PHARMACY

PTC, Genzyme ink $100 million development deal

BY Drew Buono

PLAINFIELD, N.J. PTC Therapeutics and Genzyme have agreed on a partnership deal that will help PTC develop its lead drug, PTC 124 for treatments like rare forms of cystic fibrosis and Duchenne muscular dystrophy, according to published reports.

Genzyme will pay PTC $100 million upfront and, in exchange, the company will get exclusive rights for the drug, which is currently in phase 2 clinical trials, outside the United Stated and Canada.

Also, under the terms of the deal, PTC will be responsible for finishing up four studies involving the drug. Afterward, the two companies will share research and development costs. PTC will also be eligible for additional fees up to $337 million from Genzyme based on regulatory progress and level of sales achieved by the PTC-124.

This announcement comes just one day after PTC received an award for $25 million for the same drug from the drug discovery branch of the Cystic Fibrosis Foundation.

PTC-124 is designed for patients who have a genetic disorder caused by a nonsense mutation, which interrupt sequences in DNA coding.

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PHARMACY

BMS settles with EPA over environmental issues

BY Drew Buono

NEW YORK Bristol-Myers Squibb has agreed to resolve Clean Air Act violations by reducing its emissions of ozone-depleting refrigerants at multiple facilities, paying about $3.65 million to upgrade some facilities.

The company’s settlement with the Environmental Protection Agency requires it to retire or retrofit 17 industrial refrigeration units by July 2009 at facilities in Mt. Vernon and Evansville, Ind.; Hopewell, N.J.; and Humacao and Mayaguez, Puerto Rico, the EPA said.

The units use hydrochlorofluorocarbons as refrigerants in the industrial process or in air conditioners. BMS agreed to change the units to use only non-ozone-depleting refrigerants, the EPA said.

The settlement, filed in the U.S. District Court for the Southern District of Indiana, also requires the company to retire two comfort-cooling units at its New Brunswick, N.J., plant and connect the air conditioners to the company’s new centralized refrigeration system. The new system uses water-chilled coolers to minimize the use of chemical agents.

The company also must take steps to ensure compliance with EPA regulations at 13 of its facilities and pay $127,000 in fines. It also must submit three annual reports to each EPA region describing actions it has taken to comply with the settlement.

Following an EPA information request concerning its Evansville, Indiana, facility, BMS voluntarily audited 25 other facilities and reported potential violations. According to the EPA, the audit found potential violations at facilities in Connecticut, Indiana, Massachusetts, Michigan, New Jersey, New York and Puerto Rico.

BMS said it will continue to monitor all sites.

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Vical bird flu vaccine successful in phase I

BY Alaric DeArment

SAN DIEGO A phase I study by Vical has found that its vaccine against avian influenza can protect against the virus, the company announced Thursday.

The double-blind, placebo-controlled study examined 100 volunteers ages 18 to 45 who received two injections of the vaccine and found that 50 to 67 percent of patients receiving 0.5mg and 1mg doses of the vaccine had immune responses that could protect against the H5N1 strain of avian flu.

The vaccine is made from DNA derived from plasmids, small pieces of genetic material, and designed to provoke an immune response.

H5N1 originated in Asia and spread to Europe, the Middle East and Africa. Of 385 people infected, 243 have died. Experts fear it could mutate into a form transmissible between humans and cause a global pandemic that would kill millions.

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