Cardiome whips out budget ax as Merck dumps oral heart drug pact

Posted under atrial fibrillation, Blog, Cardiome Pharma, Companies, Diagnostics, Funding, Medical Devices, Medical Supply, Merck, Pharmaceuticals, Phase I, Startups, Universities, vernakalant, Videos by John Carroll

Cardiome's long-running roller coaster ride with its atrial fibrillation drug vernakalant went into a steep descent this morning when the biotech announced that Merck ($MRK) is dumping its involvement in the oral formulation of the therapy. Shares of Cardiome ($CRME) plunged about 40% on the news, which includes a plan to swiftly slash the biotech's burn rate in half.

Just last summer Merck buttoned up rights to the IV formulation of vernakalant, which gave analysts greater confidence in its collaboration with the pharma giant. Around the same time Merck completed multiple Phase I studies for the oral program, with an eye to launching a Phase II trial in 2012. But this morning, Cardiome lost a considerable amount of that confidence when it said that Merck had decided to cut its losses on the oral end of the deal after reviewing the regulatory environment and the timeline for an approval.

"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 Cardiome CEO Doug Janzen. "However, we look forward to continuing to work with Merck on the worldwide development and commercialization of vernakalant IV."

Cardiome officials didn't immediately note just how they plan to cut costs in half, but its release noted a plan to trim down to $11 million a year, half of the current burn. The IV formulation of vernakalant is approved in Europe and has faced a rocky road at the FDA.

- here's the press release

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ARCA cardio data analysis triggers brief spike in share price

Posted under ARCA, atrial fibrillation, Blog, Companies, Diagnostics, Funding, Gencaro, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

Shares of ARCA biopharma ($ABIO) briefly went on a tear yesterday after the Broomfield, CO-based biotech reported some impressive data based on follow-up analysis of some aging late-stage data on its cardio drug Gencaro. The stock initially soared after investors heard the drug triggered a 74% reduction in the risk of new onset atrial fibrillation for a big group of patients sharing a common genotype. But then the price quickly slid back to earth.

Gencaro has followed a long, twisting path in the pipeline. ARCA originally filed for an approval three years ago, only to have the FDA hand back the application with a demand for a new study. Then in the spring of 2010 they struck an SPA agreement for the study, but have yet to launch it as the biotech ponders how it can pay for the work.

ARCA has also had plenty of experience with a gyrating share price. Back in 2009 the FDA didn't just reject the application, regulators also questioned the integrity of the data, adding that the results did "not adequately demonstrate efficacy of Gencaro in reducing all-cause mortality in patients with heart failure." That news triggered a collapse in the share price.

- here's the press release
- get the Dow Jones report

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