atrial fibrillation

FDA committee rejects Solvay's tedisamil

Thu, 13 Dec 2007 06:59:55 -0500

An FDA expert panel has unanimously turned thumbs down on Solvay's tedisamil for atrial fibrillation. The experts said they would need more and better data before they could change their decision. Solvay says it will continue to work with regulators. The key problem, says the panel, is that the trial data indicates only a narrow dosage range that could be safe and effective. Serious side effects were noted for the high dosage and lower doses were less effective in treating the condition.

"It's almost like throwing a dart (to determine) what the dose should be," Tom Marciniak, medical team leader at FDA's cardiovascular and renal unit, told the advisory panel. "What will really happen to this drug when it's put out into the real world?"

- check out this release
- read the AFX report for more

ALSO: Solvay revealed a new family of biomaterials. Report

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Wyeth, Solvay handed FDA rejection. Report
Solvay earns $25M as obesity drug advances. Report

A race to the finish for blockbuster blood thinners

Mon, 10 Dec 2007 06:59:55 -0500

Several big developers will take the stage at the American Society of Hematology meeting to provide updates on a string of new blood thinners that are in the clinic. Johnson & Johnson, Bristol-Myers Squibb and Pfizer, Eli Lilly, Boehringer Ingelheim and Portola are all testing drugs that may claim a portion of the multibillion-dollar market for blood thinners, according to the Wall Street Journal. Atrial fibrillation is the biggest clinical target with the most money at stake, say analysts. Developers want to provide an alternative to warfarin, a drug with a history of serious side effects that limit its use to about half of all prospective patients.

- read the article from The Wall Street Journal

ALSO: Shares of Germany's Bayer rose on data for its blood thinner. Release

PLUS: Seattle Genetics revealed positive, early-stage data for SGN-33, an experimental therapy for AML. Release

AND: Shares of Celgene plunged 15 percent on disappointing Revlimid data. Report

Related Articles:
Pfizer partners with BMS in $1B deal. Report

Start-ups snare big rounds of venture funds

Thu, 27 Sep 2007 06:59:57 -0400

Sagent Pharmaceuticals has lined up $53 million in venture financing, a big first round for the start-up based in Schaumburg, IL. Vivo Ventures led the round for Sagent, which was launched in 2006.

"This venture funding enables us to quickly advance many of our recent development efforts into near-term commercialization while accelerating development of our extensive pipeline," said Jeffrey M. Yordon, CEO. "We are confident that our strong financial position and experienced management team, combined with the extensive experience and capabilities of our business partners, positions us to achieve rapid success in our target specialty product market."

- check out the release for more info

ALSO: Sequel Pharmaceuticals has garnered $20 million in first round funds to develop an experimental therapy for atrial fibrillation that was spun out of NovaCardia after that company was acquired by Merck. Sequel's management is looking to in-license other cardiovascular drugs. Previous NovaCardia investors Domain Associates, Forward Ventures, InterWest Partners, Montreux Equity Partners, and Skyline Ventures participated in the Series A. Release

ALSO NOTED: Pfizer transfers HG in Germany; NICE reversal on Alimta; Barr gets copycat OK; and much more...

Mon, 09 Jul 2007 00:01:30 -0400

> Pfizer is transferring its German HQ from Berlin to Karlsruhe. Report

> The UK's NICE has reversed itself, calling for the use of Eli Lilly's Alimta in fighting asbestos-related cancer. Report

> The FDA has approved Barr's copycat version of Dostinex. Report

> InterMune has struck a new supply agreement on Actimmune. Report

And Finally... Medicare and insurers are paying billions of dollars for new therapies to treat atrial fibrillation, even though most of the therapies are unproven. Report

Cardiome upbeat on mid-stage heart drug data

Tue, 12 Sep 2006 20:01:35 -0400

Canada's Cadiome announced that the lower of two doses in a Phase IIa trial of RSD1235 for atrial fibrillation hit its primary endpoint and that the drug demonstrated a good safety profile. A higher dose of the drug "trended" positive but did not achieve a statistically significant improvement in volunteers. Eight percent of patients taking a placebo reported a serious adverse event compared to 10 percent taking the lower dose of the drug and 11 percent taking 600 mg doses.

"This clinical trial has exceeded our expectations, reinforcing the signal we saw in the 300mg interim results and giving us an even greater degree of confidence in the potential for RSD1235 (oral) as a therapy for the prevention of recurrence of atrial fibrillation," said Bob Rieder, CEO of Cardiome. "In particular, we are encouraged by the strong safety data we've seen in a target patient population which includes a high proportion of older patients and patients with congestive heart failure."

- see the release on the trial

FDA turns thumbs down on Multaq

Thu, 31 Aug 2006 20:01:37 -0400

Sanofi-Aventis says that the FDA has rejected its heart drug Multaq (dronedarone), evidently unsatisfied with the data provided to support its application. Multaq is designed to treat atrial fibrillation. Sanofi-Aventis hasn't given up on the drug, though. The company says it plans to refile for approval in the first half of 2008, after it receives a fresh batch of data from an ongoing study. Last February the FDA rejected Sanofi-Aventis' bid to market Acomplia. And analysts weren't happy to see the European drug maker rejected again as it hurries to shore up its revenue in the face of new generic competition for Lovenox and Plavix.

- here's the International Herald Tribune's report on Multaq

PLUS: Sanofi-Aventis announced that the trial to decide on its continued exclusive control of Lovenox has been postponed to early December. Report

Cardiome, Astellas revise deal for RSD 1235

Mon, 10 Jul 2006 20:01:35 -0400

Cardiome and Astellas have revised their development pact on RSD 1235, an experimental therapy for atrial fibrillation, the most common form of arrhythmia. The FDA had rejected their application for the drug last spring, citing inconsistencies and omissions in the data they provided. Developers blamed a clerical error. In the new agreement, Astellas will pay Cardiome $10 million when it files with the agency and will cover all the costs of revising the application. In their original agreement, Cardiome was to receive $10 million only if the FDA accepted the application for review. Cardiome CEO Bob Rieder called the new agreement an indication of Astellas' confidence in the therapy. Analysts have been waiting for upcoming data on a mid-stage clinical trial of an oral formulation of RSD 1235.

- here's the article on the deal from the Globe and Mail

ALSO NOTED: Salix hopes to delay generic; ViroPharma raises new generic complaint; and much more...

Tue, 04 Jul 2006 20:00:50 -0400

> Salix Pharmaceuticals is hoping it can delay a generic competitor to its most lucrative pharmaceutical. Report

> ViroPharma has added a fresh set of complaints to the objections being raised against a generic competitor to its antibiotic Vancocin. The drug developer says that the agency should require clinical studies to establish bioequivalence. Allowing laboratory work alone would significantly reduce the time it would take to gain approval. Report

> IVREA Pharmaceuticals has raised $11 million in new venture funds. Report

> Abbott Laboratories and AstraZeneca have inked a deal to develop a combinational therapy for cholesterol. Report

> Shares of Tercica jumped on the news that a federal court has ruled that its patents on Increlex are valid. Report

> Symphony Medical has begun a Phase II trial of a therapy for post-operative atrial fibrillation. Release

And Finally... Ian Wilmut, a leading expert on cloning, notes that the absence of a cloned primate underscores just how difficult it would be to clone a human. Report

ALSO NOTED: Response Biomedical raises $12M; Prestwick gets FDA OK; and much more...

Thu, 30 Mar 2006 19:00:50 -0500

> Canada's Response Biomedical has raised $12 million in financing for its diagnostic testing business and added five former officers and directors of ID Biomedical to its board of directors. Release

> The FDA has issued an approvable letter for Prestwick Pharmaceuticals' Xenazine as a treatment for chorea associated with Huntington's disease. Release

> The FDA has approved Astellas Pharma's Prograf for the prevention of rejection of a heart transplant. Release

> Cardiome Pharma has announced that its development partner Astellas has submitted an NDA to the FDA for RSD1235, an investigational new drug for the acute conversion of atrial fibrillation. Report

> Banca Intesa has increased its stake in Italy's Sigma-tau to about 5 percent. Report

And Finally…The data doesn't look good for patients who rely on the power of other people's prayers. Article

CryoCor restructures, focuses on heart therapy

Tue, 21 Feb 2006 19:01:35 -0500

CryoCor has decided to lay off 20 of 58 employees as it focuses on gaining approval for a new therapy for irregular heartbeat. Earlier this month the FDA told CryoCor that its trial data did not support an approval for the treatment, which involves freezing tissue that physicians believe causes atrial fibrillation. The therapy was approved in Europe in 2002 and CryoCor executives appear hopeful that more data may change the FDA's mind.

- read this article from the San Diego Union-Tribune

VC: ARYx leads with $30.4 million

Wed, 08 Feb 2006 19:01:32 -0500

ARYx leads with $30.4 million

VENTURE CAPITAL
COMPANY	AMOUNT/ROUND	LEAD INVESTORS	DESCRIPTION
ARYx Therapeutics Fremont, CA	$30.4 million fifth	Ascent Biomedical Ventures	ARYx has three trials underway for ATI-7505, a treatment for gastroesophageal reflux disease; ATI-2042, a treatment for atrial fibrillation, and ATI-5923, an oral anti-coagulant currently in Phase 1.
Catalyst Biosciences San Francisco	$30 million second	Morgenthaler Ventures	Catalyst's product discovery platform includes methods to rapidly create and optimize tailor-made protease drug candidates, called Alterases.
vasopharm Biotech Wurzburg, Germany	$11.8 million second	EMBL Ventures	The money is earmarked to support the further clinical development of vasopharm's compound VAS 203, a nitric oxide synthase (NOS) inhibitor for the treatment of closed head injury.
InnoCentive Andover, MA	$9 million first	Spencer Trask Ventures	InnoCentive--created by Eli Lilly--has been developing a network of scientists to tackle scientific problems posted online for cash rewards.
Accumetrics San Diego	$8.25 million third	RiverVest Venture Partners	The company makes a family of diagnostic tests that measure platelet function.

Medicines Company to resume late-stage trial of clevidipine

Tue, 18 Oct 2005 20:01:36 -0400

The Medicines Company said it plans to resume a Phase III trial of clevidipine, its intravenous, short-acting antihypertensive agent. Researchers announced a voluntary suspension "because preliminary data from an interim analysis contained more frequent reports of atrial fibrillation in patients randomized to clevidipine than in patients randomized to comparator drugs. These preliminary data from 750 patients, available at that time, showed atrial fibrillation rates of 25 percent on clevidipine and 15 percent on comparator agents... The completed data show atrial fibrillation rates of 34 percent and 31 percent in clevidipine and comparator groups respectively, with no differences in duration, severity, treatments or outcomes reported. Other safety measures in the trial were also satisfactory."

- read this press release for more

Cardiome unveils dramatic results for atrial fibrillation therapy

Thu, 29 Sep 2005 20:01:38 -0400

Canada's Cardiome and development partner Astellas said that a new set of Phase III data for their heart drug RSD1235 shows that 52 percent of patients with abnormal heartbeats--or atrial fibrillation--developed regular heartbeats after taking the drug. Only 4 percent of the patients taking a placebo saw their heartbeats return to normal. Those results are in line with an earlier Phase III data and create a case the drug companies will now present to the FDA. Cardiome shares were boosted by the results, which were disclosed after markets closed on Thursday.

- read this feature from Canada.com for more