Cardiome Pharma Corp. (CRME) recently selected privately-held Quintiles for providing lifecycle safety and global regulatory affairs services for Brinavess (vernakalant intravenous).
The services will be provided by Quintiles with immediate effect.
We note that Merck (MRK) returned global marketing and development rights for both the intravenous and oral formulations of Brinavess to Cardiome in Sep 2012.
Consequently, Cardiome reached a settlement agreement with Merck in Dec 2012 and agreed to pay $20 million on or before Mar 31, 2013, to settle its outstanding debt of $50 million which it owes to Merck.
We note the Merck/Cardiome agreement dates back to Apr 2009, when the companies announced a collaboration and licensing deal related to the development and commercialization of vernakalant.
While Merck Sharp and Dohme Corp. gained exclusive global rights to oral vernakalant, Merck Sharp & Dohme (Switzerland) and GmbH (another Merck affiliate) acquired exclusive rights to the intravenous (:IV) formulation of vernakalant outside the US, Canada and Mexico.
Merck acquired North American rights as well to the IV formulation in 2011.
Quintiles will be the service provider for Cardiome going forward. We note that Brinavess is approved in the EU, Iceland and Norway for the rapid conversion of recent onset atrial fibrillation (AF) to sinus rhythm in adults.
Additionally, it is also approved for non-surgery patients with AF of seven days or less and for post-cardiac surgery patients with AF of three days or less.
However, the product is not approved for use in the US or Canada.
Cardiome expects that Quintiles’ global reach and expertise as a service provider will fill the gap that has resulted from the termination of the collaboration agreement with Merck.
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