19:22, Friday 10 December 2010

* Pulmonary arterial hypertension drug withdrawn

* European regulators cite two deaths from liver injury

* Analyst says danger not seen with rival Actelion drug (Adds comment from Morningstar (NASDAQ: MORN – news) analyst)

NEW YORK (Xetra: A0DKRK – news) /BOSTON, Dec 10 (Reuters) – Pfizer Inc isvoluntarily recalling its drug to treat a life-threatening lungcondition and will end studies of the pill after it was linkedto potentially deadly liver toxicity.

The European Medicines Agency on Friday said themodest-selling drug, used to treat pulmonary arterialhypertension, was withdrawn due to “new information on twocases of fatal liver injury.”

Pfizer (PFIZERSL.BO – news) spokesman Curtis Allen said the drug, called Thelin,which is not sold in the United States, was being recalled inEurope (news) , Canada and Australia after being linked to a new liverproblem “that occurs rarely and unpredictably in patients.”

“The decision was based on a review of emerging safetyinformation and post-marketing reporting,” said Allen,referring to reports by doctors that have prescribed it.

Thelin and similar medicines already carry warnings ofelevated liver enzymes, a marker for potential liver damage.But the new liver risk for Thelin now suggests its overallrisks outweigh its potential benefit, Allen said.

Pfizer, the world’s biggest drugmaker, whose chiefexecutive abruptly resigned on Sunday, scrapped U.S. trials ofThelin for pulmonary arterial hypertension. Such patients haveelevated blood pressure in lung arteries and veins that causeshortness of breath and other symptoms, which can lead to heartfailure and early death.

About 1,100 patients have taken Thelin since it waslaunched in Europe in 2006 and in Australia and Canada thefollowing year.

Pfizer in 2008 paid $195 million for the company thatdeveloped the product, Encysive Pharmaceuticals, even thoughthe U.S. Food and Drug Administration had repeatedly rejectedthe drug for lack of efficacy.

Pfizer had been counting on the U.S. trials to ultimatelyprove Thelin’s worth. it is the latest in a long string ofsetbacks for Pfizer, whose labs have not generated anybig-selling drugs for more than a decade.

“It’s another ding in their pipeline, though expectationsfor it (Thelin) had been fairly low,” said Damien Conover, ananalyst at Morningstar. “Had it been approved in the UnitedStates and didn’t have the safety side effect, you could haveseen it just breaking into blockbuster sales at peak.”

Conover said investors are more focused on Pfizer’sso-called JAK inhibitor, an oral treatment for rheumatoidarthritis, and its ALK inhibitor for a subset of patients withlung cancer. Both drugs, if successful in trials, couldgenerate peak annual sales of more than $2 billion, he said.

Pfizer shares were up 1.3 percent to $16.98 in afternoontrade on the new York Stock Exchange. The stock has fallennearly 18 percent from a 52-week high of $20.36 in January.

Thelin garnered sales of $44 million in the first ninemonths of 2010, making it a small product for Pfizer.

it competes with Tracleer, a drug made by Actelion ltd that had sales of $1.4 billion in 2009. Thelin alsocompetes with Letairis, made by Gilead Sciences Inc ,which produced 2009 sales of $184 million.

Thelin, Tracleer and Letairis all block fragments ofendothelin, a protein that causes blood vessels to tighten up.

Deutsche Bank (Xetra: 514000 – news) analyst Richard Parkes said on Friday the newliver problem appears to be specific to Thelin.

“In contrast, Actelion has generated a large database ofsafety, showing that liver enzyme elevations with Tracleer canbe safely managed,” Parkes said in a research report.

Actelion shares rose 1.3 percent, as the recall of Thelineliminated a rival to Tracleer.

Pfizer late last year bought U.S. rival Wyeth (WYETHSL.BO – news) in hopesWyeth’s drugs would bolster Pfizer’s aging array of medicines,including the $11 billion-a-year cholesterol fighter Lipitor,which faces U.S. generic competition in November (Berlin: NBXB.BE – news) 2011.

on Sunday, Pfizer CEO Jeffrey Kindler surprised Wall Streetby announcing he would retire to “recharge his batteries.” Hehanded the company’s reins to Ian Read, head of Pfizer’s globaldrug business. (Reporting by Ransdell Pierson and Toni Clarke; Editing bySteve Orlofsky. Tim Dobbyn and John Wallace)