Cardiome

Cardiome shares plunge on approvable letter

John Carroll — Mon, 11 Aug 2008 11:41:46 -0400

After riding high on the news of positive data from a recent Phase IIb trial, shares of Cardiome Pharma swiftly sank 30 percent after investors heard that the FDA's "approvable" letter for Kynapid (vernakalant)--co-developed with Astellas--included a request for more information on the drug's impact on a subset of patients in trials and a safety update on users.

"Astellas will be in contact with the FDA within the next few days to discuss next steps, and we expect that several months may be required to assemble a complete and appropriate response," stated Bob Rieder, CEO and chairman. "While this action letter could result in the need for an additional clinical study, Cardiome is optimistic that the questions raised can be satisfactorily addressed from currently available data."

- check out the Cardiome's release
- read the report from the Globe and Mail

Cardiome's CBO discusses changes at FDA

Fri, 28 Mar 2008 07:59:56 -0400

During a conference call with investors yesterday, Cardiome's President and Chief Business Officer, Doug Janzen, had some interesting thoughts on the slow approval process at the FDA:

"The FDA has actually come out and said it will be missing (PDUFA) dates... I think everyone is in a brand new environment... actually, some of the old-timers in the industry are talking about we're back in the old environment where the FDA just doesn't deal with timelines. They're missing PDUFA dates, they're missing type-C meetings, they're missing meetings to discuss protocol..."

Janzen's comments stem from the approval delay of Cardiome's intravenous drug vernakalant for atrial fibrillation. Despite being approved by an expert committee, the company has been awaiting FDA approval since the drug January 19th PDUFA date. His observations highlight the ongoing problems at the FDA. The agency is struggling to meet PDUFA dates, ensure food and drug safety, and maintain enough staff to deal with it's ever-growing list of responsibilities.

On the subject of PDUFA dates, however, it seems that an approval delay may be preferable to a hastily-made decision. Just yesterday a Harvard analysis found that that drugs approved in the two months leading up to the deadline are four to five times more likely to be withdrawn or require serious safety warnings. So is it better for the FDA to scramble to meet deadlines--and possibly miss safety problems--or miss the approval date that companies pay hefty fees for the FDA to meet?

- read the Motley Fool piece
- check out Cardiome's financial results

ALSO: Speaking of that study, the FDA says that it can't replicate the Harvard study's numbers. The agency is sending a detailed letter disputing the results to the New England Journal of Medicine, which published the research. Report

Related Articles:
Study: Last-minute FDA approvals less safe. Report
Developers: Politics behind slow approval process. Report
PDUFA debate highlights drug safety issues. Report
The FDA: Caught between a rock and a hard place. Report
FDA quick to reject drugs as it gets more cautious. Report

ALSO NOTED: Rumor Mill: AstraZeneca a possible Shire suitor; Cardiome baits hook for partners; Vertex shares keep sliding; and

Tue, 18 Mar 2008 07:59:50 -0400

> Shire is suddenly the talk of the town as investors and investment banks publicly mull a match-up with AstraZeneca. Report

> Cardiome has brought in Merrill Lynch to handle the expected partnership offers for Vernakalant. Cardiome is bullish about its prospects after reporting positive interim Phase IIb data for atrial fibrillation. Release

> Vertex shares have been sliding as analysts assess its prospects for the once red-hot hep C drug telaprevir. Report

> Targacept is starting an early-stage trial of TC-5214 for major depression. A spin-off of RJ Reynolds, its researchers specialize in neuronal nicotinic receptors in the brain. Report

> Pharmacopeia is pocketing a $5 million payment from GlaxoSmithKline for completing early research discovery work. Release

> Fewer reps are knocking on doctors' doors these days. A consulting firm that advises most of Big Pharma says Pfizer, Sanofi-Aventis, and Bristol-Myers Squibb have all culled their herds of reps. And more companies will be following suit soon. Report

> A measure that would force pharmaceutical companies and medical device makers to disclose gifts valued at more than $25 seems to be gathering momentum. Report

> The FDA's Andrew von Eschenbach got peeved during an appearance at the American Enterprise Institute when someone suggested that appointing Janet Woodcock (photo) to her former post at the top of CDER was a return to the "old ways" at the agency. Au contraire, he said. She's "going back as a very, very strong change agent," he responded. Report

And Finally... A UN agency has been alarmed by the 'critical' situation posed by the continued spread of avian flu in Indonesia. Report

ALSO NOTED: Cardiome awaits FDA decision; Congress to investigate Vytorin scandal; and much more...

Fri, 18 Jan 2008 06:59:50 -0500

> Cardiome is awaiting a critical FDA decision on its drug vernakalant. Report

> It seems that many black U.S. residents are less likely to participate in clinical studies, possibly due to distrust of physicians and fears that they might be harmed by participation, according to a study published in the journal Medicine. Report

> Amgen, you're being served. The New Jersey Attorney General has sent out a subpoena to the California company, asking for "a comprehensive array of documents and information" related to Enbrel sales and marketing. Report

> The deadline bell has rung. At final count, more than 50,000 Vioxx plaintiffs have registered for the $4.85 billion settlement. Report

> Congress is promising hearings on the Vytorin controversy. Report

And Finally... What's in a name? Drug-naming experts are charging hundreds of thousands for just the right combinations of vowels and consonants. Report

Astellas inks $537M deal for Agensys

Tue, 27 Nov 2007 06:59:58 -0500

Japan's Astellas has forged a deal to buy Santa Monica, CA-based Agensys for $387 million plus up to $150 million more in milestones. The deal gives Astellas new antibody technology for combating cancer. Agensys has a Phase Ib trial underway for one antibody plus several more preclinical candidates. Astellas is betting that antibodies will play an ever-growing role in cancer treatments, which are expected to command a $32 billion market by 2015.

"Agensys will be the cornerstone of our biologics efforts and an integral component of building our oncology efforts within our franchise," explained Masafumi Nogimori, CEO of Astellas.

- see this release for more
- check out the report on the deal

Related Articles:
Astellas faces FDA delay on reformulated Prograf. Report
Cardiome, Astellas get panel date. Report
Agensys gains $41M in venture funds. Report

SPOTLIGHT: Cardiome, Astellas get panel date

Thu, 30 Aug 2007 06:59:53 -0400

The FDA as extended its review of a new therapy for abnormal heart rhythm and asked Cardiome and Astellas to sit in on a panel review of the drug. The panel review will be held on December 11 and 12 with a decision on the therapy by January 19, 2008. Astellas holds the U.S. marketing rights to the therapy. Release