Two of North Carolina's largest companies could be headed for a showdown.

The Wall Street Journal reports today that GlaxoSmithKline, which has its U.S. headquarters in Research Triangle Park, has asked the Food and Drug Administration to remove dissolvable smokeless tobacco products from stores.

Reynolds American, based down the road in Winston-Salem, has been test-marketing tiny lozenges,  called Camel Orbs, in several cities, the WSJ reports. The lozenges are basically smokeless tobacco products.

The new dissolvable tobacco products are competition for GSK's quit-smoking products such as Nicorette gum. In its letter to the FDA, sent after the agency asked for public comment on the issue, GSK expressed concern that the new products are not being marketed in a way that protects the public health.

The FDA, according to the WSJ, has already expressed its own concerns about the lozenges, writing to Reynolds that their candy-like appearance may appeal to kids.

In two major healthcare rulings today, European medical authorities suspended GlaxoSmithKline's Avandia while U.S. regulators said they will require stricter safety warnings for the diabetes drug that's packaged in Wake County.

The European Medicines Agency said Avandia will be phased out in Europe over the next several months and patients will need to find alternative treatments.

In this country, the Food and Drug Administration will require additional safety labels and restrictions on Avandia's use. The FDA adopted the July recommendation of a federal advisory panel, whose 33 members were deeply divided on the issue of the drug's safety.

Health authorities in Europe and the United States cited concerns about the increased risk of heart attack and stroke from using Avandia, once the world's leading diabetes medication that reaped $3 billion for London-based GSK in 2006.

GlaxoSmithKline has chosen two contract-research organizations to handle its future clinical drug development, including PPD of Wilmington and Parexel International, based in Massachusetts.

The news is a blow to other CROs in the Triangle, which is a hub for the drug-research industry, although it's unclear which companies were competing to work with GSK.

GSK spokeswoman Melinda Stubbee declined to name other companies that submitted bids. "It was an extremely competitive process," she added.

GlaxoSmithKline has hired a Goldman Sachs investment banker as its new chief financial officer.

Simon Dingemans, 47, leads Goldman’s European mergers business and has more than 25 years of investment banking experience, London-based GSK said in a statement today. He will become CFO-designate Jan. 4 and replace Julian Heslop, 57, as chief financial officer when he retires at the end of March, the company said.

The move comes as CEO Andrew Witty is seeking new acquisitions to replace sales that are being eroded by generic competition. GSK has done 24 acquisitions and joint ventures since Witty became CEO in May 2008, according to Bloomberg data.

GlaxoSmithKline's Avandia diabetes treatment should be withdrawn from the market, the British Medical Journal’s Editor-in-Chief Fiona Godlee wrote in an editorial published today, Bloomberg News reported.

The editorial comes as European regulators prepare to meet on the drug’s safety. The European Medicines Agency on Wednesday will discuss the “ongoing benefit-risk review” of Avandia, after research linked the drug to higher rates of heart disease.

Several large pharma companies, including GlaxoSmithKline and Merck, are being investigated by the Department of Justice and the Securities and Exchange Commission, according to the Financial Times of London.

Justice is looking at payments made by the companies for hospitality, consultants and licensing around the world to see if the companies used the money to influence the reliability of the data in clinical trials performed outside the United States.

Such payments would violate the Foreign Corrupt Practices Act, a U.S. anti-bribery law, according to the paper.

The Times quoted sources familiar with the investigation saying that Justice was looking at all aspects of the companies dealings in non-U.S. markets, including recruiting physicians for clinical trials.

London-based GSK, which has its U.S. headquarters in Research Triangle Park,  told the Times that it had received inquiries from U.S. authorities.

Merck, which has a vaccine plant in Durham, as well as Pfizer, Bristol-Myers Squibb and Eli Lilly have also disclosed being contacted by Justice and the SEC.
 

GlaxoSmithKline researchers have developed an experimental antibiotic that, if successful during  additional clinical testing, could help fight drug-resistant infections in hospitals, Bloomberg News reports.

The compound, called GSK-299423, targets an enzyme to stop bacteria from replicating. The drug is years away from being commercialized, but is unusual because few pharmaceutical companies are producing such antibiotics, Bloomberg reports.

GSK is a British drug maker with its North American headquarters in the Triangle. The company is eager to find promising new products to offset slower sales and generic competition.

GlaxoSmithKline will revamp the way it pays its U.S. drug salespeople next year, tying bonuses to customer service rather than just sales targets.

The British drug maker, which has its North American headquarters in Research Triangle Park, said it's responding to requests by physicians, who want to see fewer drug salespeople. GSK also is trying to adapt to a changing health-care system, where providers' decisions on purchasing and utilization increasingly are made from a central office.

Bonuses will be tied partly to feedback from physicians and other providers, and by "a sales professional's adherence to the company values of transparency, integrity, respect and patient-focus," GSK wrote in a news release.

"We've spent a good deal of time listening to our customers, and they are asking us for more information about reimbursement, disease education and support for improving patient health," said Deirdre Connelly, GSK's president for North American pharmaceuticals, in a prepared statement. "In response, we are changing the way we sell our medicines and vaccines."

Federal regulators have asked GlaxoSmithKline to stop enrolling new patients for a clinical trial of its controversial diabetes drug Avandia, while they review whether the drug should be pulled off the market.

Patients already enrolled in the so-called TIDE trial can continue to participate, but GSK announced today it will stop adding new patients.

In North Carolina, the only site participating in the TIDE trial is Duke University Medical Center, with Dr. Mark Feinglos as the principal investigator. Feinglos' office referred calls to a Duke spokesman, who wasn't immediately available.

GlaxoSmithKline said today it will spend a record amount of money on legal fees associated with lawsuits against its controversial diabetes drug, Avandia, and other issues.

The British company, whose North American headquarters is in Research Triangle Park, said it expects to record $2.36 billion in legal payments and fees in the second quarter.

The legal expenses are partly associated with settlements for Avandia, the onetime blockbuster diabetes drug that is associated with heart-attack risk. GSK did not provide specifics, but Bloomberg News reported this week that GSK has settled thousands of lawsuits against Avandia.