Pressure mounted on Genzyme as its shares rose 6 percent in Frankfurt a day after French drugmaker Sanofi made public its month-old proposal to buy the U.S. biotech group for $18.5 billion.

Sanofi Chief Executive Chris Viehbacher confirmed his proposal to pay $69 per share in cash for Genzyme on Sunday, hinting he could make a hostile takeover bid following several unsuccessful attempts to hold talks with Genzyme management.

The French group stopped short of making a direct approach to Genzyme shareholders, however, and Viehbacher sounded a conciliatory tone in an interview with Les Echos newspaper that nonetheless suggested there was a limit to his patience.

“We want to show that we are determined and serious, without being threatening straightaway. Quite some time can go by yet,” Viehbacher — dubbed the “Smiling Killer” by some staff for his cost-cutting zeal — he said in the interview.

Genzyme shares were up 4.3 percent at 54.71 euros ($69.60) in Frankfurt trading by 0925 GMT as investors waited for Genzyme to respond to Sanofi’s proposal.

Sanofi Aventis shares were up 1.2 percent at 45.81 euros. Sanofi is due to hold a call with analysts at 1230 GMT.

Viehbacher said on Sunday that disclosing Sanofi’s non-binding offer would give Genzyme shareholders a chance to see the “significant shareholder value and compelling strategic fit inherent in a combination of the two companies.”

Some analysts suggested Genzyme, which is trying to fix manufacturing problems that led to shortages of two of its top drugs and hit its stock price over the past year, may not get a better offer.

“Sanofi realizes these guys are in a corner and are thinking why should they pay over the odds?,” said Navid Malik, an analyst at Matrix Corporate Capital in London.

“We’ve not seen any white knights and if this offer doesn’t go through we’ll see the shares back well below $60. I don’t think there is a white knight out there. I think this is the only offer Genzyme shareholders will see.”

Sources previously told Reuters that Genzyme wants an offer of at least $75 per share before Sanofi could review its private financial records. Some shareholders want as much as $80 a share to clinch a deal.

However, Sanofi’s top two shareholders — cosmetics group L’Oreal and oil company Total SA — worry that the company might pay too much for Genzyme and are not convinced it is the best fit, bankers said last week.

Genzyme stock closed on Friday at $67.62, having jumped from around $54 before news of Sanofi’s interest surfaced.

Analysts have said they expect a deal to be finalized in the range of $74 to $77 a share. If Sanofi walks away, analysts see shares of Genzyme falling to the low $50-range. Some say it could take at least a year for them to rebuild the lost value.

Genzyme is the world’s dominant supplier of drugs to treat Gaucher and Fabry disease — rare, inherited disorders in which patients lack key enzymes for breaking down fats.

News of Sanofi’s initial approach emerged late in July and the drugmaker sent a written expression of interest on July 29.

Sanofi said Genzyme rebuffed the offer on August 11, but after some persuasion agreed to a meeting of financial advisers on August 24.

Source: GEN

Popularity: 1% [?]

It appears AstraZeneca has settled another batch of Seroquel lawsuits, again for a price tag of some $10,000 per plaintiff. Bloomberg reports that the drugmaker agreed to pay $55 million to resolve about 5,500 lawsuits, including the 4,000 cases mentioned in a recent regulatory filing. The company confirmed the settlements but said the terms are confidential.

These settlements, reached as part of court-ordered mediation in 26,000 Seroquel liability suits, could soon be followed by more. Spokesman Tony Jewell tells Bloomberg that mediation sessions are scheduled throughout the summer, and sources tell the news service that AZ is trying to settle as many cases as possible for $10,000 each.

Analysts said the “modest” amount of these settlements reflects the plaintiffs’ difficulty in proving that the atypical antipsychotic actually caused their diabetes. ”The real issue is proving liability,” Matrix Corporate Capital’s Navid Malik tells Bloomberg.

But some lawyers aren’t happy with the $10,000. Attorney Ken Bailey says his plaintiffs are planning to go to trial. ”We have not been involved in any negotiations and expect most of our cases to end up in the federal court in Boston,” Bailey says. Whether those suits will bear bigger fruit for the plaintiffs remains to be seen; so far, courts have tended to side with AstraZeneca, dismissing three cases and returning one jury verdict in favor of the company.

Source: FiercePharma

Popularity: 2% [?]

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

Popularity: 3% [?]

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

Popularity: 4% [?]

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

Popularity: 4% [?]

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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