UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of
Report (Date of earliest event reported): June 30, 2008
PEREGRINE PHARMACEUTICALS,
INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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0-17085
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95-3698422
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(State
of other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
No.)
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14282
Franklin Avenue, Tustin, California 92780
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(Address
of Principal Executive Offices)
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Registrant’s
telephone number, including area code: (714)
508-6000
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Not
Applicable
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(Former
name or former address, if changed since last
report)
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Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2 below):
o
Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425).
o
Soliciting material pursuant to Rule 14A-12 under the Exchange Act (17
CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR.14d-2(b))
o
Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
Item
1.01 Entry
into a Material Definitive Agreement.
On
June 30, 2008, Peregrine Pharmaceuticals, Inc. (the “Registrant”) entered into a
five-year contract worth up to $44.4 million to test and develop bavituximab and
an equivalent fully human antibody as potential broad-spectrum treatments for
viral hemorrhagic fever infections. The initial contract was awarded through the
Transformational Medical Technologies Initiative (TMTI) of the U.S. Department
of Defense's Defense Threat Reduction Agency (DTRA).
Under the
terms of the contact, DTRA funds are available to cover testing and development
efforts totaling up to $22.3 million over a 24-month base period, with $5
million appropriated immediately for the current federal fiscal year ending
September 30, 2008. The remainder of the $22.3 million in funding is expected to
be appropriated over the remainder of the two-year base period ending June 29,
2010. The contract can be extended by the DTRA beyond the base period to cover
up to $44.4 million in funding over the five-year contract period.
(c) Exhibits. The
following material is filed as an exhibit to this Current Report on Form
8-K:
Exhibit
Number
99.1 Press
Release issued July 1, 2008
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| PEREGRINE PHARMACEUTICALS, INC. | |||
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Date:
July 2, 2008
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By:
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/s/ Paul J. Lytle | |
| Paul J. Lytle | |||
| Chief Financial Officer | |||
EXHIBIT
INDEX
Exhibit
Number Description
0;
99.1 Press
Release issued July 1, 2008
Exhibit
99.1
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Contacts:
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GendeLLindheim
BioCom Partners
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Investors
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Media
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info@peregrineinc.com
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Jennifer
Anderson
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(800)
987-8256
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(212)
918-4642
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PEREGRINE
PHARMACEUTICALS AWARDED DTRA CONTRACT WORTH UP TO $44.4 MILLION TO DEVELOP
BAVITUXIMAB FOR VIRAL HEMORRHAGIC FEVERS
-Five-Year
Defense Threat Reduction Agency Contract Will Support Development of Bavituximab
and Fully Human Equivalent as Potential Broad-Spectrum Anti-Viral
Agents-
TUSTIN, Calif., July 1, 2008 —
Peregrine Pharmaceuticals, Inc. (Nasdaq: PPHM), a clinical stage
biopharmaceutical company developing monoclonal antibodies for the treatment of
cancer and hepatitis C virus (HCV) infection, today announced it has entered
into a five-year contract worth up to $44.4 million to test and develop
bavituximab and an equivalent fully human antibody as potential broad-spectrum
treatments for viral hemorrhagic fever infections. The initial
contract was awarded through the Transformational Medical Technologies
Initiative (TMTI) of the U.S. Department of Defense’s Defense Threat Reduction
Agency (DTRA).
Bavituximab
is Peregrine’s lead anti-phosphatidylserine (anti-PS) monoclonal antibody and is
currently in clinical trials for the treatment of HCV infections and
cancer. In preclinical animal models, bavituximab has demonstrated
encouraging anti-viral activity as a potential treatment for viral hemorrhagic
fevers. Peregrine’s fully human anti-PS antibody, which will also be
assessed under this contract, is currently in preclinical
development.
Under the
terms of the contact, DTRA funds are available to cover testing and development
efforts totaling up to $22.3 million over a 24-month base period, with $5
million appropriated immediately for the current federal fiscal year ending
September 30, 2008. The remainder of the $22.3 million in funding is
expected to be appropriated over the remainder of the two-year base period
ending June 29, 2010. The contract can be extended beyond the base period to
cover up to $44.4 million in funding over the five-year contract
period. Work and funding under this contract are expected to begin
immediately.
“This
substantial five-year contract award is especially timely in view of recent
scientific publications highlighting the broad anti-viral potential of our
anti-PS agents such as bavituximab,” said Steven W. King, president and CEO of
Peregrine. “We are pleased that DTRA has recognized bavituximab’s
safety profile to date and its promising anti-viral activity, which have been
demonstrated in proof of concept models of hemorrhagic fever infection and in
two successful clinical trials in patients with chronic HCV
infection.”
Mr. King
continued, “We welcome the opportunity to contribute to the anti-bioterrorism
mission of the Defense Threat Reduction Agency, and we also believe that some of
the work performed under this contract can be leveraged to support common
development tasks applicable to our ongoing bavituximab clinical programs for
the treatment of HCV and cancer. The non-dilutive capital provided by
this government contract will enable us to further assess the potential of
bavituximab to combat the threat of viral hemorrhagic fevers and to help advance
the overall bavituximab clinical program.”
The DTRA
biodefense contract award has the potential to create long-term value for
Peregrine, including generating future potential revenues from government
stockpiling to combat bioterrorism threats. In the near-term, funding
from this initiative will also allow Peregrine to use data and experience
obtained from the development and scale-up of bavituximab to support its ongoing
clinical development programs.
“We look
forward to a close partnership with the DTRA during the performance of this
program,” said Ronald T. Aimes, Ph.D., associate director of research &
development at Peregrine and principal investigator on the
contract. “This is an exciting opportunity for Peregrine to
contribute to the country’s defenses while also achieving important synergies
with our development programs for bavituximab and our earlier stage anti-PS
technologies.”
About
Bavituximab
Peregrine's monoclonal antibody
bavituximab is the first in a new class of targeted immunotherapeutics that
binds to phosphatidylserine (PS), a specific component of certain cellular
membranes. PS is normally present only on the inside of cell
membranes, but becomes exposed on the external surface of enveloped viruses and
the cells they infect. Enveloped viruses are responsible for about
half of all human viral diseases, including HCV, influenza, HIV, cytomegalovirus
and hemorrhagic fevers. Scientists believe that bavituximab helps
block the ability of viruses to infect cells and also helps stimulate the body's
natural immune defenses to destroy the virus particles and infected
cells. In preclinical studies, bavituximab has demonstrated the
ability to bind to a wide range of enveloped viruses and virally infected cells,
and it has shown promising activity in animal models of serious viral
diseases. In two Phase I monotherapy trials in patients with chronic
HCV infection, bavituximab demonstrated encouraging signs of anti-viral activity
and appeared safe and well tolerated, with no dose-limiting adverse events. A
clinical trial of bavituximab for the treatment of HCV patients co-infected with
HIV is ongoing. Bavituximab is also in multiple Phase II trials for
the treatment of solid cancers.
About
the Defense Threat Reduction Agency
The
Defense Threat Reduction Agency (DTRA) was founded in 1998 to integrate and
focus the capabilities of the Department of Defense that address the weapons of
mass destruction (WMD) threat. The mission of the DTRA is to
safeguard America and its allies from WMD (e.g. chemical, biological,
radiological, nuclear, and high yield explosives) by providing capabilities to
reduce, eliminate, and counter the threat, and mitigate its
effects. Under DTRA, Department of Defense resources, expertise and
capabilities are combined to ensure the United States remains ready and able to
address the present and future WMD threats.
About
Peregrine Pharmaceuticals
Peregrine
Pharmaceuticals, Inc., is a biopharmaceutical company with a portfolio of
innovative product candidates in clinical trials for the treatment of cancer and
hepatitis C virus (HCV) infection. The company is pursuing three
separate clinical programs in cancer and HCV infection with its lead product
candidates bavituximab and Cotara®. Peregrine also has in-house
manufacturing capabilities through its wholly owned subsidiary Avid Bioservices,
Inc. (www.avidbio.com),
which provides development and bio-manufacturing services for both Peregrine and
outside customers. Additional information about Peregrine can be
found at www.peregrineinc.com.
Safe Harbor Statement: Statements in
this press release which are not purely historical, including statements
regarding Peregrine Pharmaceuticals' intentions, hopes, beliefs, expectations,
representations, projections, plans or predictions of the future are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. The forward-looking statements involve risks and
uncertainties including, but not limited to, the risk that the government may
elect not to extend the award beyond the two-year base period and the risk that
the award may not create long-term value for the Company. It is
important to note that the Company's actual results could differ materially from
those in any such forward-looking statements. Factors that could cause actual
results to differ materially include, but are not limited to, uncertainties
associated with completing preclinical and clinical trials for our technologies;
the early stage of product development; the significant costs to develop our
products as all of our products are currently in development, preclinical
studies or clinical trials; obtaining additional financing to support our
operations and the development of our products; obtaining regulatory approval
for our technologies; anticipated timing of regulatory filings and the potential
success in gaining regulatory approval and complying with governmental
regulations applicable to our business. Our business could be affected by a
number of other factors, including the risk factors listed from time to time in
the Company's SEC reports including, but not limited to, the annual report on
Form 10-K for the year ended April 30, 2007 and the quarterly report on Form 10-Q
for the quarter ended January 31, 2008. The Company cautions investors not to
place undue reliance on the forward-looking statements contained in this press
release. Peregrine Pharmaceuticals, Inc. disclaims any obligation, and does not
undertake to update or revise any forward-looking statements in this press
release.
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