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.
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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