Pharma News

Condemned prisoners challenge execution-drug imports

Tracy Staton — Fri, 10 Feb 2012 12:23:55 -0500

Death-row prisoners have asked a U.S. judge to force the FDA to block imports of an execution drug. The legal challenge comes as long-used lethal-injection drugs become scarcer in the U.S., and prisons seek alternatives for use in executions. Report

Psychologists petition against DSM-5 revisions

Tracy Staton — Fri, 10 Feb 2012 12:20:39 -0500

British psychiatrists and psychologists are engaging in target practice with the under-construction DSM-5. The "bible" of mental illness, the Diagnostic and Statistical Manual of Mental Disorders is under revision, and critics say the changes pathologize normal behavior and benefit drug companies over patients, The Guardian reports.

Some 11,000 psychologists have signed a petition against revisions they say classify some normal, expected behaviors--including bereavement--as mental illnesses and create questionable new disorders. "The proposals in DSM-5 are likely to shrink the pool of normality to a puddle with more and more people being given a diagnosis of mental illness," Til Wykes, professor of clinical psychology at Kings College London, said, as quoted by The Guardian.

The British Psychological Society has opposed the DSM changes, The Telegraph says, and psychiatrists in the U.S. have also taken issue with some of them. "DSM5 will radically and recklessly expand the boundaries of psychiatry," Duke University's Allen Frances said (as quoted by The Telegraph). "Many millions will receive inaccurate diagnosis and inappropriate treatment."

The DSM revisions are important because the manual not only guides treatment and diagnosis in the U.S., but insurance coverage as well. Broadening the definitions of disorders treated with psychotropic drugs stands to increase sales, and some question whether drug companies have too much influence over the revision process. It's "hard to avoid the conclusion that DSM-5 will help the interests of the drug companies," University of Central Lancashire's David Pilgrim said, as quoted by Reuters.

- see the Telegraph story
- read the piece in The Guardian
- get the Medscape article
- find the Reuters news

Related Article:
New hints for psychiatrists on the new DSM

GSK, Takeda say nay to in-house diagnostics units

Tracy Staton — Fri, 10 Feb 2012 11:45:20 -0500

GlaxoSmithKline ($GSK) and Takeda Pharmaceutical are choosing the partnerships side of the divide when it comes to developing diagnostics to team up with their drugs. Both companies have said they're unlikely to develop in-house divisions focused on diagnostics--as Roche ($RHHBY) and Abbott Laboratories ($ABT) have--but to take a more piecemeal approach.

GSK CFO Simon Dingemans told Bloomberg the company doesn't want to add a whole new division. "We're not about to go buy medical equipment or diagnostics businesses or new legs to the group," Dingemans told the news service. "We're focused on buying things that we can add value to." But cherry-picking particular diagnostics for particular disease areas? Possibly.

Takeda figures it can work on these combinations without actually owning the diagnostics side of the business. "The tandem of diagnostics and therapeutics is a logical tandem and will be very important in the future," CMO Tachi Yamada told Bloomberg. "But I don't know that you have to control both ends of it."

Two weeks ago, Novartis ($NVS) and Sanofi ($SNY) executives said they're not interested in buying in a diagnostics division, either. "[Y]ou can get access to this technology without necessarily having to acquire the company," Novartis CEO Joe Jimenez (photo) said at the time. Sanofi chief Chris Viehbacher (photo) concurred. "You need to be part of new technologies but I think partnership is the way to go," he said.

- see the Bloomberg piece

WellPoint to drop branded Lipitor from its formulary

Tracy Staton — Fri, 10 Feb 2012 11:30:57 -0500

Lipitor just got shot down by a healthcare plan. As The Wall Street Journal reports, WellPoint ($WLP) is planning to stop covering Pfizer's ($PFE) brand-name cholesterol drug April 1, favoring its generic rivals instead. The change applies to millions of its members in 12 of the 14 states it serves; in the other two states, WellPoint members can have access to branded Lipitor, but only if they try a generic first.

It's the latest blow to Pfizer's aggressive Lipitor battle plan. The company decided not to take immediate generic erosion as a given, and made several moves designed to keep Lipitor patients on the brand-name version. The company not only offered discount cards to blunt the effects of higher co-pays on branded drugs, but negotiated cut-rate deals with pharmacy-benefits managers and set up an arrangement to sell Lipitor by mail order through a specialty pharmacy.

The cholesterol pill fell off patent Nov. 30, and Pfizer's aim was to keep up to 40% of market share, at least until multiple generic rivals hit the market in May. The brand held its own in the high thirties for several weeks in December, but its share appears to have fallen to around 34% since then. Still, as the WSJ points out, that's a bigger share than many other big-selling drugs have commanded after losing their exclusive hold on the market.

In WellPoint's case, it appears as if Pfizer's co-pay discount card worked against the branded drug. The company offers Lipitor patients a card that sets their co-pays at $4 per month, with Pfizer paying the rest. So, if Lipitor sat on a higher-priced tier than its generic counterparts, that would make no difference to a patient's out-of-pocket cost. Good for patients who want to stay on Lipitor, but not so good for insurers trying to control costs, WellPoint said.

That's not to say that Pfizer's efforts are doomed. As the WSJ reports, UnitedHealth continues to offer co-pays on Lipitor that favor the brand over the generic versions. "In this environment, health plans and [benefit managers] will act in the best interest of their business, and as such, will determine how to cover Lipitor within their pharmacy benefits structure," Pfizer spokesman MacKay Jimeson told the Journal.

- read the WSJ piece

Special Report: Pfizer - 10 Largest U.S. Patent Losses

Merck says Victrelis can interfere with HIV meds

Tracy Staton — Fri, 10 Feb 2012 10:50:57 -0500

Merck ($MRK) has notified doctors that its new hepatitis C drug Victrelis interferes with commonly used AIDS drugs. Victrelis can reduce the effectiveness of the HIV-fighters--and vice-versa--Merck said in a letter to healthcare professionals that was issued after a study found lower blood levels of several HIV meds in patients using Victrelis. The study also showed that Victrelis blood levels were diminished in patients using certain HIV drugs.

The drug interaction news isn't good for Victrelis, because up to 15% of hepatitis C patients are also HIV-positive, said ISI Group's Mark Schoenebaum. The study's conclusions could cut Victrelis sales by as much as one-quarter, Schoenebaum said. Victrelis sales have been lagging behind the other big new hepatitis C treatment, Incivek, from Vertex Pharmaceuticals ($VRTX). While Incivek saw net product revenues of $456.8 million in the fourth quarter for Incivek, Victrelis brought in $87 million (up from $31 million during the previous quarter).

Doctors already had questions about Victrelis therapy for co-infected patients. In a Sermo Survey published here last summer, infectious disease specialists said they wanted to see data on Victrelis use in patients who also had HIV. Incivek has been studied in that patient population, so some physicians were using it exclusively in their HIV-positive patients.

FDA said in a safety communication the Victrelis label would be updated with information about the drug interactions. In the meantime, the agency advised doctors to monitor their patients using these drugs together to make sure they're responding to hepatitis C treatment and their HIV levels don't rebound.

- read the FDA safety communication
- find Merck's Dear Healthcare Professional letter
- see the Reuters news
- get more from Dow Jones

LEO Pharma slapped with sales-rep overtime suit

Tracy Staton — Fri, 10 Feb 2012 10:21:03 -0500

The sales-rep overtime fight is spreading. Four LEO Pharma salespeople have filed a putative class action, alleging they're owed overtime under U.S. wage-and-hour laws. The reps accuse LEO of misclassifying them as exempt from overtime, even though their duties include non-exempt activities, the law firm Sanford Wittels & Heisler said in a press release announcing the suit.

If Sanford Wittels sounds familiar, then you've probably been following the overtime issue. The firm represented the Novartis ($NVS) reps who won their wage-and-hour lawsuit; the company recently agreed to pay $99 million to settle the dispute. So, the overarching arguments should also be familiar: Reps maintain they don't qualify as outside salespeople because they don't close sales, and they have too little autonomy to qualify for the management exemption.

The LEO suit aims to represent salespeople who work for--or used to work for--the company from Feb. 7, 2009, to the present. It's unclear just how many people might qualify, but as Business Insurance reports, LEO has said it has added 151 employees to its nationwide salesforce since opening its U.S. headquarters in late 2009. The company is the U.S. subsidiary of Denmark's LEO Pharma A/S.

"Leo Pharma has not made a good faith effort to comply with Fair Labor Standards Act or with the comparable state laws that protect workers' rights," Jeremy Heisler said in a statement. "In today's depressed economic climate, this is not only illegal, but unconscionable."

The reality is not so cut-and-dried, if LEO's case is anything like the other pharma overtime suits. Not only is each company's handling of its reps open to interpretation, but the law is as well. In fact, two federal circuit courts have come up with diametrically opposed rulings on the subject. Some reps have won their cases; some have lost. But one OT case is now on its way to the Supreme Court, so we should soon have a ruling to clarify matters.

- see the Sanford Wittels release
- get more from Business Insurance

Novartis CEO calls external focus key to fast-changing pharma

Tracy Staton — Thu, 09 Feb 2012 12:27:56 -0500

The idea of facing generic competition for a $5 billion blockbuster like Diovan would daunt almost any CEO. But Joe Jimenez (photo) says his experience hawking baby food and ketchup at Heinz made him just the right person to run Novartis ($NVS) as it confronts a crucial transition.

"If you look at my background in understanding the consumer," Jimenez tells Forbes' Matthew Herper, "it's not just about marketing. Consumer goods companies have to be very externally focused, looking at their environment and how it's changing all the time. What I have learned is that this is an industry that is changing so fast and so significantly."

Instead of following the Big Pharma slim-down game plans out there--like Pfizer's ($PFE) spinouts or Abbott's ($ABT) big split--Novartis is adding new efforts like its Alcon eye unit while improving its sales muscle in emerging markets and looking for a new product to revive the fortunes of its vaccines unit. But what really gives Novartis enduring strength is its long and successful track record at developing new drugs that can clear the bar on unmet medical needs.

The Swiss company's new drugs may not include mega-blockbusters, but Jimenez gets credit from R&D revolutionary Bernard Munos (photo), who cheers Novartis' average investment of $4.6 billion for each new drug it wins an approval on. That's far less than some rivals who are being forced to take a much different direction.

- check out the profile from Forbes

Special Report: Joseph Jimenez - The 25 most influential people in biopharma today

One father's heartbreak inspired a $250M quest for a cure

Tracy Staton — Thu, 09 Feb 2012 12:13:08 -0500

How one father's loss turned into gain for cystic fibrosis patients and Vertex Pharmaceuticals ($VRTX): After the death of his son, Boston businessman Joe O'Donnell spent years raising $250 million for the Cystic Fibrosis Foundation, which backed Vertex's development of the groundbreaking treatment Kalydeco. Report

Judge: No 1st Amendment shield for Astellas' Prograf petition

Tracy Staton — Thu, 09 Feb 2012 11:52:48 -0500

Japan's Astellas Pharma has to fight antitrust claims related to its transplant drug Prograf. The drugmaker failed to persuade a U.S. judge to dismiss consumer allegations it petitioned the FDA about generic versions of Prograf simply to extend its market exclusivity, rather than out of concern for public health, Courthouse News Service reports.

The consumer lawsuits, consolidated in a Massachusetts federal court, claim Astellas filed a "sham" petition to stop generic Prograf, then proceeded to collect almost $1 billion in exclusive sales while the FDA considered its complaint. Astellas asked U.S. District Judge Rya Zobel to dismiss the cases, citing First Amendment protection for its petition, but Zobel didn't buy it.

"When petitioning conduct is a mere sham to cover what is actually nothing more than an attempt to interfere directly with the business relationship of a competitor, such conduct is not immune," Zobel wrote in denying Astellas' motion (as quoted by CNS). The antitrust allegations were "more than sufficient to withstand a motion to dismiss," she found.

Astellas faces similar claims in a class action filed by insurers in Massachusetts court.

- read the CNS story

Shire upbeat on 2012 as earnings top estimates

Tracy Staton — Thu, 09 Feb 2012 11:39:07 -0500

Shire ($SHPGY) bucked fourth-quarter trends with a 47% increase in earnings and expectations for continued growth in the coming year. At a time when most of Big Pharma was suffering declining Q4 profits or diminished forecasts for the coming year--or both--the specialty drugmaker broke $4 billion in annual revenues on double-digit increases for its key drugs.

CEO Angus Russell touted plans for geographic expansion of his company's ADHD franchise, which delivered market-beating growth in the U.S. Its Vyvanse brand has moved into Brazil as Venvanse, which is awaiting European approval under the same brand name. Plus, Shire is working to expand use of Vyvanse to new indications; earlier this week, it won the FDA nod for adult ADHD, and the drug is under testing as an add-on for depression.

The company also has big plans for its rare-disease drugs, which grew at rates ranging from 15% (Elaprase, for Hunter Syndrome) to 79% (Vpriv, for Gaucher disease). Shire jumped at the chance to steal market share from rare-disease rival Genzyme when that company's supply problems began a few years ago. And now that the Sanofi-owned unit has gained approval for its new manufacturing facility outside Boston, Shire is close to bringing its new plant online, and it's waiting for the FDA to decide whether to approve Replagal, a rival to Genzyme's Fabry disease treatment Fabrazyme.

"Supported by our strong cash generation, we will continue to invest in growth prospects that will further leverage our established infrastructure," Russell said in a statement. "We expect 2012 to be a year of good earnings growth, as we aim to deliver increasing value to all our stakeholders."

- see the Shire release
- get more from Reuters
- read the Investor's Business Daily piece

Watson chief has big brand plans for $6B war chest

Tracy Staton — Thu, 09 Feb 2012 11:11:01 -0500

Paul Bisaro has made no secret of his branded ambitions for Watson Pharmaceuticals ($WPI). The drugmaker, which now focuses mostly on generics, is looking to remake itself as a brand-and-generics hybrid as the pace of patent losses for blockbuster drugs winds down. And Bisaro, who's been Watson's CEO since 2007, now has $6 billion in hand for a "transformational" branded-drug deal.

A few years ago, as branded drugmakers girded for the patent cliff, several Big Pharmas chose to build up their generics businesses as a way to keep collecting from off-patent products. Whether by selling generic versions in their home markets alongside other copycat drugmakers, or by capitalizing on their corporate name in emerging markets, pharma companies figured diversifying into off-brand products would be a hedge against external generic competition. Generics makers, with their less-risky R&D and preferential treatment from government types, seemed to have the advantage in a post-patent cliff world. That they would choose to make similar moves, but in reverse, didn't seem all that likely.

That's all changed now, as Bisaro attests. The patent cliff is affecting generics makers, too; how can they follow up on that bolus of growth they'll enjoy during these patent-cliff years? "It's a real blurring of the lines," Gabelli & Co.'s Jeff Jonas told Bloomberg. In a few years, he said, big generics players like Watson and Teva Pharmaceutical Industries ($TEVA), which has made its own recent moves into branded territory, may look "a lot more like a brand than a generic."

Bisaro figures Watson has what it takes to be a branded drugmaker: "Everything we need ... except for the sales force," he told Bloomberg. "And we can create that." He's also aware that generics business strategies won't work in the branded arena. "With brands, you have to pass on those things that, even though you like the idea, if it's not in your wheelhouse and you don't have the sales force, you probably ought not to spend the money on it." Which things will he pass on and which will he choose? Bisaro likes urology and women's health, as well as cancers affecting women.

- read the Bloomberg story

FDA panel nixes new use for Amgen's Xgeva

Tracy Staton — Thu, 09 Feb 2012 10:51:28 -0500

The FDA's expert advisors didn't buy Amgen's ($AMGN) argument for earlier use of its bone drug Xgeva in prostate cancer patients. The idea: Treat advanced prostate cancer patients with Xgeva to prevent or delay the disease's spread to the bone. The data: Patients who took Xgeva saw bone tumors crop up an average of 4.2 months later than those on placebo did. Overall survival time didn't differ. The vote: 12-1 against the new use.

The key issues appear to be timing and side effects. Xgeva is already approved to delay fractures and stave off tumor growth in patients who have developed bone metastases. Why not wait until the tumors develop to treat with Xgeva, panelists asked, especially since roughly one in 15 patients in the trial developed osteonecrosis of the jaw? "This isn't a question of whether this drug works," the panel chair, Wyndham Wilson, said. "It's a question of when is the most effective time to give it."

Wilson suggested the most helpful comparison wouldn't be Xgeva versus placebo, both given early on before bone metastases occur. Rather, Amgen should evaluate Xgeva use in preventing metastases versus its use in handling them once they've arisen. But Amgen's Sean Harper pointed out some Xgeva patients went 7.5 months without developing bone tumors, Bloomberg reports, and bone metastases are quite painful.

The FDA is due to decide on the new use by April 26. The agency doesn't always take its advisory committees' advice, although it usually does, and FDA staffers expressed their own reservations about Amgen's application. Analysts' viewpoints on the indication were mixed; some said revenue estimates on Xgeva had already mostly discounted the prospect of prophylactic use, while others figure their peak sales predictions would be cut by as much as $1 billion if the indication doesn't come through.

- see the Bloomberg story
- get more from Dow Jones
- check out the Reuters news

FDA issues safety alert about PPIs and C. diff

Tracy Staton — Wed, 08 Feb 2012 12:29:01 -0500

The FDA announced that proton-pump inhibitors used to treat heartburn and acid reflux can increase the risk of diarrhea associated with Clostridium difficile, and said it was working with drugmakers on label changes for their PPI products. C. diff disease can be difficult to treat and can lead to serious complications; it's been a growing problem in hospitals for the past several years. Release | Report

Sanofi, BMS collect their $444M in Plavix damages

Tracy Staton — Wed, 08 Feb 2012 12:19:31 -0500

Apotex has finally paid its Plavix dues. The generics maker has handed over $444 million to Sanofi ($SNY) and Bristol-Myers Squibb ($BMY), as repayment for its premature launch of generic Plavix back in 2006. The payment marks the end of a patent dispute that went on for almost 10 years, and follows Apotex's unsuccessful appeal to a U.S. Circuit Court in October.

The saga began when Sanofi sued Apotex in 2002, alleging the generics company's proposed version of Plavix would infringe upon its patent. The French drugmaker won a preliminary injunction four years later--but only after Apotex had already shipped its copy of the blockbuster blood thinner. The knockoff version quickly flooded the market, costing Sanofi and Bristol-Myers hundreds of millions in lost sales.

In 2007, a U.S. judge upheld Sanofi's Plavix patent and ruled Apotex had violated it. The generic version reaped more than $880 million in sales during its short time on the market. Sanofi asked for half that amount in damages, and the judge agreed. "Sanofi and Bristol-Myers Squibb are pleased that their intellectual property rights have been upheld and that Apotex has made reparation of the harm caused by the at-risk launch," the drugmakers said in announcing the payment.

- read the statement from Sanofi and BMS
- see the Financial Times story

Special Report: Bristol-Myers Squibb - 10 Largest U.S. Patent Losses

Eisai renews focus on 'more attractive' Japan

Tracy Staton — Wed, 08 Feb 2012 11:47:36 -0500

Eisai is coming to believe that there's no place like home. The Japanese drugmaker says it's planning to pull back in the U.S. and refocus on East Asia, and not just because markets such as China are growing so quickly. It's also because of renewal in Japan.

CEO Haruo Naito told The Financial Times he's looking to grow sales in Japan, Korea, China, Hong Kong and Taiwan to account for more than their current 60% of Eisai's revenues. "There is enormous potential" in the region, he told the FT. And a good part of that potential lies in Japan, which "was mature and stagnating," Naito said, but now "is growing again. It is becoming more attractive."

One thing that's helped the Japanese drug market is the government is now cutting prices at a slower pace than it had been in recent years. Plus, the country is trying to streamline its regulatory process to get new drugs onto the market faster. Japan has been notorious for its "drug lag," which often kept foreign products off the market for years after they launched in the U.S. or Europe. The changes have attracted more interest among western drugmakers as well. Big Pharma companies such as Eli Lilly ($LLY) are putting more emphasis on the Japanese market.

What does this mean for the rest of the world? Well, Eisai won't completely bow out of Western markets. But it plans to leave the aggressive expansion in Europe and the U.S. to other Japanese drugmakers such as Daiichi Sankyo and Takeda Pharmaceuticals. "We are focused on East Asia," Naito said.

- see the story from the FT