December 1, 2009 / 4:45 PM / 8 years ago

UPDATE 1-Teva seeks FDA nod for biosimilar of Amgen drug

* Teva files with FDA for white blood cell booster

* Teva’s XM02 would compete with Amgen’s Neupogen

* Already sold in Europe under TevaGrastim brand

NEW YORK, Dec 1 (Reuters) - Generic drugmaker Teva Pharmaceutical Industries Ltd(TEVA.TA) said on Tuesday it is seeking U.S. approval to market a biotechnology medicine to boost white blood cells that is similar to Amgen Inc’s (AMGN.O) big-selling Neupogen.

The Teva drug, XM02, is already being sold under the brand name TevaGrastim in several European countries, where a pathway for approving generic versions of biotech drugs -- so-called biosimilars -- exists.

There are no such rules yet in place in the United States, so Israel-based Teva submitted a Biologics License Application (BLA) with the U.S. Food and Drug Administration, which treats XM02 as a new biotech medicine.

But the company said its drug was principally developed as a similar biological medicinal product to Neupogen, known chemically as filgrastim.

The Teva drug, like Amgen’s Neupogen, is used to boost white blood cells in cancer patients undergoing some types of chemotherapy that can cause severe neutropenia, or low white blood cell count.

Amgen, which has not yet had to face any generic competition for its medicines in the United States, reported combined worldwide sales of Neupogen and a related medicine Neulasta of $1.21 billion in the third quarter.

Teva said it based its BLA submission on results from a clinical program of five studies with more than 680 patients, including a clinical trial that compared XM02, Neupogen and a placebo.

“We are pleased to complete the BLA submission for XM02, and as a result, mark a U.S. milestone for us as it is our first biologic product,” William Marth, chief executive of Teva’s North American operations, said in a statement.

Teva shares were up 55 cents, or 1 percent, at $53.34 on Nasdaq. Amgen shares were up 37 cents, or 0.7 percent, at $56.71, also on Nasdaq. (Reporting by Bill Berkrot, editing by Gerald E. McCormick) ((bill.berkrot@thomsonreuters.com; +1 646 223-6030; Reuters Messaging: bill.berkrot.reuters.com@reuters.net))

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