Release No 21/2010
- Clinical trials with AT001/r84 (anti-VEGF) and AT008 (anti-CCR4) to be
conducted
in Russia
- First step in building a clinical development pipeline of innovative new
antibody products
- Rapid value creation through unique access to Russian and CIS markets
- Generation of lead antibodies to five additional chemokine receptor targets
(G-Protein Coupled Receptors)
- Transition continues from technology company to international
biopharmaceutical
development business
Copenhagen and Oslo, June 30, 2010
Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, today
announced that the Company has commenced preclinical development of two novel
proprietary biopharmaceutical products, AT001/r84 - a highly selective human
antibody to VEGF, and AT008 - a human antibody antagonist of CCR4. Both
products are being developed as new potential treatments for cancer. As part of
Affitech's recent strategic partnership with NTS Plus, initial clinical trials
will be conducted in Russia. If successful, Affitech plans to bring both
products rapidly to market in Russia and the CIS territories through its
alliance with NTS Plus and Pharmstandard. Affitech will also look to
commercialise the products in other territories subject to successful clinical
results and further funding.
Managing Director Martin Welschof said
“Our goal is to build Affitech into an innovative, world class antibody
biopharmaceutical company operating internationally. Our new partnership with
NTS Plus, with its proven access to Russia and the CIS markets, enables us to
initiate human clinical trials in Russia rapidly and generate cost effective but
high quality clinical data within a time frame that would not be possible
elsewhere. Along with other BRIC nations, the Russian pharmaceutical environment
is one of the fastest growing and dynamically emerging pharmaceutical markets.
Our strong relationship with NTS Plus and its experienced Russian development
expertise is likely to benefit Affitech in early revenue generation, patient
safety data, and clinical proof of concept results, substantially reducing the
costs and risks involved before initiating trials in other pharmaceutical
markets such as the EU or US.”
The First Two Products in Affitechs Clinical Development Pipeline
AT001/r84
AT001/r84 is a novel, proprietary human therapeutic antibody to vascular
endothelial growth factor (VEGF) which has recently been shown to have
intriguing effects on immune cells in preclinical models.
Anti- VEGF antibody therapy is a clinically validated approach to cancer
treatment with the currently marketed product (Avastin®) having ‘blockbuster'
status and sales in 2008 of $4.6 billion. Avastin® is projected to be the
leading pharma product by 2014 with $ 9 billion in sales. Avastin® is, however,
not a fully human antibody and has various well documented side effects (e.g. GI
perforation, haemorrhage and wound healing complications; hypertension,
thromboembolic events and proteinuria). AT001/r84 differs from Avastin® in a
number of ways, including being a fully human antibody and binding to VEGF in a
more selective fashion. These properties provide potential for improvement over
Avastin® and in particular, Affitech's AT001/r84 may have a better side effect
profile. Data from the first clinical trials in Russia will allow us to assess
the potential of r84 in additional territories.
AT008/CCR4
AT008/CCR4 is a novel, proprietary therapeutic antibody directed against CCR4,
an important G-protein coupled receptor (GPCR) on the surface of many cancer
cells and cells of the immune system. AT008/CCR4 is expected to have clinical
application in the treatment of T-cell haematological cancers such as
Peripheral T-cell Lymphoma and Adult T-cell Leukaemia/Lymphoma, and is also
being evaluated for its potential as a treatment in certain solid tumours and
other diseases where T cells may play a role such as severe asthma.
Outlook for 2010
Strategic Focus on G-Protein Coupled Receptors (GPCR) Targets
Affitech will continue its focus on the discovery and development of novel
therapeutic human antibodies targeting GPCR molecules. Many of the most
clinically and commercially significant drugs in the pharmaceutical marketplace
target GPCRs. Within the broad family of GPCR targets, Affitech has initially
selected the chemokine receptor sub-group (CKR) and is currently evaluating
anti-CKR antibodies as powerful new therapeutic agents which have been difficult
or intractable by other approaches. The Company intends to generate lead
antibodies to chemokine receptor targets including CCR4, CXCR4 and CXCR3.
Industrialise CBAS™ technology
Affitech has a proven ability to create and patent high quality human antibodies
to disease targets where other companies have failed - in particular to cell
surface targets in their natural state. One of Affitechs immediate objectives is
to “industrialise” its CBAS™ technology processes to a stage where the Company
is able to generate new antibody leads targeting such highly complex cell
surface proteins significantly faster and more predictably than the competitors.
Financial Outlook 2010
The commencement of product development with two potential new medicines and the
success of the Company's CBAS™ technology platform will result in increased
research and development spending in 2010. Affitech estimates total operating
expenses for 2010 to be in the range of DKK 82-88 million and the net loss for
2010 is estimated at DKK 80-86 million. The increase from the more limited
expectations provided in the annual report for 2009 is due primarily to the
increased opportunities of the strategic alliance with NTS Plus. The first
milestone payment from the R&D collaboration agreement with NTS Plus is expected
in 2Q 2011.
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| For more information please contact Affitech A/S: |
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| Martin Welschof, Managing Director | Randi Krogsgaard, Corporate |
| | Communications |
| Tel # +47 95 12 81 37 | Tel # +45 2320 1001 |
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About Affitech
Affitech AS is a publicly traded (NASDAQ OMX Copenhagen) human therapeutic
antibody company headquartered 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.
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.
Affitech Commences Pre-clinical Development of two Novel Antibody Medicines with Initial Clinical Development to be Conducted in Partnership with NTS Plus
| Source: Affitech A/S