Denmark’s Nycomed has told PharmaTimes World News it has reached an “amicable and mutual” agreement with partner Sanofi-Aventis which sees the former firm take back marketing rights in the USA to the asthma drug Alvesco.
However, the companies noted that their collaboration for the development and commercialization of a combination of Alvesco (ciclesonide) with formoterol in the USA will continue despite this parting of the ways on the individual product. The termination of the deal, the financial details of which were not disclosed, may well have been amicable, but it means that Nycomed must now start to search for a suitable partner for commercialisation of the drug in the USA.
One potential problem in finding such a partner could be the fact that Alvesco has not had much luck when put in front of US regulators. Approved in 44 countries, it only received an approvable letter from the US Food and Drug Administration back in 2004 as the agency demanded additional data after a study threw up a small number of patients who developed lens opacity. At the time, the drug was being developed by Sanofi and Altana, which was acquired by Nycomed last year for 4.6 billion euros.
However the Danish drugmaker is confident of getting approval across the Atlantic and head of R&D Anders Ullman said “we are convinced to have prepared a comprehensive and robust data package together with Sanofi-Aventis to receive a marketing license for Alvesco in the US”. Nycomed’s Japanese partner, Teijin Pharma, has recently obtained manufacturing and marketing approval in the country for Alvesco and will start promotional activities shortly.
Looking for in-licensing opportunities
Meantime, Nycomed spokesman Christoffer Jensen confirmed to PharmaTimes World News that the firm is actively looking to in-licence products that will help it fill the void that patent expiries in 2009/10 of its best-selling drug, the gastrointestinal treatment pantoprazole, will create.
Chief executive Hakan Bjorklund was quoted in a German magazine last week as saying that the firm will in-licence at least 60% of our products from other firms in future. Mr Jensen noted that Nycomed is currently active in the therapeutic areas of cardiology, gastroenterology, osteoporosis, tissue management and respiratory drugs but any purchases will not necessarily be restricted to these conditions. “We are very open-minded,” he saying, adding that the firm “would never go for a full-blown blockbuster” but is after interesting niche products.