09.07.12, 10:26–US drug regulators gave the nod to a Teva Pharmaceutical Industries drug that boosts the production of infection-fighting white blood cells in certain cancer patients receiving chemotherapy.
Teva’s medicine is in many ways a copy of Amgen Inc’s biologic drug Neupogen, which faces the expiration of its US patent next year.
In an a settlement of patent litigation, Teva agreed last year to refrain from launching its versions of Neupogen and Neulasta, Amgen’s longer-lasting white blood cell booster, in the United States until November 2013.
“While approval at this time is somewhat unexpected, we note the two drugs are not substitutable, and it will require a launch ramp and extensive marketing efforts by Teva to gain share,” RBC Capital Markets analyst Michael Yee said in a research note.
Amgen’s US sales of Neupogen were $959 million last year, while sales of Neulasta were $3 billion.
Teva already sells its version of Neupogen, or filgrastim, in the European Union, where Yee said it accounts for about 5% of the overall market.
The agency said Teva’s drug, called tbo-filgrastim, stimulates bone marrow to increase production of white blood cells, which may help cancer patients recover more quickly from the side effects of chemotherapy.
The Israel-based generic drug maker gained its approval under a standard US Food and Drug Administration review…Read More>>