Ferring Pharmaceuticals acquires novel drug delivery technology from CTCBIO Inc.

Saint-Prex, Switzerland – 23 February 2015 –

Ferring Pharmaceuticals announced today that it has signed an agreement with CTCBIO Inc. of Seoul, South Korea to acquire rights to a novel oral drug delivery technology.

Ferring’s success in developing oral formulations for peptide drugs including the world’s first orally active peptide, desmopressin (MINIRIN®) and the fast dissolving lyophilisate (MINIRIN® Melt), is well known. CTCBIO is a growing specialist company that has developed successful manufacturing technologies for more than 30 different drugs, including treatments for dementia and asthma.

“Ferring has been a pioneer in the development of novel oral drug delivery technologies,” says Per Falk, MD, PhD, Executive Vice President and Chief Scientific Officer at Ferring, “Our portfolio of peptide therapeutics make us an attractive partner for speciality technology-based companies like CTCBIO to collaborate on new approaches for oral drug delivery of peptides and proteins.”

“Keeping the active pharmaceutical ingredient stable and secure is critical,” explained Dr. Jeon, Hongryeol, Vice President of CTCBIO. “This technology makes this possible and is particularly useful for hydrophilic macromolecules like peptides and proteins while offering the advantage of oral administration.”

Under the agreement involving an undisclosed up-front payment, milestone and royalty terms, the two companies will collaborate to develop prototype formulations for in-vitro and in-vivo testing and the subsequent up-scaling required to manufacture the technology to meet worldwide good manufacturing practice (GMP) requirements.

– ENDS –

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.

MINIRIN and FERRING are trademarks of Ferring B.V.

About CTCBIO Inc.

CTCBIO, INC. operates as a biotechnology company in South Korea and internationally. The company develops pharmaceutical products and food additives. It also develops technology for functional foods and dairy products, as well as provides various bacteria to develop products. The company was founded in 1995 and is headquartered in Seoul, South Korea. (Source: Bloomberg)

For more information, please contact

Ferring announces European launch of CORTIMENT®MMX® (budesonide) for ulcerative colitis, and new data re-confirms safety and efficacy

Saint-Prex, Switzerland – 20 February 2015 –

Ferring Pharmaceuticals announced today the European launch of CORTIMENT^®MMX® (budesonide), the first and only approved oral controlled release budesonide treatment for active mild-to-moderate ulcerative colitis (UC) where mesalazine (5-ASA) treatment is not sufficient. Simultaneously, new data from the CONTRIBUTE trial showed that adding CORTIMENT^®MMX® 9 mg was significantly more effective than placebo at inducing combined clinical and endoscopic remission in patients with ulcerative colitis experiencing a flare up despite oral 5-ASA therapy. The data were presented today at the 10^th Congress of the European Crohn’s and Colitis Organisation (ECCO).¹

“The data confirm the efficacy and safety of CORTIMENT^®MMX® in patients experiencing an active flare of UC despite initial oral 5-ASA therapy, and in a controlled setting that is consistent with clinical practice and the ECCO treatment guidelines,²” said Dr David Rubin, Professor of Medicine at the University of Chicago Medicine and lead CONTRIBUTE author. “CORTIMENT^®MMX® is an important new option for treating active mild-to-moderate ulcerative colitis.”

Ulcerative colitis, which affects over 2 million people in Europe,³ is a life-long chronic inflammatory condition affecting the colon and rectum. Where treatment with oral 5-ASA is not sufficient to induce remission, patients are currently treated with systemic corticosteroids, which are associated with significant side effects.² CORTIMENT^®MMX® therefore fulfils an unmet need, providing gastroenterologists with an orally administered alternative to systemic corticosteroids with an adverse event profile comparable to placebo.⁴

A spokesperson for the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA) said, “Ulcerative colitis can be a difficult condition to manage, particularly during a flare up, with many unpleasant symptoms on a daily basis. There are also significant emotional, societal and economic costs. Any new treatment which can induce remission with fewer side effects will be welcomed by people with ulcerative colitis across Europe and beyond.”

Michel Pettigrew, President of the Executive Board and COO at Ferring commented: “With the European launch of CORTIMENT^®MMX®, a new treatment with a novel formulation for active, mild-to-moderate ulcerative colitis, we are expanding our portfolio and delivering on the Ferring commitment to innovation in gastroenterology.”

CORTIMENT^®MMX® has been developed by Cosmo Pharmaceuticals SpA. Ferring is the licensee in the EU and Asia (excluding Japan), Australia, Canada, Latin America and Africa. In the United States, where the product is available as UCERIS®, the licensee is Salix Pharmaceuticals, Inc.

– ENDS –

About CORTIMENT^®MMX®

CORTIMENT^®MMX® contains budesonide, a locally acting glucocorticosteroid, in a novel, patented, oral tablet formulation utilizing MMX^® multimatrix colonic delivery technology that is designed to result in the controlled 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 systemic bioavailability. In phase III studies, 2.4 to 3.9 times more patients achieved clinical and endoscopic remission with CORTIMENT^®MMX® compared to placebo, and no clinically significant glucocorticosteroid side effects were seen versus placebo after eight weeks of treatment (CORE I trial and CORE II trial respectively).^4,5

CORTIMENT^®MMX® is indicated in adults for induction of remission in patients with active mild-to-moderate active ulcerative colitis where 5-ASA (aminosalicylate) treatment is not sufficient. The approved dosing regimen for adult patients is one 9 mg tablet taken once daily for up to 8 weeks. Some patients may benefit from initial treatment with CORTIMENT^®MMX® when recommended by their doctor.⁶ CORTIMENT^®MMX® may be marketed under other names in some countries.

About Ulcerative Colitis

Ulcerative colitis is 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. It is believed that 1.5 million in European Union and 2.1 million in the total European population suffer from ulcerative colitis.³

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 sufficiently 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 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.

FERRING, CORTIMENT and PENTASA are trademarks of Ferring B.V. MMX is a trademark of Cosmo Pharmaceuticals SpA. UCERIS is a registered trademark of Santarus, Inc, a wholly owned subsidiary of Salix Pharmaceuticals, Inc.

For more information, please contact

Patrick Gorman
+41 58 301 0053
patrick.gorman@ferring.com

Daniel Batty
+44 20 7300 6356
daniel.batty@bm.com

References

1. Rubin R et al. Budesonide MMX^® 9 mg for Inducing Remission in Patients with Mild-to-Moderate Ulcerative Colitis Not Adequately Controlled with Oral 5-ASAs. Abstract Number: A-1402, presented (OP011) at 10th Congress of ECCO, 20.02.2015
2. Dignass A, Lindsay JO, Sturm A et al. Second European evidence-based consensus on the diagnosis and management of ulcerative colitis part 2: current management. J Crohn’s Colitis. 2012;6:991-1030
3. Burisch J, Jess T, Martinato M, Lakatos P on behalf of ECCO –EpiCom. The burden of inflammatory bowel disease in Europe. Journal of Crohn’s and Colitis – 1 May 2013 (Vol. 7, Issue 4, Pages 322-337, DOI: 10.1016/j.crohns.2013.01.010)
4. Travis SP, Danese S, Kupcinskas L et al. Once-daily budesonide MMX in active, mild-to-moderate ulcerative colitis: results from the randomised CORE II study. Gut 2014;63:433-41
5. Sandborn WJ, Travis S, Moro L et al. Once-daily budesonide MMX^® extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012;143:1218-26
6. Ferring Pharmaceuticals. CORTIMENT® 9 mg SmPC. Date of Revision Text: October 2014.

Ferring Pharmaceuticals acquires two phase III ready orthobiologic product candidates from BioSET

Saint-Prex, Switzerland – 18 February 2015 –

Ferring Pharmaceuticals announced today that it has acquired the assets of BioSurface Engineering Technologies, Inc. (BioSET), including two phase III ready orthobiologic product candidates designed to improve bone repair. The initial indications for AMPLEX® and PREFIX® to be investigated are fusion in foot/ankle and lumbar spine surgical procedures, respectively. Both products are based on a unique biomimetic peptide designed to enhance the body’s own natural mechanisms of bone repair.

Orthopaedics has grown to become one of five key therapeutic areas for Ferring since the 2005 launch of EUFLEXXA® (1% sodium hyaluronate) for the treatment for knee pain due to osteoarthritis.

“With the acquisition of the BioSET portfolio, Ferring intends to build on its growing success in orthopaedics,” said Michel Pettigrew, President of the Ferring Executive Board and COO, “By developing new orthobiologic products for joint fusion, we will expand and diversify our offering to include innovative solutions for orthopaedic surgery.”

Each year approximately two million procedures involving bone graft materials, including approximately 700,000 fusions, are performed in the U.S. alone. This number is increasing more than 5 percent annually¹ as orthopaedic surgeons treat an expanding, aging population of patients with severe bone degeneration and traumatic defects.

In addition to AMPLEX and PREFIX, Ferring has acquired a library of rationally designed biomimetic peptides intended for applications in bone and tissue repair.

– ENDS –

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.

All trademarks mentioned are property of Ferring.

For more information, please contact

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

Patrick Gorman
+41 (0) 58 301 00 53
patrick.gorman@ferring.com

References

1. 014 BioMEDGPS

Ferring Pharmaceuticals moves to strengthen growth with appointment of Chief Medical and Chief Scientific officers

Saint-Prex, Switzerland – 27 January 2015 –

Ferring Pharmaceuticals announced today the appointment of Pascal Danglas, MD as Executive Vice President and Chief Medical Officer and Per Falk, MD, PhD as Executive Vice President and Chief Scientific Officer. Both appointments are effective as of 1 February.

“Ferring aims to expand its portfolio and improve patient access to our products,” said Michel Pettigrew, President of the Executive Board and Chief Operating Officer of Ferring. “By focusing our efforts in R&D and patient access under these two proven leaders, Ferring is positioning itself to accelerate growth and better meet patient needs.”

As Chief Medical Officer, Pascal Danglas will evaluate and advise on new product candidates. He will also focus on strengthening patient access to Ferring products as the company’s liaison to the medical community, patients and national reimbursement authorities. An industry veteran, Danglas previously served as executive vice president of clinical and product development with Ferring.

Per Falk joins Ferring as Chief Scientific Officer after a successful assignment as senior vice president responsible for biopharmaceuticals research at Novo Nordisk A/S. In his new role, Falk will be responsible for overseeing the entirety of Ferring’s research and development activities, from basic research through to regulatory approval.

– ENDS –

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

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

Patrick Gorman
+41 (0) 58 301 00 53
patrick.gorman@ferring.com

Ferring Pharmaceuticals Announces Grand Opening of U.S. Operations Center

New facility underscores long-term commitment to the U.S. and to New Jersey

© 2014 Ferring B.V.
Image: Maggie McGill Photography

Parsippany, NJ, USA – 4 December 2014 –

Ferring Pharmaceuticals has expanded its footprint in New Jersey with the opening of its new U.S. Operations Center on a 25-acre lot located at 100 Interpace Parkway in Parsippany. Instead of relocating or outsourcing manufacturing to other states or overseas, Ferring’s new center is a sign of the company’s continued commitment to New Jersey and bringing new jobs to the local community.

The facility recently completed the integration of staff into the state-of-the-art manufacturing suite and product development laboratories. The U.S. Operations Center will house 275 employees across management, administration, commercial operations, manufacturing and R&D, a set up designed to allow unique opportunities for collaboration across various operational disciplines. Ferring plans to expand that number significantly as the manufacturing facility gradually comes online over the course of the next 18 to 24 months.

“This is just the start of an exciting journey of growth to come,” said Michel Pettigrew, CEO, Ferring Holding Inc. and President of the Executive Board and Chief Operating Officer, Ferring Group. “We hope this new operations center stands as a symbol of our philosophy as a company – a place where our commitment to the science and to our patients is front and center; a learning environment where employees are encouraged to take initiative and stretch beyond their designated role; and a cornerstone of the community, dedicated to giving back.”

The facility allows the company to reinforce its commitment to New Jersey at a time when many pharmaceutical companies are making out-of-state moves. The approach is an example of Ferring’s dedication to the community it serves. Moreover, the move to stay in state provides access to experienced pharmaceutical talent and world class academic institutions. Notably, Ferring is also working with several organizations in New Jersey to offer open positions to veterans of the U.S. armed forces.

“This grand opening serves as a reminder of our commitment to the U.S., New Jersey and to our long-term view on the science that can make a real difference in the lives of the patients we serve,” said Aaron Graff, President and COO Ferring Pharmaceuticals Inc. “As I watch our teams start to integrate into the new operations center, I already see the positive impact the space has on our ability to collaborate across functions within the organization and provide a premium workspace for our employees.”

About Ferring Pharmaceuticals

Ferring Pharmaceuticals Inc. is a member of the Ferring Pharmaceuticals group, a privately owned, international pharmaceutical group. 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); visit www.FerringUSA.com.

For more information, please contact

Media Contact
Christy Maginn
202.530.4730
Christy.Maginn@bm.com