Auxilium Pharmaceuticals, Inc and Ferring International SA announced an exclusive agreement between them for the European distribution and license rights to Testim, a proprietary, topical one per cent 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.

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.

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.

Auxilium Pharma is a specialty biopharmaceutical company with a focus on developing and marketing to urologists, endocrinologists, orthopedists and select primary care physicians.