PHARMACY

Schering-Plough posts quarterly loss from purchase of Organon

BY Drew Buono

KENILWORTH, N.J. Schering-Plough today released its first-quarter results for 2008, according to published reports. The drugmaker reported a net income of $253 million, down from $543 million during the first quarter of 2007, mostly due to the acquisition of the biotech company Organon BioSciences.

Sales though rose by 56 percent to $4.66 billion. Its rheumatoid arthritis drug Remicade’s sales rose by 36 percent to $507 million.

Vytorin and another cholesterol treatment drug Zetia, which Schering markets through a joint venture with Merck saw sales of both drugs combined rise 6 percent to $1.2 billion during the quarter. But they fell 5 percent in the United States amid the widely publicized failure of Vytorin to cut plaque in neck arteries in a study for which results were presented in January.

Merck said Monday it expects its revenue from the drugs to drop by $700 million over the rest of 2008.

Chief executive officer Fred Hassan said the company is on track with its plan to cut annual costs by $1.5 billion by 2012, announced earlier this month. About 10 percent of its 55,000 jobs are to be cut.

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Contaminated heparin affects 11 countries

BY Drew Buono

WASHINGTON The Food and Drug Administration has announced that the contaminant found in the blood thinner heparin has been discovered in China and has now affected 11 countries including the United States, Canada, Japan, China, Denmark, the Netherlands, Germany, France, Italy, Australia and New Zealand.

Heparin is made from the mucous membranes of the intestines of slaughtered pigs that, in China, are often cooked in unregulated family workshops. The contaminant, identified as oversulfated chondroitin sulfate, a cheaper substance, slipped through the usual testing and was recognized only after more sophisticated tests were used.

But a Chinese official disputed the assertion that the contaminant found in the drug, heparin, caused any deaths and insisted that his country’s inspectors be allowed to inspect the American plant where the finished heparin vials were made. He said any future agreement to allow American inspections of Chinese firms should be mutual. The agency had announced plans to open inspection offices in three Chinese cities, but the agency has yet to get permission from the Chinese government.

Janet Woodcock, director of the FDA’s drug center, said that German regulators uncovered a group of illnesses among dialysis patients who took contaminated heparin. She said Chinese officials had said that heparin produced in their country contained a contaminant, though they say it was not connected to the illnesses.

Bills to require far more aggressive inspections of Chinese products and companies are being proposed by members of Congress. Hearings are scheduled for today in the House and Thursday in the Senate.

Woodcock said the Chinese had agreed to test heparin lots before allowing them to be exported. But Dr. Moheb Nasr, director of the drug agency’s office of new drug quality assessment, said that the Chinese test might not be sensitive enough to identify the contaminant.

Woodcock assured patients, however, that all heparin supplies in the United States had been tested with the most sensitive tests and had been found to be uncontaminated.

Baxter International, which bought heparin ingredients from Changzhou SPL, the Chinese plant identified as the source of contaminated heparin, sold the finished drug in the United States, and said that its tests confirmed that the contaminant could cause illness. It disputed the FDA’s analysis that its product was linked with 81 deaths, saying it had identified only 5 in which its product “may have contributed to the adverse outcome, though there is not yet enough medical data available to draw a firm conclusion that the reaction caused the death.”

Deaths linked to the drug may have been concentrated in the United States because American doctors may be more likely to use large, quickly infused amounts of the drug, said drug officials.

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FDA approves Cimzia for Crohn’s disease

BY Drew Buono

WASHINGTON The Food and Drug Administration today approved Cimzia, a new drug by UCB to treat Crohn’s disease.

Crohn’s disease is a chronic, inflammatory bowel disease. It has no cure and its cause is unknown. Crohn’s can cause diarrhea, fever, rectal bleeding, malnutrition, narrowing of the intestinal tract, obstructions, abscesses, cramping, and abdominal pain. It also can lead to abnormal connections (fistulas) leading from the intestine to the skin or internal organs.

Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks.

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