PHARMACY

Isis, Genzyme ink potential $1.9 billion deal for cholesterol drug

BY Drew Buono

SAN FRANCISCO Isis Pharmaceuticals has entered into a deal with Genzyme that could potentially see the company receive more than $1.9 billion for its new cholesterol-lowering drug called mipomersen, according to the New York Times.

Mipomersen is in the last stage of clinical trials as a treatment for a rare genetic disease that causes people to have extremely high cholesterol levels, raising their risk of premature cardiovascular disease and death. There are only about 10,000 people in the world with the most severe form of the disease, which can cause heart attacks even in young children.

In midstage clinical trials, the drug lowered levels of cholesterol and other blood lipids more than 40 percent beyond reductions achieved by statins and other existing drugs alone, Isis told the Times.

Under terms of the deal, Genzyme will pay $150 million to purchase 5 million shares of Isis, a stake of a few percent. Genzyme will also pay a $175 million license fee and could end up paying as much as an additional $1.6 billion if the drug reaches the market and achieves certain sales goals.

The companies hope to apply in 2009 for approval of the drug.

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Gardasil vaccine recipients report extreme pain, fainting

BY Drew Buono

MELBOURNE CITY, Australia New reports have shown that the Gardasil vaccine, which is given in three doses to females between the ages of 9 and 26 to prevent against a sexually transmitted virus that causes cervical and vaginal cancer, has been causing extreme pain and also has made girls faints, according to reports from Australia.

Officials at Merck, which makes the vaccine, attributes it partly to the virus-like particles in the shot. Studies showed more reports of pain from Gardasil than from placebo shots, and patients reported more pain when given shots with more of the particles. While many say the pain is short-lived, some say driving or sleeping on the injected arm is uncomfortable for up to a day after.

U.S. health officials have noticed a rise in reports of vaccine-associated fainting in girls. From 2002-04 there were about 50 reports of fainting; from 2005 until last July, there were about 230. About 180 of those cases followed a shot of Gardasil, which came on to the market in 2006.

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Pfizer, Taisho announce partnership to develop schizophrenia treatment

BY Drew Buono

NEW YORK & TOKYO Pfizer and Taisho Pharmaceuticals have signed a definitive agreement to replace their letter of intent for the worldwide (excluding Japan) collaboration to research, develop and commercialize TS-032, a drug candidate for schizophrenia, as well as other central nervous system disorders that is currently in preclinical development.

Under the agreement, Taisho will receive an initial payment of $22 million from Pfizer. The company will also receive milestone payments related to progress of development, as well as royalties and milestone payments tied to sales if TS-032 is approved by regulatory authorities and launched.

“We are pleased to partner with Taisho in this important area of research. Schizophrenia is among the most chronic and disabling of mental health conditions and there still remains a significant need for novel treatment advances with improved efficacy and fewer side effects,” said Martin Mackay, president of Pfizer Global Research and Development. “Pfizer has a long-standing strength in developing and commercializing medications for the treatment of psychiatric illnesses, including Zoloft, Xanax and Geodon. This agreement highlights our commitment to pursue opportunities that align strategically with our key development priorities and strengthen our pipeline.”

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