EffRx And Nycomed Announces First European Filing For Marketing Approval Of Osteoporosis Drug Targeting Increased Convenience For Patients

Main Category: Bones / Orthopedics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Sep 2010 - 4:00 PDT


The Lausanne, Switzerland, based drug delivery company EffRx Pharmaceuticals SA ("EffRx") and its partner, the global pharmaceutical company Nycomed, headquartered in Zurich, Switzerland, 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.

About EX101

EX101 is a proprietary once weekly administration of a 70mg buffered effervescent formulation of alendronate (bisphosphonate) for treatment of post-menopausal osteoporosis. Product is addressing the complaints of inconvenience when taking bisphosphonates in tablet form. Alendronate reduces the risk of vertebral and hip fractures.

About Nycomed

Nycomed is a privately owned global pharmaceutical company with a differentiated portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. An extensive range of OTC products completes the portfolio.

Its R&D is structured around partnerships and in-licensing is a cornerstone of the company's growth strategy.

Nycomed employs 12,000 associates worldwide, and its products are available in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS and Latin America. While the US and Japan are commercialised through best-in-class partners, Nycomed plans to further strengthen its own position in key Asian markets.

Headquartered in Zurich, Switzerland, the company generated total sales of €3.2 billion in 2009 and an adjusted EBITDA of €1.1 billion.

Source:
EffRx

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