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Teva launches generic Protonix, ups '07 EPS forecast
Mon Dec 24, 2007 8:48am EST

http://www.reuters.com/article/ousiv/idUSL2461155520071224

TEL AVIV (Reuters) - Israel's Teva Pharmaceutical Industries Ltd (TEVA.O: Quote, Profile, Research) TEVA.TA raised its 2007 earnings outlook following the launch of its generic version of Wyeth's (WYE.N: Quote, Profile, Research) ulcer drug Protonix.

Wyeth in response said it will sue Teva for alleged patent infringement on the drug, which Teva said had U.S. sales of $2.5 billion in the 12 months ended September 30, 2007.

Teva, the world's biggest maker of generic drugs, said on Monday it had been awarded a 180-day period of marketing exclusivity for pantoprazole sodium delayed-release tablets, the generic equivalent of Protonix.

Teva said it was increasing its forecast for 2007 fully diluted earnings per share to between $2.34 and $2.36, having previously predicted it would reach the higher end of its forecast range of $2.20 to $2.30.

It said it could not assess the impact of the product on its performance in 2008.

Teva shares were up 3.6 percent in afternoon trade in Tel Aviv and rose 4.4 percent to $47.18 in New York premarket trading.

"In the bottom line, this is great news for Teva at the start of 2008," Yoav Burgan, an analyst at Leader Capital Markets, wrote in a note.

LOST PROFITS

Assuming Teva will share marketing exclusivity with India's Sun Pharmaceuticals (SUN.BO: Quote, Profile, Research) as well as an authorized generics version from Wyeth, pantoprazole could add an estimated $150 million a year in sales for Teva and 10 to 15 cents a share in earnings in the coming six months, Burgan said.

But Wyeth said it will seek to recover its lost profits and other damages and a permanent injunction against future sales of generic pantoprazole prior to expiration of the Protonix patent.

The patent will expire in July 2010, but Wyeth said its marketing exclusivity may be extended until January 2011 as a result of clinical research undertaken by the company regarding the pediatric use of the product.

"We believe our patent is valid and enforceable and that Teva will be required to compensate Wyeth for the substantial damages caused by Teva's violation of our patent rights," Lawrence Stein, Wyeth's general counsel, said in a statement. A trial date has not been set.

Protonix makes up an estimated 10 to 12 percent of Wyeth's earnings.

A U.S. court in September denied a motion by Wyeth and business partner Altana, recently acquired by privately held Nycomed, for a preliminary injunction related to Teva's pantoprazole.

Teva subsequently accelerated launch preparations for the product, which had been granted final approval by the U.S. Food and Drug Administration on August 2.

However Teva and Wyeth/Altana have begun settlement talks and have entered into a standstill agreement under which Teva agreed not to ship additional product for 30 days, Teva said.