Pfizer Inc. is recalling its lung drug Thelin worldwide and halting trials of the medicine after it was linked to potentially life-threatening liver damage.
No new patients should be prescribed Thelin and those receiving it should be transferred to other therapies, Pfizer, based in New York, said in a statement today.
The medicine treats pulmonary hypertension, an incurable condition where there is increased pressure in the arteries of the lungs, causing shortness of breath, according to the National Institutes of Health. It is sold in the European Union, Canada and Australia. It’s not approved in the U.S. The drug generated $44.4 million in the first three quarters of 2010, said Pfizer spokesman Curtis Allen.
“Thelin was not expected to become a major player” because of its safety profile, Brigitte de Lima, an analyst for Bank of America Merrill Lynch, wrote today in a research note.
Pfizer rose 26 cents, or 1.6 percent, to $17.02 at 4 p.m. in New York Stock Exchange composite trading.
Other treatments for pulmonary hypertension include oxygen, Pfizer’s Revatio, calcium channel blockers, which relax the muscles in the wall of the blood vessels, and diuretics, which lower the amount of water in the body, reducing the amount of work the heart has to do, according to the Mayo Clinic.
Pfizer gained Thelin in its $195 million purchase of Encysive Pharmaceuticals Inc. in February 2008.
Patients taking Thelin or participating in studies of the drug should continue using it, and consult their doctor at their next scheduled appointment, the European Medicines Agency said in a statement on its website.
The medicine has been approved for sale in the European Union since 2006, the agency said. The EMA’s Committee for Medicinal Products for Human Use will review Thelin at its monthly meeting Dec. 13-16 and provide detailed advice, according to the statement.
Thelin’s withdrawal is a slight positive for Actelion Ltd.’s competing drug Tracleer, said Richard Parkes, an analyst with Deutsche Bank in London, in a note to clients today.