PHARMACY

Pfizer receives antitrust watchdog permission to acquire Coley

BY Drew Buono

NEW YORK Pfizer has received clearance from U.S. and German antitrust reviews to acquire Coley Pharmaceuticals, according to published reports. Coley is a biotech company that specializes in making vaccine technology and drugs to treat cancer, allergies, asthma and autoimmune diseases.

On Nov. 30, Pfizer commenced a tender offer for all of Coley’s outstanding shares for $8 apiece in cash, in an offer worth $164 million. The deal had been on hold until expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, and once that occurred on Tuesday, Pfizer received clearance from the Federal Cartel Office of Germany for the buyout offer.

Expiration of the waiting period under the HSR Act and the FCO’s actions meet one of the conditions needed to complete the pending acquisition. Other customary closing conditions still apply. Unless extended, the tender offer is scheduled to expire at midnight on Dec. 28.

The deal though is expected to close in the first quarter of 2008.

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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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