The market introduction of Daxas® (roflumilast) in Europe is promising. Nycomed's US partner Forest Laboratories, Inc. (NYSE: FRX) has submitted a response to the US Food & Drug Administration (FDA) addressing topics raised in the complete response letter regarding the New Drug Application (NDA) for roflumilast (Daxas®). Nycomed and Forest expect a response from the FDA in the first quarter of 2011.
Pantoprazole sales erosion decelerated resulting in a slowdown of declining sales in Europe. The company experienced strong sales in emerging markets, with especially solid performances in Russia/CIS and Latin America, namely Brazil. Protonix® sales in the United States have sharply decreased, and now account for the predominant share of the decline in pantoprazole sales.
- Net turnover up 8.7% in third quarter (+1.5% in local currencies) excluding a one-time payment in Q3/2009. In euro, total net turnover slightly down by 0.7% to €814.6 million (Q3/2009: €820.0 million).
- Adjusted EBITDA increased by 1.2% (-9.8% in local currencies) excluding a one-time payment in Q3/2009. In euro, adjusted EBITDA down by 23.9% to €217.1 million (Q3/2009: €285.3 million).
Håkan Björklund, CEO of Nycomed, commented on the company's third quarter results: "We are very satisfied with Nycomed's sales performance in the third quarter. It demonstrates that our strategy of focusing on emerging markets and specialty products is delivering results. The acquisition of the majority stake in Guangdong Techpool Bio-Pharma underlines Nycomed's Asian growth strategy and provides us with access to a leading, high-quality manufacturer of innovative products and creates an enhanced commercialization base for Nycomed products in China.
In September, we opened our newly expanded manufacturing facility for active pharmaceutical ingredients (APIs) in Mumbai, India, which we operate in a joint venture with Zydus Cadila. This is a significant step forward to getting high quality APIs in Nycomed's branded generic portfolio produced at competitive costs.
2010 revenues will be adversely influenced by the effect of pantoprazole's loss of exclusivity and price cutting measures which have been announced by authorities in several markets."
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.
For more information visit www.nycomed.com.