Replies to post #55888 on Biotech Values

[genisi]

CRME- safety concerns for IV vernakalant

>Do you think there is enough room to speculate the drug may not have been related in that case as well?<

The patient in the IV program, who died of fatal MI, became hypotensive in response to vernakalant, which likely contributed to his death. The other death in the IV program was in a patient that received ibutilide, which is known to be associated with high rates of ventricular fibrillation.

Regarding other drugs, I don't know for sure. Will search when I'll have the time.

[genisi]

CRME -

>Do you know if the other approved (oral) drugs have had any associated mortality or SAE's? <

ghmm,

At least for the existing agent amiodarone, no clinical trial that I'm aware of, has shown that it produces a net increase in mortality.
However, the adverse event profile of existing agents has highlighted the need to ameliorate safety and adverse effect concerns.

[krenjp]

Amiodarone is not always recommended beyond 12 months because it can cause eye troubles..If they show efficacy as a prevention drug the other question would be whether low blood pressure can limit chronic use.
An analyst was more bullish in the Vancouver Sun..

"
Although an initial news report indicated one patient in Cardiome's study died as a result of heart spasms triggered by the drug, Janzen said that report was incorrect and the death was deemed unrelated to the study drug.

Investors appeared spooked by the review but analysts say it indicates the drug will likely be approved.

Shares in Cardiome dipped to a low of $8.01 Friday before recovering some ground to close at $8.90 on the Toronto Stock Exchange, down almost five per cent from Thursday's close of $9.35.

"We're more bullish," Brian Bapty, a biotechnology analyst with Raymond James said in the wake of the review. "Both reviewers recommended approval for the drug."

Initial news reports after the FDA posted the review on its website suggested it was bad news for Cardiome, but analysts said a close reading indicates the opposite.

"It was a 300-page document," said Bapty, who is maintaining his target of $19 and a strong buy rating on the stock. "People came out with headlines within five minutes after it was released.

"In fact, this was one of more bullish briefing documents they have come out with."

Prakash Gowd, senior healthcare analyst with National Bank Financial who recently opened coverage of Cardiome with a sector perform rating and a 12-month target price of $10 said he doesn't anticipate any changes to his rating in the wake of Friday's news.

"Obviously the document does discuss some safety issues and that will be discussed at the panel meeting," he said.

There appears to be agreement that the death of a study participant wasn't directly related to the drug, he added. "I don't necessarily see anything that would indicate to the panel to reject the product.

"Our opinion previously was they would likely recommend approval and that really hasn't changed."

Gowd said he was not surprised by the review's suggestion that the drug's approval might come with restrictions on which patients would be able to use it.

"That's not too surprising to me, the clinical trials were not designed with certain patient types in mind, in fact those patients were excluded from the trial," he said. "I think those restrictions would be emphasized."

from Canada.com:
http://tinyurl.com/2q2bgk