Genzyme is in play. After days of fevered speculation over what Genzyme would be worth to a company like Sanofi-Aventis, the big pharma outfit appears to have set its sights on the low side of the spectrum. According to a flurry of news reports, Sanofi CEO Chris Viehbacher and the board think that $70 a share–that’s $18.7 billion total–would be a fair price to pay. But any bidding could start under that level.

Significantly, Sanofi appears ready to move past the discussion stage and lay its cards out on the table in a formally presented letter which spells out its terms, Bloomberg reports, quoting “three people with knowledge of the situation.” The New York Times, meanwhile, said that the pharma company would likely issue a “bear hug” letter, indicating it would like to keep the bidding process friendly but would go hostile if necessary – a ploy that could help win over some of the board members who have been on the fence in recent days.

Genzyme, though, isn’t likely to leap at any $70 bid that comes its way. Market analysts have been quick to target $80 as a good premium over the current trade, which has soared 30 percent on the back of all the rumors that have been floating around.

“My guess is that Genzyme would turn them down,” Cowen & Co’s Phil Nadeau told the business news wire, “do some negotiations, and the price would go up a little bit, maybe to $73 or $75.”

True, Genzyme has been damaged by its recent manufacturing snafus, but that’s unlikely to intimidate a player like Sanofi, which could use Genzyme’s storehouse of biotech knowledge. And a rich M&A deal could be just the way Genzyme CEO Henri Termeer would like to cap his long-running career.

While Sanofi’s board has been leaking like an old wooden ship, Viehbacher publicly is keeping a tight lip on the deal. “We are under no pressure to do a deal,” Viehbacher told analysts on a call, vowing to stay disciplined on its M&A strategy.

Source: FierceBiotech

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The most commonly used tool for detecting prostate cancer, routine PSA screening, has become “a hugely expensive public health disaster,” its discoverer said on Wednesday.

Dr. Richard Ablin of the University of Arizona joined the ongoing debate over the blood test, saying the screening procedure is too costly and ineffective.

“I never dreamed that my discovery four decades ago would lead to such a profit-driven public health disaster,” Ablin wrote in a commentary for The New York Times.

Ablin said that as Congress searches for ways to cut costs in the U.S. health care system, a significant savings could come from changing the way PSA is used.

“The test’s popularity has led to a hugely expensive public health disaster,” he wrote.

He said the annual bill for PSA screening is at least $3 billion, with much of it paid for by Medicare and the Veterans Administration.

“As I’ve been trying to make clear for many years now, PSA testing can’t detect prostate cancer and, more important, it can’t distinguish between the two types of prostate cancer — the one that will kill you and the one that won’t,” he wrote.

“Instead, the test simply reveals how much of the prostate antigen a man has in his blood.”

Prostate cancer is the second most common cancer in men worldwide after lung cancer, killing 254,000 men a year.

PSA is a protein made only by prostate cells, and levels can shoot up as a prostate tumor proliferates. But levels can also rise as the prostate naturally enlarges with age.

A high PSA reading is usually followed by a biopsy, which is a sample of the prostate tissue taken and examined for signs of a tumor.

SLOWLY TURNING AGAINST

Doctors have routinely recommended PSA tests to men over 50 in the belief that early diagnosis and aggressive treatment for any cancer is better than standing by and doing nothing.

But prostate cancer can often be a slow-growing tumor and men will often die of something else before the cancer becomes dangerous.

Prostate cancer treatments, including surgery or radiation, can cause incontinence and erectile dysfunction in about a third of patients. Many men also experience bowel problems.

Citing recent studies and reversals of some early screening proponents, Ablin said the medical community is slowly turning against PSA screening.

“So why is it still used? Because drug companies continue peddling the tests and advocacy groups push ‘prostate cancer awareness’ by encouraging men to get screened,” Ablin wrote.

Ablin said PSA testing does have a place, after treatment for prostate cancer and for men with a family history of prostate cancer.

“Testing should absolutely not be deployed to screen the entire population of men over the age of 50, the outcome pushed by those who stand to profit,” Ablin wrote.

He urged the medical community to “confront reality and stop the inappropriate use of PSA screening.”

Source: Reuters

Popularity: 2% [?]

Two U.S. drug safety reviewers have recommended that GlaxoSmithKline PLC’s diabetes drug Avandia be pulled from the market after concluding it is more dangerous to the heart than a rival medicine, according to documents released on Saturday.

The Food and Drug Administration will again ask an advisory panel to consider the risks of the drug, Glaxo’s second biggest-selling product before questions about a possible link to heart attacks emerged in 2007.

Senators Max Baucus and Charles Grassley meanwhile released a report saying evidence suggested Glaxo knew of possible cardiac risks associated with Avandia years before the issue became public.

“I await the recommendations of the advisory committee,” FDA Commissioner Margaret Hamburg said in a statement.

“Meanwhile, I am reviewing the inquiry made by Senators Baucus and Grassley and I am reaching out to ensure that I have a complete understanding and awareness of all of the data and issues involved,” she said.

In an October 2008 memo released by the senators, FDA reviewers David Graham and Kate Gelperin concluded “the risks of (Avandia) are serious and exceed those for” Takeda Pharmaceutical Co’s competitor Actos.

They said there was “strong evidence that (Avandia) confers an increased risk of” heart attack and heart failure when compared to Actos. They estimated that 500 more heart attacks and 300 cases of heart failure were occurring every month with use of Avandia instead of Actos, based on levels of use at the time of their memo.

Graham, an outspoken critic of the FDA’s handling of drug risks, had argued to an advisory panel in 2007 that Avandia sales should be stopped. The panel voted 22-1 to urge the FDA to keep the drug on the market.

Glaxo said in a statement “the scientific evidence simply does not establish” that Avandia increases risks of cardiovascular problems such as heart attacks.

Sales of Avandia, known generically as rosiglitazone, topped $3 billion in 2006 but fell to $1.2 billion in 2009.

The FDA decided in November 2007 Avandia should carry a warning saying a review of 42 studies associated the drug with an increased risk of a heart attack or chest pain compared with a placebo. But it said overall data were “inconclusive.”

Concerns about Avandia emerged in May 2007 when Cleveland Clinic researchers published a study saying there was a link between the drug and heart attacks.

FINDINGS MISREPRESENTED?

The senators’ report said evidence reviewed by investigators on the Senate Finance Committee, which Baucus chairs, showed Glaxo “knew for several years prior to this study that there were possible cardiac risks associated with Avandia.”

Glaxo executives “attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk and sought ways to downplay findings that a competing drug might reduce cardiovascular risk,” the report said.

Committee staff reviewed more than 250,000 documents provided by Glaxo, the FDA and others, the report said. Anonymous whistleblowers provided hundreds of other pages.

The New York Times first reported on the memo from FDA reviewers and the senators’ report on Friday night on its website.

Glaxo said it rejected the report’s conclusions. The company said the report “cherry-picks information from documents, which mischaracterizes GlaxoSmithKline’s comprehensive efforts to research Avandia and communicate those findings to regulators, physicians and patients.”

Glaxo said it had rigorously studied Avandia’s safety and “consistently shared this data with regulators around the world.” The company said it “does not condone any effort to silence scientific debate.”

FDA spokeswoman Karen Riley said on Saturday an advisory panel, a group of outside experts, will be asked “to provide advice about safety issues” with Avandia. The FDA usually follows panel recommendations.

Glaxo spokeswoman Mary Anne Rhyne said the company was told the panel would review results of a Glaxo-sponsored study called Record. That study showed Avandia was not associated with an increase in cardiovascular-related hospitalization or death compared to older diabetes drugs, she said.

The company has asked the FDA for permission to include those results in Avandia’s prescribing instructions, she said.

Source: Reuters

Popularity: 3% [?]

A US federal court judge ordered Wyeth to unseal company records about its alleged use of ghostwritten medical-journal articles to market hormone replacement therapies Prempro and Premarin, Bloomberg reported. The request had been made by PLoS Medicine and The New York Times to US District Judge William Wilson, whose court is overseeing more than 8000 lawsuits involving women who claim the drugs caused their breast cancer.

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Wilson noted that Wyeth has five days to appeal the decision and said the files will remain confidential while the appeal is pending. In response to the news, Wyeth spokesman Doug Petkus remarked that “this is a continuing effort by the plaintiffs’ product-liability attorneys to recycle arguments that have been rejected by judges and juries alike.” He stated that Wilson ruled in previous cases that there was no support for claims that Wyeth endorsed articles that the company knew to be false or misleading in regards to the benefits of menopause drugs.

Lawyers for PLoS Medicine, The New York Times and the plaintiffs indicated that their objective is to increase physicians’ awareness of drugmakers’ influence over medical research. In December, US Senator Charles Grassley alleged Wyeth paid ghostwriters to produce articles favourable to the company’s hormone therapies. The senator’s claims were made as part of a wider probe into the influence of the pharmaceutical industry on healthcare spending.

Source: FirstWord

Popularity: 4% [?]

Medicare has expanded patient access to cancer treatments to include automatic coverage for a broader range of off-label uses for the drugs. The new policy, which took effect in November and was reported by The New York Times on Tuesday, increased the number of compendia that Medicare consults to determine which off-label drug uses should be covered from one guide to four.

The new policy obliges Medicare to pay for a cancer treatment as long as at least one compendium recommends its use, though the agency would not be required to cover a particular cancer drug if other guides specifically advised against it. Peter Ashkenaz, a spokesman for Medicare, stated that a drug’s inclusion in the compendia does not mean it will automatically be covered; doctors will be required to show that the prescribed drug is both “reasonable and necessary.”

However, a draft report commissioned by Medicare last year criticises the new rules for taking decisions about off-label use of medications out of Medicare’s purview and allowing compendium recommendations to become “the final word.” A final version of the draft document is expected to be released shortly.

Among the treatments most likely to benefit from the changes is Roche’s and Genentech’s Avastin (bevacizumab), which is expected to be routinely covered for ovarian cancer, as well as brain and kidney cancer. Eli Lilly’s Gemzar (gemcitabine), approved by the FDA for four types of cancer, is now expected to be covered by Medicare for use in nearly a dozen other forms, including cervical cancer.

Commenting on the Medicare policy changes, a spokesperson for PhRMA said the new rules ensure “that cancer patients have access to the treatments they need.” The American Society of Clinical Oncology also welcomed the new rules, saying the group will ensure that off-label prescribing will be done appropriately.

Source: FirstWord

Popularity: 4% [?]

The New York Times reported Eli Lilly is expected to agree to pay $1.4 billion, as early as Thursday, to settle US criminal and civil charges related to a government investigation into alleged improper marketing of Zyprexa (olanzapine) for off-label uses.

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The case is being prosecuted by the US attorney’s office for the Eastern District of Pennsylvania, which declined to comment on the matter, as did company spokesperson Angela Sekson. Eli Lilly booked a $1.4 billion charge in the third quarter of 2008 while it was engaged in advanced talks with the US government about the case. The settlement agreement would be the largest recovery for a corporate whistle-blower case, according to the newspaper.

Last October, Eli Lilly paid $62 million to settle investigations in 32 US states and the District of Columbia related to the sales, marketing and promotion of the antipsychotic.

Source: FirstWord

Popularity: 2% [?]