The agreement grants Debiopharm an exclusive worldwide license to develop and commercialize Ipsen's first-in-class inhibitor of the CDC25 phosphatase enzyme, now called Debio 0931, for the treatment of various human cancers.
CDC25 is a key enzyme involved in the regulation of the cell cycle. Its over-expression is associated with the progression of cancer. By blocking the cell cycle and thus interrupting tumour growth, Debio 0931 represents a promising novel target for cancer therapies. This preclinical candidate will now be the subject of a full development program under the responsibility of Debiopharm.
Dr. Rolland-Yves Mauvernay, president and founder of Debiopharm Group, explains, "Over the past two decades Ipsen and Debiopharm have been able to establish, maintain and develop a climate of trust for a sustainable partnership. Both companies have understood the mutual interest to work jointly relying on their complementary strengths, Ipsen using the broad experience and many-year-expertise of Debiopharm in the field of drug development and sustained release formulation, especially in the field of oncology, and Debiopharm benefiting from the highly professsional and competent sales and marketing organization of Ipsen."
Under the terms of the agreement, Debiopharm will be exclusively responsible for the development of Debio 0931, with Ipsen having an option to reacquire development and commercialization rights post-completion of Phase II clinical trials. Ipsen will receive an upfront payment and be eligible for milestone payments and royalties. <!--[endif]-->
The collaboration between Ipsen and Debiopharm started in 1983 with regards to LHRH analogs, in particular for the triptorelin analog Decapeptyl (also known as Pamoreline and Diphereline, which are commercialized under the name Trelstar by Watson Pharmaceutials in the United States). In October 2007, their partnership was extended to grant Ipsen access to future sustained-release formulations of Decapeptyl developed by Debiopharm, among which is a six-month sustained release formulation that was filed in Europe in September 2008, for the treatment of locally advanced or metastatic prostate cancer. Decapeptyl pne- and three-month formulations are currently sold in more than 60 countries worldwide, including 25 in Europe, and they generated almost $367 million in sales in 2008.
Ipsen is a specialty pharmaceutical group with more than 20 products on the market and a total worldwide staff of nearly 4,200, 800 of whom are in R&D. Its development strategy is based on a combination of specialty medicine, which is Ipsen's growth driver, in targeted therapeutic areas (oncology, endocrinology, neurology and haematology), and primary care products that contribute significantly to its research financing. In 2008, research and development expenditure was about $271 million, or about 1 percent of consolidated sales, which amounted to $1.4 billion.
Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed four products with global combined sales in excess of $2.6 billion in 2008. The company attributes its success to an unusual if not unique business model—in-license, add value through innovative R&D strategy and implementation and out-license to maximize commercial potential—which it refers to as NRDO (no research development only).
"Our business strategy is to partner through the in-licensing of therapeutic products from biotechnology, pharmaceutical and academic organizations worldwide," Mauvernay says. "We develop the products while paving the way to global registration, and we carefully select optimal marketing partners to maximize commercialization."