pharmaceutical
Teva and Barr settle patent dispute
Albany Molecular Research (AMRI) announced this morning an agreement with Teva Pharmaceuticals and Barr Laboratories to settle patent infringement litigation. The settlement involved the U.S. dispute over Allegra and Allegra D-12 between Teva, Barr and Sanofi-Aventis.
The settlement will result in an amended licensing agreement between AMRI and Sanofi-Aventis, which will allow Sanofi-Aventis to sublicense the patents to Teva and Barr. Sanofi-Aventis will pay ARMI $10 million in sublicensing fees.
Sanofi-Aventis will continue to pay royalties to AMRI for the products, as well as for authorized generics, for the remaining term of the patents, but sales of products outside of the United States will be unchanged. The royalties will be on all products containing fexofenadine hydrochloride, or combinations of fexofenadine hydrochloride and pseudoephedrine hydrochloride, generic ingredients in Allegra and Allegra D-12.
While the settlement protects patents only having to do with companies in the current litigation, there will be ongoing patent infringement litigation for other makers of generics in the U.S. and abroad.
- view the AMRI release
- check out the Teva release
- see what Barr had to say
- read the story in the Wall Street Journal
- see what BusinessWeek said
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Scientists recommend ‘black box’ for Avastin
A report released in the new issue of the Journal of the American Medical Association said that Genentech’s blockbuster cancer drug, Avastin, could raise the risk of blood clots by about 12 percent, which means a risk of blood clots that is about 33 percent higher than that of patients not on the therapy. The increased risk of blood clots is especially problematic for cancer patients, because increased clotting is a major cause if illness–and even death–for them. However, the study found that while 6.3 percent of the clots required treatment, few of the clots were fatal.
Earlier studies were too small to base recommendations upon, but that the new review of 15 studies and close to 8,000 patients is strong, said study author, Shenhong Wu of Stony Brook University in New York.
With sales of about $2 billion this year, about 350,000 cancer patients across the globe are treated with Avastin, which the FDA approved for use in 2004. It can cost as much as $55,000 per year.
According to the JAMA review, the drug should receive the FDA’s strongest warning, but a spokesperson for Genentech said that all cancer patients are at increased risk for blood clots and that the label already warns patients about the risk.
- check out the USA Today report
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FDA to examine CV side effects of several meds
Dr. John Jenkins, the director of the FDA’s Office of New Drugs, says that one of the agency’s top concerns are the cardiovascular risks associated with many drugs aimed at treating chronic conditions, like pain and diabetes. He gave examples of meds now known to have serious cardiovascular side effects, including GlaxoSmithKline’s diabetes medication, Avandia; Novartis’ bowel med, Zelnorm; and Merck’s off-the-market pain drug, Vioxx.
Today, more and more patients take medications for chronic conditions. At the same time, the incidence of cardiovascular disease in the general population is high and rising. Therefore, teasing out the intricacies of which medications lead to increased heart risks is complicated.
As a result, the agency is changing how it will consider new medicines, Jenkins said, adding that this is the “the biggest safety shift in the last few years,” as well as “a driver for a lot of the public concern about drug safety.”
Patients take many medications indefinitely, and Jenkins said that FDA will consider which of these would need additional research into cardiovascular side effects. Of priority are medications for chronic conditions like diabetes and high cholesterol, where the conditions themselves increase the risk of heart problems. Approved medications might also have more stringent research and data requirements.
- read the Pharmalot blog post
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Wrinkle injections may not be safe
Injectable pharmaceuticals aimed at smoothing out fine lines and deeper wrinkles are becoming increasing popular. Last year, about 1.36 million women and 84,000 men received such injections, make from animal collagens or synthetic chemicals, to help maintain a youthful appearance.
According to FDA staffers, current prescribing information describes most of the side effects as temporary and noticeable for only a short period. However, side effects that are more serious include scarring and permanent tissue damage, which the current prescribing information downplays. In fact, according to FDA briefing documents filed in between January 2003 and September 2008, 930 side effects were reported. The manufacturers point out that this is less than 1 percent of procedures performed, but FDA staffers noted that it is likely that the side effects are under-reported.
The intent of the FDA meeting was to review products from Allergan, which makes Juvederm, and Medicis Pharmaceuticals, which makes Restylane. The panel discussed modifying the labels as experts learn more about the risks associated with the injections.
The agency does not have to take the advisors’ advice, although it typically does. Still, the panel has not voted formally about increasing warnings on the labels at this time.
- read the full story at CNBC.com
- find the Pharmalot blog post
Are all antidepressants alike?
Are all antidepressants alike? That’s the question on the minds of many patients and clinician’s following the release of a new clinical practice guideline by the American College of Physicians published in the latest issue of the Annals of Internal Medicine.
The authors of the guideline looked at second-generation antidepressants–reviewing more than 200 studies–and found no significant differences in efficacy. The medications reviewed were bupropion, citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, trazadone and venlafaxine.
The authors did find differences in adverse effects, however. Lead author, Dr. Amir Qaseem, a senior medical associate in ACP’s Clinical Programs and Quality of Care Department, said the drugs are “equally effective for treating depression.” He also said that the “ACP recommends that physicians make treatment decisions based on side effects, cost and patient preferences, and make necessary changes in therapy if the response is not sufficient after six to eight weeks.”
Second generation medications generally are considered effective for the approximately 16 percent of individuals who suffer from depression, and many say the newer drugs have fewer side effects than older formulations, such as tricyclic antidepressants. Still, when it comes to efficacy and quality of life, the medications are pretty much the same, the reviewers said, despite the millions of dollars spent by drugmakers trying to differentiate them from each other.
Nonetheless, while there wasn’t a single drug with an increased risk of suicide according to the review, patients receiving SSRIs had an increased risk for nonfatal suicide attempts. Other concerns about the review include possible ties of some of the reviewers to manufacturers of the medications under review.
- see the story in the US News & World Report
- find the LA Times version
- read the Pharmalot blog post
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FDA goes to China
The FDA today opened an office in China’s capital city Bejing to help monitor imports to the United States. The office is the first FDA office beyond the borders of the U.S. It’s part of FDA’s new global safety strategy, as companies increasingly move operations offshore with plans to import products back to the U.S. In addition, Chinese quality officials will set up a station in the U.S.
While concerns about infant formula, food and toothpaste have brought headline-grabbing attention to Chinese imports, problems with pharmaceuticals, including contaminated blood thinners, are a major concern.
The vice health minister and head of China’s food and drug administration, Shao Mingli, said that the FDA presence in China will provide “a very clear signal to the whole world.” U.S. Health and Human Services Secretary Mike Leavitt said that this marks a new strategy to “build safety into products at every step of the way,” rather than just monitoring it upon importation at U.S. boarders.
The two countries will work cooperatively to detect contamination. Together, they will require greater corporate responsibility and increase data and information sharing.
The FDA will soon open two more offices in the Chinese cities of Shanghai and Guangzhou, as well as offices in Europe, India and Latin America. The new China offices will oversee regulation, policy, food, medicines and medical devices.
- read the Associated Press story
- find what the LA Times said
- see the Forbes version
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FDA questions pediatric antipsychotic
Amid increasing reports of safety issues regarding antipsychotic medications in adults (particularly in the elderly), are reports that children are receiving antipsychotic medications at alarming frequency.
Clinicians often prescribe the medications “off label” for conditions the medications the FDA has not approved them to treat, but an FDA advisory committee now says the FDA needs to step up to control such prescribing. Physicians are at liberty to prescribe medications off-label once FDA approves a medication for any condition.
The New York Times cites this example: more than 389,000 children received Risperdal, Johnson & Johnson’s antipsychotic drug. Clinicians often prescribed the drug to treat the spectrum of attention deficit disorders, although the medication is not indicated for such use. Of these children, nearly a quarter-million were 12 or younger. Risperdal’s side effects can be serious and permanent. These include permanent muscle problems such as tardive dyskinesia and dystonia, which the advisory panel said makes it not worth prescribing for many children. Other drugs of concern included Abilify, Geodon, Seroquel and Zyprexa.
Between 1993 and 2008, 1,207 children have suffered serious problems after taking Risperdal, and 31 of them has died. Of the 31 children who died, about one-third were taking the medication for unapproved uses.
The intent of the meeting was a routine review of the safety of Risperdal and Eli Lilly’s Zyprexa and the hope was that the committee would endorse the agency’s safety efforts.
Instead, the committee pointed out its frustration with FDA’s reaction to the increased prescribing. The agency responded that there wasn’t much it could do besides what it had already done (warnings on the labels), and that the responsibility for over-prescribing should fall on the shoulders of specialty medical societies.
- read the New York Times story
- see the Pharmalot blog post
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J&J yanks mom-offending Motrin ad
A Johnson & Johnson online ad has captured headlines all over the place. Too bad it’s the wrong kind of headline. The online commercial looked to promote the Motrin painkiller to new moms. But its flip approach got them all riled up instead.
The ads promise Motrin can treat backs, necks, and shoulders that ache from Mom’s toting baby in one of those slings or packs that keep infants close and their mothers’ hands free. Baby-wearing women were not amused. Offended moms spewed complaints via Twitter, YouTube, and various motherhood blogs. Some even called for a boycott of the medicine, which is one of the standard treatments for childhood fevers.
By the end of the day yesterday, J&J had posted an apology on the Motrin.com website and pulled the online commercial. Magazine ads are also set for the axe, though they’ll take longer to get out of circulation. The ad was “meant to engender sympathy and appreciation for all that parents do for their kids, a VP of marketing wrote on JNJ BTW, the company’s blog, “but did so through an attempt at humor that missed the mark.”
As the Wall Street Journal noted, both the outcry and the swift response shows how quickly Internet-savvy consumers can influence corporate behavior.
- here’s the video
- read the story at Scientific American
- check out the WSJ’s article
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Genentech: Second Raptiva patient has PML
Suddenly, PML is cropping up all over the place. Genentech announced another case of progressive multifocal leukoencaphalopathy, the potentially deadly brain infection, in a 73-year-old women who used its Raptiva psoriasis treatment. It’s the second PML case reported among Raptiva users, both in patients in their 70s. Both patients died.
According to a Dear Doctor letter issued by the company, Genentech believes that Raptiva “likely increases the risk of PML.” In addition, both patients used the drug for several years, raising the possibility that prolonged Raptiva exposure, combined with older age, may further increase that PML risk.
Genentech says it’s working with the FDA on any “appropriate next steps.” As you know, Raptiva’s label was updated last month with a “black box” warning of serious infections, including PML. Meanwhile, Merck KGaA, which markets Raptiva in Europe, said it’s working with European regulators on a label update and that it’s also “seeking to determine if further action is needed.”
So far this year, PML has been reported not only in these two Raptiva patients, but in several patients taking the Biogen Idec multiple sclerosis treatment Tysabri; in patients on the Novartis immunosuppressant drugs–used in transplant patients but also off-label for some lupus sufferers–CellCept and Myfortic; and in one patient using Genentech’s arthritis treatment Rituxan.
- read the Genentech release
- check out the PharmaTimes article
- get the Merck news from Healthcare Digital
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Cephalon hikes prices to fight generic
Today’s Wall Street Journal dissects a familiar drug-pricing strategy: pre-patent-expiration sticker shock. On the table is the Cephalon narcolepsy treatment (and sometime cognitive booster) Provigil. That drug faces generic competition in 2012. Naturally, Cephalon doesn’t want to say goodbye to all that brand-name revenue; the drug brought in $707 million during the first nine months of this year, or about half of the company’s year-to-date sales of $1.43 billion.
So Cephalon is developing a longer-acting version of Provigil, to be dubbed Nuvigil. The new formulation is set to launch next year. In preparation for that launch, Cephalon has been ratcheting up the price of Provigil, to give users reason to switch to the less-expensive new version. “You should expect that we will likely raise Provigil prices to try to create an incentive for the reimbursers to preferentially move to Nuvigil,” the WSJ quotes a Cephalon VP as saying.
And here’s how those numbers are shaking out so far: Provigil is now 28 percent more expensive than is was in March and 74 percent costlier than it was four years ago, according to DestinationRx. And Cephalon plans to continue raising that price, the WSJ says.
The idea is that, by the time 2012 rolls around, most Provigil users will have switched to the cheaper Nuvigil, which will be under patent through 2023. Firmly entrenched as Nuvigil users, they’ll have less reason to adopt the cheaper generic. Or so Cephalon hopes.
- read the WSJ story
- check out the post at the WSJ Health Blog
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Is pharma liable for knockoff meds, too?
While we were watching Wyeth v. Levine have its day in the U.S. Supreme Court, another Wyeth case hit the California appeals courts–and what happened there stunned drug-law types. That’s because three justices ruled Wyeth could be held liable for harm caused not by one of its own drugs, but by a generic version of a medication that went off patent more than 25 years ago.
In the case of Conte v. Wyeth, a woman alleged that she developed a neurological disorder because of her long-term use of metoclopramide, the copycat form of Wyeth’s acid-reflux med Reglan. Conte argued that Wyeth should have warned doctors that Reglan and its generic forms shouldn’t be used for more than 12 weeks at a time. The trial judge ruled for Wyeth.
But in a unanimous ruling, the appeals court reversed that decision. “As the foreseeable risk of physical harm runs to users of both name-brand and generic drugs,” Justice Peter Siggins wrote in the court’s opinion on the case, “so too runs the duty of care.”
Will that verdict stand when it inevitably reaches the California Supreme Court? Liability lawyers want to say “No.” Two attorneys who blog about drug and device law wrote that the ruling “stands product liability law on its head.” And one of them, Mark Herrmann, a Jones Day partner, told Law.com, “Virtually all the precedents went the other way.” And over at In the Pipeline, Derek Lowe pronounces himself incredulous. “How Wyeth can be held liable for the use of a product that it did not manufacture, did not label and did not sell is a mystery to me.” Stay tuned.
- read the article at Law.com
- check out the In the Pipeline post
- see the story at AmLawDaily
Byetta uptick, Icahn news boost Amylin
Maybe Amylin Pharmaceuticals isn’t so bad off after all. With Carl Icahn boosting his stake in the company and Byetta sales reversing their downward slide, industry observers are taking another look at the embattled company.
Byetta’s fourth quarter sales are still down 9 percent year-over-year, but the diabetes med boosted scrips by 3.9 percent during the first week of this month, IMS Health data shows. As you know, Byetta has been beset by doubts since August, when the FDA flagged cases of pancreatitis in patients who used the drug, including six deaths. There’s no proof that Byetta caused the problem, but scrips numbers deteriorated anyway. Until now.
And as Byetta sales are ticking upward, Carl Icahn has been snapping up Amylin stock. At less than $7 a share these days, it’s a lot cheaper than it was just three months ago, when it was trading at almost $30. Just since June 30, Icahn has added some 4 million shares to his Amylin stake, bringing it to a total of 10.7 million.
Other investors are apparently following along: Amylin was up 8 percent Monday to $6.91.
- get the Associated Press news
- check out Mike Huckman’s take at Seeking Alpha
- read The Street’s coverage
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Industry Voices: NICE tries to expand healthcare coverage
This week Senator Max Baucus released a blueprint to create a national health plan. A central feature of his proposal is something called the The Health Care Comparative Effectiveness Research. The Institute is modeled on Britain’s National Institute for Health and Clinical Excellence (NICE) which was established to compare the relative value of medical technology. The Institute has enthusiastic support from advocates of government-run healthcare and the health insurance industry’s lobby, America’s Health Insurance Plans (AHIP). Both groups argue that the institute should compare treatments for the same disease, find which works best, chuck the one’s that are less effective and use the savings to pay for expanded insurance coverage.
Baucus claims the Institute’s decisions would not be binding. The problem is that voluntary decisions don’t stay voluntary for long. NICE decisions were immediately adopted by Britain’s National Health Service to determine what it would pay for and to further tighten the government’s control over healthcare.
Comparative effectiveness advocates like the fact that NICE focuses on the value of care. Recently the group ruled that four drugs used to extend the life of people with stomach cancer “aren’t effective enough to warrant their high cost and shouldn’t be prescribed to new patients.” NICE decided that the $39,000 the drugs would cost to keep people alive wasn’t worth the money.
NICE determines what’s valuable by assuming that anything that costs too much isn’t worth the money, even if it helps people live longer or better for a year. That so-called ‘quality-adjusted life year’ is the upper limit NHS uses to determine what it will pay for. To NICE, breast enhancements and Viagra are a bargain, but new drugs for stomach cancer are a waste of money.
Many comparative effectiveness advocates claim that in America, which spends more per person on health than Britain, the appraisals would only eliminate “wasteful” care. Tell that to Barbara Wagner. She’s enrolled in Oregon’s Health Plan which used comparative effective analysis from Oregon’s Drug Effectiveness Review Project to tell her it wouldn’t pay for Tarceva, a drug proven to extend life in people with her particular type of lung cancer.
DERP receives funding from the federal government’s Agency for Health Care Quality and Research, which already produces comparative effectiveness research. AHRQ also funds the comparative effectiveness institutes of HMOs who, along with DERP, crank out reports used by Medicaid and insurance plans to ration drugs for cancer, mental illness, arthritis and other serious disease in over 25 states.
AHRQ and these organizations would essentially run the new Institute with a budget of about $300 million a year. The legislation says they should do large studies that compare one drug or device to another. Such research take years to complete. All the better if you want to dodge paying for some new cancer drug or medical device. And such studies ignore racial, gender or genetic differences that allow doctors to match the right treatment to the right patient. That makes it easier to conclude that there is no difference between any treatments, and to recommend using the cheapest available.
Comparative effectiveness fans point to the ALLHAT trial (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) as another “gold standard” for what they want. That five-year, 42,000 patients trial compared older blood pressure drugs (diuretics) against newer medicines in reducing heart attacks.
The study concluded cheaper diuretics were just as effective at reducing death from all forms of heart failure. Michael Weber, professor of medicine at Downstate Medical Center and a study adviser, points out diuretics only seemed better overall because the study produced a 40 percent excess stroke rate in African American patients who were given a type of blood pressure drug called ACE inhibitors. It’s known that blood pressure in African Americans responds poorly to ACE inhibitors. The one-size-fits-all approach to treating hypertension taken in ALLHAT exposed black patients to certain danger and even death.
Comparative effectiveness is marketed as a tool for promoting better health and universal coverage. In fact, it’s used mainly to deny people care when they need it most by the folks holding the purse strings. Both NICE and the new Institute will ration care by deciding some lives are worth saving and others are not. The difference is, in America, the insurance companies have found a way to have us pay them to do it. - Bob Goldberg
Pharma bets its chips in developing countries
We’ve been talking a lot about drug sales in the developing world lately, as Big Pharma eyes markets such as Brazil, China and India–the so-called BRIC countries–to make up for stalling sales in the U.S. This week’s Economist comes to the party, taking a look at America’s declining contribution to pharma profits, and just how developing countries might help take up the slack.
As the magazine rightly notes, pharma’s a bit late. Other industries started targeting the growing markets in Asia and Latin America years ago. While consumer brands and high-tech companies poured billions into those countries, drugmakers sniffed about weak intellectual property laws and low per-capita incomes. Now, however, that’s changed, partly because other countries have started to beef up IP protections and partly because incomes have been growing.
But at least half the reason is that China, India, et al, are among the only countries pharma hasn’t fully tapped. Consider a new report from Decision Resources, which predicts that China’s market for antidepressants will triple by 2012 to $226 million. The research firm expects SSRI sales to post continuing double-digit growth there. Plus, Chinese docs and patients consider Western-made antidepressants to be better-quality than those made domestically.
The roll call of companies looking eastward and southward includes GlaxoSmithKline and Pfizer, which just announced that it would put emerging markets on its priority list. And then there’s Abbott Laboratories, which has quietly been building up its Chinese business and now ranks as that countries’ No. 1 outside pharma firm. Plus, news is just now breaking that AstraZeneca is building up a supply hub in China that’s aimed at helping the company not only build its “In China for China” manufacturing strategy, but also its “In China for Global” business.
Meanwhile, look no further than the FDA, which is cutting ribbons at three new offices in China this week: Beijing, Guangzhou and Shanghai. “Establishing a permanent FDA presence in China will greatly enhance the speed and effectiveness of our regulatory cooperation and our efforts to protect consumers in both countries,” HHS Secretary Michael Leavitt said in a statement.
So pharma appears to be meeting itself coming and going, from developed nations to developing countries and back again. And the FDA won’t be the only ones watching.
- read the story in The Economist
- see the AstraZeneca news at Supply Chainer
- check out the release on China’s antidepressant market
- see the article about new FDA offices at CBC
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United licenses Cialis indication to Lilly for $150M
Are you ready for an erectile dysfunction drug revamped to treat high blood pressure? Eli Lilly and United Therapeutics are betting big on it. The two companies have inked a deal to commercialize the active ingredient in Cialis–tadalafil–for pulmonary arterial hypertension. That indication is currently under review by watchdogs in the U.S., Canada, Mexico, Japan, and the E.U.
Under the deal, United Therapeutics will pony up $150 million for exclusive rights to tadalafil for the hypertension use in the U.S. The company will also get a manufacturing-and-supply deal for its money: Lilly will make the molecule for United Therapeutics and will handle all the regulatory and patent details.
In return, Lilly will take a $150 million stake in United Therapeutics. “United Therapeutics brings substantial expertise and passion to the treatment of patients with PAH and will be an excellent partner for this product,” Lilly’s Dr. Gwen G. Krivi said in a statement. “Their experience in this field will greatly enhance the ability to provide tadalafil for PAH, if approved, as a new therapeutic option for this very serious disease.”
United Therapeutics’ stock slumped on the deal, which investors appeared to consider too expensive for the smaller company.
- see the Lilly release
- check out the story at MarketWatch
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Merck launches long-term Januvia trial
Can it be that Merck is going out looking for unexpected cardiovascular side effects? The drugmaker is preparing to launch a massive trial of its diabetes med Januvia, specifically to check for potential heart problems. The 14,000-patient study, helmed by Duke University, aims to gauge the safety of long-term use of the drug–which makes sense, considering diabetes is a chronic, lifelong illness.
It makes sense, but it’s not necessarily every drugmaker’s practice to seek out data on the long-term safety of meds for chronic maladies. Think Zyprexa, the Eli Lilly antipsychotic that’s been shown to boost the risk of weight gain and diabetes, or Avandia, the GlaxoSmithKline diabetes drug that’s been linked with cardiac problems. Or, closer to home for Merck, there’s Vioxx, the arthritis painkiller pulled from the market after a plethora of serious adverse events such as heart attack and stroke.
Barbara Ryan, the Deutsche Bank analyst who dug up info on the new trial, said in an investor note (and we’re quoting CNBC’s Mike Huckman here), “MRK appears to have taken a proactive approach for Januvia in this regard, which is a positive in our view, as it will have such data well ahead of its competitors (though not till the end of 2014), which should help it to maintain a dominant position in the…market….”
The news of the study comes on the heels of an FDA advisory committee vote in favor of heart side-effect studies on new diabetes meds. Just for the record, Januvia posted third-quarter sales double the same period last year.
- read Huckman’s column at Seeking Alpha
ALSO: We heard from Merck about our story last week on CVS’s doctor letter in support of Januvia use. The drugmaker wanted to point out that the letter advocated adding Januvia to drug regimens that weren’t currently working, rather than a complete drug switcheroo. Plus, as we noted in our piece, CVS wrote and sent the letter, and Merck didn’t get ahold of any private patient info.
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FDA backs pediatric warnings on Zyprexa, Lamisil
In advance of tomorrow’s pediatric advisory committee meeting at the FDA, agency staffers are recommending new cautionary language for Eli Lilly’s antipsychotic Zyprexa (about the risks of weight gain and diabetes in children) and Novartis’ antifungal Lamisil (about the risk of psychiatric side effects, also in children). Report
Vytorin and Zetia may have hit bottom
Well, it’s not good news for those long-suffering cholesterol meds Vytorin and Zetia–but at least it’s not more bad news. The two drugs, which have seen new scrips fall and fall again since less-than-stellar research news first hit in January, may finally be bottoming out.
The latest sales report from Schering-Plough shows that prescriptions for the two meds actually took a tiny tick upward to $2.19 million in October from $2.17 million in September. That’s way down from the $3 million-plus posted back in January, but the numbers could definitely be worse.
As you know, Schering and Merck together sell Vytorin, a combo of the Merck statin Zocor (generic simvastatin) and Zetia, another cholesterol fighter that works via a different mechanism. Since January, the Vytorin/Zetia franchise has sustained a series of blows, starting with the Enhance study, which suggested that Vytorin doesn’t slow heart disease any better than Zocor would on its own. Another study suggested that Vytorin and Zetia might boost the risk of cancer, and though that data has been called anomalous by various experts, the continuing debate hasn’t helped sales.
As the Wall Street Journal Health Blog notes, next month’s scrip figures could be telling: If the numbers continue to hold their own, Vytorin and Zetia may finally have hit bottom.
- read the Health Blog post
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Is the FDA persecuting India’s generics makers?
Indian drugmakers are feeling a bit paranoid these days. Big Brother, a.k.a. the FDA, is looking over their shoulders, and they’re not happy about it.
There appears to be reason to fear, Pharmalot reports: Three major Indian pharma companies have felt the long arm of the law in recent months. First, the FDA banned 30 Ranbaxy Laboratories drugs because of manufacturing irregularities at two of its Indian plants. Then the agency nixed drugs made at Sun Pharma’s Detroit plant. And last week, FDA warned Lupin about 15 manufacturing problems at a plant in Madhya Pradesh.
Some Indian pharma types are even wondering whether the regulatory scrutiny amounts to a sort of trade barrier. “[T]here may be an attempt by global innovator majors to question the standards of Indian drugs and stop their entry,” Daara Patel, chief of India’s pharma trade association, told the Economic Times.
But others say Indian generics makers just need to toughen up. The companies have an edge in the copycat-med market, and with the U.S. government and other payers looking to control healthcare costs, Indian drugmakers can certainly benefit. One expert told the Times, “The three companies who have come under (the FDA) scanner should be ready for any test conducted by any regulator, anytime.” Hear, hear.
- check out the Economic Times story
- see the Pharmalot post
- get the Lupin news from NDTV
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Unilever, Phytopharm scuttling Hoodia deal
Another weight-loss product bites the dust: Phytopharm said Friday that it is in discussions with Unilever, its partner for the development of Hoodia extract as a functional food targeting weight management, with a view to mutually terminating their agreements. Release
