In its first move to settle some of its Seroquel liability suits, AstraZeneca has agreed to pay $2 million to 200 plaintiffs, Bloomberg reports. That works out to more than $10,000 per plaintiff, which is a lot less than other drugmakers are paying to settle lawsuits over their atypical antipsychotics.

Analysts hailed the arrangment, reached in court-ordered mediation. UBS analyst Gbola Amusa tells Bloomberg, “The amount of the settlement implies a very low liability, much lower than the $1 billion to $2 billion range we expected a couple years ago.”

So why the difference? The deal comes after AstraZeneca won its first jury trial in a Seroquel liability case, and three other cases were tossed by a Delaware judge for lack of evidence. Legal experts say that plaintiffs’ lawyers may be second-guessing their cases. “It also may be a reflection of the difficulty the plaintiffs are having in getting these cases to trial,” Carl Tobias, a mass-tort law expert, tells the news service. “The plaintiffs have to be asking themselves after the New Jersey trial whether they can win one of these.”

But lawyers for the plaintiffs say they’re not rolling over. ”This litigation is not going to go away at $10,000 a case, I can assure you,” Paul Pennock, who’s representing 2,200 plaintiffs, tells the Delaware News-Journal. Pennock also represented the losing plaintiff in the sole jury trial.

Meanwhile, AstraZeneca wouldn’t comment on the settlement, saying that the mediation process is confidential. A spokesman did tell the News-Journal that the company has “multiple mediation sessions scheduled throughout the summer.”

Source: FiercePharma

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As GlaxoSmithKline defended Avandia before an FDA advisory panel yesterday, its lawyers were making sure that defense doesn’t move to a courtroom–in some 10,000 lawsuits, that is. The company agreed to pay about $460 million to settle those suits, which amount to a majority of the Avandia litigation outstanding, Bloomberg reports.

Those lawsuits alleged that the diabetes drug caused heart attacks and other cardiovascular problems–just the outcomes under debate by the FDA committee. Until this settlement, GSK had been facing 13,000 or more claims that it hid Avandia’s heart attack risks, UBS analyst Gbola Amusa tells the news service. The company agreed two months ago to pay $60 million to resolve 700 other suits.

The settlement amounts to about $46,000 per plaintiff, far below UBS’s worst fears for the company. ”This is exceptionally good news given the market has discounted $6 billion in liability,” Amusa tells Bloomberg. “We had outlined an absolute worst-case scenario where $500,000 per case would have to be paid.”

Lawyers for the plaintiffs praised the deal, saying it’s a “prompt resolution” of litigation that’s been dragging on for three years already, with the first case finally scheduled for trial in October. ”It’s a compromise that allows both sides to put this behind them and move on,” attorney Michael Miller, who represents some 1,500 patients in the suits, said in a statement. GSK declined comment on pending litigation.

Source: FiercePharma

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If the first round of Avandia settlements sets the trend, GlaxoSmithKline could suffer a lot less from the thousands of lawsuits filed over the diabetes drug. Sources tell Bloomberg the company has agreed to pay $60 million to resolve more than 700 Avandia suits, which amounts to about $86,000 per case. That’s way below the $500,000 per case that some analysts had forecast.

Back in 2007, a New England Journal of Medicine study linked taking Avandia to an increased risk of heart attack, touching off a debate over the drug’s safety that continues to this day. FDA warnings have been applied; new data has surfaced; Avandia sales have dropped. And along the way, Avandia users have sued the company, claiming that the drug caused their heart attacks and strokes. As Reuters notes, Morgan Stanley recently said that GSK’s stock is discounting a $6 billion liability risk from those lawsuits.

In all, some 13,000 Avandia suits have been filed, Reuters says. And as the first trial nears, news of this settlement has surfaced. The company wouldn’t comment, but says it’s prepping for Avandia trials scheduled for later this year. “GlaxoSmithKline stands by Avandia and is fully prepared to defend any litigation,” spokeswoman Bernadette King tells Bloomberg.

Still, analysts cheered the settlement news. ”We take the $86,000 per case liability as a key positive and look for more insights on other potential settlements,” UBS analyst Gbola Amusa says in a note to clients. “We continue to believe science favors Avandia’s place in the U.S. market.”

Source: FiercePharma

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J&J has rattled analysts with a new timeline for the Alzheimer’s drug bapineuzumab, saying that full, late-stage results for the closely-watched therapy may not be available for two years.

“We are conducting some of the largest-scale trials ever in Alzheimer’s disease,” a J&J spokesperson told Bloomberg an e-mailed comment. “When they are complete, we expect to have a very comprehensive understanding of the clinical impact of bapineuzumab.” The delay was attributed to the fact that J&J is still recruiting patients for the late-stage trials, and final results will have to wait until 18 months after the last patient is enrolled. Pfizer, which is partnered on the drug, has its own studies underway.

UBS analyst Gillaume van Renterghem quickly dubbed the delay “bad news,” saying that analysts were eagerly expecting the data on the potential mega-blockbuster “as quickly as possible.” J&J obtained the drug for its portfolio when it bought out Elan’s rights to the Alzheimer’s program last year.

Elan and Wyeth had started Phase III for bapineuzumab back in 2007. They launched a late-stage program even before the Phase II data was in, hoping that an aggressive development timeline would lead to a swifter approval. Van Renterghem estimates top potential worldwide sales at $8 billion, adding that there are a number of pitfalls for this program that would significantly cut that back.

Source: FierceBiotech

Popularity: 3% [?]

That U.S. Senate probe of GlaxoSmithKline and its diabetes drug Avandia may not yield any new regulatory action. But with more than 13,000 personal injury lawsuits outstanding, UBS analysts say, the company could be looking at a multibillion-dollar liability.

The safety of Avandia has been open to debate for almost three years now, and the Senate report didn’t bring up anything entirely new about the drug’s risks. The FDA already was planning to look at safety info on the diabetes med again, with a new advisory panel meeting on the schedule for this summer. The worries focus on a.) political pressure from the Congressional committee that sponsored the probe; and b.) those lawsuits.

“[O]ur concerns are solely on personal injury lawsuits,” UBS analyst Gbola Amusa said. Experts polled by UBS put the potential liability at anywhere from $1 billion to $6 billion; the bank itself expects something less than $3.5 billion. “Bellwether trials start from 1 June and will help narrow our liability range,” Amusa also notes.

Source: FiercePharma

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Now that the cardiovascular drug market has a couple of new entries, analysts are applying their skills. Their take: Eli Lilly’s clot-buster Effient has been “sluggish” out of the gate, while Sanofi-Aventis’ atrial fibrillation drug Multaq has hit the ground running. But even Multaq hasn’t made huge advances.

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According to data from IMS/Leerink Swann (as quoted by BNet Pharma), Sanofi’s Multaq captured 3,606 scrips over a five-week period. Lilly’s Effient, by contrast, accounted for only 1,823 scrips over the same period. “These IMS data reinforce our view that Effient’s U.S. launch will be muted,” Leerink’s accompanying investor note stated.

There’s a caveat, however. The drugs hit the market in the summer, when folks are vacationing, not going to the doctor to tune up their drug regimens. That’s likely to slow initial uptake. Plus, Effient’s indication for post-procedure use means that it’s started in the hospital, and drug-sales trackers don’t have access to those scrips. So its numbers could see a quick upswing once those hospital scrips move to the pharmacy.

“There will be a delay in prescription data showing up in IMS, given that initial use occurs in the hospital setting,” Lilly CFO Derica Rice told investors at a UBS conference (as quoted by Dow Jones). He added that Lilly has made “positive” progress in persuading health insurers to pay for the drug. We’ll keep an eye on the figures to see if those efforts bear fruit on the scrip side.

Source: FiercePharma

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Sanofi-aventis announced that the FDA approved Multaq (dronedarone) to reduce the risk of cardiovascular hospitalisation in patients with atrial fibrillation or atrial flutter. The company said it plans to launch the drug in the next three months.

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The FDA believes Multaq “represents a therapeutic innovation for treatment of the heart rhythm disorder of atrial fibrillation,” according to  director of the agency’s division for cardiovascular and renal drug products. However, Multaq is contraindicated for patients with severe heart failure. Sanofi-aventis explained that it will implement a risk mitigation programme that will help physicians identify appropriate patients to ensure the safe use of the product.

In response to the news, UBS analyst Gbola Amusa noted that the prescribing limits signal that Multaq may have “a slow uptake out of the gate,” with meaningful earnings contributions beginning around 2011. Nonetheless, he remarked that “the drug is now approved, ending sanofi-aventis’ streak of pipeline futility.” The analyst forecast that annual sales of Multaq, which is currently under review in Europe, will reach 1.4 billion euros ($2 billion) in 2015.

Source: FirstWord

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Multaq, Sanofi-Aventis’s treatment for heart-rhythm disorders, has made a comeback. Rejected by the FDA in 2006 because of safety concerns, the agency has approved Multaq, the company announced today.

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The drug approval is the French drug maker’s first major U.S. approval in seven years, according to Bloomberg. Late last year, Sanofi decided to discontinue development of obesity drug Acomplia, which was once thought to have much promise. Lately, the company has faced questions lately about whether its diabetes drug, Lantus, is linked to cancer.

Sanofi has predicted that Multaq, which treats atrial fibrillation and atrial flutter, eventually will bring in annual sales of more than $1 billion, notes Dow Jones Newswires.

The FDA rejected Sanofi’s initial attempt for approval because a study showed that patients on Multaq were more likely to die than those who received a placebo. The company has since conducted more research looking at patients at a less-advanced stage of heart disease.

Sanofi will also implement a risk evaluation and mitigation strategy to help “ensure the safe use of Multaq” and help health-care workers identify patients appropriate for the treatment, according to the company.

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“The drug is now approved, ending Sanofi’s streak of pipeline futility,” UBS analyst Gbola Amusa told Dow Jones.

Source: The Wall Street Journal

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UBS analysts said Bristol-Myers Squibb is not in discussions to buy a stake in Elan, Bloomberg reported. Roopesh Patel and Keyur Parekh remarked on Monday that Bristol-Myers Squibb “has confirmed to us that it is not currently in talks to buy a minority stake.”

Shares in Elan rose as much as 10 percent Monday following recent reports that the US drugmaker was one of two serious bidders for a minority stake in Elan, according to people with knowledge of discussions.

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The analysts from UBS explained that both Bristol-Myers Squibb and Elan are focused on specialty drugs for Alzheimer’s disease, Parkinson’s disease and multiple sclerosis. Patel and Parekh commented that the value of a potential deal would depend on a positive outcome for trials of experimental Alzheimer’s disease drug bapineuzumab, “which in our view has meaningful development risks,” they noted. Bapineuzumab is being jointly developed by Elan and Wyeth, which is in the process of being acquired by Pfizer.

Bristol-Myers Squibb spokesman Brian Henry commented that the company “has no comment on rumours and speculation.” Elan spokeswoman Niamh Lyons declined to comment on the matter as well.

Source: FirstWord

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GlaxoSmithKline and Pfizer announced Thursday that the drugmakers agreed to combine their HIV-drug segments into a new company focused on the research, development and commercialisation of HIV medicines. GlaxoSmithKline CEO Andrew Witty stated that “at the core of this specialist business is a broad portfolio of products and pipeline assets, which can be more effectively leveraged through the new company’s strong revenue base and dedicated research capability.”

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At the closing of the transaction, expected in the fourth quarter, GlaxoSmithKline will control 85 percent of the joint venture and Pfizer will hold 15 percent. According to the terms of the agreement, Pfizer’s interest could rise to as much as 30.5 percent in the event that certain sales and regulatory milestones are achieved. Dominique Limet, head of GlaxoSmithKline’s Personalised Medicine Strategy, was appointed CEO designate of the combined entity.

The new company will have 11 marketed products, including Combivir (lamivudine/zidovudine), Epzicom/Kivexa (abacavir/lamivudine), and Selzentry/Celsentri (maraviroc), and will hold a 19-percent share of the HIV market. The company will have 6 drugs in its pipeline, including 4 compounds in mid-stage development, as well as 17 molecules at its disposal to develop in fixed-dose combinations as possible new HIV treatments. Based on 2008 results, sales from the combined portfolio reached 1.6 billion pounds ($2.4 billion).

Commenting further on the deal, Witty remarked that “this is a new and unique way of incentivising research success and deciding how to allocate research and development capital.” He said the new company is “going to have two parents out there with, I think, a very rapid decision-making mechanism to allow it to be funded for what it needs to do.” The executive also explained that the new venture will not include GlaxoSmithKline’s vaccine programme. “Who knows down the road whether or not there would be a commercial collaboration opportunity if and when those vaccines make it to market, but they’re not currently scheduled to go into this business,” Witty noted.

In response to the news, analyst Navid Malik of Matrix Corporate Capital suggested that “GlaxoSmithKline is looking to consolidate its franchise through this tie-up with Pfizer, who are probably looking to exit HIV.” In addition, he suggested that “it’s quite a dramatic step, for two rival companies to put their pride aside and work together like this. But if they don’t there is a good chance that both their HIV businesses will fade away over time.” UBS analyst Gbola Amusa said the agreement could lead to more partnerships that result in company break ups and sales, and speculated that “we’ll look back in a few years and highlight this deal as being industry-shifting.”

Source: FirstWord

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