GlaxoSmithKline has paid out almost $1 billion to settle lawsuits related to its antidepressant Paxil, Bloomberg reports, citing court records and sources familiar with the litigation. That total includes about $390 million for suicides or suicide attempts allegedly linked to the drug. Some $200 million has gone to settle cases related to Paxil addiction and birth defects and another $400 million to settle antitrust, fraud and design claims.

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Some of these settlements, of course, have been made public. And the company had a provision for legal and other disputes of $3 billion-plus at the end of 2008 (that figure includes all disputes, not just Paxil). But analyst Navid Malik of Matrix Corporate Capital told Bloomberg that the $1 billion in legal costs for Paxil “would be worse than many people are expecting.”

The company wouldn’t confirm the $1 billion tote-up. “It would be inappropriate and potentially misleading to aggregate payments in these various types of litigation,” a spokeswoman told the news service via email.

That figure could continue to grow, some industry-watchers believe. Some 600 birth-defect claims remain outstanding. But only about a dozen of the suicide-related suits haven’t been settled. “A liability totaling $1.5 billion is possible,” a Panmure Gordon analysts wrote to investors after a birth-defect case was decided in favor of the plaintiff.

But with cases remaining untried–and even some of the wrapped-up suits awaiting appeal–there’s no way of knowing where the eventual total will fall. And to put things into perspective, even a $1.5 billion legal bill won’t set any records.

Source: FiercePharma

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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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AstraZeneca reported on Monday that the FDA issued a complete response letter regarding the company’s request to expand approval for Symbicort (budesonide/formoterol) for the long-term maintenance treatment of asthma in patients between the ages of 6 years and 11 years.

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The agency determined that AstraZeneca did not provide adequate data to establish the appropriate dose or doses of the drug’s individual ingredients in this age group. AstraZeneca stated that it “is evaluating the complete response letter and will provide a response to the agency in due course.”

Commenting on the news, Matrix Corporate Capital analyst Navid Malik suggested the latest development could add to negative sentiment that arose last week when FDA staff expressed concerns about AstraZeneca’s application to expand use of Seroquel XR (quetiapine). Malik noted that the delay “won’t help” Symbicort in the US, where sales of the product have been weak, according to the analyst. Symbicort generated global sales of $2 billion last year.

Source: FirstWord

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The FDA recently advised AstraZeneca to strengthen Seroquel’s (quetiapine) label about potential side effects which could lead to diabetes, according to court documents submitted as part of a lawsuit alleging that the antipsychotic causes the disease. The trial is slated to begin in Florida on February 2.

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In letters sent to AstraZeneca executives in December, agency officials said the product’s “warnings and precautions” section should be revised to include the risk of significant weight gain, according to a filing by the plaintiffs’ lawyer. The agency also wants “data for Seroquel-induced weight change and glucose changes” that are currently on the label to be moved into the warning section.

AstraZeneca spokesman Tony Jewell stated that the drug’s label has “always provided accurate and appropriate information and warnings…we continue to work with the FDA to share accurate information with the public as more scientific data becomes available about the medicine.” Both Jewell and a spokesperson from the FDA declined to comment on whether the agency had asked for stronger warnings for the compound. Commenting on the news, Matrix Corporate Capital analyst Navid Malik remarked that “this warning will reduce the attractiveness of using this drug, given the risk of developing a serious condition.”

Source: FirstWord

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