Puma Biotechnology Announces Licensing Agreement With Pfizer

Puma Biotechnology, Inc., a development-stage biopharmaceutical company, recently announced an agreement with Pfizer to license the worldwide commercial rights to neratinib, a potent, irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, ErbB1 (EGFR), ErbB2 (HER2), and ErbB4 (HER4) kinases. Neratinib is being studied in the neoadjuvant, adjuvant, and metastatic settings in patients with HER2/ErbB2 positive breast cancer.

Under the terms of the agreement, Puma will assume sole responsibility of global product development and commercialization of neratinib. Pfizer will be entitled to receive payments upon Puma’s achievement of certain development milestones of neratinib, as well as royalty payments for any sales of neratinib.

Puma intends to focus the development of neratinib on the treatment of patients with HER2-positive locally advanced or metastatic breast cancer who have received prior trastuzumab-based therapy. Neratinib has previously been tested in numerous clinical trials both as single agent and in combination with other anticancer drugs in this patient population. In these studies, neratinib demonstrated substantial clinical activity and was well tolerated. Based on the results of these studies, Puma intends to initiate clinical trials in this patient population in the first half of 2012.

Prior to the licensing agreement with Puma, Pfizer had been sponsoring two clinical trials of neratinib: 1) the NEfERTT trial, a Phase II randomized trial of neratinib in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of patients who have not received previous treatment for HER2-positive metastatic breast cancer, and 2) the ExteNET trial, a Phase III study investigating the effects of neratinib after adjuvant trastuzumab in patients with early stage breast cancer. Consistent with Puma’s strategy to refocus clinical development of neratinib in patients with HER2-positive metastatic breast cancer who have received prior lines of trastuzumab-based therapy, Puma intends to stop enrollment of new patients and proceed with winding down both trials.

In addition, Puma announced that it completed a private placement of approximately 14.7 million shares of its common stock to institutional investors that resulted in gross proceeds of approximately $55 million to the company. The shares were issued at a purchase price of $3.75 per share. Leerink Swann LLC acted as sole placement agent for the transaction. Adage Capital Partners, L.P. was the lead investor in this financing, which also included significant participation from Brookside Capital, H&Q Healthcare Investors, H&Q Life Science Investors, Jennison Associates LLC, Orbimed Private Investments IV, and funds managed by T. Rowe Price Associates, Inc., as well as a number of other well-known healthcare institutional investors. Proceeds from the private placement will be used primarily to fund the continued clinical development of neratinib.

In conjunction with the private placement, Puma completed a reverse merger with Innovative Acquisitions, Inc., a public reporting company with no prior business operations. The transaction was completed by the merger of a wholly owned subsidiary of Innovative Acquisitions with Puma that resulted in Puma remaining as the surviving company and a wholly owned operating subsidiary of Innovative Acquisitions. Immediately after the initial merger, Puma was merged directly into Innovative Acquisitions, and this resulted in Innovative Acquisitions surviving. Stockholders of the former Puma (including those that participated in the private placement) received shares of Innovative Acquisitions in exchange for their Puma shares, and the former Puma stockholders now hold 100% of the resulting company’s equity in the same proportion as such stockholders owned immediately following the precedent private placement.

Puma Biotechnology, Inc., is a development-stage biopharmaceutical company that acquires and develops innovative products for the treatment of various forms of cancer. The company focuses on in-licensing drug candidates that are undergoing or have already completed initial clinical testing for the treatment of cancer and then seeks to further develop those drug candidates for commercial use. The company is initially focused on the development of PB-272 (oral neratinib), a potent irreversible tyrosine kinase inhibitor, for the treatment of patients with HER2 positive metastatic breast cancer.