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R&D news in brief

Our weekly round-up of R&D news in brief

Not enough successful orphan applications, says study
Not enough orphan drugs for rare diseases are gaining European approval, according to research published in the British Journal of Clinical Pharmacology. The study found that while more than 79 per cent of other drug applications submitted to the European Medicines Agency (EMEA) gained approval, only seven per cent of orphan drug applications were approved between 2000 and 2004. ìIt's difficult to find a balance between the urgent need for drugs for patients with rare diseases and guaranteeing their quality, safety and, where necessary, making comparisons with existing drugs,î said co-author of the study, Professor Silvio Garattini from the Mario Negri Institute for Pharmacological Research in Milan. ìThe lack of reliable methods for evaluating orphan drugs in a small number of people probably explains the poor quality of the applications,î he added.

Moviprep gets European go-ahead
European speciality company, Norgine, has received a marketing authorisation for its new bowel cleansing drug, Moviprep (formerly known as NRL994). The drug is indicated for bowel cleansing prior to clinical procedures such as bowel endoscopy, radiology or digestive tract surgery. Chief operating officer Peter Martin described the product as ìan important addition to our gastroenterology portfolioî. In December 2005, Norgine granted Salix Pharmaceuticals exclusive rights to market Moviprep in the US. The drug is currently being reviewed by the US Food and Drug Administration.

CeNeS reinforces patent protection for painkiller
Cambridge-based biotech firm, CeNeS has signed a deal with Innovata to acquire certain patent rights covering a proprietary synthetic method for the manufacture of its lead product M6G, to treat moderate to severe post-operative pain. The drug is seen as an alternative to morphine treatment. ìM6G is currently undergoing a pivotal phase III clinical study with results expected later in 2006,î said CeNeS chief executive, Neil Clark. ìCeNeS already has good patent protection around the synthetic route for M6G and also expects to receive ten years of data and market exclusivity in Europe from the date of first market approval.î

Biotech research centre opens its doors
A new publicly owned centre to allow biotech companies to develop early-stage products for clinical trials has opened for business. The National Biomanufacturing Centre, which is run by Eden Biodesign is based on Merseyside and will begin lab work this week for its first client, SR Pharma. Eden Biodesign business development director, Derek Ellison said the facility offers a bridge between research and clinical trials. ìWe can provide Big Pharma quality for small-scale research,î he told the Financial Times.

30th September 2008


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