Puma Biotech Announces Deal with FDA on SPA for Phase 3 Trial of PB272

Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceuticalcompany, today announced that it has reached agreement with the U.S. Food andDrug Administration (FDA) under a Special Protocol Assessment (SPA) for theplanned Phase III clinical trial of the Company's lead drug candidate PB272(neratinib) in patients with HER2-positive metastatic breast cancer who havefailed two or more prior treatments (third-line disease). The SPA is a writtenagreement between the Company, as the trial's sponsor, and the FDA regardingthe design, endpoints and planned statistical analysis approach of the PhaseIII trial to be used in support of a New Drug Application (NDA) for PB272. TheEuropean Medicines Agency (EMA) has also provided follow-on scientific advice(SA) consistent with that of the FDA regarding the Company's Phase III trialdesign and endpoints to be used and the ability of such design to support thesubmission of a European Union (EU) Market Authorization Application (MAA).Pursuant to the SPA and SA, the Phase III trial will be a randomized trial ofPB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-lineHER2-positive metastatic breast cancer. The trial is expected to enrollapproximately 600 patients who will be randomized (1:1) to receive eitherPB272 plus Xeloda or Tykerb plus Xeloda. The trial will be conducted atapproximately 150 sites in North America, Europe and Asia-Pacific. The agreedupon co-primary endpoints of the trial are progression-free survival andoverall survival. The Company plans to use the progression-free survival datafrom the trial as the basis for submission of an NDA/MAA forAccelerated/Conditional Approval for PB272 from the regulatory agencies. Pumaanticipates that it will begin patient enrollment in this Phase III trial inMarch or April of this year.Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology,said, "Obtaining FDA and EMA agreement on the overall Phase III trial design,and more specifically patient population and primary endpoints, represents animportant milestone in the global development of PB272 and for Puma as acompany. We look forward to initiating patient enrollment in the Phase IIItrial shortly."