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LONDON–AstraZeneca PLC said yesterday it is buying U.S.-based biotech drug maker MedImmune Inc. in a $15.6 billion (U.S.) deal that will allow the British company to enter the vaccines market.

AstraZeneca, looking to strengthen its pipeline of future drugs as it faces patent challenges and escalating generic competition, will pay $58 per share for MedImmune, a 21 per cent premium to the stock's close Friday.

The deal, which AstraZeneca hopes to close in June, will increase the company's proportion of biotechnology drugs in its pipeline to 27 per cent from 7 per cent, and enlarge its total pipeline by 45 projects to 163 projects.

Worries are emerging about the safety of new diabetes medicines Januvia and Galvus, drugs expected to be big sellers for makers Merck and Novartis. But it is unclear if the concerns are justified or just the result of a hair-trigger tendency concerning drug safety on the part of doctors and regulators.

On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus. Analysts say that could take another year; the pill has already been delayed for three months.

That follows a Feb. 1 article in The New England Journal of Medicine that questioned the safety data available for these drugs. David M. Nathan, a Harvard Medical School endocrinologist, wrote that it is "surprising" that the FDA decided to clear Januvia at all, given the "paucity of published data from long-term clinical trials on its safety and efficacy." Nathan, who is a consultant for Novartis and other drug makers but not Merck , did not return requests for comment.

Pharmaceutical giant GlaxoSmithKline (GSK) is being forced to recruit overseas because there is such a dire lack of science graduates in the UK, the drugs company has warned.

Dr Jackie Hunter, a senior vice-president at GSK, who leads one of the firm’s global drug development centres, said the UK was suffering from an acute shortage of qualified scientists, the Times reports. 

The situation meant GSK had to recruit from France, Spain, Germany and India.

 

Merck & Co., mired in multibillion litigation over its withdrawn painkiller Vioxx, has eliminated another legal headache, resolving several tax disputes with the Internal Revenue Service by agreeing to a $2.3 billion settlement.

In announcing the agreement Wednesday, the Whitehouse Station, N.J.-based company said the settlement resolves all outstanding tax disputes with the IRS, covering the years 1993 through 2006. Merck had faced potential taxes, interest and penalties totaling as much as $3.8 billion, but the agreement apparently reduced that amount.

Neither Merck nor the IRS would discuss the reduction.

In an unsourced story, French financial newsletter La Lettre de l'Expansion said a pre-merger deal is thought to have been signed last week.

In Frankfurt trading, shares of Bristol-Myers Squibb jumped 7.5% to close at 21.66 ($27.99). On the New York Stock Exchange, Bristol shares soared $1.22, or 4.7%, to $27.43.

Shares of Sanofi-Aventis slipped 1.4% to finish at 69 euros ($89.16) in Paris. The company's U.S. traded shares lost 77 cents to $44.57 on the NYSE.

Lilly (LLY) published data showing that Gemzar doubled the median disease-free survival time in patients with pancreatic cancer whose pancreases were surgically removed. In a trial involving 368 patients, the median disease-free survival was 13.4 months in the Gemzar cohort and 6.9 months among those who did not receive chemotherapy. Also, the cancer recurred within 4 years in 92% of those who received no post-surgical drug treatment, but only in 74% of the Gemzar group. Lilly was 3 cents lower at $52.85.

Shire plc (SHPGY) received FDA approval for Lialda, its mesalamine drug with MMX technology. The drug is the only once-daily oral therapy for patients with active, mild to moderate ulcerative colitis. Shire expects to launch Lialda in Q1 of 2007. Shire rose 65 cents to $64.20.

GlaxoSmithKline (GSK) was given a $63 million HHS contract to develop pre-pandemic and pandemic flu vaccines. Glaxo is doing research that combines new adjuvants in combination with antigens to provoke a strong immune response. The goal would be to extend a limited supply of flu vaccines in the face of a pandemic. GSK will also ship 15.5 million treatment courses of flu-drug Relenza for the US stockpile. GSK gained 69 cents to end the day at $55.23.

Eli Lilly has paid out 700 million dollars to over 8,000 litigants who accused the company of injuring them with the antipsychotic drug Zyprexa.

Author: Evelyn Pringle

On January 3, 2007, a hearing was held before Judge Jack Weinstein in a US District Court in New York, on a motion by Eli Lilly to extend an injunction to conceal company documents that show Lilly hid the lethal side effects of Zyprexa for a decade and engaged in an illegal off-label marketing scheme to promote the drug for unapproved uses.

Zyprexa is only FDA approved to treat adults with conditions related to schizophrenia and bipolar disorder, and yet its Eli Lilly's number one best selling drug with sales of over $4 billion last year.

By Jim Edwards

NEW YORK -- Sometimes marketers can do almost everything right to launch a product, but it still doesn't catch on.

That apparently is the case with Rozerem, an insomnia drug from Takeda. In the sleep-drug category, which is known for advertising clichés like white-coated doctors and happily sleeping couples, Takeda took a chance on an eye-catching campaign featuring Abe Lincoln and a beaver.

The company also took a creative approach to its media buy, tapping alternatives like coffee sleeves and airplane seat trays. Moreover, it waited a year after the drug's approval to start consumer advertising so doctors would be familiar with the drug.

BRISBANE, Calif., Jan. 5 -- VaxGen Inc. announced today that it has restructured the company to significantly reduce operating costs and is actively pursuing avenues to enhance shareholder value through a strategic transaction.

Additionally, the company announced that Lance K. Gordon, Ph.D., has resigned as VaxGen's President, CEO and Executive Director. He will remain as an adviser to the company. VaxGen's Board of Directors unanimously appointed James P. Panek, VaxGen's Executive Vice President, as the company's new President and CEO and appointed him to fill the board vacancy left by Dr. Gordon.

"Lance Gordon was the architect of VaxGen's strategy to become a leader in biodefense and to develop its now significant capabilities in process development and GMP biopharmaceutical manufacturing," said Randall L-W. Caudill, Chairman of VaxGen's Board of Directors. "In addition, under his leadership, VaxGen played a pivotal role in the establishment of Celltrion, an undertaking which recently culminated in the realization of substantial financial benefit through the sale of VaxGen's holdings in Celltrion. The entire board thanks him for his contributions and wishes him the best in his future endeavors."

Pfizer (PFE) is an enormous company with approximately $52B in sales per year, $12B in profit per year, and $180B market cap. The company has a large stable of prescription medications such as Lipitor, Norvasc, Zoloft, Viagra, Celebrex and others.

Lipitor is the number one selling prescription drug worldwide with over $12B in sales. Pfizer also has a gigantic research effort, spending several billion dollars per year to bring out more prescription medicines. Also, as seen by the purchases of Warner-Lambert and Pharmacia, Pfizer is willing to buy other companies to expand its product portfolio. Additionally, PFE often buys the rights to compounds being tested by much smaller companies.