On September 20, an FDA expert panel will review Boehringer Ingelheim’s Pradaxa (dabigatran), an experimental blood thinner that the company says is safer, more effective and simpler to use than the generic warfarin. The drug is indicated to prevent stroke in those with irregular heartbeats.

It’s good news for Boehringer, as some analysts speculated an expert panel wouldn’t be scheduled to review Pradaxa until 2011. Bristol-Myers Squibb and partner Pfizer, Merck and Daiichi Sankyo are all racing to develop a warfarin replacement. But the panel date puts Boehringer in line to be the first company to market with a new class of blood thinner. The drug is already approved in non-U.S. markets for clot prevention knee or hip replacement patients.

Warfarin has been approved since 1954. While it’s commonly used to prevent clotting, it’s prone to interacting with many other drugs and even some foods. There’s an unmet need for new drugs that are as effective and safer than current treatment options. According to the Wall Street Journal, Barclays estimates the anti-clotting drug market could hit $12 billion by 2021.

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Earnings season continues with a couple of biggies: Merck unveiled profits that suffered from merger-and-restructuring charges, and Amgen reported street-beating earnings despite some sales declines. Meanwhile, two Japanese drugmakers posted mixed results. Here are the highlights:

• Merck reported a 52 percent decline in second-quarter profit, as merger-related and restructuring costs more than offset a near doubling in sales as a result of its takeover of Schering-Plough. But without those one-time charges, profits actually grew, beating analysts’ estimates. The company’s biggest drug, Singulair, posted flat sales of $1.26 billion, while the newly-off-patent blood-pressure drugs Cozaar and Hyzaar saw revenues drop 46 percent to $485 million.

• Amgen posted better-than-expected Q2 earnings, but lost ground on some of its most important drugs. The anemia drug Aranesp lost 13 percent of its sales, which came in at $603 million; Enbrel sales fell two percent to $877 million. But as Reuters points out, investors were looking past this quarter’s numbers, counting on the newly launched Prolia to give Amgen a new boost.

• Daiichi Sankyo said it might boost its annual outlook after quarterly profit skyrocketed, aided by a turnaround at its Indian subsidiary Ranbaxy Laboratories. Profits grew to $808 million, almost ten times what they were a year earlier.

• Takeda Pharmaceutical took a big hit from the loss of patent protection on the ulcer treatment Prevacid. Profits fell by one-fourth to $1.2 billion, and the company stuck to its lower-than-last-year forecast for 2010.

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In a potential blow to Eli Lilly’s hopes for the new blood thinner Effient, a study has tied the drug to an increased risk of cancer. The researchers analyzed data from a study that was key to FDA approval–Triton-Timi 38, which pitted Effient against its established rival Plavix–and found that the risk of new or worsened solid tumors was 60 percent higher with Effient (prasugrel).

An accompanying editorial calls for curtailed used of the drug, plus a boxed warning for Effient’s label. Dr. Sanjay Kaul–an advisory panel member excluded from the Effient meeting–and Dr. George Diamond, state they “believe that to optimize the benefit-risk balance, prasugrel use should be limited to a duration of weeks rather than months,” until more clinical data are available (as quoted by MedPage Today).

The researchers, Dr. James Floyd of the University of Washington and Dr. Victor Serebruany of Johns Hopkins, posit that as an antiplatelet drug, Effient may promote cancer growth by inhibiting the body’s natural defenses against tumors. Lilly and Daiichi Sankyo pan that argument in a statement, maintaining that the drug isn’t likely to cause cancer and that Serebruany’s hypothesis has been previously presented and published and reviewed by the FDA. Furthermore, the agency “concluded that a causal link was unlikely.”

They add that they continue to monitor worldwide experience in the use of prasugrel and report those findings to appropriate regulatory bodies.

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With late-stage data on an experimental blood thinner with blockbuster potential due next year and ambitious plans to push revenue, Daiichi Sankyo’s European chief tells Bloomberg that the Japanese pharma company would like to do some more deals along the lines of its $235 million buyout of Germany’s U3 Pharma AG.

Reinhard Bauer made it clear that he’s not on the lookout for any generic drugs or meds already approved for use. U3, which Daiichi Sankyo bought two years ago, provided the pharma company with antibodies for breast, colon and lung cancers. And the blood thinner edoxaban could gin more than a billion dollars a year in new revenue. Edoxaban would also offer new competition to Bayer and Boehringer Ingelheim.

“We’re still looking energetically for venture capital companies and biotechnology companies that could lead to acquisitions or partnerships,” Bauer told the business news wire.

U3 Pharma was founded by Professor Axel Ullrich of the Max Planck Institute of Biochemistry, whose gene technology and oncology research helped lead to the development of Herceptin and Sutent.

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“In evaluating an anticoagulant,” says heart researcher Michael Ezekowitz, “it’s all about getting the dose right.”

That’s the next big challenge for Merck and its partner Portola as they prepare to advance the closely held South San Francisco biotech’s drug betrixaban into a large-scale clinical trial in the burgeoning race to develop a replacement for the heart drug warfarin.

Ezekowitz, a cardiologist at Lankenau Institute for Medical Research, Wynnewood, Pa., told a packed auditorium at the annual science meeting of the American College of Cardiology on Monday that a daily 40-milligram dose of betrixaban caused significantly fewer cases of major or clinically important bleeding than standard treatment with warfarin. Bleeding rates were similiar to warfarin at 60 and 80 milligrams, said Ezekowitz, who led the study. Side affects included diarrhea and nausea.

The Phase 2 study tested the medicine in patients with atrial fibrillation, a heart rhythm disorder that afflicts some 2.5 million Americans and carries the risk of blood clots that can lead to a stroke.

Warfarin, a half-century old workhorse anticoagulant from Bristol-Myers Squibb and generic companies, effectively prevents such clots. But patients need regular blood checks and frequent dose changes to prevent life-threatening clots or bleeding episodes.

After decades of frustration in the hunt for an effective alternative that doesn’t require monitoring, the pipeline is now full of promise. Boehringer Ingleheim, Daiichi Sankyo and joint ventures between Pfizer and Bristol-Myers and Johnson & Johnson and Bayer all have compounds in development for a global market that some analysts expect will exceed $10 billion by later in the decade.

Merck and Portola trail most of their rivals at the moment, but they believe features of its compound, including once-daily dosing and the fact that Portola is developing an antitode that could quickly turn the drug off in the event of a dangerous bleed, could be advantages for betrixaban if it reaches the market.

First they have to find the dose that hits the sweet spot between too much clotting and too much bleeding. Will a 40-milligram dose with the favorable bleeding risk be strong enough to effectively prevent clots? That’s one big question Merck and Portola will ponder in the months ahead as they plan a trial they hope will lead to the drug’s approval.

Bill Lis, Portola’s new CEO, indicated one possibility is to move more than one dose into a Phase 3 trial. “It’s clear we have an active drug that is safe and tolerable and ready for the next stage of development,” Lis says.

Source: The Wall Street Journal

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Will a new FDA warning on Plavix help the personalized-medicine cause, or will it just confuse people? That’s the question the Wall Street Journal Health Blog asks today. A new “black box” warning has been added to Bristol-Myers Squibb/Sanofi-Aventis’ anti-clotting medicine Plavix, which is poorly metabolized by up to 14 percent of patients who use it. Those patients, who have a particular genetic variant, could do better on another anticoagulant or on higher Plavix doses, the warning states.

Perhaps the FDA envisions that doctors will now be more likely to follow its recommendation to test patients for that variant before prescribing Plavix. But do enough doctors have access to the tests? Will they have time to wait for the results? Before such an approach grows common, cardiology associations will have to develop treatment protocols, experts tell the WSJ. Meanwhile, says one Harvard Medical School associate prof, “I expect mass confusion in response to this FDA warning.”

This could be an opportunity for upstart Plavix competitor Effient, from Eli Lilly and Daiichi Sankyo, but that drug carries an increased bleeding risk. Or it could be an opportunity for Medco Health Solutions, which last week said it was expanding its personalized-medicine programming–and planned to extend that program to Plavix at some point. Maybe that point has arrived.

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The FDA says it added its strongest warning today to the label of the widely used bloodthinner Plavix, Bristol-Myers’ best-selling drug, to help physicians treat patients correctly. But the warning could make doctors’ job more difficult.

Docs prescribe Plavix to reduce the risk of heart attacks, strokes and other serious heart problems. The drug prevents dangerous blood clots that can cause those conditions. As a growing number of studies has demonstrated, however, Plavix doesn’t work well in certain patients – those with a genetic variation that makes it difficult for them to metabolize the drug.

The FDA says between 2% and 14% of Plavix users don’t respond well to the drug and might benefit from alternative treatment. Hence the new so-called black-box warning.

Genetic testing could identify the poor responders. But most doctors aren’t well equipped to do genetic testing. They don’t have quick access to the tests. Even if they did, they might not have time in the cases of many patients to wait for results to come back.

What’s more, the FDA has approved only one genetic test, Roche’s AmpliChip, to look for the variation, but not specifically for determining treatment with Plavix. Many laboratories offer other tests, whose quality the FDA says doctors will have to assess before using. Doctors should make sure the tests are at least 98% accurate, FDA officials told reporters.

Christopher Cannon, a Harvard Medical School associate professor and editor-in-chief of Cardiosource, tells the WSJ’s Ron Winslow that heart-doctor associations will need to develop protocols for testing and treatment. The alternatives include increasing the dose of Plavix or switching to bloodthinner Prasugrel from Lilly and Daiichi Sankyo, but Cannon says neither has been tested for that purpose.

“Thus a real conundrum” for patients and their physicians, Cannon said. “I expect mass confusion in response to this FDA warning,” he added.

Plavix, which is also marketed by Sanofi Aventis, is the second-best selling drug world-wide with $8.6 billion in sales in 2008, according to IMS Health.

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While Big Pharma bewails the forthcoming loss of patent protection on many top-selling drugs, the knock-off drug business is rubbing its hands in anticipation. Just witness the Indian pharma industry, which is positioning itself to capture as much of that business as it can.

Considering that nearly $60 billion worth of drugs fall off patent over the next four years, who could blame Indian drugmakers for angling for their share? After all, they’ve spent years building up their generics businesses. “While we are not too much into new drug inventions, we are quite strong in manufacturing formulations and bulk drugs,” J. Jayaseelan of the Indian Pharmaceutical Association tells the Times of India. “When the $60 billion worth of patents expire … Indian companies will be able to capture a major chunk of the market.”

In fact, Indian pharma firms are gathering over the weekend to discuss how they plan to do that. One strategy has to be hooking up with multinational drugmakers. After all, Pfizer, GlaxoSmithKline, Daiichi Sankyo and now AstraZeneca have forged ties in India for that very reason: To gain access to that generics capability and the attached sales-and-distribution networks. It may just be that when Indian drugmakers capture a share of the off-patent market, they’ll be bringing Big Pharma along, too.

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Eli Lilly executives said there’s every reason to be optimistic about future sales of Effient, the blood thinner launched last summer with expectations of perhaps growing to become a billion-dollar seller one day. The only worry seems to be early sales of the drug are headed in the wrong direction.

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Reporting its fourth-quarter results, Lilly said that sales of Effient, which the company co-markets with Japan’s Daiichi Sankyo, slid to a tiny $3.8 million world-wide in the fourth quarter. In the third quarter following the drug’s August launch, world-wide sales totaled $22.6 million.

On the conference call with analysts, Lilly execs said they were undeterred about Effient’s prospects, offering comments like “we feel just as good about Effient today as we did when we launched the product.” CEO John Lechleiter explained it was still early days in the roll-out and noted there was an initial jump in third-quarter sales because wholesalers were stocking up on the drug.

Lilly has long had high hopes for Effient to help replace the revenue from drugs that are losing patent protection in the next few years. But Effient also is in a tough market, competing against Plavix whose fourth-quarter sales rose 10% to $1.6 billion, Bristol-Myers reported today.

There was some better fourth-quarter numbers in Lilly’s results today and Lilly and Bristol-Myers also announced a settlement in a fight stemming from Lilly purchase of Imclone in 2008. Here’s the Dow Jones Newswires report with more details.

Source: The Wall Street Journal

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What kind of company gets a drug through the FDA? If you’re a Japanese company, it seems to help if your main business isn’t prescription pharmaceuticals.

Perusing the list of FDA new drug approvals from Washington Analysis, we found four that originated in the labs of Japanese companies. A new drug for gout came from Teijin, a major textile maker. (Teijin licensed U.S. rights to Takeda.)

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The Otsuka group of companies, best known in some circles as the maker of the Pocari Sweat sports drink, came up with approval for a niche product for certain patients with low sodium levels in plasma.

Then there’s Kowa, which won approval for a cholesterol-lowering statin called Livalo. We’re somewhat at a loss to describe its core business. Its Web site mentions professional broadcasting equipment, apparel, textiles, home fashion, “bioarchitectural research” and a few other areas in addition to medicines.

Less successful at getting drugs through the FDA were the pharmaceutical giants that spend billions of dollars each year for precisely that purpose. Pfizer and Merck were among the big names that struck out for the year. That’s food for thought as the pharma industry tries to survive a wave of patent expirations and growth in U.S. prescription-drug spending slows sharply.

To be sure, some of the bigger names did get new drugs through the FDA in 2009, including Tokyo’s Daiichi-Sankyo, which won approval for the clot-buster Effient (co-marketed with Eli Lilly).

Source: The Wall Street Journal

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