Nycomed's performance was driven by strong growth of Key Products and in most emerging markets. This overall positive performance could not fully offset the expected negative impact of pantoprazole's patent expiry in Europe. Daxas® (roflumilast) is advancing well: Nycomed received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of Daxas® in the European Union. With Merck & Co., Inc. (MSD) a co-promotion agreement for five European countries and Canada has been signed.
Nycomed also made significant advancement in its partnerships: With the FDA approval of TachoSil®, Baxter International will be able to market this surgical patch in the United States. In Russia/CIS, an agreement with GE Healthcare to form a joint venture for the local sales, marketing and distribution of GE Healthcare's medical diagnostic contrast agents has been announced.
A jury in the U.S. District Court for the District of New Jersey held that the US pantoprazole (Protonix®) patent is not invalid. Nycomed and its US partner Pfizer Inc. are pleased with the jury's findings and announced that as soon as the decision is final the companies will be seeking the full measure of their damages.
Håkan Björklund, CEO Nycomed, commented on the company's results: "We saw a very satisfactory performance in the first quarter of 2010 confirming our direction. Both Key Products and the emerging markets are developing well.
With a positive opinion from the CHMP, we have cleared an important hurdle of the European approval process for Daxas. To further utilize the potential of Daxas, we have signed a co-promotion agreement with Merck for several European countries and Canada. All of this confirms our belief in the future of this product. We were disappointed with the outcome from the recent FDA Advisory Committee meeting that reviewed Daxas. However, we remain optimistic that concerns expressed by the Committee and the FDA can be satisfactorily resolved.
For 2010, we will see the full effect of pantoprazole's loss of exclusivity. In some markets we anticipate pressure on pharmaceuticals prices from authorities. We do expect further growth of our Key Products and in emerging markets and are preparing the launch of Daxas."
|Q1 2010 (€m)||Q1 2009 (€m)||Change|
|Operating profit (EBIT)||41.6||130.9||-68.2%|
Adjusted EBITDA and EBITDA are key figures used in order to have a more comprehensive analysis of our operating performance and of our ability to service our debt. EBITDA means net income adjusted for net financial terms, income taxes, depreciation of tangible assets and amortisation of intangible assets. Adjusted EBITDA is EBITDA adjusted for unusual or non-recurring items not related to the future and ongoing business. For the first quarter 2010 the difference between EBITDA and adjusted EBITDA mainly comprises integration, projects and restructuring costs.
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