|Cardiome Provides Update on Merck's Development Plans; Watson Confirms Patent Challenge|
|By Staff and Wire Reports|
|Monday, 19 March 2012 19:12|
Cardiome Pharma Corp. (Nasdaq:CRME) (TSX:COM) announced Merck, known as MSD outside the United States and Canada, has communicated to Cardiome their decision to discontinue further development of the oral formulation of vernakalant. The decision was based on Merck's assessment of the regulatory environment and projected development timeline. Vernakalant oral was being evaluated as maintenance therapy for the long term prevention of atrial fibrillation recurrence.
"It is our understanding that vernakalant oral has continued to have a safe and effective profile as demonstrated by studies conducted since the product was licensed to Merck. We are extremely disappointed with the decision Merck has made" said Doug Janzen, President and Chief Executive Officer at Cardiome. "However, we look forward to continuing to work with Merck on the worldwide development and commercialization of vernakalant IV."
Merck will continue to support the intravenous formulation of vernakalant, which is marketed in the European Union and Latin America under the trade name BRINAVESSTM. Currently, BRINAVESSTM is approved for the rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults in 37 countries. Merck has plans to expand the commercialization of the product throughout this year into new markets, and anticipates launching the product in approximately 30 additional countries in 2012.
In response to the discontinuation of the vernakalant oral program, Cardiome will reduce its annual operating cash burn going forward to a target of approximately $11M before interest expense, roughly half of the current cash burn. The company ended 2011 with over $53M of cash and cash equivalents and received an additional $25M from the available line of credit from Merck in January 2012. Cardiome expects to release its 2011 year-end financial results on March 28th, 2012 which will allow time to make the necessary changes to its annual filings following this news.
Cardiome is reviewing the impact of this event on its business strategy moving forward, and will report the results of that review when it is complete.
Teleconference Details: Cardiome will hold a teleconference call and webcast at 9:00am EST (6:00am PST) March 19th, 2012 to discuss these corporate updates.
To access the conference call, please dial 1-877-670-9780. There will be a separate dial-in line for analysts on which we will respond to questions at the end of the call. The webcast can be accessed through Cardiome's website at www.cardiome.com .
Webcast and telephone replays of the conference call will be available approximately two hours after the completion of the call through April 19th, 2012. Please dial 1-855-859-2056 or 1-404-537-3406 and reference conference ID#63670695 to access the replay.
Merck Cardiome Agreement: In April 2009, Cardiome and Merck announced a collaboration and license agreement for the development and commercialization of vernakalant. The agreement provides Merck Sharp and Dohme Corp. with exclusive global rights to vernakalant oral, and provides another Merck affiliate, Merck Sharp & Dohme (Switzerland) GmbH, with exclusive rights outside of the United States, Canada and Mexico to vernakalant IV. In 2011, Merck also acquired North American rights to vernakalant IV, becoming our global partner for the entire vernakalant franchise.
Watson Pharmaceuticals, Inc. (NYSE: WPI) confirmed its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Niacin Extended-release Tablets, 500 mg and 1000 mg. Watson's ANDA products are generic versions of Abbott Laboratories' NIASPAN®.
Abbott Laboratories (NYSE:ABT) and Abbott Respiratory LLC filed suit against Watson on March 16, 2012, in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its ANDA products prior to the expiration of U.S. Patent Nos. 6,080,428 and 6,469,035. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiffs received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.
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