* Teva's biotech drug Neutroval similar to Neupogen
* Teva already selling version in Europe
* Teva up 0.6 pct; Amgen up 0.5 pct
(Adds analyst comment, share prices, byline; previous dateline
By Lewis Krauskopf
NEW YORK, Sept 30 U.S. health regulators on
Thursday delayed approval of Teva Pharmaceutical Industries
Ltd's TEVA.O (TEVA.TA) biotechnology medicine to boost white
blood cells that is similar to Amgen Inc's (AMGN.O) big-selling
The U.S. Food and Drug Administration issued a complete
response letter seeking "several items" related to Teva's drug,
known as Neutroval, as a treatment for cancer patients
undergoing chemotherapy, the Israel-based company said in a
The FDA did not ask for additional clinical trials of the
drug, Teva said. Such clinical studies can often mean lengthy
delays, so analysts viewed the lack of such a request as
positive for Teva. A company spokeswoman declined to comment
beyond the statement.
If the Teva drug were launched commercially in the United
States, it would be the first competitor in the country for
Amgen's Neupogen, which had U.S. sales of $225 million in the
second quarter. Teva has already been selling the drug, also
known as XM02, under the name TevaGrastim in several European
Teva and Amgen are involved in patent litigation over two
Neupogen patents expiring in 2013. Should Teva launch sales of
its drug before settlement of the litigation, it would face the
risk of having to pay damages to Amgen, according to analysts.
"Given the slow uptake in Europe of biosimilars and patent
litigation filed by Amgen against Teva on the product, we
believe expectations were quite contained both in terms of
financial impact and launch timing," Needham & Co analyst
Elliot Wilbur, who covers Teva, said in a research note.
The newly passed U.S. healthcare reform law creates an
approval process for similar versions of pricey biotechnology
medicines. But Teva, which has criticized the new process as
flawed, sought approval for Neutroval before the law passed
under the standard marketing application for brand-name
biotechnology medicines, known as a Biologics License
Although Neupogen remains a significant product for Amgen,
the downside from new competition will be mitigated by the fact
that the company now gets far more revenue from a newer,
longer-lasting version, known as Neulasta, which had $643
million in second-quarter U.S. sales.
Teva is also developing a similar version of Neulasta.
On Nasdaq, Teva was up 0.6 percent at $52.89, and Amgen
rose 0.5 percent to $55.21 at mid-afternoon.
(Reporting by Lewis Krauskopf and Deena Beasley; Editing by
Gerald E. McCormick and Richard Chang)