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. -------------------------------------------------------------------------------- | For more information please contact Affitech A/S: | -------------------------------------------------------------------------------- | Martin Welschof, Managing Director | Randi Krogsgaard, Corporate | | | Communications | | Tel # +47 95 12 81 37 | Tel # +45 2320 1001 | -------------------------------------------------------------------------------- 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