Orexo´s European licensing partner ProStrakan Group plc, for the cancer breakthrough pain product Rapinyl on the European market, today announced that Rapinyl will be referred for review by the Committee for Medicinal Products for Human Use (CHMP) of the EMEA. Of the 25 member states involved in the EU Decentralised Procedure (DCP) for Rapinyl, 21 consider this product to be approvable.
Anticipated news flow until the end of 2008 • Short term cash generating and pipeline value enhancing business development
– EU approval and launch of Rapinyl – Partnering agreement OX-17 – NLA Nasal Spray partnering agreement – Partnering agreement Sublinox – Partnering agreement dual effect respiratory drug and EOXIN inhibitor
• Product development – FDA filing of Sublinox – EU approval and launch of Rapinyl – FDA filing of Rapinyl in the US – Initiation Phase II PDE4 inhibitor in asthma and COPD – Initiation Phase I EOXIN inhibitor in asthma – First Phase II data PDE4 inhibitor – Phase I data EOXIN inhibitor in asthma
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