Indevus announces agreement with Pliva for overactive bladder treatment drug

Indevus Pharmaceuticals, Inc. has announced that it has entered into a co-promotion and licensing agreement with PLIVA d.d. through its specialty branded subsidiary, Odyssey Pharmaceuticals Inc., for the U.S. commercialization of SANCTURA™ (trospium chloride), under review by the U.S. Food and Drug Administration (FDA) as a treatment for overactive bladder. The agreement provides for payments to Indevus from PLIVA that include $30 million upon signing and $120 million upon the approval of SANCTURA by the FDA. In addition, Indevus could receive up to $45 million in future payments contingent upon the achievement of certain milestones related to the development of a once-a-day formulation of SANCTURA, as well as a payment of $20 million related to the achievement of a long-term commercialization milestone in 2013.

For at least six months following the approval of SANCTURA, Indevus will receive a commission based on net sales of SANCTURA, a portion of which will fund its own sales force and certain advertising and promotional costs. PLIVA and Indevus will co-promote SANCTURA through a joint sales force of approximately 500 sales representatives. Indevus will establish a sales force initially numbering approximately 280 representatives who will promote SANCTURA to urology specialists, obstetricians and gynecologists, and certain primary care physicians.

At any time beginning six months after the approval of SANCTURA, each company has the right to convert the agreement into a royalty-bearing structure, whereby Indevus will receive royalties from PLIVA based on net sales of SANCTURA, and PLIVA will be responsible for promotional, advertising and sales force-related costs. Should this right be exercised, Indevus will retain a specialty sales force promoting SANCTURA to urology specialists, obstetricians and gynecologists, and high prescribers.

Under the agreement, Indevus will be responsible for funding the development of the once-a-day formulation of SANCTURA. Indevus will purchase trospium from Madaus AG, the European innovator and manufacturer of the product, and will supply it to PLIVA. PLIVA will be responsible for product distribution and will record revenue for sales of the product. Zeljko Covic, president of the PLIVA Management Board and chief executive officer, commented: “We are very excited about the addition of SANCTURA to our portfolio as it represents an excellent strategic fit with PLIVA’s existing urological franchise and capabilities. It is a very significant addition to our specialty branded business and will further strengthen the U.S. market position, while providing a platform for ongoing development of a sustainable long-term proprietary business.”

Paul Cottone, president and chief executive officer of Odyssey Pharmaceuticals added, “By adding SANCTURA to its portfolio, Odyssey will confirm its position as a true specialty U.S. pharmaceutical company. We are very excited about this deal, as we firmly believe that this product has an excellent profile which, complemented by our expertise in urology, can successfully be positioned as the primary drug of choice among physicians who treat overactive bladder.”