Cordaptive

FDA-rejected Merck med gets E.U. approval

Tracy Staton — Tue, 15 Jul 2008 11:21:55 -0400

Merck's cholesterol drug Tredaptive received approval in the European Union, Iceland, and Norway, clearing the way for marketing in 29 nations; formerly known as Cordaptive, it was rejected by the FDA earlier this year. Report

Merck layoffs inspire poets to versify

Thu, 08 May 2008 06:59:54 -0400

Curious what one laid-off Merck rep thinks about the company's latest cost-cutting move? He (or she) is not calling it "Plan to Win" as Merck is, that's for sure. No, the wounded one waxed poetical on CafePharma's company board: "'Twas the night before layoffs and all through the house," is how the tale of woe begins. Our favorite stanza? "Oh it was a nice run, Merck once had great style/But then along came the results of the Enhance Trial/I thought a nice long career was gonna be mine/Now I'm riding my bike to the unemployment line."

- read the rest at the Pharma Marketing Blog
- get more about the "Plan to Win" moniker at Seeking Alpha

FDA panel rejects broader Fentora use

Wed, 07 May 2008 06:59:57 -0400

No go, Fentora. An FDA advisory panel voted against broadening the use of Cephalon's painkiller, citing worries that it would in fact be misused. Already the potent drug has caused overdoses and death when it was improperly substituted for another painkiller. Plus, the panel said it could be more attractive to potential abusers because it's stronger than other opioids. The expert advisers told Cephalon to get more data on a proposed risk-management plan for the drug.

The FDA doesn't have to follow the panel's recommendations, but usually does. And an FDA briefing document raised these concerns in advance of the panel meeting. A final decision is expected in mid-September. If the FDA decides to go ahead and approve the expanded label, Fentora could have a potential market of more than 10 million patients, the panel estimated.

After yesterday's meeting, analysts said even if Fentora doesn't get the FDA go-ahead this time around, the drug may still be approved for broader use: It's "a matter of when--not if," one said.

- see Cephalon's release
- see the story in BusinessWeek
- check out the AP article

ALSO: The FDA's decision to reject Merck's new cholesterol med Cordaptive is further proof that the agency is remaining cautious, according to the Star-Ledger. Report

ALSO NOTED: China accuses U.S. of obstructing heparin probe; GSK exec charges Mass. with demonizing pharma;

Wed, 07 May 2008 06:59:50 -0400

> China continues to point fingers at the U.S. over the heparin investigation, saying the FDA refused to hand over details about patients who experienced severe allergic reactions to the blood thinner. Report | Report

> GlaxoSmithKline's top U.S. exec, Christopher Viehbacher, harshly criticized Massachusetts' plans to bar drugmakers' gifts to doctors in letters sent to state Senate President Therese Murray, House Speaker Sal DiMasi, and Gov. Deval Patrick. Report

> Discount retailer Target is matching Wal-Mart's recent expansion of its cheap generics program. Report

> Par Pharmaceutical bought Spectrum's interest in the generic versions of GlaxoSmithKline's migraine drug Imitrex, boosting its share of profits to 95 percent from 38 percent once the products are launched late this year or early next. Release

> Lundbeck posted a 40 percent increase in first-quarter profits on a 12 percent growth in revenues, beating market estimates. Report

> OSI Pharmaceuticals saw its first-quarter earnings jump to $29.2 million, or 49 cents per share, from 12 cents per share last year on higher sales of its cancer med Tarceva. Report

> Onyx Pharmaceuticals reported a street-beating first-quarter profit of $15.4 million on fast-growing sales of its cancer med Nexavar. Report

> MAP Pharmaceuticals announced that it secured a $20 million loan for working capital from Oxford Finance and Silicon valley Bank. Release

> Pharma wholesaler McKesson has agreed to pay $13 million in fines for failing to report large and frequent Internet sales of controlled substances. Report

> Shares of France's NicOx tumbled 38 percent after Pfizer announced that it would not advance their experimental therapy for glaucoma into Phase III. NicOx report

> One analyst is predicting a long delay for Merck's Cordaptive. Report

> Two doctors engaged in RNA research became the first women to win the prestigious Albany Medical Center Prize, one of the richest awards available for biomedical research. Report

> Researchers for Purdue Pharma laid out their data for a new, tamper-resistant form of the blockbuster OxyContin to an expert FDA panel, and promptly had their heads handed back to them. Report

And Finally... UK cell biologist Robert Edwards says he can see a time in the not-too-distant future when humans will be able to grow new body parts through the use of stem cell technology. Report

Where Merck loses, Abbott gains

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

What's bad for Merck is good for Abbott Labs. When the FDA said "no" to Merck's niacin-based cholesterol treatment Cordaptive, it raised the prospects for Abbott's extended-release form of niacin, Niaspan, and its regular niacin drug Simcor. As long as Merck can't enter that market, Abbott has much more room to grow and solidify its market share.

Already Abbott's niacin meds had gotten a boost from problems at Merck: After the Enhance study results were presented at the American College of Cardiology meeting, the New England Journal of Medicine put niacin drugs higher on the cholesterol-treatment ladder than the Zocor-and-Zetia combo Vytorin.

Investors punished Merck, sinking its stock by 10 percent yesterday, and rewarded Abbott with a 3.6 percent boost to $53.48. Analysts scrambled to boost their sales outlooks for Niaspan and Simcor; some estimated that Cordaptive might now be delayed for two to three years. Given that sales estimates for the med were as high as $2 billion annually, that's a big blow. Analysts cut their stock-price targets accordingly--but reaffirmed their "buy" ratings, saying, just as Merck officials are, that the company is strong enough to weather the setback. But some said they're only recommending Merck to long-term investors.

- read the Houston Chronicle story
- see the item in the Wall Street Journal Health Blog
- check out the Associated Press coverage
- find an FAQ on the Cordaptive rejection at In the Pipeline

Fissures in Merck, Schering relationship?

Thu, 24 Apr 2008 06:59:58 -0400

Are fault lines in the Merck/Schering-Plough joint venture beginning to open up? Market-watchers are reading the earnings-call transcripts--and the tea leaves--and finding evidence of "the diverging interests of Merck... and its partner."

Part of the problem is that Merck depends less on Vytorin revenues than Schering does. Merck was perfectly willing to admit that it expects a $700 million hit on Vytorin this year, but Schering danced around that prospect like a fire-walker. "We really have no model" for figuring out how much Zetia and Vytorin sales might drop, Schering CEO Fred Hassan told analysts during his earnings call yesterday. A big company like Schering, with plenty of financial types at its disposal? Color the pundits skeptical

Plus, as Forbes points out, Merck is hoping to launch a new heart med this year, Cordaptive, a tweaked form of niacin that could be an add-on to statins--just as Schering's Zetia is. Imagine patients taking Merck's Zocor--one half of Vytorin--along with Cordaptive instead of Zocor-plus-Zetia, otherwise known as, yes, Vytorin. Why would Merck mind that? Schering, on the other hand, would mind it quite a bit.

The "trouble in Merck/Schering-Plough land" chatter must have some traction, because Merck CEO Richard Clark (photo) addressed it in a Star-Ledger interview published today. The fallout from the controversial Enhance study "won't result in any changes" to the partnership, the Star-Ledger reports. "The joint venture is well-managed," Clark said. "This was an unfortunate outcome."

- see the Forbes article
- check out the item at BNET's pharma blog
- read the Star-Ledger piece

ALSO NOTED: FDA, Researchers butt heads over genetic screening;FDA approves Omrix's Evithrom;

Wed, 29 Aug 2007 06:59:50 -0400

> Perhaps this is a taste of genetic-screening battles to come: researchers at the University of North Carolina are questioning the FDA's genetic screening guidelines for the cancer drug Camptosar. The agency recommends that patients be checked for genes that make them susceptible to harmful side effects, but in a study published in the Journal of the National Cancer Institute, the researchers found that the troublesome genes only increase the risk of side effects at high doses of the drug. Report

> Omrix Biopharmaceuticals got a boost yesterday with the FDA's approval of Evithrom, a protein used to control bleeding during surgery. It's the first human thrombin product approved since 1954. The product will be distributed by Johnson & Johnson. Release

> The FDA has accepted Merck's new drug application for its cholesterol drug Cordaptive, a form of niacin designed to raise levels of HDL, or "good" cholesterol. The company expects regulatory action on the remedy by second quarter 2008. Release

> The oral form of Pharmion's blood disorder remedy Azacitidine stepped onto the FDA fast track today. The drug is already approved in its injectible form, sold as Vidaza. Release

And Finally... Democrat John Edwards proposed raising the cancer stakes first. Now, GOP candidates Sam Brownback, Mike Huckabee, and Mitt Romney are pitching in with their own proposals to boost federal spending on cancer research and prevention. Report