cholesterol drug

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

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

Merck shares hammered after FDA rejects Cordaptive

Tue, 29 Apr 2008 06:59:58 -0400

Shares of Merck were sliding again this morning on the news that the FDA has turned thumbs down on MK-0524A, its new cholesterol therapy. The stock dropped eight percent after regulators announced that the experimental therapy, a combination of niacin and laropiprant that had been high up on the drug giant's list of potential blockbusters, failed to make the grade. Getting an approval on Cordaptive, as the therapy was dubbed, would have gone a long way to easing the sting from the massive fallout that has hit Merck since new Vytorin data cast doubt on its efficacy.

"We plan to meet with the FDA and to submit additional information to enable the agency to further evaluate the benefit/risk profile of MK-0524A," said Peter Kim, executive vice president of the company and president of Merck Research Laboratories, in a prepared statement.

- see Merck's release
- check out the report in TheStreet.com

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

Safety, efficacy problems sink Takeda drug

Fri, 28 Mar 2008 07:59:58 -0400

Japan's Takeda has walked away from development of its once-promising cholesterol drug TAK-475. The first sign of trouble came late in October, when the FDA recommended Takeda stop trials using higher doses of TAK-475 after seeing signs of elevated enzymes that indicate possible liver damage. Takeda discontinued TAK-475 development because, according to a release, the drug's profile was not superior to existing marketed drugs from both efficacy and safety standpoints. TAK-475 is a squalene synthase inhibitor which, had it been successful, would have been the first drug of its kind on the market. Takeda badly needs another blockbuster in its pipeline to make up for the loss of Actos patent protection in 2011.

In order to fill the gap, Takeda said it will aim for the "earliest possible launch of SYR-322 and TAK-390MR of which NDAs are now under review by the FDA, and for earliest possible NDA submission of the development projects in the late stage such as Hematide, a treatment for chronic kidney disease related anemia and cancer related anemia, and Lu AA21004, a treatment for mood and anxiety disorders."

- see Takeda's statement

Related Articles:
Safety questions cloud future of Takeda's TAK-475. Report
Takeda expands R&D budget, may look for buyout. Report
Takeda scraps licensing deals, inks $100M pact. Report

Full speed ahead for Vytorin II at Merck, Schering

Wed, 16 Jan 2008 06:59:56 -0500

The disastrous results of the recent Vytorin study have apparently done nothing to blunt the appetites of Merck and Schering-Plough for a follow-up therapy that is designed to work--or not work--in much the same way. Spokesmen for both companies tell Dow Jones that it is full speed ahead for a program to develop a similar cholesterol pill that combines Vytorin and a generic Lipitor as they looks to expand their command of the $32 billion market for cholesterol drugs.

Researchers released data earlier this week showing that Vytorin failed to perform better at reducing the rate of artery clogging than a generic statin, even though the drug reduced greater levels of bad cholesterol. Scientists at the Big Pharma companies are planning to complete studies on a Zetia-atorvastatin (Lipitor) combo so they can begin marketing it when the blockbuster Lipitor loses patent protection in 2010. AstraZeneca and Abbott are also both working away at a new combo cholesterol pill.

- here's the Dow Jones report

ALSO: Day three of chatter about Vytorin's poor performance in the ENHANCE study, and the furor seems to be increasing. Report

Related Articles:
Heart docs back Vytorin. Report
Vytorin fallout doesn't faze analysts. Report
Merck, Schering's Vytorin fails trial. Report
Merck, Schering left trial chief out. Report
Schering CEO defends Vytorin decisions. Report
Merck, Schering backpedal on Vytorin. Report

ALSO NOTED: Big Pharma rethinks animal testing; FDA extends telavancin review; and much more...

Fri, 11 Jan 2008 06:59:50 -0500

> In a move that will please animal rights activists, a number of pharmaceutical companies have determined that they will no longer conduct acute toxicity tests. They say that new technology has rendered these animal tests redundant, slowing down the drug development process. Report

> The FDA is calling for more reviews of Theravance's telavancin. Report

> Merck's good news? It looks as if enough plaintiffs will sign on to the $4.85 billion Vioxx settlement. Merck's bad news? Some plaintiffs are opting out, and some lawyers are challenging settlement provisions designed to prevent that. Report

> Just how did Merck and Schering-Plough get themselves into hot water with the ENHANCE trial, which compared Zetia and Vytorin to a generic cholesterol drug? Maybe by excluding their lead investigator from key discussions. Report

> Here's more evidence that the developing world is hot, hot, hot. Teva Pharmaceutical Industries plans to invest a whopping $1 billion in India. The generics giant will spend between a quarter and a third of that on new manufacturing plants. The rest will go into acquisitions. Report

> Will Florida join other states suing makers of atypical antipsychotics? Report

And Finally... Researchers have identified small pieces of ribonucleic acid that suppress the spread of breast cancer to the lungs and bone. Release

Genzyme wins Isis pact with $1.9B bid

Tue, 08 Jan 2008 06:59:58 -0500

Shares of Isis Pharmaceuticals rocketed up 45 percent after the biotech announced that Genzyme had signed on as a partner to develop the promising cardiovascular drug mipomersen, its flagship product. Genzyme is paying a whopping $175 million in an upfront fee and will buy five percent of the company. Potential milestone payments could make the deal worth more than $1.9 billion. Genzyme survived a bidding war that involved 10 companies interested in mipomersen, according to Isis.

The drug blocks a gene that opens the gate to cholesterol in the blood. It's now about to enter Phase III trials after posting some impressive data for lowering bad cholesterol. Isis can now budget a maximum of $75 million in new discovery costs for the program with Genzyme shouldering the rest of the load. Genzyme, which has emerged as an aggressive biotech powerhouse, also gets "preferred access" to other Isis therapies in the future.

- see this release on the deal
- here's the article from The San Diego Union-Tribune

Related Articles:
Genzyme on buyouts: Thanks but no thanks. Report
Is Carl Icahn out to buy Genzyme? Report
More good news from RNAi company Isis. Report
Isis gains from big RNAi deal. Report

ALSO NOTED: Savient shares soar on trial results; Pharming handed a rejection on Rhucin;ARCH closes $400M VC fund; and much mor

Thu, 13 Dec 2007 06:59:50 -0500

> It wasn't all bad news on Wall Street. Shares of Savient jumped almost 50 percent after researchers announced that its experimental gout therapy, Puricase, met the main goal of a late-stage trial. Report

> Pharming says that the CHMP in Europe has rejected its marketing application for Rhucin. The company says it will appeal. Release

> With Congressional committee breathing down its neck for the latest trial data on the cholesterol drug Vytorin, shares of Schering-Plough slid about 3.7 percent. Lawmakers want the data, but researchers in the project say they've delayed it due to the complexity of the information. Report

> Chutes & Ladders: Fundamental Applied Biology has raised $21 million in its second round and named former HGS VP Daniel Gold as its new chief executive. Report

> Just months after Pfizer stopped selling its inhaled insulin product, West Pharmaceuticals announced that it will slash 250 jobs in its Tech Group. Release

> Arch Venture Partners, a big player in the biotech arena, has closed its latest fund with $400 million to invest. Arch specializes in backing startups that rely heavily on new scientific research and entrepreneurial management. "We have a firm belief that investing in fundamental biotechnology innovations is one of the few areas that wins in cyclical economies." said Robert Nelsen, Managing Director. "We have seen our biotech platform companies do quite well throughout repetitive cycles, contrary to the industry trend toward 'product-only' companies. Our focus is on the most innovative opportunities, from pioneering technology to landmark products to expanding into unconventional markets." Release

> Lonza and BioWa will collaborate on creating an optimized production platform for more potent antibodies. Report

> The FDA has issued a new warning on carbamazepine, an epilepsy-slash-bipolar drug that can cause rare but severe side effects in certain patients of Asian descent. Report

> Surprise! You're the next CEO. So said Shire to CFO Angus Russell (photo), who got an unexpected promotion to the company's top slot. Report

> Scrub the gilt edge off those bonds. Fitch Ratings ripped the AAA rating off Pfizer's debt, citing the drug maker's "maturing" drug portfolio and its thinly populated pipeline. Report

And Finally… With 20 high-cost procedures leading the way, the nation's hospital bill jumped 7 percent in 2005, twice the rate of inflation. Report

Merck presents pipeline update to analysts

Wed, 12 Dec 2007 06:59:58 -0500

At a meeting with investors yesterday, Merck highlighted several of its late-stage pipeline hopes. One of the most-watched drug candidates in Merck pipeline, of course, is anacetrapib--a drug in the same class as Pfizer's failed torcetrapib. Investors are waiting to see whether the potential blockbuster can succeed where Pfizer's drug failed. Merck officials assured analysts that torcetrapib's flame-out wasn't indicative of problems with the entire class of CETP inhibitors. Phase III trials of anacetrapib are planned for 2008.

Among other pipeline hopes is Merck's obesity drug taranabant, which is in Phase III and could be up for FDA approval in 2008. Taranabant is in the same class of drugs as Sanofi-Aventis' Acomplia, which has thus far failed to gain approval in the U.S. Merck is expecting an FDA decision on NDAs for Emend for Injection and Cordaptive, a cholesterol drug that combines a known ingredient with a new one that reduces the risk of flushing. Also in 2008, Merck anticipates filing an NDA for MK-0524B, simvastatin combined with laropiprant and extended-release niacin.

- see this release from Merck
- see the company's update on its pipeline

ALSO: Get more on Merck's Phase III candidates. Report

PLUS: In reviewing Merck's application to convert Mevacor to over-the-counter, FDA staff said it wasn't clear whether consumers could use the statin safely and effectively. But the agency didn't say consumers clearly couldn't, either. Report

Related Articles:
Merck's CETP program advances--with caution. Report
Torcetrapib disaster unlikely to sink other CETP inhibitors. Report
Merck cautiously upbeat on cholesterol drug. Report

Torcetrapib disaster unlikely to sink other CETP inhibitors

Tue, 06 Nov 2007 06:59:56 -0500

Pfizer researchers rolled out the data on torcetrapib--the would-be blockbuster felled by data indicating a heightened risk of death and stroke--at the annual scientific meeting of the American Heart Association. And the numbers were being carefully scrutinized by developers advancing a group of similar CETP inhibitors--drugs that raise the level of good cholesterol and lower bad cholesterol--that are advancing under the shadow of significant risk factors.

Pfizer, of course, halted development of torcetrapib in one of the most spectacular trial failures of 2006. Researchers for the company say they still don't know why the drug spurred cardiovascular problems. Meanwhile, Merck and Roche are both considering pivotal trials for their own CETP inhibitors, weighing the enormous costs of trials that would need more than 10,000 volunteers to gather the kind of data that could satisfy regulators. The NYT's Alex Berenson concludes that from what he's heard the new therapies will likely stay in the clinic, but advancement will be slow and very cautious.

- read the article from The New York Times
- and read the report from The Wall Street Journal

Related Articles:
Pfizer halts Torcetrapib development. Report
Merck cautiously upbeat on cholesterol drug. Report
Merck's CETP program advances--with caution. Report
Merck scores high in race for cholesterol drug. Report
Pfizer halts Torcetrapib development. Report
Session to detail torcetrapib's stunning failure. Report

ALSO NOTED: Osteologix reports positive Phase II; Crestor fails in heart study; Wyeth CEO: FDA creating monopoly meds; and much

Mon, 05 Nov 2007 06:59:50 -0500

> Osteologix says it harvested positive top-line results in an international Phase II clinical trial of its lead investigational drug, NB S101 (strontium malonate). The trial of 289 postmenopausal women with low bone mineral density met its primary endpoint by significantly decreasing CTX-1, a biomarker for measuring bone resorption activity, at all dose levels compared with the control group. Release

> AstraZeneca's Crestor failed to reduce deaths from heart failure among older people suffering from heart failure. AstraZeneca had been looking to expand the market for its blockbuster cholesterol drug. Report

> Transition Therapeutics has regained all rights to E1-I.N.T after it failed to reach an exclusive licensing pact with Novo Nordisk. Transition says it's in talks with other potential partners. Release

> Gentium plans to submit an amendment to the protocol for its ongoing Phase III trial of Defibrotide of the treatment of hepatic veno-occlusive disease with multi-organ failure. Release

> Bayer is withdrawing the anti-clotting drug at the FDA's request, the agency says, after preliminary data from a new study showed Trasylol increased the risk of death. Report

> Pfizer isn't letting Lipitor go gently into the good night of off-patent drugs. It's fighting to keep the cholesterol remedy's sales up until the bitter end. Report

> U.S. drug regulators aren't playing fair, says outgoing Wyeth CEO Bob Essner. New meds that should be allowed on the market--because they're safe and effective--are blocked if they're not demonstrably better than existing products. Report

And Finally… Scientists at the University of Liverpool have discovered that mice rely on a special set of proteins to recognize each other. Release

Safety questions cloud future of Takeda's TAK-475

Mon, 29 Oct 2007 07:59:58 -0400

One of Takeda's brightest drug prospects has run into a major stumbling block. The FDA is recommending the company halt clinical trials that are using higher doses of TAK-475 after seeing signs of elevated enzymes that indicate possible liver damage. The agency is also looking for additional clinical data ahead of an NDA for the therapy, which is in late-stage studies.

Analysts quickly estimated that the hitch will add at least two years to the development timeline of the drug, which had been tapped as a possible blockbuster able to make up for lost Actos revenue when the diabetes drug loses patent protection in 2011. With the FDA on high alert regarding any safety issues, the potential for liver damage could also be a deal killer for Takeda, which had been expected to file for approval as early as next April. TAK-475 is a "squalene synthase inhibitor" which is being studied to lower levels of bad cholesterol. If it is successful, it would be the first such drug on the market.

- see Takeda's release on the drug
- here's the AFX report for more information

Related Articles:
Takeda expands R&D budget, may look for buyout. Report
Takeda scraps licensing deals, inks $100M pact. Report
Patent 'cliff' looms for Big Pharma. Report

Merck cautiously upbeat on cholesterol drug

Fri, 05 Oct 2007 06:59:57 -0400

Merck is looking to succeed where Pfizer so spectacularly failed. Merck presented positive Phase II data for its CTEP inhibitor anacetrapib, a drug designed to increase good cholesterol and decrease bad cholesterol. Anacetrapib significantly reduced LDL-cholesterol and Apolipoprotein B and increased HDL-cholesterol and Apolipoprotein A-1 both as monotherapy and in combination with Lipitor compared to placebo.

The key, of course, is creating a drug that doesn't increase blood pressure--the side effect that led to torcetrapib's demise. The question regulators will want answered is whether the mortality associated torcetrapib is common to the entire class of CTEP inhibitors. Roche is also developing a Phase II CETP-Inhibitor, R1658. Merck plans to evaluate what went wrong with torcetrapib before proceeding with the next stage of testing. Analysts estimate the market for such a drug could be $15 billion dollars.

- see this release on the data from Merck
- read the Star-Ledger article for more

Related Articles:
Merck's CETP program advances--with caution. Report
Merck scores high in race for cholesterol drug. Report
Pfizer halts Torcetrapib development. Report
Session to detail torcetrapib's stunning failure. Report

More good news from RNAi company Isis

Fri, 05 Oct 2007 06:59:56 -0400

Isis has been on a good-news roll lately, and today is no exception. The company announced positive results from a Phase II open-label extension trial of of ISIS 301012, a cholesterol-lowering drug for with familial hypercholesterolemia. The study included 16 patients who had participated in an earlier Phase II study of the drug. These patients received weekly doses of ISIS 301012 for as long as six months and didn't experience any new or worsening adverse events.

"We are particularly pleased to have had such an uneventful experience with patients in the long-term study. Until now, the longest exposures to ISIS 301012 had been three months, and now to have patients dosed for a total of more than six months without any tolerability issues is quite reassuring," stated John J.P. Kastelein, M.D., Ph.D., a principal investigator for the studies. "Of course, we will all be eager to see more patients and longer exposure times to strengthen our confidence that ISIS 301012 could truly be a transformational new drug for the treatment of refractory high cholesterol."

- see the release from Isis for more

Related Articles:
Isis touts positive cholesterol data in LDL study. Report
RNAi leaders Isis, Alnylam form new company. Report
Isis acquires Symphony GenIsis. Report
Isis gains from big RNAi deal. Report
Mid-stage cholesterol data sends Isis stock soaring. 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

ALSO NOTED: Pfizer's Lipitor patent request rejected; Spherix sells InfoSpherix; and much more...

Fri, 17 Aug 2007 06:59:50 -0400

> Pfizer's request for a reissued Lipitor patent was stamped "Rejected" by the U.S. Patent and Trademark Office--but the decision is only preliminary, so the drug maker can still hope for extended exclusivity on the cholesterol drug. FiercePharma

> Spherix's shareholders approved the sale of the company's InfoSpherix subsidiary to The Active Network for $17 million in cash. Release

> They weren't dishonest, just incompetent--or so says an outside investigator who's been looking into Bayer's Trasylol snafu. FiercePharma

And Finally... Japanese stem cell scientist Shinya Yamanaka conducts his ground-breaking research on lean budget. FierceBioresearcher

Pfizer halts Torcetrapib development

Sun, 03 Dec 2006 19:01:38 -0500

In a huge blow to the world's largest drug maker, Pfizer announced that it will halt development of its cholesterol drug Torcetrapib, one of the biggest drugs in Pfizer's pipeline. The decision came after an independent Data Safety Monitoring Board recommended terminating the study because of an imbalance of mortality and cardiovascular events. "Based on all the evidence we have seen regarding Torcetrapib and in light of prior study results, we were very surprised by the information received from the DSMB, the only body with access to the unblinded safety data. We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug," said Dr. Philip Barter, Director of the Heart Research Institute in Australia and Chairman of the Steering Committee overseeing the Torcetrapib study.

Tapped by many as a future blockbuster, the drug was expected to take the place of Lipitor--a $12 billion-a-year blockbuster--before that drug loses patent protection in 2010. Pfizer spent more than $800 million developing Torcetrapib and now says it will refocus its efforts on other opportunities and "continue to invest in a wide range of pipeline opportunities across a diverse range of therapeutic areas." Potential Pfizer collaborators will, no doubt, take advantage of Pfizer's tough situation and demand premium prices for new pacts. Just last week the company reassured analysts that the company's pipeline was healthy, pointing to Torcetrapib as a promising new blockbuster.

- check out Pfizer's press release on the decision to halt Torcetrapib development
- see the FDA's statement on Pfizer's decision

PLUS: Pfizer isn't the only company dealing with cholesterol drug woes. Shares of Forbes Medi-Tech lost half their value this morning when the drug developer announced FM-VP4 did not lower bad cholesterol by 15 percent. However, the drug did hit its primary endpoint. Release

Related Articles:
Pfizer told to pack up presentation on Torcetrapib. Report
Pfizer prepares red carpet for market analysts. Report
CEO McKinnell gets the boot as Pfizer struggles. Report

Mid-stage cholesterol data sends Isis stock soaring

Sun, 12 Nov 2006 19:01:36 -0500

Isis' experience at the AHA meeting was decidedly happier than Pfizer's, with the drug developer seeing its stock surge 28 percent on the review of its Phase II data for ISIS 301012, an experimental drug for lowering the level of "bad" cholesterol. Patients taking 300mg a week for five weeks had an average reduction of 51 percent in bad LDL cholesterol, a 42 percent drop in total cholesterol and a 41 percent decline in triglycerides. All outcomes were ahead of what patients recorded on statins alone. Increasing the dosage for patients with high cholesterol for three months also spurred impressive results.

- here's a report from MarketWatch for more

Related Article:
Isis to sell $75M in stock. Report