Nycomed applies for EU approval of osteoporosis drug

Nycomed has applied for European regulatory clearance for a new collaboratively-developed treatment for osteoporosis.

In association with development partner EffRx Pharmaceuticals, the firm has filed for approval of EX101, a once-a-week 70mg buffered effervescent alendronate that helps to reduce the risk of vertebral and hip fractures.

Under the terms of the licensing agreement signed with EffRx in 2009, Nycomed holds exclusive marketing and commercialisation rights to the drug in all territories other than the US and Japan.

It will join products such as Preotact and Calcium D3 in Nycomed's anti-osteoporosis portfolio, with EffRx receiving a milestone payment from the firm following the regulatory filing.

Christer Rosen, chief executive officer of EffRx, said: "This is obviously a key step in getting EX101 to the market and shows Nycomed's commitment to get EX101 into their osteoporosis portfolio of products as soon as possible."

Nycomed is currently conducting a global rollout for its key chronic obstructive pulmonary disease product Daxas, launching the drug in Germany earlier this month.