PHARMACY

Pfizer initiates purchase of CovX

BY Drew Buono

NEW YORK Pfizer has bought the privately owned biotech company CovX, which specializes in combining the strengths of peptides and antibodies into new drugs, according to published reports.

An antibody discovery made at The Scripps Research Institute was the main reason for the acquisition. As licensor of the technology, Scripps Research will receive a percentage of the proceeds from the sale, as well as royalties from any resulting therapies.

When the deal is completed early next year, CovX will operate as a division of Pfizer’s new Biotherapeutic and Bioinnovation Center. Pfizer bought the company as part of a trend of big pharma companies buying biotech companies to bolster their own pipelines.

The biotech firm has three early-stage compounds, one for diabetes and two for cancer. Their most advanced drug candidate is CVX-045, which began Phase I trials in cancer patients back in February 2007. By slowing down blood vessel growth, it is hoped CVX-045 could starve a tumor of oxygen and nutrients and therefore slow down its growth.

CovX’s second potential cancer drug is CVX-060, which binds to Angiopoietin-2 and also stalls blood vessel growth. A Phase I trial of this drug was approved in October. The firm’s diabetes drug is called CVX-096 and a Phase I trial is expected in the second half 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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