last accessed: June 2016.
5. ESTHER-2 trial. www.clintrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT01956123. Last accessed: June 2016.
6. 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.
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):1299–307.

Please note that this press release does not imply endorsement by ESHRE^®

Ferring Pharmaceuticals announces approval of new tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label in MRP countries in Europe

Ferring Pharmaceuticals has successfully finalised a Mutual Recognition Procedure (MRP) submitted in Europe on 28 October 2015 with the UK as a Reference Member State (RMS). The proposed variation introduces a tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label as supported by the results of the OPTIMA trial. National Marketing Authorisations are expected in the majority of EU countries in the following months.

Saint Prex, Switzerland – 27 June 2016 –

Ferring Pharmaceuticals today announced that the tailored dosing regimen in the PICOPREP® (sodium picosulfate, magnesium oxide, citric acid) label has received approval in the MRP countries in Europe.

The approval is based on data from the OPTIMA clinical trial demonstrating that the PICOPREP® tailored dosing regimen was superior in providing good to excellent visibility in the entire colon compared to the currently approved PICOPREP® day-before dosing regimen¹.

In the tailored dosing regimen, 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 to 18 hours before, and the second sachet 4 to 6 hours before the colonoscopy in line with guideline recommendations^3–5.

The time interval between the last dose of the bowel preparation and the colonoscopy procedure can be considered the most important determinant of colon cleansing quality², with shorter time intervals associated with colon cleansing of higher quality^2–5.

“The approval is a significant milestone in aligning the label with the guideline recommendations of shorter time interval between the last dose of the bowel preparation and the colonoscopy procedure^3–5,” said Pascal Danglas, MD, Chief Medical Officer, Ferring Pharmaceuticals. “Compared to the current day-before dosing regimen, tailored dosing of PICOPREP® results in higher quality colon cleansing enabling more successful colonoscopies¹.”

– 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 one year old and adults. This product is sold in some countries under the trademarks PICO-SALAX^®, PICOLAX^® or PREPOPIK^®.

About OPTIMA trial

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.

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-oncology, gastroenterology, endocrinology and orthopaedics. Ferring Pharmaceuticals has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

To learn more about Ferring Pharmaceuticals 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. Kiesslich R, Angelin C, Raymond K, et al. A randomised, assessor-blinded, multicentre trial comparing the efficacy, safety, and tolerability of a new tailored dosing regimen to day-before dosing regimen of colon cleansing agent used before colonoscopy. J Crohn Colitis 2016;10,suppl.1:S278.
2. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.
3. Hassan C, Bretthauer M, Kaminski MF, et al. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) Guideline Endoscopy 2013;45:142-150.
4. Mathus-Vliegen E, Pellise M, Heresbach D, et al. Consensus guidelines for the use of bowel preparation prior to colonic diagnostic procedures: colonoscopy and small bowel video capsule endoscopy Curr Med Res Opin 2013; 29: 931 – 945.
5. Johnson DA, Barkun AN, Cohen LB, et al. Optimizing adequacy of bowel cleansing for colonoscopy recommendations from the US Multi-Society Task Force on colorectal cancer. Gastroenterology 2014;147:903–924.

Ferring demonstrates commitment to R&D investment through expanded Innovation Grants Program

Saint Prex, Switzerland – 21 June 2016 –

The Ferring Innovation Grants Program, which is now open for applications, has been significantly expanded as part of Ferring’s continued commitment to investing in research and development (R&D).

An initiative of the Ferring Research Institute (FRI), the program provides annual grants of up to $100,000 for early stage research, with a focus on novel extracellular drug targets addressable with peptides or proteins within Ferring’s core therapeutic areas: reproductive health, gastroenterology, urology, and endocrinology.

Total funding for this year’s program has been increased from $250,000 to $950,000. Together with changes to the application process and grants structure, this will open up the program to more applicants from leading research centres.

“The Innovation Grants Program is part of our broader commitment to stimulating basic research, with the ultimate aim of developing innovative products that improve the lives of patients,” said Per Falk, Executive Vice President and Chief Scientific Officer, Ferring Pharmaceuticals.

“It’s tremendous to be able to tap into the wider research community for new ideas,” said Keith James, President of FRI and Senior Vice President, Research and Development. “The program gives us a powerful window on external innovation in
our therapeutic areas of interest.”

For more information on this year’s program, please visit: www.ferring-research.com/ferring-grants

– ENDS –

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
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