Copenhagen and Oslo, 24th May, 2012, 2012-05-24 18:36 CEST (GLOBE NEWSWIRE) --
- After completion of the voluntary public purchase offer of 28th February, 2012 Trans Nova Investments Ltd. owns 71.3% of the shares in Affitech
- Cash reserves of DKK 13.5 million as per 31st March 2012
- Net loss for the first three months DKK 16.4 million
- Trans Nova Investment Ltd. has committed to support Affitech’s research and development activities until end of first quarter 2013
- Maintain estimated net loss for 2012 of DKK 45-50 million
In addition, the Company reports key events following the end of the first quarter of 2012:
- Approval of Clinical Trial Application (CTA) in Russia for clinical trials with anti-VEGF antibody AT001/r84 – first-in-man trial to start in June 2012
- Resolution at the AGM at 27th April , 2012 to decrease the share capital by writing down the nominal value of the Company's shares
- Resolution at the AGM at 27th April, 2012 to authorize the Board of Directors to increase the share capital of the Company with an amount nominally up to DKK 100 million
- Resolution at the AGM at 27th April, 2012 to apply for delisting of Affitech and the Board of Affitech has initiated the process for an application for delisting of the Company
Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, today reported progress on the main R&D projects and the financial result of the first quarter of 2012. Affitech generated a loss for the first three months of 2012 of DKK 16.4 million and had cash of DKK 13.5 million as of 31th March 2012.
Highlights of the first quarter of 2012
- On 27th January, 2012, Trans Nova Investments Ltd. (Trans Nova) published the results of a voluntary conditional public offer to the shareholders of Affitech A/S made on 21st November, 2011. At the expiry of the offer period, Trans Nova had received valid acceptances in respect of 31.5% of the shares of Affitech which was not sufficient to satisfy the condition for the offer. As a consequence, Trans Nova waived their rights and shareholders, having accepted the offer, were no longer bound by their acceptances.
- On 28th February, 2012, Trans Nova made a second offer for all shares of Affitech against a cash consideration of DKK 0.20 per Affitech share, this time with no condition regarding level of acceptances.
- On 12th March, 2012 Affitech’s Board of Directors recommended the shareholders to accept the voluntary conditional purchase offer from Trans Nova.
- On 30th March, 2012, Trans Nova published the results of the second voluntary conditional public offer to Affitech’s shareholders. At the expiry of the offer period on 27th March, 2012, Trans Nova had received valid acceptances in respect of 152,419,544 shares of Affitech, corresponding to 31.3 % of the Affitech’s share capital. All conditions for the offer were met. Trans Nova decided to complete the offer and the valid acceptances were settled on 4th April, 2012. Trans Nova intends to use its increased influence in Affitech to seek a substantial restructuring of Affitech keeping only essential research activities of Affitech and, if possible, to seek a delisting of Affitech shares from NASDAQ OMX Copenhagen.
- Preparation for a first-in-man trial in Russia with fully human antibody AT001/r84, an anti‐angiogenesis development compound, is ongoing and patient selection is expected to start in June 2012
- The development of Affitech’s first anti-GPCR antibody program AT008, designed to block the binding of chemokine ligands to its cell surface receptor CCR4, is progressing well. A primary development candidate has been selected; in-vitro proof-of-concept has been achieved as well as in-vivo proof of concept in hematological tumor and solid tumor disease models; and further, the development of a manufacturing cell line has been initiated. The program includes several different antibodies with multiple potential mechanisms of action targeting both hematological cancers and solid tumors, and also has potential utility in some immunological diseases such as severe asthma.
Progress with AT001/r84
AT001/r84 is a fully human antibody that binds to vascular endothelial growth factor A (VEGF-A), a drug target validated clinically and commercially by bevacizumab (Avastin®). Bevacizumab is a humanized monoclonal mouse antibody whereas the Affitech product is a fully human antibody with more selective binding site properties than bevacizumab and different binding kinetics to VEGF-A. Higher selectivity and altered affinity offer potential for an increased safety/efficacy profile when compared to the bevacizumab in the treatment of human cancer.
Manufacturing
AT001/r84 is a recombinant human antibody and, under Good Manufacturing Practice (GMP) standards, sufficient quantities of drug substance have been produced to support multiple clinical trials. Drug product in sterile vials has been manufactured, met all required tests under ICH guidelines and released ready for human administration. A new production cell line has been developed that is expected to result in improved production efficiency at larger scales and discussions with contract manufacturing companies to scale up manufacturing are ongoing.
Preclinical development
Pre-clinical testing of AT001/r84, including CMC and toxicology testing to support a clinical trial application (CTA) in most territories, was completed in 2011 and IBC Generium, Affitech’s collaboration partner in Russia, submitted a CTA for a phase I clinical trial in Russia, which was approved in April 2012.
Clinical
The clinical strategy for AT001/r84 is to develop the product for improved treatment of patients with various cancer sub-types known to be susceptible to anti-angiogenesis therapy, such as metastatic colorectal cancer, including co-administration with chemotherapy and other anticancer treatments. The first human clinical study will involve administration of single doses of the antibody to cancer patients to assess human safety and dosage levelling. Affitech’s Russian collaboration partner, IBC Generium, is preparing the initiation of the first clinical trial with AT001/r84 in June 2012. Furthermore, a 3 month exploratory toxicology animal study has been successfully completed to help understand effects of longer term treatment. Currently a 26 week GLP animal study to support multiple dosing is ongoing.
Commercial
The pharmaceutical anti-angiogenesis market is large with world wide sales approaching $15 billion and Roche is predicting peak annual sales of bevacizumab (Avastin®) reaching USD 7.6 billion. AT001/r84 has the potential to have similar efficacy to bevacizumab with an improved safety profile. However, the properties and potential of AT001/r84 have yet to be confirmed through human clinical studies and until such data is available, it is not possible to make meaningful estimates for the probability of achieving marketing approval in different territories nor potential market size or share. Several new anti-angiogenic drugs have recently been approved for human use, while others are in late stage clinical development by a variety of pharmaceutical and biopharmaceutical companies.
Subsequent events after the end of the reporting period 31st March, 2012
- On 17th April, 2012, Affitech announced that the Russian Health Authority had approved the CTA submitted by Affitech’s collaboration partner IBC Generium and that a phase 1 clinical trial with Affitech’s leading antibody drug candidate AT001/r84 should commence in June, 2012.
- On 27th April, 2012 Affitech held its Annual General Meeting (AGM) and Affitech announced that it was resolved to decrease the share capital of the Company by writing down the nominal value of the Company's shares. Furthermore, it was resolved to apply for delisting of the Company. All existing members of the Board of Directors, except Keith McCullagh, who did not stand, were re-elected, and the Board has been constituted with Aleksandr Shuster as Chairman and Yegor S. Vassetzky as Vice-Chairman.
- On 9th May 2012, Affitech announced the completion of the first part of the capital reduction as approved by the AGM in April.
Outlook for 2012
Affitech’s financial performance for 2012 is mainly dependent on the progress and expenses of its ongoing R&D projects. Affitech will focus on the further development of its novel anti-VEGF antibody AT001/r84, in particular on supporting the Company’s Russian strategic partner, IBC Generium, in its drive to conduct clinical trials of the drug in cancer patients.
Trans Nova has confirmed its intentions to use its influence in Affitech to seek a further restructuring of the Company as well as implementing cost reduction measures to allow the Company to operate within its available funds. Trans Nova has started the process of a further capital increase and will seek a delisting of all Affitech shares from NASDAQ QMX Copenhage.
On 31st March, 2012, Trans Nova stated that they are willing to support Affitech’s research and development activities throughout the next 12 months and that they are currently considering different measures in order to do so. Affitech will need financial support in second half of 2012 to fund its operations.
At current staffing levels and project commitments, expected net loss is estimated to be in the range of DKK 45-50 million as announced in the Annual Report 2011.
About Affitech
Affitech A/S 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 programs AT001/r84 and AT008/CCR4 with Russian partner IBC Generium. 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 announcement may contain forward-looking statements including statements about Affitech’s expectations of the progression of its pipeline including the timing for commencement and completion of clinical trials and with respect to cash burn guidance. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Affitech cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors, including, but not limited to, the following: 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: ir@affitech.com
