PHARMACY

FTC waives waiting period for $1.65 billion GSK acquisition of Reliant

BY Drew Buono

LONDON and PHILADELPHIA GlaxoSmithKline has completed its acquisition of Reliant Pharmaceuticals in a deal worth $1.65 billion. This acquisition follows the Federal Trade Commission’s early termination of the waiting period required by antitrust law.

GSK now will add Reliant’s cardiovascular medicines to its portfolio. The drugs are: Lovaza, a drug used to treat very high levels of triglycerides; DynaCirc CR and InnoPran XL, which treat high blood pressure; and Rythmol SR, which treats abnormal heart rhythms. GSK will have marketing rights for Lovaza in the U.S. and Puerto Rico, with the drug’s originator, Pronova BioPharma, licensing the rights in other markets to other companies. As a result of the acquisition, biotechnology company Alkermes is to receive $174 million for its stake in Reliant, which it will use to repurchase shares of common stock.

“We’re eager to begin building on Reliant’s success with Lovaza,” said Chris Viehbacher, president of U.S. Pharmaceuticals at GSK. “We think this medicine has significant potential to help larger numbers of patients, and we expect it to become an important driver of sales growth in the U.S.”

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Mylan, Forest get FDA approval of Bystolic for hypertension

BY Drew Buono

WASHINGTON The Food and Drug Administration has approved Mylan and Forest Labs’ new drug, nebivolol, for the treatment of high blood pressure. Forest will market the drug under the prescription name Bystolic.

Nearly 1-in-3 adults in the United States has high blood pressure, also called hypertension, which can increase the risks for stroke, heart failure, heart attack and kidney failure. “High blood pressure is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” said Douglas Throckmorton, the FDA’s deputy director of the Center for Drug Evaluation and Research. “Bystolic offers a new treatment option for people who need to control their high blood pressure.”

More than 2,000 people received Bystolic during clinical trials. The drug’s efficacy was similar to that of other approved beta blockers, the FDA said. The most common reported side effects were headache, fatigue, dizziness and diarrhea.

On Dec. 2 of this year, Forest and Mylan had said that final approval was contingent upon resolution of manufacturing deficiencies at a plant in Belgium.

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Genzyme gets expanded approval for Thyrogen from FDA

BY Drew Buono

CAMBRIDGE, Mass. The Food and Drug Administration has granted expanded approval for Genzyme’s thyroid cancer drug Thyrogen, according to published reports.

The new indication allows for Thyrogen (thyrotrophin) to be used in combination with radioiodine, a radioactive iodine used to treat thyroid cancer, to destroy the remaining thyroid tissue in patients who have had their cancerous thyroids removed.

Thyrogen was initially approved in the U.S. in 1998 for use as a diagnostic tool in the management of patients being tested for the recurrence of well-differentiated thyroid cancer. The drug helps increase the sensitivity of testing while allowing patients to avoid the potentially debilitating symptoms of thyroid hormone withdrawal.

“This new indication extends the significant benefits of Thyrogen to patients during their initial treatment for thyroid cancer, in addition to its current use in follow-up diagnostic procedures to detect recurrence,” said Mike Heslop, senior vice president and general manager of Genzyme’s endocrine business.

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