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DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER

Affitech A/S reports progress in product and financial results for the first quarter of 2011

26-05-11 kl. 26/5 2011 13:03 | Affitech 0,05 (-44,44%)

Release no. 9/2011

Copenhagen and Oslo, 26th May, 2011, 2011-05-26 15:03 CEST (GLOBE NEWSWIRE) --

-- Net loss for the quarter DKK 22.6 million as expected
-- Maintains expectation of net loss for 2011 (DKK 50‐60 million)
-- Cash reserves of DKK 50.5 million as per 31st March 2011
-- Anti-angiogenesis antibody AT001/r84 completed preclinical toxicology
-- Clinical trial material manufactured for AT001/r84
-- Anti-cancer antibody AT008/CCR4 drug candidates identified and production
cell line being developed
-- European patent granted for CBAS(TM) technology platform
-- US patent granted for multivalent multiple antigen binding antibodies
-- Exclusive license agreement with Cancer Research UK for the use of
anti-CCR4 antibodies in treatment of solid tumors and diagnostic tests
-- Sponsored research agreement with University of Texas Southwestern to
further understand the mechanism and potential differentiation of lead
antibody drug candidate AT001/r84 as an anti-angiogenic compound

Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, today
announced that in the first quarter of 2011 its two most advanced research and
development programs had both made strong progress and that the Company
generated a loss for the period of DKK 22.6 million. Affitech had cash of DKK
50.5 million as of 31st March 2011 and maintains its expectation of a net loss
for 2011 in the range of DKK 50‐60 million.


Martin Welschof, Managing Director of Affitech A/S commented on the interim
report:

“I am pleased to report that in the first part of 2011 the Company continued to
make significant progress. We achieved the goals in our development programs as
planned. AT001/r84 is now close to completion of the pre-clinical program and a
CTA (Cinical Trial Application) is currently in preparation such that clinical
trials can be started in Russia later this year. Preclinical research with our
AT008/CCR4 cancer program is also progressing well, and we will soon be
selecting a drug development candidate. Meanwhile, material revenues from
license fees and milestone payments from the cooperation with NauchTekhStroy
Plus are expected over the remaining quarters of 2011.”



Highlights of the first quarter 2011

-- Fully human antibody AT001/r84, an anti‐angiogenesis development compound,
is in late pre-clinical testing with initial clinical trials planned for
this year
-- Preclinical GLP toxicity studies of AT001/r84 have been successfully
completed at high doses with no significant safety issues reported
-- A Clinical Trial Application for phase I clinical trials with AT001/r84
is in preparation
-- GMP manufacturing of AT001/r84 material to be used in clinical trials
has been completed

-- Affitech's first anti-GPCR antibody program AT008, designed to block the
binding of chemokine ligands to its cell surface receptor CCR4, is in
preclinical pharmacology testing. The program includes several different
antibodies with a multiple potential mechanism of action targeting
hematological cancers, solid tumors, metastatic lesions and regulatory T
cells (in stroma and circulation)
-- Preliminary proof of concept completed
-- Potential development candidates to be confirmed
-- Development of an AT008/CCR4 manufacturing cell line initiated

-- Six other chemokine receptor programs are being profiled in pharmacology

-- Technology patents
-- Affitech's proprietary Cell Based Antibody Selection -
CBAS(TM)technology was granted European patent in January 2011. This
significantly strengthens Affitech's intellectual proprietary position.
CBAS(TM) technology is used to generate antibodies to highly complex
antigens on cell surfaces
-- In January, 2011 Affitech announced a granted US patent for multivalent
multispecific antibodies that covers a specific format of recombinant
antibody and antibody fragments. This format enables the construction of
next generation designer antibodies which allows new approaches for
treatment of cancer and other diseases



Outlook for 2011

During the remainder of 2011, Affitech expects to continue its research and
development programs in line with its objectives of building a pipeline of
novel antibody products in development. At the same time the Company
anticipates receiving significant revenues from its Russian development
partnership and expects the net loss for 2011 to be in the range of DKK 50‐60
million (as announced in the Company's Annual Report for 2010).

During 2011, Affitech expects to make the following progress in its R&D
programs:

-- Complete pre‐clinical development of AT001/r84
-- File a Clinical Trial Application in Russia and commence the first human
clinical trial for AT001/r84
-- Complete pharmacological testing of potential drug candidates in the AT008
program targeting CCR4, to confirm a development candidate and commence
preclinical toxicology testing
-- Continue optimization of the proprietary CBAS(TM) technology platform
through investments in quality control and new equipment and to continue
the process of making new antibody libraries
-- Identify the next target program likely to result in the Company's third
pipeline product candidate

Subsequent Events after the end of the reporting period 31st March, 2011

On 27th April 2011 Affitech announced two collaboration agreements:

-- A license agreement with Cancer Research Technology (CRT), the commercial
arm of Cancer Research UK that grants Affitech exclusive rights to a CRT
patent application and relevant know how to develop and use therapeutic
antibodies that recognize and block the function of CCR4, a protein found
on certain tumors, in therapeutic and diagnostic applications
-- A sponsored research agreement with Dr. Rolf Brekken at the University of
Texas Southwestern to further understand the mechanism and potential
differentiation of Affitech's lead antibody drug candidate AT001/r84 as an
anti-angiogenic compound

The hearing in the court case where a certain group of minority shareholders
have sued the company was completed on 25th March, 2011. The decision of the
Eastern High Court was scheduled to be published on 25th May, 2011 but has been
postponed to 7th June, 2011.


About Affitech

Affitech AS is a publicly traded (NASDAQ OMX Copenhagen) human therapeutic
antibody company based 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. Affitech co-develops its two lead antibody drug
candidates AT001/r84 and AT008/CCR4 with Russian partner NauchTekhStroy Plus.
The Company's initial focus is on rapid and cost effective development by
partnering clinical trials in emerging markets. Further information is
available at www.affitech.com.


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.







Contact:

Randi Krogsgaard, Director IR & Corporate Communications

Tel # +45 2320 1001, e-mail: [email protected]




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