Pharmaceutical Executive Europe - October 2008 - (Page 3)

News & Analysis For more on these news stories and all the latest breaking pharma news, look at our website www.pharmexeceurope.com, which now features daily updates, interactive surveys and dedicated sections for your particular area of interest. Sanofi to tackle TB The Global Alliance for TB Drug Development (TB Alliance) and Sanofiaventis have announced that they have entered into a collaboration agreement to accelerate the discovery, development and clinical use of drugs against tuberculosis (TB). The TB Alliance is a notfor-profit, product development partnership, whose goal is the development of new TB drugs. The announcement was made at the 39th World Conference on Lung Health, organised by the International Union Against Tuberculosis and Lung Disease in Paris, France. The collaboration agreement aims to address the significant need to develop new TB drugs that will shorten treatment and be effective against drug-susceptible and drugresistant strains of TB. Every year, more than 1.5 million people worldwide die from TB. Today's TB drugs are more than 40 years old and must be taken for six to nine months for drug-sensitive disease and up to 24 months for drug-resistant disease. Long, demanding treatment schedules prove too Every year 1.5 million people worldwide die from TB. much for many patients and the resulting erratic or inconsistent treatment can result in drug resistance, treatment failure or death. Biosimilars regulation ‘still in 20th Century’ Speaking at 2008’s EuroBio event in Paris this month, Theodore J. Roumel, VP of research, innovation and commercialisation at University of Maryland Biotechnology Institute (UMBI), said that policy makers must fully understand current manufacturing processes if they are to provide adequate regulation for biologicals (or, biosimilars, as they are known in Europe). “Manufacturing has come into the 21st century — regulatory hasn’t… A decade ago FDA was the Gold Standard in the world; now they’re under suspicion daily,” he said. Mr Roumel’s comments were part of the EuroBio meeting’s Health BioDialogues, in which major concerns surrounding both the European and US biotechnology sectors were under discussion. He added: “What is needed at this point in time is additional research on biological products in support of approvals. There needs to be new measurement techniques and standards…” The current thinking on biosimilar regulation in Europe is that it is “stuck” and much of that problem, according to Amgen’s senior strategy planning manager, Peter Bast, has come from the tendency to regard biosimilars in the same way as generic drugs. Until this is overcome, there will continue to be serious implications for efficacy and safety. Mr Roumel concluded: “The determination of follow-on biologicals— regardless of their impact on healthcare—must be science-based, must be deliberative and must place patient safety first.” Merck abandons anti-obesity drug Merck & Co has abandoned 6 Calendar Upcoming events in Europe and around the world 7 BioFutures Gerhard Symons on the dark side of Russian healthcare 10 Strategy Brian Smith on the best company culture thinking 12 Executive Recruitment ‘Downshifting’ can be a good move for the ambitious http://www.pharmexeceurope.com

Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - October 2008

Pharmaceutical Executive Europe - October 2008 Contents News and Analysis Calendar BioFutures Strategy Fundamentals Executive Recruitment: Small Company, Big Career Executive Recruitment: Instant Pharma Named Patient Programmes Executive Review: Turkey

Pharmaceutical Executive Europe - October 2008

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