cholesterol

PreMD shares in nosedive on FDA's rejection

John Carroll — Tue, 19 Aug 2008 12:14:21 -0400

PreMD CEO Brent Norton told the wire services that the company is "facing some tough decisions" after learning that the FDA had upheld ts earlier decision to reject the expanded use of its skin cholesterol test.

The agency had decided at the beginning of the year that the Canadian biotech's clinical trial determining the test was functionally equivalent to approved cardiovascular risk tests had been defective. Its stock plunged 68 percent on the news and was trading at nine cents. PreMD said in a statement that it "will be working with its advisors and partners to examine its options."

--read the report from RTT News
--check out the press release

Merck shelves study of cholesterol drug

Wed, 21 May 2008 06:59:57 -0400

Saying it had the wrong patient population, Merck has discontinued its ACHIEVE imaging study for its cholesterol drug MK-0524A. Its steering committee recommended a new imaging study that included a "more appropriate patient population." The ACHIEVE trial was intended to gauge the drug's impact on the thickness of artery walls.

Merck emphasized that the decision to discontinue the trial was not related to a recent Not Approvable letter from the FDA and that all other studies would proceed as planned. The FDA turned thumb's down on MK-0524A last April. The drug is a combination of the B vitamin niacin and the drug laropiprant.

- here's the release
- read the report from Hemscott

Analyst predicts a long delay for Merck's Cordaptive

Tue, 06 May 2008 06:59:55 -0400

There's more bad news--or analysis--for Merck's drug development efforts. After the FDA turned down Cordaptive, Merck's new cholesterol medication, there was much head scratching over why. The drug giant never explained the reasons for the rejection. Now Pharmalot is highlighting a note from a Credit Suisse analyst who believes that the combination of niacin and the chemical component laropiprant--to prevent flushing--may have been doomed by cardiovascular signals emitted by the chemical.

The numbers of patients who demonstrated these signals may have been small, but Merck researchers couldn't explain just why they had them. With plenty of me-too alternatives on the market and an uncertain risk profile, the agency had little reason to provide an approval.

The kicker, for Merck, is that the analyst doesn't see any definitive new data on laropiprant coming from an ongoing study, leaving the drug giant to mount new trials if it wants to make its case to the FDA. And that could delay any approval for years.

- read the report from Pharmalot

ALSO: The axeman cometh to Merck's sales force. The drugmaker plans to lop off about 15 percent in the sales ranks, or 1,200 jobs. Layoff report

Esperion gets second shot as an independent drugmaker

Mon, 05 May 2008 06:59:55 -0400

After getting squashed in Pfizer's restructuring crunch, Esperion Therapeutics is reopening this week. The company, which specializes in cardiovascular and metabolic disease work, is hiring about 10 researchers from Pfizer and Esperion. Esperion was shut down last year during Pfizer's restructuring, a move that affected about 60 people working for the company, which was acquired in 2003. Aisling Capital, Alta Partners and Domain Partners are providing more than $22 million to re-start the venture, with Pfizer holding on to a stake.

Michigan officials count the reopening as a hopeful bright spot following Pfizer's decision to shutter its Ann Arbor R&D facility, which employed 2,100 people. CEO Roger Newton was cautious about describing the developer's plans, but says he expects to do some more hiring. He also told Crain's Detroit Business that Esperion has gained "control of a series of compounds and will pursue development of a small molecule that inhibits the creation of fatty acid and cholesterol synthesis."

- read the article from the Detroit News
- check out this report for more

FDA rejections signal tougher developers standards

Wed, 30 Apr 2008 06:59:58 -0400

Faced with back-to-back rejections of two would-be blockbuster drugs for cholesterol, analysts have been reading the tea leaves for what this could portend for developers. What they've come up with boils down to a tougher set of standards for cholesterol drugs and a much more skeptical view of me-too drugs. Regulators are increasingly interested in seeing data regarding superior benefits over existing meds. And that will take more time and money to produce.

"The party for all these 'me-too' drugs has been over for at least two years," WBB Securities analyst Steve Brozak told the AP. "It's just that these pharmaceutical companies are only now beginning to realize it."

It seems clear now that the FDA--in the wake of the Vytorin fiasco--will demand data on new cholesterol drugs demonstrating that they can improve outcomes rather than simply influence cholesterol levels.

- check out the AP report

Cholesterol drug delay signals new FDA standards

Mon, 28 Apr 2008 06:59:58 -0400

In what may signal a major shift in FDA standards, Isis and Genzyme say that they expect to add another year to the development timeline for a closely watched cholesterol therapy in order to produce data demonstrating a reduced risk of heart attacks and related diseases rather than just an ability to lower levels of cholesterol. Researchers for the two companies say they now plan to file for approval in 2010. Shares of both companies were hurt by the announcement, with Isis shares dropping 29 percent Friday.

Genzyme agreed to buy $150 million of Isis shares and provide $175 million in a large upfront fee last January. The two companies planned to file for approval of mipomersen as a therapy targeted against a rare genetic disease. The decision, though, could have a wide ranging impact on drug developers if the FDA will no longer approve a drug based simply on its ability to lower cholesterol. And that could be a direct result of the brouhaha over data showing that Vytorin--while effective in lowering cholesterol--was no better than a generic in preventing thickening of the arteries.

- see this Genzyme/Isis release
- read the story in the Wall Street Journal

SPOTLIGHT: Merck halts trial enrollment

Mon, 31 Mar 2008 07:59:53 -0400

Merck's giant migraine over the Vytorin data is spilling into one of its development programs. Researchers halted enrollment in a late-stage study of the cholesterol drug Cordaptive to ponder results from similar trials as well as the lessons learned from Vytorin. The trial will continue with 300 volunteers instead of the planned 900. Report

Merck scores high in race for cholesterol drug

Tue, 04 Sep 2007 06:59:55 -0400

Merck is reporting success in its Phase III trial of a new cholesterol drug that combines a known ingredient with a new one that reduces the risk of an uncomfortable and common side effect. Cordaptive--which has been submitted for FDA approval--uses an extended-release form of niacin with another therapy that has significantly reduced the number of times patients experience "flushing," a reddening of the skin that is associated with a burning sensation. By week 24 in the study, patients taking Cordaptive reported one incident of flushing per month on average compared to one incident per week for patients taking niacin alone. Not surprisingly, the groups reported similar levels of cholesterol. Abbott, meanwhile, is advancing its own new version of Niaspan, which also is intended to reduce the number of incidences of flushing. The FDA is expected to make a decision on Cordaptive in the second quarter of '08.

- see the release
- read more on the data from MarketWatch
- and here's the analysis from the Wall Street Journal

Related Articles:
Merck to delay filing on new cholesterol drug. Report
Pathway found to raise "good" cholesterol. Report
Penn researchers report success in cholesterol control. Report

AstraZeneca, Abbott plan combo pill

Fri, 31 Aug 2007 06:59:56 -0400

Abbott and AstraZeneca are planning to Phase III trial a pill combining two drugs to target all three major blood lipids--LDL-C "bad" cholesterol, HDL-C "good" cholesterol, and triglycerides. Abbott's ABT-335 and AstraZeneca's Crestor will make up the combo drug. If the drug is successful in trials, the companies plan to market the drug by 2009. Programs combining drugs have become very popular as of late as they offer beleaguered drug developers a way to make a quick buck.

- see this release for more

Related Articles:
New combos of old drugs may be boon to biotech. Report
Drug combos not a sure thing. Report