BioWorld International Correspondent

Brussels - Ablynx, of Ghent, Belgium, aims to start Phase II development of its ALX-0081 anti-thrombotic this year. It has initiated a program to develop a subcutaneous delivery form of the product, and plans to file an investigational new drug application equivalent by year-end.

The product entered Phase I clinical trials in April, and positive final results were reported in December. Chairman and CEO Edwin Moses said, "We are focused in 2008 on driving our lead programs further along the clinical development path, building our pipeline by progressing existing program and adding six to eight new ones." He also said the company would continue to expand in terms of both physical space and headcount.

The announcement came as the company reported its 2007 results, which highlighted the €85.2 million (US$128 million) it raised from its initial public offering when it listed on Euronext Brussels in November - the largest ever biotech IPO on Euronext. Ablynx also reported €126.5 million in cash at year-end, a 150 percent increase in revenues to €9.9 million, and a research and licensing deal worth up to €1.3 billion signed in September 2007 and a collaborative agreement in the area of Alzheimer's disease worth up to €206 million announced in January 2007, both with Boehringer Ingelheim.

In addition, Wyeth confirmed it was extending a research collaboration with Ablynx as part of its $212 million TNF-alpha licensing agreement in December, and the drug discovery and development alliance with Novartis was extended in December for another year.

Research and development expenses increased by 39 percent to €18.8 million, primarily because of a €2.1 million increase in personnel costs as research and development staff increased to 116 as at the end of 2007. Losses decreased to €12.5 million, from €13.2 million in 2006. Cash flow from operating activities represented a net inflow of €3 million, in contrast to a net outflow of €4.8 million in 2006, largely because of the positive impact of the new collaborative agreements in 2007.

Galapagos Earnings Reported

Galapagos of Mechelen, Belgium, has also produced optimistic statements. On Feb. 28, it announced its intention to submit investigational new drug applications for rheumatoid arthritis and bone metastasis programs later this year, with initiation of clinical trials in late 2008 and early 2009. The company also intends to select a pre-clinical candidate in osteoarthritis in 2008.

In a trading update, it also predicted 2007 group revenues exceeding the high end of its earlier guidance of €64 million. Onno van de Stolpe, CEO, reported "excellent progress in our research programs and a substantial increase in revenues." When full results appear on March 7, Galapagos' service division BioFocus DPI is expected to report segment revenues of about €48.5 million, an increase of 39 percent over 2006, and a segment loss of €4.9 million, before exceptional costs. Due to strong cash flow in the second half of 2007, year-end cash balance was €49 million, down €2 million on year end 2006.

During last year, €4.4 million in cash was received through capital increases. Strong cash flow in the second half of the year was related to up-front payments received from Galapagos' alliance partners Janssen Pharmaceutica, GlaxoSmithKline plc, and Eli Lilly and Co., contributing to the €49 million cash balance at year-end. To reduce its cost base and improve efficiencies, BioFocus DPI integrated sites in Cambridge, moved the Heidelberg operations into the Basel site and relocated the Leiden activities.