Affitech A/S announced today that its Russian collaboration partner, IBC Generium, has submitted a Clinical Trial Application (CTA) to the Russian Health Authority to commence a phase 1 clinical trial with Affitech’s leading anti­body drug candidate  AT001/r84.  The product candidate is a new patented human mono­clonal antibody to human vascular endothelial growth factor (VEGF), and is being developed as a potential treatment of cancer. The anti-VEGF antibody will be evaluated in patients with various cancers and is a possible competitor to bevacizumab (Avastin® – Roche).  The Phase 1 clinical trial will start as soon as the Russian CTA has been approved.

On November 1st. 2011 Affitech gave a presentation at the biopartnering conference BioEurope in Düsseldorf, Germany.

Please see the presentation.

Affitech gave a presentation at the Biotech in Europe Investor Forum in Zürich, which took place at 13th-14th September 2011. Please see the presentation.

Affitech A/S, (NASDAQ OMX: AFFI), the antibody medicines company, announced today that IBC Generium has exercised the license to Affitech’s lead anti-VEGF antibody drug candidate AT001/r84. The license grant triggered a payment of Euro 2.5 million by IBC Generium to Affitech A/S and provides IBC Generium with the exclusive rights to develop and market AT001/r84 in Russia and CIS while Affitech maintains the rights for the rest of the world. 

Managing Director of Affitech Martin Welschof said: “I am very pleased that our Russian partner has exercised the license for AT001/r84. We have made good progress with our lead antibody candidate and we share with IBC Generium the excitement about the clinical and commercial potential of our human anti-VEGF antibody. IBC Generium is committed to proceed with the development of AT001/r84 and initial clinical development is scheduled this year.” 

Affitech A/S announced today that the Danish High Court has found in its favor in the court case brought by some minority shareholders  which challenged the validity of certain decisions taken by the Company in 2009 and 2010. As expected by Affitech, the High Court rejected all of the plaintiffs’ claims. Affitech was, furthermore, awarded costs in the amount of DKK 500.000.

Report on the Annual General Meeting of Affitech A/S
Copenhagen and Oslo, 28th April, 2011
Affitech A/S, (Nasdaq OMX: AFFI), the antibody medicines company, today announced that the Annual General Meeting of the Company was held on Thursday April 28th in Copenhagen at 10:00 am.

The matters decided at the Annual General Meeting were as follows:
• The Board of Directors presented the Annual Report, this was adopted and the discharge of the board of Directors and the Management board was approved
• The Board of Directors' proposal that losses for the year be carried forward to the following year was approved
• The Board of Directors' motion to authorize the board of directors to acquire own shares was adopted
• The Board of Directors' motion to change the company's currently effective general guidelines for incentive payment for the Board of Directors and executive management of Affitech A/S and remuneration policy was adopted
• Aleksandr Shuster, Andrei Petrov and Keith McCullagh were re-elected to the Board of Directors. Viktor Kharitonin, Pål Rødseth and Arne Handeland resigned, and Steven Morell, Igor Fisch and Yegor S. Vassetzky were elected as new members of the Board of Directors.
•  Ernst & Young  was elected as the Company's state authorized public accountant.
• The chairman of the meeting was authorized to file any resolutions required to be registered with the Commerce and Companies Agency.
 
Following the General Meeting, the newly elected Board of Directors met and elected Aleksandr Shuster as Chairman and Keith McCullagh as Vice Chairman.

Affitech has announced its Financial Statement 2010.

Read the summary here

• In 2010 Affitech achie­ved all goals in the development program for its lead antibody drug candidate AT001/r84 which will enter clinical trials in 2011.
• Affitech generated new GPCR antibodies and now have six different chemokine receptor programs. The Company will select its first GPCR antibody drug candidate in 2011.
• Affitech (the Group) reported a net loss of DKK 71.7 million in 2010, compared to a net loss of DKK 67.9 million in 2009.
• The Group’s balance sheet total at 31^st December, 2010 was DKK 116.9 million. Compared to 2009, the balance sheet is substantially influenced by the new equity financing in the direct offering in April 2010.
• The consolidated net cash flow for 2010 is positive at DKK 78.5 million, compared to negative cash flows of DKK 25.6 million in 2009. Cash flow in 2010 primarily relates to the cash flow from operating activities of DKK -76.5 million and a net amount of DKK 153.1 million from the directed share offering to Trans Nova Investments Ltd. in April, 2010.
• The Company expects total operating expenses excluding royalty costs for 2011 to be in the range of DKK 85-95 million and the net loss to be in the range of DKK 50-60 million.

Please see the full text of the statement in the press release.

The Danish Magazine for Danish Biotech's October issue brings an article on Affitech.

Please see  the article on pages 28-29 in the e-version of the magazine here www.e-pages.dk/scanpub/217