Terms include worldwide licensing rights outside the United States, Canada, Mexico and Japan
NORRISTOWN, PA and PARIS, FRANCE (April 6 , 2004) - Auxilium Pharmaceuticals Inc. and Ipsen announced today that they have entered into a licence and distribution agreement for the marketing of Auxilium's product Testim® 1% testosterone gel. Under the terms of the agreement, Ipsen will hold marketing and distribution rights in all countries except the United States, Canada, Mexico and Japan. Auxilium will receive a combination of milestone and royalty payments. Financial details of the arrangement were not disclosed.
According to Christophe Jean, executive vice-president, chief operating officer of the Ipsen Group, "we are very pleased to partner with Auxilium for Testim®, which represents an important addition to Ipsen's growing endocrinology portfolio, in line with our commitment to offer improved therapeutic options to physicians and patients."
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 Bentley Pharmaceuticals, Inc. (AMEX: BNT), and was launched in the U.S. by Auxilium's sales force in the first quarter of 2003. Auxilium received regulatory approval for Testim® in the UK in 2003 and has applied for regulatory approval in other countries in Europe through the Mutual Recognition Procedure.
Ipsen in endocrinology
Endocrinology is one of the focused therapeutic areas for Ipsen. Ipsen endocrinology sales are driven by Somatuline" and Somatuline" Autogel" mainly indicated in the treatment of acromegaly and neuroendocrine tumors. Moreover, in March 2004, the EMEA approved NutropinAq™ 10 mg/ 2 ml cartridge. Ipsen is to launch NutropinAq™ for use with the NutropinAq™ Pen in Europe. NutropinAq™ is a recombinant human growth hormone indicated for the treatment of several conditions associated with growth hormone deficiency in children and adults.
Among Ipsen R&D programs in endocrinology, three major molecules are under clinical development:
- BIM51182 and BIM51077 (GLP-1 analogues), respectively in preclinical and phase II clinical development are intended for the treatment of Type 2 diabetes;
- BIM44058 in phase I clinical development is intended for the treatment of acute osteoporosis and bone fractures.
About Ipsen
Present in over 110 countries, with a total staff of nearly 3700, the Ipsen Group had a turnover of €718 million in 2002, 27.1% outside of western Europe. The Group develops products in targeted therapeutic fields, in particular oncology and endocrinology which represent its priority development centres. Currently, Ipsen has over 20 products on the market. These are distributed between medicines commercialised for specialists who are involved in the targeted therapeutic fields, as well as medicines commercialised for other therapeutic fields linked to the history of the Group. In 2002, 18.2% of Ipsen's turnover was reinvested in Research and Development, carried out from four centres: Paris, Boston, Barcelona and London through an international network of about 550 scientists. Ipsen's internet website is www.ipsen.com
About Auxilium
Auxilium Pharmaceuticals, Inc., was founded in 1999 to develop and market pharmaceutical products that focus on urology and sexual health. In addition to development and commercialization of products for androgen replacement, the company is pursuing product opportunities to treat other urologic and sexual health disorders. For additional information, visit www.auxilium.com.
For further information:
Ipsen
Didier Véron
Director, Public Affairs and Corporate Communications
Tel.: +33 (0)1 44 30 42 15
Fax: +33 (0)1 44 30 42 04
e-mail: didier.veron@ipsen.com
Good Relations Healthcare
Louise Blakeborough
Tel.: +44 (0) 1932 350006
Fax: +44 (0) 1932 353336
e-mail: lblakeborough@grhealthcare.co.uk
Contacts:
Jim Wetmore
Berry & Company Public Relations
(212) 253-8881