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Firma Ferring ewoluowała i rozwijała się, odkąd Frederik i Eva Paulsen założyli firmę w latach 50. XX wieku. Zespół zbudowany jest w duchu innowacyjności i dążeniu do tworzenia zmieniających życie terapii dla osób, które ich potrzebują.
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Rozwój firmy Ferring to historia ludzi i peptydów. To dalekosiężna wizja kreatywnych naukowców, aby wykorzystać fundamentalną rolę hormonów peptydowych w kontrolowaniu wielu kluczowych procesów organizmu w celu opracowaniu medycyny na warunkach własnych organizmu. To także wizja przedsiębiorczości podszyta wyzwaniem aby te leki były dostępne na całym świecie.
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Ferring Pharmaceuticals donates $1 million to McGill University
- by pulseFerring Pharmaceuticals donates $1 million to McGill University
Saint-Prex, Switzerland – January 22, 2009 –
Today, Ferring Pharmaceuticals, the international bio-pharmaceutical company, announced a $1 million donation to McGill University of Montreal, Canada. The money will be used to create Ferring Fellowships for graduate students, to finance environmental research in the Arctic, and to fund scientific research projects. Since its creation in 1950 by Dr Frederik Paulsen, Ferring has been focused on research, the application of rigorous scientific principles, and the best independent academic study. By donating to McGill University, Ferring will be able to continue this focus through creating a number of Ferring Pharmaceutical Fellowships. These will provide support to graduate students in McGill’s Faculty of Medicine.
Marc Weinstein, Vice-Principal, Development and Alumni Relations, commented.
“We are thrilled that Ferring Pharmaceuticals is partnering with McGill University in this great initiative to provide support to our best graduate students and to further research at McGill.”
Underlining its commitment to the global environment, Ferring will also be funding research in the Arctic, led by the climate change scientist, Professor Bruno Tremblay. This research will investigate both the causes of, and possible solutions to, the challenge of climate change.
Finally, Ferring will be providing ad hoc funding to scientific projects over the course of the next three years. McGill graduate students will be invited to submit proposals to the Ferring Research and Development team and funds will be allocated on merit.
Michel Pettigrew, President of the Executive Board and Chief Operating Officer of Ferring Pharmaceuticals, himself a graduate of McGill University, said:
“McGill is one of the world’s best research-based universities and will be an excellent partner for Ferring going forward. We have always believed in the importance of investing in scientific education and research, and the programme we have developed with McGill will, we believe, make a telling contribution across a wide range of different areas.”
– ENDS –
About McGill University
McGill University, founded in Montreal, Quebec, in 1821, is Canada’s leading post-secondary institution. It has two campuses, 11 faculties, 10 professional schools, 300 programs of study and more than 33,000 students. The university launched Campaign McGill: History in the Making in October, 2007. With a starting goal of $750-million, the Campaign is the most ambitious fundraising drive ever by a Canadian university. To learn more about McGill University please visit www.mcgill.ca.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals 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, gynecology, fertility and urology. In recent years Ferring has expanded beyond its traditional European base and has operations in over 45 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.com0pulseFDA Approves Ferring Pharmaceuticals’ Degarelix (Generic Name) for Treatment of Advanced Prostate Cancer
- by pulseFDA 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
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- American Cancer Society. What Are the Key Statistics About Prostate Cancer? http://www.cancer.org; Last accessed 11/12/08.
- American Cancer Society. Cancer Reference Information, Overview: Prostate Cancer. http://www.cancer.org; Last accessed 11/12/08.
- 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.
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Committee for Medicinal Products for Human Use (CHMP) recommends granting marketing authorisation for FIRMAGON® (degarelix) for treatment of prostate cancer
- by pulseCommittee 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 testosterone1,2 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.comMonica Gounaropoulos
Tonic Life Communications
+44 207 798 9910
monica.g@toniclc.comHelen Gallagher
Ferring Pharmaceuticals
+41 58 301 00 51
helen.gallagher@ferring.comReferences
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- 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.
- 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.
- 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.
- 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.
- 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.
Press KitPress release Viewpulse-
Ferring and Conaris complete license agreement for new recombinant molecule in gastroenterology
- by pulseFerring and Conaris complete license agreement for new recombinant molecule in gastroenterology
Saint-Prex, Switzerland and Kiel, Germany – 10 December 2008 –
Ferring Pharmaceuticals and Conaris Research Institute AG today announced that they have completed an exclusive worldwide license agreement for the development of FE301 a new recombinant protein inhibitor of the IL-6 pathway for inflammatory conditions such as IBD and rheumatoid arthritis.
IL-6 acts early in the inflammatory cascade and, therefore, it is hoped that FE301 could offer physicians more options than current biologic treatments for Crohn’s disease and ulcerative colitis. This agreement represents another step in Ferring’s move into biotech research and development.
“Gastroenterology is one of the three key therapeutic areas on which Ferring focuses and we believe that FE301 represents the next generation of anti-inflammatory agents in this field”, said Dr Pascal Danglas, Ferring’s Executive Vice President of Clinical and Product Development. “We are also delighted to have this opportunity to work with Prof Schreiber, who is head of the Scientific Board of Conaris and such a renowned expert in the area.”
“We have high hopes for this new biologic therapy in the treatment of IBD”, commented Prof. Stefan Schreiber, Gastroenterologist and Institute Director at University Hospital Schleswig Holstein. “It is very pleasing, therefore, to secure this development programme with Ferring – one of the leading companies in the field – to bring this important new therapeutic principle to patients with chronic inflammatory diseases.”
“We are confident that FE301 has great potential, if successful in pre-clinical and clinical studies, to compete with all biological drugs which are currently on the market”, adds Dr. Dirk Seegert, Chief Executive Officer of Conaris.
Jost de Jager, Science Secretary of State of the Ministry of Science, Economic Affairs and Transport of Schleswig-Holstein commented, “This is a big achievement for our Excellence Cluster of Inflammation. Conaris’ success is a good example of the effective interaction between academic and commercial institutions and underlines Schleswig-Holstein’s leading position in this scientific and medical field.”
FE 301 is undergoing pre-clinical testing prior to moving in to Phase I in 2010.
– Ends –
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.
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 people1,2,3 – 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 Both UC and CD show strongly rising incidences in the developing Asian countries including China.
In 2007 IBD sales were $2.65 billion in the seven major markets (Japan, US, and EU5). Crohn’s Disease represented 57% of this market with sales of $1.51 billion.5
About Conaris
Conaris, a biotech company based in Kiel, Northern Germany, is specialized in the discovery and optimization of innovative anti-inflammatory drug candidates and their transfer into early clinical development stages. Beside own research projects, Conaris always entertains several academic collaborations to amend its product pipeline. For further information, please visit www.conaris.de.
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 gastroenterology, urology and fertility. In recent years Ferring has expanded beyond its traditional European base and now has offices in 45 countries. To learn more about Ferring or our products please visit www.ferring.com.
For more information, please contact
Michael George of Ferring Pharmaceuticals on +41 58 301 0053.
References
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- Rubin GP et al. Aliment Pharmacol Ther 2000; 14(12): 1553-1559.
- Farrokhayr F et al. Scand J Gastroenterol. 2001; 36(1): 2-15.
- Satsangi J and Sutherland L (2003) In: Inflammatory Bowel Disease, Churchill Livingstone.
- Loftus EV et al. Gastroenterology 1998; 114: 1161-1168.
- Commercial Insight: Inflammatory Bowel Disease, (DMHC2433) Datamonitor, February 2008.
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Ferring signs distribution agreement with BioGaia in Ireland and the Middle East
- by pulseFerring signs distribution agreement with BioGaia in Ireland and the Middle East
Saint-Prex, Switzerland – 3rd December 2008 –
BioGaia has extended its collaboration with the Swiss biopharmaceutical company Ferring Pharmaceuticals giving Ferring exclusive rights to sell BioGaia’s Probiotic Drops in Ireland and exclusive rights to sell BioGaia’s Probiotic Drops and Tablets in Bahrain, Yemen, Qatar, Oman, Kuwait and United Arab Emirates.
“We are very happy to again expand the contract with Ferring in to these interesting markets. Ferring is taking the BioGaia brand to markets we have not been before and it is yet another step in our effort to build a global probiotic brand”, says Peter Rothschild, President, BioGaia AB.
“Our collaboration with BioGaia is going very well. BioGaia’s Probiotic therapeutic products have been very well received by the medical profession and patients in the countries where we have already launched and we are very happy to be able to make it available to patients in the Gulf States and Ireland”, says Michel Pettigrew, COO at Ferring.
About BiGaia
BioGaia is a biotechnology company that develops, markets and sells probiotic products with documented health benefits. The products are primarily based on the lactic acid bacterium Lactobacillus reuteri (Reuteri), which has probiotic, health-enhancing effects. The class B share of the Parent Company BioGaia AB is quoted on the Small Cap list of the Nordic Stock Exchange in Stockholm. To learn more about BioGaia please visit www.biogaia.com.
About Ferring Pharmaceuticals
Ferring Pharmaceuticals 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 operations 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.comPeter Rothschild
Managing Director, BioGaia
+46 8 – 555 293 00Jan Annwall
Deputy Managing Director, BioGaia
+46 8 – 555 293 00pulseAuxilium Pharmaceuticals, Inc. Announces Distribution and License Agreement for Testim® in Europe with Ferring Pharmaceuticals
- by pulseAuxilium Pharmaceuticals, Inc. Announces Distribution and License Agreement for Testim® in Europe with Ferring Pharmaceuticals
Malvern, PA, USA and Saint-Prex, Switzerland – December 01, 2008 –
Auxilium Pharmaceuticals, Inc. (Nasdaq: AUXL) and Ferring International S.A. today announced an exclusive agreement between them for the European distribution and license rights to Testim®, a proprietary, topical 1% testosterone once-a-day gel indicated for the treatment of hypogonadism.
“We are very pleased to have Ferring as our partner, given the strength of their European specialty urology and endocrinology franchises, their existing commercial infrastructure across Europe, and the successful track record they have established in commercializing differentiated products in the European Union,” said Armando Anido, Chief Executive Officer and President of Auxilium. “This agreement enables us to bring our innovative testosterone replacement product to patients in all of the 15 countries where Testim has been approved and potentially in additional new countries within Europe, thus expanding the reach of our Testim franchise outside the United States.”
“Testim will be an excellent complement to our urology portfolio, where we already have Minirin® for primary nocturnal enuresis and hope to receive approval for our prostate cancer treatment, degarelix, in the first half of next year,” commented Ferring’s Chief Operating Officer, Michel Pettigrew. “It is a great pleasure to have cemented this partnership with Auxilium, with whom we share a commitment to the field of urology and a strong focus on patients.”
Under the agreement, Auxilium will be responsible for manufacturing and supplying Testim to Ferring, while Ferring will be responsible for all regulatory, sales, marketing and distribution activities in Europe. Under the agreement with Ferring, Auxilium will receive a combination of upfront, milestone and royalty payments. Financial details of the agreement were not disclosed. Testim is currently approved for sale in 15 countries in Europe. The Company and Ipsen Pharma GmbH recently agreed to mutually terminate their distribution agreement for Testim in Europe and other countries outside North America and Japan.
About Testim
Testim is a novel, topical gel formulation that normalizes low levels of testosterone in men with hypogonadism, a condition that occurs when a man’s body does not produce adequate amounts of testosterone. Men with hypogonadism or androgen deficiency may suffer from a decrease in energy, reduced muscle mass, an increase in abdominal fat, decline in libido, decreased sexual function, anemia, fatigue, depression and reduced bone density that may result in an increased risk of osteoporosis.
Testim was developed by Auxilium using a proprietary technology licensed from CPEX Pharmaceuticals, Inc. (NASDAQ: CPEX), and was launched in the U.S. by Auxilium’s sales force in the first quarter of 2003. Auxilium received its first European regulatory approval for Testim in the UK in 2003 and currently has regulatory approval in 15 countries in Europe through the Mutual Recognition Procedure.
About Hypogonadism
A 2006 study that was published in The International Journal of Clinical Practice showed 39% of men over 45 years of age have low testosterone (total testosterone levels below 300 ng / dL). Hypogonadism is defined as reduced or absent secretion of testosterone which can lead to symptoms such as loss of libido, adverse changes in body composition, irritability and poor concentration. Auxilium research estimates that approximately 10% of men with hypogonadism currently receive TRT and that this low diagnosis rate stems primarily from low patient and physician awareness of the symptoms, treatment options and monitoring requirements.
About Auxilium
Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians. Auxilium markets Testim® 1%, a topical testosterone gel, for the treatment of hypogonadism through its approximately 190-person sales and marketing team. Auxilium has five projects in clinical development. XIAFLEXTM (clostridial collagenase for injection), formerly referred to as AA4500, is in phase III of development for the treatment of Dupuytren’s contracture and is in phase II of development for the treatment of Peyronie’s disease and Frozen Shoulder syndrome (Adhesive Capsulitis). Auxilium’s transmucosal film product candidate for the treatment of overactive bladder (AA4010) is in phase I of development.
The Company is currently seeking a partner to further develop this product candidate. Auxilium also has one pain product (fentanyl) using its transmucosal film delivery system in phase I of development. Auxilium has rights to seven additional pain products and products for hormone replacement and urologic disease using its transmucosal film delivery system. Auxilium also has options to all indications using XIAFLEX for non-topical formulations.
For additional information, visit www.auxilium.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 urology, gastroenterology, and infertility. In recent years Ferring has expanded beyond its traditional European base and now has offices in 45 countries. To learn more about Ferring or our products please visit www.ferring.com.
SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
This release contains “forward-looking-statements” within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the size of the market for Testim, the sales of Testim by Ferring in Europe, the effect of the distribution agreement with Ferring on the Company’s revenues, the ability of Ferring to fulfill its obligations under the distribution agreement, and products in development for the treatment of Dupuytren’s contracture, Peyronie’s disease, Frozen Shoulder syndrome, overactive bladder and pain. All statements other than statements of historical facts contained in this release, including but not limited to, statements regarding future expectations, plans and prospects for the Company, financial guidance and other statements containing the words “believe,” “may,” “could,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” and similar expressions, as they relate to the Company, constitute forward-looking statements. Actual results may differ materially from those reflected in these forward-looking statements due to various factors, including general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries and those discussed in the Company’s Annual Report on Form 10-K for the period ended December 31, 2007 and the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2008 under the heading “Risk Factors”, which are on file with the Securities and Exchange Commission (the “SEC”) and may be accessed electronically by means of the SEC’s home page on the Internet at http://www.sec.gov or by means of the Company’s home page on the Internet at http://www.auxilium.com under the heading “Investor Relations – SEC Filings.” There may be additional risks that the Company does not presently know or that the Company currently believes are immaterial which could also cause actual results to differ from those contained in the forward-looking statements. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements.
In addition, forward-looking statements provide the Company’s expectations, plans or forecasts of future events and views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s assessments to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s assessments as of any date subsequent to the date of this release.
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For more information, please contact
James E. Fickenscher
Chief Financial Officer, Auxilium Pharmaceuticals, Inc.
+1 484 321-5900
jfickenscher@auxilium.comWilliam Q. Sargent Jr.
Vice-President, Investor Relations and Corporate Communications, Auxilium Pharmaceuticals, Inc.
+1 484 321-5900
wsargent@auxilium.comMichael George
Senior Corporate Communications Manager, Ferring Pharmaceuticals
+41 58 301 00 53
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