Cardiome Pharma Corp.
) recently announced that Cardiome will regain global marketing and
development rights for the intravenous (IV) as well as the oral
formulations of vernakalant from Merck.
The Merck/Cardiome agreement dates back to April 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) 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
However, earlier this year in March, Cardiome announced Merck's
decision to discontinue the development of the oral formulation of
vernakalant. Merck decided to stop developing oral vernakalant
based on its assessment of the regulatory environment and the time
involved in the development process.
Merck and Cardiome were studying the candidate as a maintenance
therapy for the long term prevention of atrial fibrillation
Meanwhile, the IV formulation is approved in the EU under the
trade name Brinavess for the rapid conversion of recent onset
atrial fibrillation to sinus rhythm in adults. However, Brinavess'
development path in the US has not been smooth with the US Food and
Drug Administration (FDA) placing a clinical hold on the
development program for the IV formulation. A phase III study, ACT
V, which was suspended in 2010, was terminated later.
Merck's decision to return vernakalant rights reflects the
company's efforts to streamline its pipeline and allocate funds
across its entire portfolio. As far as Cardiome is concerned, the
company will most likely need to seek a partner for the
commercialization and further development of vernakalant. Moreover,
the company has a weak pipeline consisting of a few early stage
We currently have a Neutral recommendation on both Merck and
Cardiome. While Merck carries a Zacks #3 Rank (short-term Hold
rating), Cardiome carries a Zacks #4 Rank (short-term Sell
CARDIOME PHARMA (CRME): Free Stock Analysis
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