Positive phase III data unveiled for new GnRH blocker degarelix

Degarelix suppressed testosterone within three days in 96% of patients.

Milan, Italy – 27 March 2008 –

Data from a Phase III study presented at the 23rd Annual European Association of Urology Congress demonstrated that the investigational GnRH blocker, degarelix, produced a significant reduction in levels of testosterone^1,2 within three days in more than 96% of study patients.²

The new data show that degarelix provided an extremely fast effect on testosterone levels, close to the immediate effect achieved with surgery (orchidectomy).^2,3

The phase III study compared monthly administration of degarelix with monthly LHRH agonist leuprorelin’s 7.5 mg in a 12-month randomised, open-label, parallel-group study in prostate cancer (PCa) patients. In comparison to leuprorelin, degarelix suppressed serum testosterone and Prostate Specific Antigen (PSA) significantly faster. In addition, degarelix was able to sustain these low levels during the entire 12 month study.²

By day 3 of the study, testosterone levels were suppressed to ≤ 0.5ng/mL in 96.1% of patients in the degarelix arms of the study compared to 0% in the leuprorelin arm. By day 14, 100% of patients in the degarelix arms achieved suppression of testosterone levels at ≤0.5ng/mL compared to 18.2% in the leuprorelin arm.²

“Our goal is always to have a fast and sustained reduction in testosterone levels” said Mr John Anderson, Consultant Urological Surgeon, The Royal Hallamshire Hospital, Sheffield, United Kingdom “This new data shows that degarelix produced an extremely rapid impact, approaching the immediacy of surgery.”

After 14 days of treatment, PSA levels had declined in the degarelix treated patients by a median of 64%, while patients who were administered leuprorelin saw an 18% decline. Both treatments were well tolerated and showed similar side effect profiles.

“What patients want is a medical treatment which has the efficacy impact of orchidectomy but without its more distressing physical and psychological effects,” commented Dr Erik Briers, of patient organization Europa Uomo, Belgium. “A pharmaceutical treatment that could offer extremely rapid suppression of testosterone would be a very welcome addition to the options for men with prostate cancer.”

Degarelix went through an extensive clinical programme of more than 20 studies. All studies have found degarelix to be safe, well tolerated and with no evidence of systemic allergic reactions.^2,4,5

– Ends –

Notes for editors

About Prostate Cancer

Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In the US 218,890 new cases were estimated for 2007, with a mortality rate of 27,050. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan.

About degarelix

Degarelix is a GnRH blocker currently being developed for prostate cancer. Ferring submitted a New Drug Application (NDA) to the FDA and EMEA in February 2008.

About Ferring Pharmaceuticals

Ferring is a Swiss-based, research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of urology, endocrinology, gastroenterology, gynaecology, and fertility. In recent years Ferring has expanded beyond its traditional European base and now has offices in over 40 countries. To learn more about Ferring or our products please visit www.ferring.com.

References

1. 1. Van Poppel H, De La Rosette JJ, Persson B.E, Oleson TK, Degarelix Study Group; Long-term evaluation of degarelix, a gonadotrophin-releasing hormone (GnRH) receptor blocker, investigated in a multicentre randomised study in prostate cancer (CAP) patients. Abstract (23.) Euro Urol Suppl 2007;6(2):28.
   2. Boccon-Gibod L, Klotz L, Schröder FH, Andreou C, Persson BE, Cantor P, Jensen JK, Olesen TK; Degarelix compared to leuprolide depot 7.5 mg in a 12-month randomized, open-label, parallel-group phase III study in prostate cancer patients. Abstract 537 presented at the 23rd EAU Congress, Milan, Italy, 2008.
   3. Nielsen S, Connolly M, Persson B, Variation between countries in the perceived use of antiandrogens to prevent flare symptoms: results of a comprehensive survey. Abstract 539 presented at the 23rd EAU Congress, Milan, Italy, 2008.
   4. Gittelman M, Pommerville P, Persson B, Olesen T, One-year North American multicentre, randomized dose-finding study of degarelix, a gonadotropin-releasing hormone (GnRH) receptor blocker, in prostate cancer patients. Poster presented at 1st EMUC, Barcelona, 2-4 Nov 2007.
   5. Tammela T, Iversen P, Johansson J, Persson B, Jensen J, Olesen T.Degarelix-a phase II multicentre, randomised dose escalating study testing a novel GnRH receptor blocker in prostate cancer patients (Abstract No. 904) European Urology Supplements 4 (2005) No.3, pp 228.

Ferring Pharmaceuticals submits new drug application for degarelix, a prostate cancer treatment

Plan to launch GnRH blocker in 2009 subject to regulatory approval.

Saint-Prex, Switzerland – February 28, 2008 –

Ferring Pharmaceuticals announced today that it has submitted applications in Europe and the United States for the marketing authorisation of its prostate cancer treatment, degarelix, a new GnRH receptor blocker intended for patients in whom androgen deprivation is warranted.

The applications follow the successful completion of a pivotal phase 3 study, in which degarelix was studied for the speed of the suppression in levels of testosterone, the maintenance of the reduction during the one year study period as well as prostate-specific antigen (PSA) reduction.

“We believe that the data for degarelix is convincing and demonstrates the benefits that this drug can offer to patients suffering from the most common form of cancer in men,” said Dr. Pascal Danglas, Ferring’s Executive Vice President of Clinical and Product Development. “Subject to approval by regulatory bodies, we plan to start launching globally in 2009.”

– Ends –

Notes for editors

About Prostate Cancer

Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In the US 218,890 new cases were estimated for 2007, with a mortality of 27,050. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan.

About Ferring Pharmaceuticals

Ferring is a Swiss-based, research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, fertility and urology.  In recent years Ferring has expanded beyond its traditional European base and now has offices in over 40 countries. To learn more about Ferring or our products please visit www.ferring.com.

Launch of new, prestigious infertility and gynaecology research grant (FRIGGA) at “Update in Infertility 2008”

Update in Infertility Meeting, Cape Town, South Africa – 30 January, 2008 –

Ferring Pharmaceuticals today launches the first Ferring Research Infertility and Gynaecology GrAnt (FRIGGA) for fundamental fertility and gynaecology research. This is an international, themed, biennial initiative open to individual researchers or research units/departments with the first awarded research projects to be completed by January 2010.

The chairman of the Update in Infertility meeting, Professor Paul Devroey, Free University Brussels, will lead the international expert judging panel for FRIGGA. Two grants to the value of €50,000 each will be awarded with the announcement of first recipients of the awards at the European Society of Human Reproduction and Embryology (ESHRE) congress in Barcelona (6 – 9 July 2008). The deadline for the submission of grant applications is 30 April 2008.

The award is named after Frigga, the goddess of fertility, motherhood, love, family and home from Scandinavian mythology. This name encapsulates both the objective of infertility research and treatment – parenthood – and echoes the company’s Scandinavian roots. The theme for the 2008 award is fundamental research leading to an increased understanding of the role of human chorionic gonadotrophin (hCG) in assisted reproduction.

Speaking at the Update in Infertility 2008 meeting, Mr. Michel Pettigrew, Chief Operating Officer at Ferring said, “We are committed to taking the lead in the field of assisted reproductive technologies (ART) and the launch of FRIGGA reflects this commitment. We look forward to innovative research carried out through the FRIGGA award that will increase our understanding of infertility and that in the future will help infertile couples around the world achieve their goal”.

In announcing the theme of the 2008 award, Paul Devroey, told the meeting “We have made great progress in the treatment of infertility in what is quite a short period of time for medicine. If, however, we are to meet the growing needs for treatment and the growing expectation of treatment standards, we need to progress much further. Further research is key to this progress. We know, for example, that hCG has great importance in the fertility process, but the exact role of this hormone still remains a mystery. The theme we have selected for the 2008 award is, therefore, fundamental research leading to an increased understanding of the role of human chorionic gonadotrophin (hCG) in assisted reproduction. I would like to thank Ferring for their commitment to the infertility field of medicine and for establishing the FRIGGA grant for research.”

For more information and a downloadable application form, please visit: www.ferringresearchgrant.com.

About Ferring Pharmaceuticals

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 fertility, obstetrics, urology, gastroenterology and endocrinology.  Ferring’s fertility portfolio of treatments gives infertile couples the chance to have babies and includes its flagship brand MENOPUR®, a recognised high quality treatment for infertility.  Ferring has operating subsidiaries in over 40 countries.  To learn more about Ferring or our products please visit www.ferring.com.

For more information, please contact

Yvonne Turner or Samantha Chalmers
Greenhouse Communications
+44 20 7798 9900 (direct)
+44 7905 294 576 (mobile)
+44 7790 001 959 (mobile)
samantha.chalmers@greenhouse-communications.com

Ferring pharmaceuticals completes phase III study of degarelix in prostate cancer patients

New drug application submission to be made in Q1 2008

Saint-Prex, Switzerland – December 3, 2007 –

Ferring Pharmaceuticals announced today that it has successfully completed the pivotal phase III study for degarelix, its novel prostate cancer treatment. The study met the primary objective of reducing levels of testosterone, while the safety profile was in line with previously conducted studies.

Degarelix is one of the first drugs in the emerging GnRH blocker class of treatments for prostate cancer. This class can offer important benefits versus existing prostate cancer therapies. Ferring intends to submit a New Drug Application (NDA) to the FDA and EMEA in the first quarter of 2008.

Dr. Pascal Danglas, Ferring’s Executive Vice President of Clinical and Product Development, commented: “with the successful completion of this phase III study, degarelix has become one of the most studied molecules in development in the field of prostate cancer. We are confident that the data generated will meet FDA and EMEA requirements and allow a fast and successful review of the file.”

“We believe that degarelix offers physicians and patients an important new prostate cancer treatment which can satisfy as yet unmet medical needs,” said Ferring’s Chief Operating Officer, Michel Pettigrew. “Once approved, we hope to launch globally beginning in the second half of 2009.”

Notes for editors

How degarelix works

Currently used hormonal treatments for prostate cancer include GnRH (gonadotrophin releasing hormone) agonists. Unlike degarelix, agonist therapies stimulate the natural hormone’s receptor on the pituitary gland. These agents also have a desired clinical effect, but they initially stimulate testosterone production before shutting it down. This initial stimulation of the receptors stimulates hormone-dependent tumour growth rather than inhibits it, and may lead to a worsening of cancer symptoms or ‘flare’.
Degarelix is designed to target and block the GnRH receptor. This immediately prevents the production of testosterone and thereby avoids the surge of testosterone and flare of the disease.

About Prostate Cancer

Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In the US 218,890 new cases were estimated for 2007, with a mortality rate of 27,050. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan.

About Ferring Pharmaceuticals

Ferring is a Swiss-based, research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, fertility and urology.  In recent years Ferring has expanded beyond its traditional European base and now has offices in over 40 countries.  To learn more about Ferring or our products please visit www.ferring.com.

For more information, please contact

Michael George
Ferring Pharmaceuticals
+41 58 301 00 53
FICCorporateCommunications@ferring.com

Superior remission rates for once daily use of Pentasa® (mesalazine) in ulcerative colitis

New data submitted at the 15th United European Gastroenterology Week congress

Paris, France – October 30, 2007 –

For the first time a once daily dosing regime of mesalazine (Pentasa® granules) has proven to be statistically superior to twice daily dosing for the effective maintenance of remission in patients suffering from mild to moderate ulcerative colitis (UC), finds a trial presented at the 15th United European Gastroenterology Week (UEGW) congress.

The primary objective of the 12-month multi-centre, randomised controlled, investigator blinded PODIUM trial, was to demonstrate equal efficacy of a single 2g sachet taken once daily compared to two separate 1g sachets per day. However, in a surprisingly strong result, of the 362 UC patients in remission who had relapsed within the past year, 73.8% of once daily patients were in clinical and endoscopic remission compared with 63.6% in the twice daily group (P=0.024).

“Once-daily studies conducted with other mesalazine drugs have focused on acute disease where compliance isn’t so much of a problem. None of them suggested superior efficacy compared to multiple doses. It is therefore particularly interesting that this trial of Pentasa® sachets focuses on maintenance and has shown superior efficacy for the once-daily, single sachet regime”, said co-ordinating investigator, Prof Dr. Axel U. Dignass, Markus Hospital, Frankfurt, Germany.

At the end of the PODIUM trial, once daily dosing had a higher compliance than twice daily dosing in terms of percentage of sachets used. Patient questionnaires yielded higher compliance scores for once daily than twice daily and patient acceptability of treatment was significantly better for once daily.

Compliance expert, Dr Andrew Robinson, Consultant Physician and Gastroenterologist, Hope Hospital, Salford, commented, “This is the first large study to demonstrate greater efficacy and compliance with once daily mesalazine compared to multiple dosing. Although it was designed as a non-inferiority trial the results unexpectedly favour single daily dosing which may be due to better compliance, altered pharmacodynamics or both. The true test of compliance and effectiveness is in a real life, non-trial environment and this trial not only reassures us that outcomes will not be compromised by single daily dosing but also asks us to think about factors such as having a whole dose in a single sachet”.

Speculating on why this trial shows superiority, Professor Dignass added, “In addition to helping compliance by dosing once per day with a single sachet, there may be other influencing factors where questions still remain, such as differences in sustained bioavailability of active drug substance between the pH independent, sustained release profile of Pentasa® compared to more pH dependent formulations.”

UC is an ongoing disease and, although symptoms may disappear with treatment, they tend to come back over time. Thus, patients are at risk of future episodes unless they continue to take their medication to keep them in remission. Furthermore, consistently complying with mesalazine therapy is associated with reduced risk of colorectal cancer, which is elevated in patients with UC.

“Whatever can be done to assist people with ulcerative colitis and to help them in regularly taking their treatments is another positive step towards improving the quality of life and quality of care of patients with this chronic illness, especially if they are able in time to take their medication only once a day” said Rod Mitchell, Chairman of the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA).

– Ends –

Notes for editors

The PODIUM study is also known as Pentasa® Once Daily In Ulcerative colitis for Maintenance of remission (PODIUM) trial.

Inflammatory Bowel Disease (IBD)

IBD describes a range of chronic diseases of the gastrointestinal system, encompassing Ulcerative Colitis (UC) and Crohn’s Disease (CD). IBD is characterised by intermittent flares with debilitating symptoms (such as diarrhoea, abdominal pain and weight loss) that can result both in a significant worsening of the patient’s quality of life as well as causing emotional distress and social isolation. In addition, patients can also suffer from a number of serious complications of the disease and may require life-long treatment and often surgery.

Both CD and UC are ongoing diseases and, although symptoms may disappear with treatment, they tend to come back over time. Thus, patients are at risk of future attacks unless they continue to take their medication to keep them in remission.

During the acute, active phase of IBD doctors may prescribe stronger therapies to control the inflammation, despite their potential harmful effects, if they will help the patient get better. However, side effects from a treatment being used for maintenance therapy are far less acceptable. Since patients will most probably have to take these medications over their entire lifetime, they must be both effective and safe. Mesalazine fulfils these requirements, as well as being convenient for the patient.

Incidence of IBD

IBD is mainly a condition of the industrialised world. It affects men and women equally and all races, although it is more common in some races than others.

In Northern Europe and the USA, the number of people affected by UC is approximately 120-270 per 100,000 – that is 1 in every 370-830 people^1,2,3 – with between 3-25 new cases per 100,000 people diagnosed each year.

For CD, the number of people affected is approximately the same, with 145 per 100,000 affected, and between 6-8 new cases per 100,000 people diagnosed each year.^1,2,3 However, unlike UC, the number of new cases of CD each year is increasing, particularly in young people, although the reasons for this are unclear.⁴

About Pentasa® (mesalazine)

Pentasa® belongs to a class of anti-inflammatory drugs called the aminosalicylates, which are used to treat and control the symptoms of inflammatory bowel disease (IBD) – both ulcerative colitis (UC) and Crohn’s disease (CD).

About Ferring Pharmaceuticals

Ferring is a Swiss-based research driven, speciality biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, fertility and urology.  In recent years Ferring has expanded beyond its traditional European base and now has offices in over 40 countries.  To learn more about Ferring or our products please visit www.ferring.com.

For more information, please contact

Michael George
Ferring Pharmaceuticals
+41 58 301 00 53
FICCorporateCommunications@ferring.com

References

1. Rubin GP et al. Aliment Pharmacol Ther 2000; 14(12): 1553-1559.
2. Farrokhayr F et al. Scand J Gastroenterol. 2001; 36(1): 2-15.
3. Satsangi J and Sutherland L (2003) In: Inflammatory Bowel Disease, Churchill Livingstone.
4. Loftus EV et al. Gastroenterology 1998; 114: 1161-1168.

Ferring Pharmaceuticals Forges Worldwide Licensing Agreement for Budesonide MMX™

Saint-Prex, Switzerland – October 10, 2007 –

Ferring Pharmaceuticals today announced that it had come to an agreement with Cosmo Pharmaceuticals SpA for the licensing of Budesonide MMX™. The agreement grants Ferring an exclusive worldwide license (excluding Japan and the USA) for Budesonide MMX™, which is predicted to become the first world wide approved oral corticosteroid for ulcerative colitis.

Corticosteroids are known to have a stronger effect than first line mesalamine treatments that approximately 70% of all patients take. At this point in time no corticosteroid drug has been granted worldwide approval for treatment of ulcerative colitis because of the side effect profile associated with the drug group. Budesonide MMX™, however, retains the effectiveness of classical corticosteroids but has substantially reduced side effects, thanks to its targeted release in the colon

Ferring will immediately partner with Cosmo on the extensive multi-centre phase III clinical trials in Europe. Ferring will make an initial payment of € 2 million for licensing rights. Post market entry (scheduled for 2010), Ferring will make revenue-related milestone payments which, depending on the market success of the product, could potentially reach € 58 million over the product life. Ferring has also agreed to pay double-digit royalty on net revenue.

Michel L.Pettigrew, Chief Operating Officer of Ferring Group commented: “We have been following Cosmo’s development quite closely and believe that Budesonide MMX™ fits well with our treatment portfolio. We have long been at the forefront of IBD treatment and strive to improve the treatment available in this therapy area. The advantages Budesonide MMX™ offers through its efficacy and better tolerability will help us address a major need of patients with ulcerative colitis.”

Mauro Ajani, CEO of Cosmo, stated: “I am very proud of this agreement because it formalizes our relationship with one of the most respected European pharmaceutical companies and further validates our innovative MMX technology. Ferring is one of the pioneers in the IBD sector and has a very experienced and extensive distribution network in Europe.”

About Ulcerative Colitis

Ulcerative colitis is a type of inflammatory bowel disease (IBD) that produces inflammation and ulcers along the inside of the large intestine. 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 strongly affect the quality of life. It is believed that as many as 2.2 million people in Europe have IBD. Ulcerative colitis is a chronic relapsing-remitting illness for which there is no known cure. Patients can manage their symptoms. A known issue that arises with ulcerative colitis patients is medication compliance and excessive pill burden: many currently available ulcerative colitis treat¬ments require multiple pills to be taken several times daily, and often involve inconvenient means of administration.

About Cosmo Pharmaceuticals

Cosmo is a speciality pharma company that aims to become a global leader in optimised therapies for certain gastrointestinal diseases. The company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, such as ulcerative colitis and Crohn’s disease, and colon infections. Cosmo’s first product is LIALDA™ / MEZAVANT™ that is licensed globally to Giuliani and Shire Pharmaceuticals. 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. For further information on Cosmo, please visit the Company’s website: www.cosmopharmaceuticals.com.

About Ferring Pharmaceuticals

Ferring is a Swiss-based research driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, fertility and urology. In recent years Ferring has expanded beyond its traditional European base and has offices in over 40 countries. To learn more about Ferring or its products please visit www.ferring.com.

For more information, please contact

Helen Gallagher
Ferring Pharmaceuticals
+41 58 301 00 51
+41 58 301 0039
helen.gallagher@ferring.com

Dr. Chris Tanner
CFO and Head of Investor Relations, Cosmo Pharmaceuticals
+39 02 9333 7614