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PEREGRINE AND AFFITECH TO AMEND LICENSE AGREEMENTS TO EXPEDITE DEVELOPMENT OF NOVEL FULLY HUMAN ANTI-VEGF ANTIBODY AT001/r84

30-09-10 kl. 30/9 2010 10:44 | Affitech 0,05 (-44,44%)

Release no. 32/2010

-- To Amend Terms for Brazil and Russia/CIS Markets to Expedite Clinical
Development of AT001/r84 --
-- Peregrine's Subsidiary Avid Bioservices Secures Biomanufacturing Contract to
Support AT001/r84 Clinical Studies -

TUSTIN, CA, COPENHAGEN and OSLO, September 30, 2010 -- Peregrine
Pharmaceuticals, Inc. (NASDAQ: PPHM), a clinical-stage biopharmaceutical
company, and Affitech A/S (NASDAQ OMX: AFFI), the antibody medicines company,
today announced that the companies have agreed to amend certain terms of their
worldwide license agreements for Brazil, Russia and other countries of the
Commonwealth of Independent States (CIS) to expedite the development of a fully
human antibody called AT001/r84 for these territories.

Under the amended terms, Peregrine and Affitech will reinvest their respective
portions of any future milestone payments to be received under the agreements
for the countries of Brazil, Russia and the CIS toward the further advancement
of AT001/r84. In the event Affitech enters into a licensing deal for AT001/r84
in a major pharmaceutical market, Affitech has agreed to reimburse Peregrine for
its milestone payments that were applied to the program while Affitech will be
eligible to be reimbursed for up to 50% of its development costs in Brazil,
Russia and CIS territories. The remaining terms of the original license
agreements remain unchanged, including milestone and royalty payments.
Additional terms were not disclosed.

In July 2009, Affitech licensed exclusive worldwide rights to develop and
commercialize certain products under Peregrine's anti-VEGF (Vascular Endothelial
Growth Factor) antibody technology platform, including the fully human antibody
AT001/r84, a selective blocker of VEGF binding to VEGF receptor 2 (VEGFR2).
AT001/r84 was discovered by Affitech and jointly developed by the companies
under an ongoing collaboration. As part of Affitech's recent strategic
partnership with NauchTekhStroy Plus (NTS Plus), initial clinical trials will be
conducted in Russia. If successful, Affitech plans to market the product in
Russia and the CIS territories through its alliance with NTS Plus and in other
territories, subject to successful clinical results and further funding.

“We believe our long-term relationship with Peregrine has enabled us to
restructure a deal that is mutually beneficial by enabling us to speed up the
development of AT001/r84 by partnering with NTS Plus in Russia and the CIS
countries,” said Martin Welschof, Managing Director of Affitech. “With funding
provided by NTS Plus, we will accelerate our goal of developing a selective
anti-angiogenesis antibody for these growing markets.  We believe expediting the
development of AT001/r84 in the exciting emerging pharmaceutical markets of
Russia and eventually Brazil will dramatically increase the value of this
program for Affitech, Peregrine, and a potential global pharmaceutical partner.”

Separately, Peregrine's wholly-owned biomanufacturing subsidiary Avid
Bioservices has secured a biomanufacturing contract to supply clinical material
to Affitech over the coming year. The initial contract for committed services
provides for several large-scale cGMP manufacturing runs as well as other
cGMP-related services.

“By initially focusing on markets that offer the potential for expedited
development, we expect Affitech to more rapidly increase the value of our
collaboration and the probability of success for this program,” said Steven W.
King, president and chief executive officer of Peregrine Pharmaceuticals. “We
look forward to seeing Affitech advance the development of AT001/r84 to realize
the potential value of our anti-VEGF platform technology, while benefiting
near-term from this new biomanufacturing contract.”

Additionally, Peregrine and Affitech have agreed to modify the terms under their
research collaboration agreement to eliminate Affitech's future obligations for
the development of new antibody targets, in exchange for reduced future license
fees, milestone payments and royalty obligations due from Peregrine for existing
antibody targets. The collaboration has generated several fully human
antibodies, including AT001/r84; PGN 635, an antibody being evaluated as part of
Peregrine's government contract; and other antibodies in preclinical evaluation
for the treatment of a broad range of cancer and infectious diseases
indications.

About AT001/r84
AT001/r84 is a fully human, selective therapeutic antibody to vascular
endothelial growth factor (VEGF) and has demonstrated encouraging effects on
immune cells in preclinical models. Anti-VEGF antibody therapy is a clinically
and commercially validated approach to treating cancer and the leading marketed
anti-VEGF product is Avastin®, which generated global sales of $6.3 billion USD
in 2009.

AT001/r84 has demonstrated potent anti-tumor activity with limited induction of
side effects in mice studies
- Fully human antibody AT001/r84 binds human and mouse Vascular Endothelial
Growth Factor (VEGF) and selectively blocks VEGF from interacting with VEGF
receptor 2
- AT001/r84 has potent anti-tumor activity that is comparable to bevacizumab
(Avastin) or sunitinib (Stuent®) and shows no significant side effects after
chronic high dose therapy in mice
- AT001/r84's ability to bind to and block VEGF receptor 2 provides a valuable
tool for characterizing tumor progression driven by VEGF receptor pathway and
highlights the utility and potential safety of more selective blocking of VEGF
induced VEGF receptor 2 signaling in anti-tumor therapy

Source: r84, a novel therapeutic antibody against mouse and human VEGF with
potent anti-tumour activity and limited toxicity induction, L. Sullivan et al.,
Public Library of Science (PLoS ONE). August 6, 2010.

AT001/r84 limits the emergence of immunosuppression in preclinical cancer
models
- AT001/r84 demonstrates equivalent efficacy to bevacizumab (Avastin) and
sunitinib (Sutent) in a preclinical model of cancer
- AT001/r84 limits emergence of immunosuppression in three preclinical models
of cancer

Source: Cytokine Levels Correlate with Immune Cell Infiltration after Anti-VEGF
Therapy in Preclinical Mouse Models of Breast Cancer, CL Roland et al., Public
Library of Science (PLoS ONE). November 3, 2009.

About Peregrine Pharmaceuticals
Peregrine Pharmaceuticals, Inc. is a biopharmaceutical company with a portfolio
of innovative monoclonal antibodies in clinical trials for the treatment of
cancer and serious viral infections. The company is pursuing multiple clinical
programs in cancer and hepatitis C virus infection with its lead product
candidate bavituximab and novel brain cancer agent Cotara(R). Peregrine also has
in-house cGMP manufacturing capabilities through its wholly-owned subsidiary
Avid Bioservices, Inc. (www.avidbio.com), which provides development and
biomanufacturing services for both Peregrine and outside customers. Additional
information about Peregrine can be found at www.peregrineinc.com.

About Affitech
Affitech AS is a publicly traded human therapeutic antibody company located in
Copenhagen, Denmark with R&D facilities in Oslo, Norway. The company utilizes a
range of proprietary antibody technologies for the discovery of fully human
antibodies for application in oncology, inflammation and other disease areas.
CBAS™ (Cell Based Antibody Selection) is Affitech's premier discovery engine for
the isolation of lead antibodies to cell surface molecules in situ. Several of
the Company's proprietary product candidates were generated by CBAS™. Further
information is available at www.affitech.com.

Peregrine's 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 results of future studies
may not be consistent with the results from the preclinical models, the risk
that Affitech and Peregrine may not be able to expedite the development of
AT001/r84 in a major pharmaceutical market, the risk that milestones may not be
achieved under this program, and the risk that initial clinical trials in Russia
may not be successful and the risk that Affitech may not be successful in
commercializing AT001/r84 in any territories. 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, 2010 and quarterly report on Form 10-Q for the quarter ended July 31,
2010. 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.

Affitech's Safe Harbor Statement (disclaimer)
This news release contains
forward-looking statements and forecasts based on uncertainty, since they relate
to events and depend on circumstances that will occur in the future and which,
by their nature, will have an impact on results of the financial condition and
operations of Affitech A/S. There are many factors that could cause actual
results and developments to differ materially from those expressed or implied by
these forward-looking statements and forecasts. These factors include, among
other things, risks associated with technological development, the risk that
research & development will not yield new products that achieve commercial
success, the impact of competition, the ability to transact viable and
profitable commercial deals, the risk of non-approval of patents not yet
granted, and difficulties of obtaining relevant governmental approvals for new
products.
No expressed or implied representations or warranties are given concerning
Affitech A/S or the accuracy or completeness of the information provided herein,
and no claims shall be made by the recipient of this news release by virtue of
the information contained herein.

Peregrine Contact:
Amy Figueroa
Peregrine Pharmaceuticals
+1(800)987-8256
[email protected]

Affitech Contact:
Randi Krogsgaard
Affitech A/S
+45 2320 1001
[email protected]




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