Nycomed and Forest Laboratories, Inc. (NYSE: FRX) today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roflumilast (Daxas^®). Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations.

• Strong growth of Key Products and in emerging markets. Impact of pantoprazole's patent expiry in May 2009 as expected.
• Total net turnover decreased 7.6% (-8.9% in local currencies) to €776.4 million (Q1/2009: €839.9 million).
• Adjusted EBITDA decreased 24.1% (-24.8% in local currencies) to €233.1 million (Q1/2009: €307.0 million).
• Daxas^® (roflumilast) is advancing: Nycomed received a positive opinion from CHMP and signed a co-promotion agreement w

• Joint venture shows commitment to growth in Russia & CIS

• Partners optimize distribution model for key market

Zurich, Switzerland, and Whitehouse Station, N.J, April 26, 2010 - Nycomed and Merck & Co., Inc. (based in Whitehouse Station, New Jersey and known as MSD outside the USA and Canada) today announced that they have entered into a co-promotion agreement for Canada and certain European countries for the commercialization of Daxas^® (roflumilast), an investigational once-daily tablet for patients with chronic obstructive pulmonary disease (COPD).  In addition, the two companies have signed an exclusive distr

Nycomed and Pfizer Inc. confirmed today that a jury in the U.S. District Court for the District of New Jersey has rendered positive findings in a trial involving the main U.S. patent covering pantoprazole (Protonix^®).

• First once-a-day oral tablet for treatment of Chronic Obstructive Pulmonary Disease (COPD)
• First new class of treatment for COPD in more than a decade
• Anti-inflammatory treatment aimed at patients with severe COPD associated with chronic bronchitis

• US Food and Drug Administration (FDA) has granted approval for the surgical patch TachoSil^® in cardiovascular surgery.

• Strong growth of Key Products and in most emerging markets was partly offset by the negative impact of pantoprazole's patent expiry in Europe, the economic downturn and adverse currency fluctuations.
• Total net turnover decreased 3.6% (-0.6% in local currencies and excluding one-time effects) to €3,228.0 million (FY/2008: €3,348.0 million). In the fourth quarter, total net turnover decreased 4.9% (-0.4% on a comparable basis) to €781.1 million (Q4/2008: €821.1 million).
• Adjusted EB

• Total net turnover increased 0.9% (3.2% in local currencies) to €820.0°million (Q3/08: €812.4°million)⁽¹⁾
• Adjusted EBITDA decreased 3.1% (1.5% in local currencies) to €285.3°million (Q3/08: €294.4°million)⁽¹⁾
• Pantoprazole sales resilient after loss of exclusivity. Newly-launched OTC variant performing strongly in Europe
• Roflumilast (Daxas^®) submitted to FDA and agreement with Forest Laboratories on US commercialisation

Asthma is not controlled in almost two thirds of affected children according to the largest ever international survey undertaken in paediatric asthma(1).

This poor result is despite apparently straightforward clinical guidelines and widely available preventative treatments for children with asthma.

• Roflumilast an investigational drug
• Offers a new treatment principle that addresses the underlying inflammation of chronic obstructive pulmonary disease (COPD)
• Clinically meaningful benefit, also when given in addition to established bronchodilator therapy. 

• Once-a-day tablet Daxas^® (roflumilast) is a first-in-class treatment under development targeting inflammation, the underlying cause of chronic obstructive pulmonary disease (COPD)

  Nycomed and Forest Laboratories today announced that results of four phase III trials have been published in the prestigious peer-reviewed medical journal The Lancet showing that roflumilast, a phosphodiesterase 4 (PDE4) inhibitor, improved lung function and reduced exacerbations in patients with moderate to