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Merck Says FDA OK's Antifungal Cancidas

January 29, 2001
NEW YORK (Reuters) - Merck & Co Inc said on Monday that U.S. regulators had approved its experimental drug Cancidas, the first member of a new class of medicines meant to battle deadly fungal diseases that are becoming increasingly common in people with weakened immune systems.

The U.S. Food and Drug Administration approved Cancidas for treatment of invasive aspergillosis in patients who do not respond to or cannot tolerate other antifungal therapies, including amphotericin B and itraconazole.

Analysts have predicted Cancidas could achieve peak annual sales of perhaps $500 million, respectable revenues but not quite blockbuster scale for a company like Merck, which has annual revenues of over $40 billion. Shares of Merck edged up 41 cents to $82.66 on the New York Stock Exchange.

Aspergillosis is a common fungus that poses little threat to the average person. But in people with weakened immune systems, it can infect the lungs and spread throughout the body to damage the heart, brain, kidneys and eyes -- a condition called invasive aspergillosis.

"Despite current treatments, the mortality rates in patients with invasive aspergillosis range from 50 to over 90 percent," the company said in a statement.

It is especially dangerous to cancer patients, organ and bone marrow transplant recipients, and patients with HIV/AIDS, Merck said, adding that Cancidas demonstrated effectiveness among patients who had previously failed to benefit from other therapies. Cancidas, which is given intravenously, is the first member of the new class of antifungals called echinocandins or glucan synthesis inhibitors. They block synthesis of a protein, D-glucan, that is an important component of the fungal cell wall but that is not found in human cells.