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Nycomed and Forest Labs sign Daxas deal

Nycomed has announced an exclusive development, manufacturing and commercialisation agreement in the US with Forest Laboratories

Privately-owned global pharmaceutical company, Nycomed has announced an exclusive development, manufacturing and commercialisation agreement in the US with Forest Laboratories – a US-based pharmaceutical company - for Daxas (roflumilast), a once-daily oral treatment for patients suffering from symptomatic chronic obstructive pulmonary disease (COPD). Nycomed will retain marketing rights to Daxas in Europe and the rest of the world.

Under the terms of the agreement, Forest Laboratories will make an upfront payment of $100m and additional milestone payments to Nycomed based on defined regulatory and commercialisation achievements. Nycomed will also receive royalties on US net sales typical for a product in registration. Forest will assume responsibility for the US regulatory approval and commercialisation of Daxas and the companies will collaborate on future development programmes. Further details of the financial terms of the agreement were not disclosed.

Nycomed's Daxas is an orally-administered phosphodiesterase 4 (PDE4) enzyme inhibitor targeting cells and mediators in the body believed to be important in the COPD disease process. It is expected to act on the underlying mechanism of COPD and related inflammatory diseases. A New Drug Application (NDA) for Daxas was filed with the US Food and Drug Administration (FDA) in July and a Marketing Authorisation Application (MAA) was filed with the European Medicines Agency (EMEA) in May 2009. If approved, Daxas will be the first drug in its class. It will also be the first new approach to the management of COPD in a generation. Current treatment for COPD patients includes the use of inhaled bronchodilators and inhaled corticosteroids.

According to Hakan Bjorklund, chief executive officer of Nycomed: "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 salesforce, 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 States as possible who suffer from COPD, a disease which is predicted to become the third-leading cause of death worldwide by 2030."

COPD remains a significant area of unmet medical need. It is a progressive and irreversible lung disease resulting in difficulty in breathing. The disease is characterised by severe episodes of worsening, called exacerbations. According to World Health Organisation (WHO) estimates, 80 million people have moderate to severe COPD worldwide. More than three million people died of COPD in 2005, which equates to 5 per cent of all deaths globally. The WHO predicts that total deaths from COPD could increase by more than 30 per cent in the next 10 years unless urgent action is taken to reduce the underlying risk factors, especially smoking.

10th August 2009

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