FIRMAGON® (degarelix) is launched in Europe for the treatment of advanced prostate cancer

Stockholm, Sweden – 18 March 2009 –

Today marks the European launch of FIRMAGON® (degarelix), a new treatment option in hormonal therapy for prostate cancer, with details presented at the 24th Annual European Association of Urology (EAU) Congress in Stockholm. FIRMAGON® is a new GnRH receptor blocker indicated for the treatment of patients with advanced hormone-dependent prostate cancer.

FIRMAGON® has a novel mechanism of action that is different from commonly used hormonal therapies. Administered as a subcutaneous injection, FIRMAGON® rapidly reduces levels of prostate specific antigen (PSA) by immediately blocking the GnRH receptors in the pituitary gland. Blocking the receptors suppresses the luteinising hormone, which decreases production of testosterone by the testicles. Prostate cancer is dependant on testosterone for its growth, so reducing testosterone levels can slow the growth of cancer cells.

In clinical studies, FIRMAGON® suppressed testosterone and PSA faster than leuprolide, an existing treatment for advanced prostate cancer.¹

“This is an important new step for the treatment of advanced, hormone-dependent prostate cancer, with FIRMAGON® offering a new option and hope for many patients,” comments John Anderson, Consultant Urological Surgeon, The Royal Hallamshire Hospital, Sheffield, United Kingdom. “Our goal is to achieve fast and sustained reduction in testosterone levels, and FIRMAGON® offers a rapid impact which is comparable to the immediacy achieved by surgery.”

The European launch of FIRMAGON® follows the decision of the European Commission to grant marketing authorisation in the European Union last month. This approval was based on pivotal Phase III studies where FIRMAGON® produced a reduction in levels of testosterone^1,2 below 0.5ng/ml within three days in more than 96% of study patients.¹ Testosterone plays a major role in the growth and spread of prostate cancer cells, and the data showed FIRMAGON® provided a fast reduction of testosterone to very low levels, close to the immediate effect achieved with surgery (orchidectomy).^1,3 This effect was sustained over the whole study period.

In clinical trials FIRMAGON® was generally well tolerated. Common side effects are hot flushes, injection site pain and erythema, increased weight, nasopharyngitis, fatigue and back pain.

FIRMAGON® will be marketed in Europe by Ferring Pharmaceuticals. Today’s launch represents another important milestone in the company’s long-standing commitment to develop new and improved treatment options in the field of urology.

– Ends –

Notes to Editors

About Prostate Cancer

Prostate cancer is the most common form of cancer in men, and the second leading cause of cancer death. In 2005 127,490 new cases were diagnosed in the 5 biggest European countries and 18,310 in Japan. In the US 218,890 new cases were estimated for 2007, with a mortality rate of 27,050. For further media information and news alerts on prostate cancer please visit Ferring’s information website www.prostatecancerliving.com.

About Ferring Pharmaceuticals

Ferring is a Swiss-headquartered, 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.

For more information, please contact

Katie Fyfe
Tonic Life Communications
+44 207 798 9920
katie.fyfe@toniclc.com

Monica Gounaropoulos
Tonic Life Communications
+44 207 798 9910
monica.g@toniclc.com

Michael George
Ferring Pharmaceuticals
+41 (58) 301 00 53
michael.george@ferring.com

References

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. World Health Organization. Priority diseases and reasons for inclusion. Postpartum haemorrhage. Available at: http://www.who.int/medicines/areas/priority_medicines/Ch6_16PPH.pdf Last accessed: May 2018.
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.

European Commission grants Ferring Pharmaceuticals approval of FIRMAGON® (degarelix) for treatment of prostate cancer

Saint-Prex, Switzerland – 19 February, 2009 –

Ferring Pharmaceuticals announced today that it has received marketing authorisation from the European Commission, for FIRMAGON® (degarelix), a new GnRH receptor antagonist indicated for patients with advanced, hormone-dependent prostate cancer.

In Phase III studies degarelix produced a significant reduction in levels of testosterone^1,2, within three days in more than 96% of study patients.³ Testosterone plays a major role in the growth and spread of prostate cancer cells.

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

“We are delighted with the approval of FIRMAGON® (degarelix), which demonstrated in clinical trials both an immediate onset of action and a profound long-term suppression of testosterone and PSA” commented Dr. Pascal Danglas, Executive Vice President Clinical & Product Development at Ferring Pharmaceuticals. “We will work with local authorities to ensure the launch of FIRMAGON to patients across European Union countries as soon as possible.”

The European Commission approval for FIRMAGON® (degarelix) follows approval from the FDA in the US in December 2008.

– ENDS –

Notes to 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 receptor antagonist indicated for advanced prostate cancer. Ferring plans to communicate a range of information about the treatment at the European Academy of Urology (EAU) congress in Stockholm in March.

About Ferring Pharmaceuticals

Ferring is a Swiss-headquartered, 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 45 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 0053
michael.george@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 randomised, 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.

FDA Approves Ferring Pharmaceuticals’ Degarelix (Generic Name) for Treatment of Advanced Prostate Cancer

New Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist Demonstrates Rapid, Long-term Suppression of Testosterone – a hormone that stimulates prostate cancer growth.

Parsippany, N.J. – December 24, 2008 –

Ferring Pharmaceuticals, USA today received approval from the U.S. Food and Drug Administration (FDA) for degarelix, a new injectable gonadotropin-releasing hormone (GnRH) receptor antagonist, indicated for patients with advanced prostate cancer. Potential trade names are still under review with the FDA. Following issuance of a trade name, Ferring Pharmaceuticals, USA will immediately begin commercialization in the U.S. On December 18, the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMEA), recommended granting a marketing authorization for degarelix in Europe. Degarelix is awaiting approval in other key global markets. It is a milestone for the company and represents Ferring’s first global product launch.

Phase III studies showed that degarelix is at least as effective as leuprolide (Lupron Depot(R)) in sustaining castrate levels or lower of testosterone, and had a statistically significant faster reduction of testosterone. At Day 3 of treatment, 96% of degarelix patients achieved castrate levels of testosterone, compared with zero percent receiving leuprolide. By Day 14, 99% of degarelix patients achieved castrate levels of testosterone, compared with 18% receiving leuprolide.

In the clinical trial, prostate specific antigen (PSA) levels were also monitored as a secondary endpoint. PSA levels were lowered by 64% two weeks after administration of degarelix, 85% after one month, 95% after three months, and remained suppressed throughout the one year of treatment. These PSA results should be interpreted with caution because of the heterogeneity of the patient population studied. No evidence has shown that the rapidity of PSA decline is related to a clinical benefit.

Prostate cancer is known to grow in the presence of testosterone. Suppression of testosterone has been a treatment goal for advanced prostate cancer for many years. Surgical castration was the standard method of reducing testosterone from the 1940s until the mid-1980s when the earliest forms of medical castration, luteinizing hormone releasing hormone (LHRH) agonists, were introduced.

Degarelix is the only GnRH receptor antagonist approved by the FDA for the treatment of hormonally-sensitive advanced prostate cancer. Degarelix achieves medical castration differently than LHRH agonists, specifically by binding reversibly to GnRH receptors on cells in the pituitary gland, quickly reducing the release of gonadotropins and consequently testosterone.

“Degarelix was discovered in San Diego, developed by Ferring Pharmaceuticals in the U.S. and Europe, and in its pivotal Phase III study demonstrated both an immediate onset of action and a profound long-term suppression of testosterone and PSA,” commented Dr. Pascal Danglas, Executive Vice President Clinical & Product Development, at Ferring. “We are delighted to deliver a new treatment option for advanced prostate cancer to the medical community. Ferring has a considerable pipeline of urology products in development, and we expect to introduce additional treatment advances in the urology field in the near future.”

“Use of a GnRH receptor antagonist is a highly efficient way to stop the production of testosterone,” said Neal Shore, MD, FACS, Medical Director for Carolina Urologic Research Center, a clinical trial investigator and advisor to Ferring. “The approval of degarelix offers the medical community an effective alternative in the treatment of hormonally-sensitive prostate cancer. Now prostate cancer can be treated with immediate inhibition of the GnRH receptors, inducing rapid reduction of testosterone to castrate levels, and sustaining those levels over time, which are the goals of systemic therapy. When a patient has disease recurrence, it is always encouraging to clinicians and patients to see PSA levels fall so rapidly.”

Wayne Anderson, President and CEO Ferring Pharmaceuticals, USA added, “We are enthusiastically preparing to enter this therapeutic area of urology. We respect the challenges physicians and patients face in their fight against prostate cancer and hope that we can help them with this new treatment option. This is a big milestone for the U.S. operating unit, and we have been carefully preparing for over two years for this launch.”

Phase III Study Results

he 12-month, randomized, open-label, parallel-group Phase III study evaluated the efficacy and safety of degarelix compared with leuprolide administered monthly over one year of prostate cancer treatment. Patients with histologically confirmed prostate cancer were randomized to either degarelix or leuprolide: a degarelix subcutaneous (under the skin) injection of 240 mg for one month with monthly maintenance doses of 80 mg (n=207) or monthly intermuscular (into the muscle) injections of leuprolide depot 7.5 mg (n=201).

The primary endpoint was testosterone suppression to less than or equal to 50 ng/dL during monthly measurements from Day 28 to Day 364. Degarelix was at least as effective as leuprolide in achieving and maintaining castrate levels of testosterone.

                           N          Patients with         % (95% CI)
                                    treatment response

    Degarelix             207              202                  97.2
    240/80 mg

    Leuprolide 7.5 mg     201              194                  96.4

Suppression of testosterone levels to less than or equal to 50 ng/dL occurred significantly faster in patients receiving degarelix than in those receiving leuprolide. At Day 3, 96% of patients demonstrated treatment response. In that same time period, none of the patients who received leuprolide demonstrated treatment response. Conversely, testosterone levels had increased by a median of 65% in 80% of those receiving leuprolide at Day 3.

Overall, the most commonly observed adverse reactions during degarelix therapy included injection site reactions (e.g. pain, erythema, swelling or induration), hot flushes, increased weight, fatigue, and increases in serum levels of transaminases and gamma-glutamyltransferase (GGT). 99% of these observed adverse reactions were Grade 1 or 2 (mild to moderate). Specifically relating to the injection site adverse reactions, most were transient, of mild to moderate intensity, occurred primarily with the starting dose and led to few discontinuations (<1%). Grade 3 (severe) injection site reactions occurred in 2% or less of patients receiving degarelix. Degarelix is contraindicated in patients with known hypersensitivity to degarelix or to any of the product components. Degarelix is not indicated in women or pediatric patients. Long-term androgen deprivation therapy prolongs the QT interval. Physicians should consider whether the benefits of androgen deprivation therapy outweigh the potential risks in patients with congenital long QT syndrome, electrolyte abnormalities, or congestive heart failure and in patients taking Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic medications.

*Lupron Depot(R) (leuprolide acetate for depot suspension) is a registered trademark of TAP Pharmaceuticals Inc.

About Prostate Cancer

Prostate cancer is the most common cancer, excluding skin cancers, and the second leading cause of cancer death in American men. About one man in six will be diagnosed with prostate cancer during his lifetime, and one in 35 will die of this disease.¹ Prostate cancer develops from cells in the prostate gland that begin to grow out of control. In most cases, prostate cancer grows slowly and can remain undetected throughout a man’s life, although it can grow and spread quickly.² The four types of standard treatment are: watchful waiting, surgery, radiation therapy, and hormone therapy, also called androgen deprivation therapy (ADT). Degarelix is a new form of hormone therapy that reversibly binds to the GnRH receptors, inhibiting the production of testosterone. By suppressing the production of testosterone, tumor growth is inhibited.³

About Ferring Pharmaceuticals

Ferring Pharmaceuticals Inc. is a subsidiary of Ferring Pharmaceuticals, a privately owned, international pharmaceutical company. Ferring Pharmaceuticals offers a line of urology, orthopaedic and infertility products in the U.S. market. They include: EUFLEXXA(R), (1% sodium hyaluronic acid), BRAVELLE(R) (urofollitropin for injection, purified), MENOPUR(R) and REPRONEX(R) (menotropins for injection, USP), Novarel(R) (chorionic gonadotropin for injection, USP), ENDOMETRIN(R) (progesterone) Vaginal Insert, ACTHREL(R) (corticorelin ovine triflutate for injection), PROSED(R) DS (methenamine, phenyl salicylate, methylene blue, benzoic acid, hyoscyamine sulfate), and DESMOPRESSIN.

Ferring Pharmaceuticals specializes in the research, development and commercialization of compounds in general and pediatric endocrinology, urology, orthopaedics, gastroenterology, obstetrics/gynecology and infertility. For complete prescribing information, call 1-888-FERRING (1-888-337-7464) or visit www.FerringUSA.com.

References

1. 1. American Cancer Society. What Are the Key Statistics About Prostate Cancer? http://www.cancer.org; Last accessed 11/12/08.
   2. American Cancer Society. Cancer Reference Information, Overview: Prostate Cancer. http://www.cancer.org; Last accessed 11/12/08.
   3. National Cancer Institute. Prostate Cancer (PDQ(R)): Treatment: Treatment Option Overview. http://www.cancer.gov/cancertopics/pdq/treatment/prostate/patient/; Last accessed 11/12/08.

Committee for Medicinal Products for Human Use (CHMP) recommends granting marketing authorisation for FIRMAGON® (degarelix) for treatment of prostate cancer

New gonadtropin-releasing hormone (GnRH) receptor antagonist demonstrates rapid, long-term suppression of testosterone

Saint-Prex, Switzerland – 18 December 2008 –

Ferring Pharmaceuticals received today notification that the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMEA), has adopted a positive opinion and is recommending to grant a marketing authorization for FIRMAGON® (degarelix), a new GnRH receptor antagonist indicated for patients with advanced, hormone-dependent prostate cancer. In Phase III studies degarelix produced a significant reduction in levels of testosterone^1,2 within three days in more than 96% of study patients.² Testosterone plays a major role in the growth and spread of prostate cancer cells.

The 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 luteneising hormone releasing-hormone (LHRH) agonist leuprorelin’s 7.5 mg in a 12-month randomised, open-label, parallel-group study in prostate cancer 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 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. The most common side effects of degarelix are hot flushes, injection site pain, injection site erythema, increased weight, nasopharyngitis, fatigue and back pain.

“Degarelix was discovered and developed by Ferring Pharmaceuticals and in its pivotal Phase III study demonstrated both an immediate onset of action and a profound long-term suppression of testosterone and PSA” commented Dr Pascal Danglas, Executive Vice President Clinical & Product Development at Ferring Pharmaceuticals. “We will be delighted to deliver a new treatment option for advanced prostate cancer to the medical community. Ferring has a considerable pipeline of urology products in development and we expect to introduce additional innovations in the urology field in the near future.”

“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 “Degarelix produces an extremely rapid impact, approaching the immediacy of surgery and it is good news that the product should become imminently available.”

Ferring Pharmaceuticals plans to launch FIRMAGON® (degarelix) in Europe in the first quarter of 2009 and is also awaiting an imminent FDA decision on approval for commercialisation in the US. It is expected that commercialisation in other key global markets will follow during 2009 and 2010 once approval is received from the relevant local regulatory authorities.

Michel Pettigrew, Chief Operating Officer Ferring Pharmaceuticals, stated: “The recommendation from the CHMP to grant marketing authorisation for FIRMAGON® is a significant milestone for Ferring. It is the first positive opinion we have received from a regulatory authority for FIRMAGON® which, in turn, will be the first product that Ferring will launch on a global basis. We are truly excited to be on the brink of introducing this new therapy to physicians and patients, and we look forward to providing an innovative tool that will add meaningfully to the treatment options for addressing prostate cancer.”

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

– Ends –

Notes to 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 receptor antagonist indicated for advanced prostate cancer.

About Ferring Pharmaceuticals

Ferring is a Swiss-headquartered, 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 45 countries.  To learn more about Ferring or our products please visit www.ferring.com.

For more information, please contact

Katie Fyfe
Tonic Life Communications
+44 207 798 9920
katie.fyfe@toniclc.com

Monica Gounaropoulos
Tonic Life Communications
+44 207 798 9910
monica.g@toniclc.com

Helen Gallagher
Ferring Pharmaceuticals
+41 58 301 00 51
helen.gallagher@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 randomised, 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, A 1-year, open label, randomised Phase II dose finding study of degarelix for the treatment of prostate cancer in North America. Journal of Urology, Vol. 180, November 2008.
   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.

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

Ferring and Astellas enter a license agreement on Degarelix for the treatment of prostate cancer in Japan

Lausanne, Switzerland / Tokyo, Japan – 31 January, 2006 –

Ferring Pharmaceuticals (“Ferring”; headquarters: Lausanne, Switzerland; executive chairman: Frederik Paulsen) and Astellas Pharma Inc. (“Astellas”; headquarters: Tokyo; President and CEO: Toichi Takenaka) announced today that they have entered into a license agreement that gives Astellas exclusive rights to develop and market degarelix for the treatment of prostate cancer in Japan.

“This agreement marks another significant step for degarelix,” said Michel Pettigrew, Ferring’s Chief Operating Officer. “We are convinced that this partnership with Astellas will be a strong one, especially as both companies have a strong commitment to the area of Urology.”

“We are delighted to enter into partnership with Ferring on degarelix,” said Toichi Takenaka, Ph.D., President and CEO of Astellas. “Degarelix is an important addition to Astellas’ pipeline and allows us to deepen our commitment to contribute to the treatment of Urology disease, the existing business franchise of Astellas.”

Degarelix is a gonadtrophin-releasing hormone (GnRH) blocker discovered by Ferring, with a unique sustained-release injectable formulation. GnRH is a hormone produced in the hypothalamus in the brain and is involved in the production of the male hormone testosterone. Although testosterone is an important hormone that plays a central role in the maintenance of function and growth of the prostate, it also stimulates prostate cancer to grow and to spread out and in result, often aggravates symptoms in prostate cancer patients. Degarelix suppresses the release of luteinizing hormone (LH) by blocking the GnRH receptors in the pituitary gland and controls the growth of prostate cancer by suppressing level of testosterone circulating in blood.

The license agreement grants Astellas the exclusive rights to develop and market degarelix for the treatment of prostate cancer in Japan. Astellas will make upfront and milestone payments to Ferring. In addition, Astellas will pay a royalty on product sales. In Japan, Ferring’s subsidiary Ferring Pharma Co., Ltd. is currently conducting a Phase I clinical trial. Following the conclusion of the licensing agreement, Astellas will undertake clinical development in Japan from Phase II onward. Ferring is conducting a Phase III clinical trial in the US and Europe on a three-month formulation of degarelix in prostate cancer patients, and a Phase III trial on a one-month formulation is also in preparation.

– ENDS –

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 197,800 new cases, 126,900 in the 5 biggest European countries and 30,400 new cases in Japan were estimated in 2003. All in all, in 2002 GLOBOCAN cancer database reported 542,909 new cases of prostate cancer diagnosed worldwide and 204,000 death events due to this disease. An actual annual growth rate, of prostate cancer incidence, is equal to 1%. The maturity of markets is different when it comes to screening and active treatment. This results in different phases in dynamics of incidence/ prevalence and death rate for prostate cancer for different regions in the world. The US leads the development of screening and treatment practices.

About Astellas

Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information on Astellas Pharma Inc., please visit the company’s website at www.astellas.com.

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, infertility 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 21 614 27 47
FICCorporateCommunications@ferring.com

Akihiro Tanaka
Ph.D., Astellas Pharma Inc.
+81 3 3244 3201

Ferring strengthens its infertility portfolio through agreement with Metris Therapeutics for Vorozole

Copenhagen, Denmark – 8 February, 2005 –

Ferring Pharmaceuticals announced today that it has signed an agreement with Metris Therapeutics for all potential infertility indications of the compound vorozole. Under the agreement Ferring has the rights to manufacture, develop, register and market vorozole in ovulation induction and IVF.

Vorozole belongs to the family of aromatase inhibitors which have shown promising results in the area of infertility. Aromatase inhibitors act by blocking the synthesis of oestrogen and early tests indicate vorozole’s potential to improve ovulation.

Ferring R&D is planning to embark on a full clinical trial development program for vorozole, starting in 2005, with the aim of developing a new treatment for ovulation induction and In-Vitro Fertilisation (IVF).

“We are very pleased to sign this agreement with Metris Therapeutics. Vorozole is a valuable addition to our infertility portfolio, which is now the widest in the area of infertility”, says Dr. Pascal Danglas, Executive Vice President for clinical and product development.

Vorozole will complement Ferring’s existing therapies (MENOPUR, BRAVELLE, NORPROLAC, CHORAGON, LUTRELEF and the GnRH agonist DECAPEPTYL), as well as the current pipeline of compounds in development.

“We at Metris Therapeutics are delighted to be associated with a key player in infertility and we look forward to exciting developments for vorozole in this setting”, said Dr Peter Knox, Managing Director at Metris Therapeutics.

The treatment of infertility represents one of the most exciting and innovative areas of medicine, with an increasing demand for successful and cost-effective treatments with a good safety profile, to satisfy the growing number of infertile couples seeking help. With vorozole in the pipeline Ferring has taken another step as a key provider of infertility treatments.

Notes for editors

Ovulation Induction (OI)

Can be used as a treatment on its own, or in combination with other infertility treatments such as artificial insemination, or in-vitro fertilisation (IVF). The anti-oestrogens clomifene and tamoxifen have been used traditionally in the treatment of infertility to stimulate ovulation in women with infrequent or irregular periods, or in those whose menstrual cycles have stopped due to polycystic ovaries. They induce the release of gonadotrophins by making the hypothalamus believe the woman’s oestrogen levels are too low.

In-Vitro Fertilisation (IVF)

The first and most well-known procedure in the area of assisted reproductive technology (ART). The procedure has four stages and involves stimulation of the ovaries to produce and release a number of mature eggs, collection of the eggs from the ovaries, fertilisation outside the body to produce young embryos and transfer of the embryos into the uterus.

About Metris Therapeutics

Metris Therapeutics is a relatively new biopharmaceutical company, founded in 1996. It is located in the United Kingdom and focuses on women’s healthcare and in particular on the treatment of endometriosis.

About Ferring Pharmaceuticals

Ferring is a research driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynaecology, infertility and urology.

In recent years Ferring has expanded beyond its traditional European base and now has operating subsidiaries in over 40 countries.

Study reveals that women undergoing a cycle of IVF treatment with MENOPUR may have a significantly improved chance of becoming pregnant

Lausanne, Switzerland – 10 May, 2004 –

The publication was based on a sub-analysis of the landmark trial EISG (European-Israeli Study Group) which was designed to demonstrate non-inferiority of MENOPUR (HP-hMG) when compared with GONAL F (rFSH, Serono Group) in more than 700 IVF and ICSI patients.

The sub-analysis showed impressive results: the ongoing pregnancy rate in the 233 women who underwent IVF was significantly higher in the MENOPUR group (31%) compared with the GONAL F group (20%), (p=0.037).¹

The study analysis also showed that although less oocytes were retrieved in the MENOPUR group vs. GONAL F, MENOPUR appeared to have a clear beneficial effect on the pregnancy rates in women undergoing IVF.

IVF procedures make up more than 60 percent of all ART (assisted reproduction treatment) procedures.

To confirm these new results, Ferring is launching a state-of-the-art prospective, multi-national, comparative study powered to demonstrate superiority of MENOPUR vs GONAL F in IVF patients on ongoing pregnancy rate. The study called MERiT will be the largest, international prospective superiority trial comparing MENOPUR vs. GONAL F in IVF.

Included in the state of the art study design and innovative approaches:

• Centralized embryo assessments
• Intrafollicular endocrine environment
• Cryosurvival and frozen embryo cycles

Researchers are confident that the sub-results of EISG will be confirmed with MERiT as MENOPUR provides both FSH activity and LH activity (both of which are important contributors to achieving pregnancy). Several studies conclude that LH activity from either LH or hCG has several positive effects: it stimulates the development of high quality large follicles and it diminishes the number of small follicles which theoretically could reduce the risk of Ovarian Hyperstimulation Syndrome (OHSS).²

Interestingly new data also suggests that hCG/LH activity may have a beneficial effect on the blood flow in the endometrium consequently improving the chances of successful egg implantation.³

According to the sub-analysis, adequate hCG levels during treatment with MENOPUR group appear to have a favourable impact on ongoing pregnancy rates in IVF and ICSI patients, but more markedly in IVF.

The sub-analysis authors suggest that the beneficial effect of the LH activity in MENOPUR seen in IVF patients could also be mediated by cumulus oophorus cells which are present during the IVF and not during the ICSI procedure.

“It is becoming increasingly evident that MENOPUR may have real advantages over rFSH (GONAL F) in IVF treatment for infertility’, said Dr. Pascal Danglas, vice-president of Clinical and Product Development at Ferring. ‘Studies like this are important because they provide evidence to identify the gonadotropin most likely to work best in certain populations. We are confident that our new study MERiT will echo these results.”

EISG Study Details

The EISG1 (European-Israeli Study Group) was an open-label, randomised, multi-center, multinational study to demonstrate non-inferiority of MENOPUR compared to GONAL F on going pregnancy rates.

• 727 patients ( HP-hMG:373, rFSH:354)
• Long protocol, down-regulation with GnRH agonist (daily or depot)
• HP-hMG (MENOPUR) vs rFSH (GONAL F), subcutaneous route
• IVF/ICSI and embryo transfer procedures according to center practice. Transfer of 1-3 developed embryos
• Luteal support according to center practice

About Ferring Pharmaceuticals

Ferring is a research driven, specialty biopharmaceutical group active in global markets.  The company identifies, develops and markets innovative products in the areas of endocrinology, gastroenterology, gynecology, infertility and urology.

In recent years Ferring has expanded beyond its traditional European base and now has operating subsidiaries in over 40 countries.

To learn more about Ferring or our products please visit us at
www.Ferring.com.

For more information, please contact

Sharmi Albrechtsen
Corporate Communication Manager, Ferring International Center
+45 28 78 72 09
sharmi.albrechtsen@ferring.com

References

1. The European and Israeli Study Group on Highly Purified menotropin versus Recombinant Follicle-Stimulating Hormone. Fertility and Sterility. 2004 May, 81(5)1401.
2. Filicori M et al. Human Reprod Update 2002 Nov-Dec; 8(6): 543-57.
3. Licht P. et al. Semin Reprod Med. 2001; 19(1): 37-47.