2011 Press Releases
Puma Biotechnology Announces Licensing Agreement with Pfizer for the Development and Commercialization of Neratinib, an Investigational PanHER Inhibitor; Closes $55 Million Private Placement and Completes Merger
Los Angeles, CA, October 5, 2011- Puma Biotechnology, Inc., a development stage
biopharmaceutical company, today 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.
Completes $55 Million Private Placement
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 (NYSE:HQH),
H&Q Life Science Investors (NYSE:HQL), 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. ("Innovative Acquisitions"), 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 percent of the resulting
company’s equity in the same proportion as such stockholders owned immediately following the
precedent private placement. Further, the officers and directors of Puma, pre-merger, replaced all
of the officers and directors of Innovative Acquisitions. Subsequently, Innovative Acquisitions
was renamed Puma Biotechnology Inc. The resulting company has adopted and will implement
the pre-merger business plan of Puma and will continue to be a public reporting company.
Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma stated "We are
pleased to be able to complete this licensing agreement with Pfizer for neratinib. To date,
neratinib has demonstrated strong evidence of antitumor activity, both as a single agent and in
combination with other anticancer drugs, in patients with HER2-positive locally advanced or
metastatic breast cancer who have received prior lines of treatment that include trastuzumabbased therapy. We look forward to the continued development of neratinib in this patient
population." Mr. Auerbach further added, "We are additionally pleased to be able to close this
private placement with such a leading group of institutional healthcare investors. We expect the
proceeds from this financing will allow us to move forward expeditiously with the clinical
development of neratinib."
About Puma Biotechnology
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.
Alan H. Auerbach
Puma Biotechnology, Inc.
+1 310 443 4150
Andreas Marathovouniotis or David Schull
+1 212 845 4235
Forward-Looking Statements: This press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from these statements. These risks include, among other things, that the Company has no product revenue and no products approved for marketing, the Company’s dependence on its lead drug candidate, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company's drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company’s products, the Company’s reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates and the Company’s dependence on licensed intellectual property. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.
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Puma Biotechnology, Inc.
10880 Wilshire Blvd., Suite 2150
Los Angeles, CA 90024