If Laypeople can also post here, I'll start with CRME's PR today. Note that some discussion of parts of it occurred on the Bio Valuation thread earlier today.
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Cardiome, Astellas revise marketing deal
LEONARD ZEHR
Cardiome Pharma Corp. has revised its marketing deal with Astellas Pharma U.S. Inc. after the two companies met with the U.S. Food and Drug Administration last Friday to resolve details about resubmitting an application for a new drug to treat irregular heartbeat.
In May, the FDA refused to accept the new drug application, citing "inconsistencies and omissions" in the clinical data submitted by Astellas.
The two companies blamed a clerical error for the snafu and promised to refile later this year.
But Datamonitor PLC, a British market research firm, said the setback for Cardiome's RSD1235 drug at the FDA will likely cost the two companies a full year of potential sales in a burgeoning arrhythmia market. It predicts the market will triple in size to more than $3-billion a year (U.S.) by 2015 because of an aging population and new treatments set to arrive next year.
Atrial fibrillation is the most common form of arrhythmia, which can put patients at risk of suffering a stroke. An estimated 40 per cent of AF patients in the United States take medications to prevent strokes. But Datamonitor said there has been a lack of innovative research and development in the sector, with no new products launched in the current decade.
In a new market forecast, it suggested Procter & Gamble Pharmaceuticals Inc.'s Stedicor drug will be the "highest selling pipeline anti-arrhythmic drug by 2015, with RSD1235 having to settle for second place."
But Rodman & Renshaw analyst Michael King said RSD1235 has the "most attractive safety and efficacy profile of any AF agent to date" and its strong clinical data will increase its "attractiveness as the drug-of-choice to terminate and suppress AF occurrence after conversion."
In earlier late-stage clinical studies, Vancouver-based Cardiome said 52 per cent of patients treated in hospital with an intravenous version of RSD1235 converted to normal heart rhythm, with a median time to conversion of eight minutes, compared with 4 per cent of patients receiving a placebo.
Under the new accord, Cardiome said that Astellas will cover all the costs of the revised filing. It will also receive $10-million from Astellas when it files with the FDA. Previously, the cash injection was conditional on the FDA accepting the application for review.
"This action by our partner Astellas is a clear demonstration of their confidence in the RSD1235 intravenous program," said Cardiome chief executive officer Bob Rieder.
Cardiome is also testing an oral formulation of RSD1235 to prevent recurrence of AF and analysts say mid-stage clinical data is expected to be released in the next few weeks. "This will be a key inflexion point for the stock," said CanaccordAdams analyst Karl Keegan, who rates the stock a "buy," with a 12-month target price of $17.90 (Canadian).
On the Toronto Stock Exchange yesterday Cardiome shares closed up 30 cents or 2.9 per cent at $10.60. |
