FDA will seek advice on new version of a Genzyme drug

October 18, 2008

The Food and Drug Administration will ask a panel of experts week whether studies by the Cambridge biotech firm Genzyme Corp. support approval of a new version of its drug Myozyme. Genzyme markets Myozyme for Pompe disease, a rare disorder that interferes with muscle development and can cause respiratory problems. The disease is often fatal in the first year of life; only 5,000 to 10,000 patients worldwide are estimated to live with it, according to the United Pompe Foundation. The new version would be for patients 2 years and older. The version now on the market is only approved for infants and babies. Genzyme currently makes the drug in a 160-liter tank but has asked the FDA to approve manufacturing in a 2,000-liter tank to increase production. The FDA decided the new version would have to be evaluated separately because of significant manufacturing differences. (AP)

Delta Air Lines Inc. said it will inspect the engines on 132 Boeing 757 jetliners after one engine failed and another, on an American Airlines plane, developed cracks. The National Transportation Safety Board has asked the Federal Aviation Administration to order the inspections. As of yesterday, the FAA had not made a decision. It has said it needs to determine if all Pratt & Whitney PW2037 engines need inspections, or just those made during a certain time period. The NTSB began examining the engines after Delta pilots heard a bang and lost engine power during a takeoff at the Las Vegas airport in August. (AP)

Crude oil prices rose $2, buoyed by signs that OPEC will reveal a production cut at its meeting next week. The Organization of Petroleum Exporting Countries, which supplies more than 40 percent of the world's oil, moved up its November meeting to discuss output levels. The price of oil has tumbled more than 50 percent since reaching a trading record of $147.27 in July because the financial crisis threatens to push the world into a recession, curbing fuel demand. Crude oil for November delivery rose $2, or 2.9 percent, to settle at $71.85 a barrel on the New York Mercantile Exchange. Fuel demand in the United States, consumer of 24 percent of the world's oil, was at the lowest since July 1999 during the past four weeks, the Energy Department said. (Bloomberg)

Drug giant Pfizer Inc. has reached an $894 million deal to settle the bulk of the 7,000 lawsuits over its withdrawn pain reliever Bextra, following the lead of rival Merck & Co., which is spending five times as much to settle Vioxx suits. The Pfizer agreement also would end lawsuits over its popular Celebrex, the only one of the three - all in the same class of anti-inflammatory drugs and all linked to elevated risk of heart attacks and strokes - still on the market. (AP)

Merck & Co. is expanding an already large study of an experimental cholesterol drug - rejected this spring by US regulators - to get results sooner so it can move up its second bid for approval. The drug, known as MK-0524A, combines the B vitamin niacin and a drug called laropiprant to limit the facial flushing caused by niacin. It was rejected in April by the Food and Drug Administration, which said it wanted results of a major international trial known by the acronym THRIVE before ruling again, a Merck spokesman said. The study, run by Oxford University in England, began in May 2006 and was to end in 2013. The university's Clinical Trial Services Unit said it would expand the number of patients included to 25,000, from 20,000. (AP)

A large French mutual bank, Groupe Caisse d'Epargne, said it lost $807 million as a result of unauthorized derivatives trading by a team on the bank's own account. The lender, which is in merger talks with a French rival, said the loss was the result of "extreme market volatility" on stock exchanges last week. A bank spokeswoman said the situation was "a big mistake" rather than a fraud. (New York Times News Service)