Nycomed gains European, Russian, Middle Eastern, North African, Latin American, and Canadian rights.

Nycomed and EffRx inked a deal worth $59 million covering the latter’s Phase III osteoporosis treatment. The payments will be in the form of an up-front fee and milestones.

The licensing agreement includes Europe, Russia, The Middle East, North Africa, Latin America, and Canada. EffRx will receive double-digit royalties on sales in these countries. Nycomed will sponsor the additional studies required for marketing approval.

Final approval and launch in U.S. is expected in 2010, while European approval could be slightly later, the companies note. As a bisphosphonate, EX101 will complement Nycomed’s osteoporosis portfolio, which consists of Preotact® for post-menopausal women at high risk of fractures and a broad Calcium D3 product range for the prevention of the condition.

“EX101 offers several benefits for the osteoporosis patient, who will get a more convenient drug compared to other bisphosphonates and with strong potential to increase compliance, which is a well-known problem with existing treatments,” according to Christer Rosén, chairman and CEO of EffRx.

Bisphosphonate tablets like Fosamax, Actonel, and Boniva have been associated with upper gastrointestinal problems, the firms point out. They say that gastric imaging and pH telemetry studies on EX101 demonstrates reduced stomach acid after dosing and that alendronate is never present under acidic conditions. The firms add that EX101 shows high absorption consistency compared with Fosamax tablets.


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