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Nycomed and Forest Laboratories to Collaborate on US Commercialisation of Daxas(R) in COPD
Date:8/10/2009

tration (FDA) in July and a Marketing Authorisation Application (MAA) was filed with the European Medicines Agency (EMEA) in May 2009.

Commenting on today's announcement, Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories, said, "We are pleased to have entered into this collaboration with Nycomed. Nycomed has demonstrated great dedication in bringing Daxas to its current NDA stage of development and we are looking forward to working with such a talented and committed group as we consider ways to further develop and expand the use of Daxas. Daxas represents the first in a new class of agents to treat COPD and would be the first oral agent to be approved for this debilitating disease. If approved, Daxas will give physicians and patients a much needed new treatment option in a unique oral dosage form that can augment the existing armamentarium of inhaled therapies."

Hakan Bjorklund, Chief Executive Officer of Nycomed, said: "We have received considerable interest in the marketing rights to Daxas and we believe Forest Laboratories is the best possible partner for Nycomed in the United States. Forest Laboratories has a significant national sales force, an increasing focus on respiratory products and an unrivalled track record of partnering with European companies to build hugely successful franchises. We believe their absolute commitment to Daxas will help to bring this innovative new therapy to as many patients in the United Sates as possible who suffer from COPD, a disease which is predicted to become the third-leading cause of death worldwide by 2030."

Nycomed submitted MAA and NDA filings earlier this year following encouraging results from a preliminary analysis of four Phase III trials of Daxas (roflumilast) in the treatment of symptomatic COPD. Two pivotal 12-month studies showed positive effects on exacerbation rates and pulmonary function (FEV1). Two supporting six-month studies a
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SOURCE Nycomed; Forest Laboratories, Inc.
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