Sweden's Orexo has been boosted by the news that the US Food and Drug Administration has accepted its opioid dependence drug Zubsolv for review.
Zubsolv is a sublingual formulation of Reckitt Benckiser's Suboxone (buprenorphine/naloxone) which dominates a market that is estimated to reach sales of $1.5 billion in 2012 and "continues to display steady growth of more than 15% per year". Orexo notes that its drug now has a Prescription Drug User Fee Act (PDUFA) action date of July 6 next year.
Chief executive Anders Lundstrom said the FDA's decision "is yet another step for Orexo towards becoming a fully-integrated specialty pharmaceutical company with a US commercial presence". He added that "we have a good chance of becoming the first company to offer an alternative treatment option to Suboxone".
Opioid dependence affects over two million Americans, costing society an estimated $25 billion in related healthcare costs. Orexo said that "to differentiate Zubsolv from competitors and maximise the commercial potential, comprehensive clinical development and product life cycle management programmes have now been initiated". It is also looking at further dose strengths and providing an additional flavour of Zubsolv "to complement the current product offering".
Sobi files Kineret for CAPS
Staying in Sweden and Swedish Orphan Biovitrum (Sobi) has filed a marketing application with the European Medicines Agency for its rheumatoid arthritis drug Kineret (anakinra) in the indication of cryopyrin associated periodic syndromes (CAPS).
The filing is based on positive data from a long-term study in people with neonatal-onset multisystem inflammatory disease (NOMID), the most severe form of CAPS. The EMA application follows the filing for Kineret for NOMID with the US Food and Drug Administration (FDA) in July 2012, which has been granted priority review and has an expected approval date of December 25.
Chief executive Geoffrey McDonough said the two submissions "are important milestones on Sobi's journey to increase our support for the paediatric rheumatology field as well as for the rare disease community as a whole".