Caligor Opco LLC to Provide Regulatory and Logistical Management
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company,
has initiated an expanded access program (EAP) in the United States to
provide its investigational therapy, PB272 (neratinib), to patients with
HER2-positive breast cancer or HER2-mutated cancers. The program will
provide access to neratinib for the treatment of early stage
HER2-positive breast cancer (extended adjuvant setting), HER2-positive
metastatic breast cancer and HER2-mutated solid tumors. Patients must
not be able to participate in any ongoing neratinib clinical trial to
qualify for Puma’s expanded access program. Puma announced a Managed
Access Program for neratinib outside the United States in the fourth
quarter of 2016.
The U.S. Food and Drug Administration (FDA) permits expanded access to
investigational drugs for treatment use for patients with serious or
immediately life-threatening diseases or conditions who do not otherwise
qualify for participation in a clinical trial and lack satisfactory
therapeutic alternatives.
Caligor Opco LLC, which administers the Managed Access Program for
neratinib, also will manage the U.S. expanded access program by
providing regulatory and logistical support.
“This expanded access program reflects our commitment to make neratinib
available to eligible patients who lack therapeutic treatment options,”
said Alan H. Auerbach, Chief Executive Officer and President of Puma.
“As a specialist firm that focuses on early access to medicines, Caligor
will facilitate access to neratinib for patients who may benefit from
this therapy.”
About the Neratinib Expanded Access Program
The neratinib EAP is a program for U.S. patients with early stage
HER2-positive breast cancer (extended adjuvant setting), HER2-positive
metastatic breast cancer and HER2-mutated solid tumors. This EAP is
being administered on behalf of Puma by Caligor Opco LLC. U.S.
healthcare professionals seeking more information about the neratinib
EAP can email [email protected]
for additional information. Patients who are interested in enrolling in
the neratinib EAP should speak with their physician to determine if
neratinib is an appropriate option. Neratinib is an investigational
agent and, as such, has not been approved by the FDA or any other
regulatory agencies in any markets.
About Caligor
Caligor Opco LLC, a portfolio company of Diversis Capital, LLC, is a
global company that manages the regulatory, logistics and supply chain
needs for global access programs as well as the sourcing, storing and
distribution of comparator drugs for clinical trials. Caligor’s global
access programs help to meet the medical needs of patients worldwide by
providing access to medicines in situations where the drug has not yet
been approved, or is otherwise commercially unavailable. In addition,
through its proprietary TrialAssist™ program, Caligor optimizes its
services by providing for labeling, QP certification, storage,
distribution and destruction of clinical trial and unlicensed medicines
managed in the access programs. The company serves pharmaceutical and
biotechnology companies from facilities in Secaucus, New Jersey and
Dartford, UK, as well as strategically situated depot locations
worldwide. More information is available at http://caligorrx.com.
About Puma Biotechnology
Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on
the development and commercialization of innovative products to enhance
cancer care. The Company in-licenses the global development and
commercialization rights to three drug candidates—PB272 (neratinib
(oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a
potent irreversible tyrosine kinase inhibitor that blocks signal
transduction through the epidermal growth factor receptors, HER1, HER2
and HER4. Currently, the Company is primarily focused on the development
of the oral version of neratinib, and its most advanced drug candidates
are directed at the treatment of HER2-positive breast cancer. The
Company believes that neratinib has clinical application in the
treatment of several other cancers as well, including non-small cell
lung cancer and other tumor types that over-express or have a mutation
in HER2.
Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.
Forward-Looking Statements:
This press release contains forward-looking statements, including
statements regarding the expanded access program for PB272 (neratinib)
for the treatment of early stage HER2-positive breast cancer (extended
adjuvant setting), HER2-positive metastatic breast cancer and
HER2-mutated solid tumors. All forward-looking statements included in
this press release 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, and actual outcomes and results could differ materially
from these statements due to a number of factors, which include, but are
not limited to, the fact that the Company has no product revenue and no
products approved for marketing; the Company’s dependence on PB272,
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;
the Company’s dependence on licensed intellectual property; and the
other risk factors disclosed in the periodic reports filed by the
Company with the Securities and Exchange Commission from time to time,
including the Company’s Annual Report on Form 10-K for the year ended
December 31, 2016. 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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