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GSK's Avandia increases heart risks, panel says

A federal regulatory panel today agreed that GlaxoSmithKline's controversial diabetes drug Avandia increases the risk of heart attacks and other cardiovascular problems.

But the panel also said that Avandia doesn't increase the risk of death compared with other treatments for the disease, Bloomberg News reported.

The advisers are considering in a series of votes whether available Avandia research is sufficient to determine the risk of the drug approved in 1999.

The panel is expected to recommend later today whether Avandia should be pulled from the market, slapped with stronger warnings or left alone. The FDA typically follows its panels' recommendations, but doesn't have to.

GSK officials say the drug is safe. The company wants to avoid the financial hit, legal hassle and PR headache that would come from withdrawing the drug.

Recall Avandia? "Keep an open mind," says one FDA commissioner

A Food and Drug Administration commissioner said today that regulators considering a recall of GlaxoSmithKline's diabetes pill Avandia should "keep an open mind," Bloomberg News reports.

Margaret Hamburg made her comments during the first day of a two-day FDA advisory panel meeting on Avandia being held in suburban Washington.

"Follow the science, wherever it leads, and the rest will fall into place," Hamburg said.

Bloomberg also reported today that GSK has agreed to pay $450 million to settle a majority of the lawsuits, about 10,000, alleging Avandia can cause heart attacks and strokes.

At the conclusion of the two-day hearing, the panel is expected to recommend to the FDA whether the drug should be pulled or whether new warnings or restrictions are warranted because of safety concerns.

Future uncertain for RTP landmark

Last week's announcement by GlaxoSmithKline that it would be vacating a half dozen buildings that it owns has left some worried about the future of one of the Triangle's most unique buildings.

GSK plans to vacate the Elion-Hitchings Building, a hexagonal structure that was designed by the famed architect Paul Rudolph.

Rudolph was commissioned to build the Burroughs Welcome Company's corporate headquarters. (Glaxo Wellcome and SmithKline Beecham merged in 2000 to create GSK.)

The original 300,000-square-foot building was finished in 1972. Rudolph was brought back in 1982 to design a 100,000-square-foot annex of extra office space and a staff dining room.

The futuristic interior of the building was used as the set for the 1983 movie "Brainstorm."

Sanofi's Viehbacher said to plan major U.S. acquisition

Chris Viehbacher's shopping list could include targets with Triangle operations.

The CEO of French drug maker Sanofi-Aventis is reportedly working on a major acquisition in the United States. Viehbacher, who previously was GlaxoSmithKline's top executive in Research Triangle Park, briefed his current company's board last week about a proposed transaction, according to Bloomberg News and other published reports.

Among the rumored takeover candidates: Biogen Idec, which employs about 850 people at its RTP manufacturing campus, and Hospira, which has more than 300 workers at a Clayton plant. Other potential targets include Allergan and Genzyme.

GSK using small research teams to spark drug development

A front page story in today's Wall Street Journal details how GlaxoSmithKline has carved its research units into smaller groups in an effort to spur innovation of new drugs.

The move, the story notes, is an attempt to replace the bureaucracy of a corporate giant with the more nibble ways of a biotech startup.

Many large pharmaceutical companies have struggled to develop new blockbuster drugs over the last decade.

The smaller working groups tie in with the renovations now underway at GSK's Moore Drive campus in Research Triangle Park.

Over the next year and a half GSK will vacate a half dozen buildings it owns and leave its office space in downtown Durham's American Tobacco Campus.

The moves will result in about 1,000 employees relocating to the Moore Drive campus.

 

Fat paycheck arrives at Pozen

Today was a $20 million payday for Pozen.

The Chapel Hill drug company announced that it received a $20 million milestone payment from partner AstraZeneca. The money was tied to the Food and Drug Administration's approval of the companies' new arthritis medicine on April 30.

Next up is a $25 million payment for winning government approval in a major foreign market, which could happen later this year. Pozen also stands receive up to $260 million for achieving sales performance milestones.

The drug, known as Vimovo, is Pozen's second product approved for sale to patients. It also developed Treximet, a migraine drug sold by partner GlaxoSmithKline.

Pozen shares closed at $7.57, down 25 cents. The stock is down 37 percent since Vimovo won FDA approval. suggesting that Wall Street followed the adage of "buy on the rumor, sell on the news."

UNC-CH planetarium gets 723K from GlaxoSmithKline

The Morehead Planetarium and Science Center at UNC-Chape Hill has received a $723,000 grant from GlaxoSmithKline to expand summer science programming.

The programs will expand the drug manufacturer's Science in the Summer program, which the planetarium administers. It will focus on a different science discipline each year; in 2010, it will tackle oceanography and water quality.

The curriculum will be presented hosted at public libraries and other community sites throughout North Carolina.

"We want students to learn about the wonders of science at an early age so that they can begin to develop a lifelong interest and appreciation," said Mary Linda Andrews, director of Community Partnerships for GlaxoSmithKline, in a UNC-CH news release.

GlaxoSmithKline created the Science in the Summer program 24 years ago in Pennsylvania and expanded it to North Carolina in 2008, choosing the Morehead planetarium to administer it.

Patients avoiding Avandia drug trials

GlaxoSmithKline is having trouble recruiting patients for a large clinical trial of its controversial diabetes drug Avandia, the Wall Street Journal reports this morning.

The drug has been linked to an increased risk of heart attack, but GSK officials have said it's a safe and effective product. Federal regulators are considering whether to halt the so-called TIDE clinical trial early because of Avandia's health risks.

Two sites, including Wake Forest University Baptist Medical Center in Winston-Salem, have pulled out of the safety study, GSK reports. The British company, which has its North American headquarters in Research Triangle Park, didn't name the second site.

GlaxoSmithKline reportedly settles Avandia suits

GlaxoSmithKline has reportedly agreed to pay about $60 million to settle 700 lawsuits alleging that its Avandia diabetes drug causes heart attacks and other health problems.

Bloomberg News reported the settlements today, citing unnamed sources.

Officials with the British drugmaker, which has its North American headquarters in Research Triangle Park, declined to comment on possible settlements.

“GlaxoSmithKline stands by Avandia and is fully prepared to defend any litigation,” spokeswoman Bernadette King said in an e-mailed statement.

GSK faces about 4,000 lawsuits so far over the drug, and is preparing for the first trial, in state court in Philadelphia, in July.

GSK reports higher profit, sales

GlaxoSmithKline reported stronger first-quarter profit, as the British drugmaker boosted sales of its flu vaccine, Advair asthma medicine and other products.

The company's net income rose about 19 percent from a year earlier to $2.04 billion, beating analysts' expectations.

GSK is the largest pharmaceutical company in the Triangle, with about 5,000 employees at its North American headquarters in Research Triangle Park and a manufacturing plant in Zebulon.

The company reported some signs of recovery for its U.S. pharmaceuticals business, with sales down 1 percent compared to a 24 percent drop in the same quarter last year.

GSK has been cutting thousands of jobs worldwide to offset slowing sales, especially in the U.S. And in February, the company announced it was cutting research on depression and pain treatments to focus on more promising therapies for Alzheimer’s and Parkinson’s diseases and multiple sclerosis.

"GSK has made a good start to 2010 and this provides further confirmation that our strategy is working," said CEO Andrew Witty. "[We] remain confident of our prospects for the year."

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