Massachusetts, USA-based Altus Pharmaceuticals has re-acquired development and commercialization rights to ALTU-135 from German drug developer Dr Falk Pharma, which originally licensed the drug in Europe, countries of the former Soviet Union, Israel and Egypt in 2002 (Marketletters passim).
The product, which is intended to improve digestive function in patients suffering from cystic fibrosis, was granted Orphan Drug designation by the European Medicines Agency (EMEA) in July 2004. The announced repurchase includes the transferral of these orphan rights. In exchange, Altus will pay the German firm 12.0 million euros ($16.0 million) over the next three years. In the USA, ALTU-135 has been granted Orphan Drug designation, as well as CMA Pilot 2 status by the Food and Drug Administration. Currently, it is being assessed in pivotal Phase III trials.
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