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LTW and Wire Reports

RESEARCH TRIANGLE PARK, N.C. – It’s been a tough Thursday for GlaxoSmithKline (NYSE: GSK).

GSK, who is based in Britain with its North American headquarters here in RTP, is having trouble recruiting patients for a large clinical trial of its controversial diabetes drug Avandia in addition to news from Germany that a key patent for their best-selling lung drug Advair is not valid.

The ruling relates to the combination of Advair’s active ingredients salmeterol and fluticasone propionate. Glaxo, the U.K.’s biggest drug maker, said the Munich-based court’s decision relates solely to the German combination patent for Viani, Advair’s German brand name, and isn’t binding in any other jurisdiction.

Advair made up 18 percent of Glaxo’s sales last year, according to reports, and while there are worries about competition in the United States, it appears the threat in Europe might be more immediate.

The decision is the conclusion to a hearing conducted in February. GSK is studying the judgment and will be considering an appeal to a higher court, according to wire reports.

Avandia, on the other hand, has been linked to an increased risk of heart attacks, but GSK officials intend that it is 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, according to the Wall Street Journal.

The Raleigh News & Observer reports that two sites, including Wake Forest University Baptist Medical Center in Winston-Salem, have pulled out of the safety study. The second site was not named by GSK.

Wake Forest’s decision to withdraw wasn’t related to any safety concerns, but because the medical school was struggling for months to find subjects, dean William Applegate told the Wall Street Journal.

GSK is eager to prove that Avandia is safe and has added dozens of clinical-test sites overseas in Pakistan, India, Mexico, Latvia, Colombia and other countries.

In July, the U.S. Food and Drug Administration plans to meet outside advisors to discuss Avandia and the TIDE trial. The tests compare cardiovascular risks for Avandia and a rival diabetes drug.

Earlier this month, GSK reportedly agreed to pay about $60 million to settle 700 lawsuits alleging that Avandia caused heart attacks and other health problems. The company has declined to comment on possible settlements, which were reported by Bloomberg News.

The company still faces more than 4,000 lawsuits over the drug.