Biotech Values

[DewDiligence]

PFE to Submit Bosutinib MAA/BLA in 1st- and 2nd/3rd-Line CML in 2011

[The first-line submission is planned for the EU and the 2nd/3rd-line submission is planned for the FDA. Thus, there could soon be *three* approved drugs in each of the CML treatment lines, although the T315i mutation remains un unmet need.]

http://finance.yahoo.com/news/Pfizer-Plans-Regulatory-prnews-1520686916.html?x=0&.v=1

›Friday December 3, 2010, 5:01 pm EST

NEW YORK, Dec. 3, 2010 /PRNewswire/ -- Pfizer Inc. (NYSE:PFE) announced today it is planning regulatory submissions of bosutinib in patients with chronic myeloid leukemia (CML) based on data from a clinical program evaluating the compound in newly diagnosed and previously treated patients. These regulatory submissions are planned for 2011.

Pfizer has begun the process of preparing a Marketing Authorization Application (MAA) for submission to the European Medicine Agency (EMA) for bosutinib as a treatment option for patients with newly diagnosed Philadelphia chromosome positive (Ph+) CML. The submission will be based on the results of the ongoing, Phase 3, randomized, open-label study of bosutinib versus imatinib in newly diagnosed patients with chronic phase Ph+ CML, called the BELA (Bosutinib Efficacy and safety in chronic myeloid LeukemiA) study.(1)

The Company has also had discussions with the United States (U.S.) Food and Drug Administration (FDA) regarding a possible regulatory submission for the use of bosutinib in the treatment of previously treated Ph+ CML patients. This submission would be based on the pending 24-month efficacy and safety data in the primary cohort of Study 200, which consists of more than 200 previously treated CML patients. Study 200 is a single arm study of bosutinib in over 500 patients with previously treated Ph+ CML, including patients resistant or intolerant to imatinib as well as patients who have become refractory to dasatinib or nilotinib. Currently, there are no approved therapies available for CML patients who fail dasatinib or nilotinib in second line.

"We are excited about the potential opportunities to bring bosutinib to market for patients with CML given the need for options in this patient population," said Garry Nicholson, president and general manager of the Pfizer Oncology business unit. "Our ongoing analysis of the bosutinib clinical development program reinforces our belief that bosutinib may provide benefit for patients living with CML, and we are working closely with health authorities and other experts toward our goal of making this promising compound available to patients who need it."

Further details of the BELA study and Study 200 will be presented at the upcoming 52nd Annual Meeting of the American Society of Hematology (ASH) (Abstract #208,(1) December 6 and Abstract #892,(2) December 7, respectively).

About Bosutinib

Bosutinib is an investigational oral dual Src and Abl kinase inhibitor.(1) It is believed that by dual inhibition of the Src and Abl tyrosine kinases, bosutinib may inhibit signaling in CML cells that allows the cells to grow, survive and reproduce.‹