The Lausanne, Switzerland, based drug delivery company EffRx Pharmaceuticals SA ("EffRx") and its partner, the global pharmaceutical company Nycomed, headquartered in Zurich, Switzerland, today announced that the first European filing for marketing approval of EX101, a once-a-week 70mg buffered effervescent alendronate, for the treatment of osteoporosis, has been submitted. The filing triggers a milestone payment to EffRx.
“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”
The licensing agreement for EX101 between Nycomed and EffRx was announced early 2009 and Nycomed recently amended its original licensing agreement with EffRx and holds now exclusive rights to develop, manufacture and commercialise the effervescent formulation of alendronate for the treatment of osteoporosis in all territories in the world except USA and Japan.
EX101 will complement Nycomed's osteoporosis portfolio, which consists of Preotact® (full-length parathyroid hormone [PTH 1-84]) for treatment of osteoporosis in post-menopausal women at high risk of fractures, and the company's broad Calcium D3 product range for the prevention and an adjunct of the condition.
"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," stated Christer Rosén, CEO of EffRx.
Study focuses on COPD progression in younger populations