Biotech Values

[DewDiligence]

Teva Submits BLA for Neupogen Biosimilar

[Unlike such non-glycosylated proteins as insulin and hGH, which are regulated by the FDA as small-molecule drugs, AMGN’s Neupogen is regulated by the FDA as a biologic. Hence, Teva has submitted a full-fledged BLA for its Neupogen knockoff (XM02) that is based entirely on its own dossier of clinical data. In the EU, on the other hand, Teva’s drug has been approved as a biosimilar, based in part on AMGN’s clinical data.

If the US does not create an attractive regulatory pathway for generic biologics, investors should expect to see many more of these kinds of BLA’s.]

http://finance.yahoo.com/news/Teva-Announces-the-Submission-bw-1434647316.html?x=0&.v=1

›Teva Announces the Submission of a Biologics License Application (BLA) for XM02 for the Treatment of Chemotherapy-Induced Neutropenia

8:32 am EST, Tuesday December 1, 2009

JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), today announced the submission of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for XM02, a granulocyte colony-stimulating factor (G-CSF) for the reduction in the duration of severe neutropenia and the incidence of febrile neutropenia in patients treated with established myelosuppressive chemotherapy for cancer. XM02 was principally developed as a similar biological medicinal product to Neupogen®, the trademark for filgrastim (G-CSF). In September 2008, XM02 received marketing authorization in the European Union (EU) where a biosimilars pathway exists. XM02 was launched in several EU markets under the trade name TevaGrastim® and will be launched in additional EU markets over time.

Teva’s BLA submission is based on results from a clinical program consisting of five studies with more than 680 patients. The key study, conducted in breast cancer patients, was a three-arm study of XM02, Neupogen® or placebo in the first cycle of chemotherapy. Two additional clinical trials evaluating safety and efficacy were conducted in lung cancer and Non-Hodgkin’s Lymphoma patients, which compared XM02 and Neupogen during the first cycle of chemotherapy. These studies demonstrated the efficacy of XM02 with regard to the duration of severe neutropenia, incidence of febrile neutropenia and measure of absolute neutrophil count change over time, which now needs to be reviewed by the U.S. Food and Drug Administration.

“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. Our G-CSF product was the first G-CSF biosimilar product approved in Europe and we look forward to working closely with the FDA to bring this important treatment option to the U.S.,” William S. Marth, President and Chief Executive Officer of Teva North America stated. “Teva is dedicated to bringing high quality and affordable biologics to our customers, including a portfolio of additional follow on biologic drugs currently in research and development.”‹