Biotech companies generally are admired for their research capabilities but perhaps not so much for their business sense says Onno van de Stolpe, founder and CEO of Galapagos NV, the Euronext listed drug discovery and development company. He explains that Galapagos takes a realistic approach; outlicensing its platform technology to third parties gives them the financial basis from which they can finance the advancement of their own pipeline. The company has entered into long term alliances for the majority of its research programs with top ten pharma companies. Mr. van de Stolpe studied at the Agricultural University in Wageningen when he started to develop an interest in biotech, which was further boosted during an internship at Biogen, one of the first biotech start-ups in the US. He started his professional career as a business development director at MOGEN, in Leiden, the Netherlands, and subsequently worked for the Dutch government in the US, recruiting biotech and medical device companies to locate in the Netherlands. Upon his return to the Netherlands, he joined Introgen (now Crucell) as Managing Director of Genomics. From there he established Galapagos in 1998. Galapagos, he explains, initially operated as a Crucell and Tibotec joint venture and was financed by those two. Historic company milestones in his view include the closing of their first (and only) VC financing round, in 2002, and their listing on Euronext, in 2005. The latter raised 22 million and generated the resources for the 2006 acquisition of Inpharmatica, and, in the same year, of ProSkelia, the French subsidiary of UK-based ProStrakan. Another highlight in 2006 was Galapagos entering into the first of a number of alliances with major pharmaceutical companies, notably including GlaxoSmithKline and Janssen Pharmaceutica. For Mr. van de Stolpe personally, however, the main highlight in Galapagos' development so far is the fact that they have successfully completed their first-in-human trial, of the novel candidate drug GLPG0259 for rheumatoid arthritis (RA), this year. "That was just a great moment for us," he adds. "Seeing a drug candidate through the preclinical stage and then being able to test it in humans is wonderful." GLPG0259 is a novel mechanism-ofaction inhibitor of the protein kinase MAPKAPK5, which was discovered through Galapagos' target discovery platform and which represents a new approach for the treatment of RA. "We can't afford to take this to the commercial stage," Mr. van de Stolpe points out. "This is typically a product that requires the development, marketing and distribution resources of a large pharma. That's why we've signed an option agreement with Janssen Pharmaceutica. If the phase I and II trials go to plan, Janssen has the exclusive option to license the program for Euro 60 million, with further potential milestones to Galapagos of Euro 776 million and double-digit royalties on global sales. We've so far tested the product on healthy volunteers, mostly looking at side effects. The next stage is to test it on actual RA patients." In the bone and joint diseases Galapagos has one of the largest discovery programs in the world. In the osteoarthritis and antiinfectives program, the company has partnered with GSK, and for the osteoporosis program with Eli Lilly. A key differentiator for Galapagos, Mr. van de Stolpe adds, is their technology platform. "We're very good at drug development but we're not unique in that. Finding targets is our specialisation." This patented technology platform offers a biologically-focused discovery technology that enables the identification of novel targets based on their function in specific diseases. Galapagos uses engineered adenoviruses to stop the production of specific human proteins in a human cell. These primary cells are used in an assay that mimic the disease of interest. By removing one by one a specific protein from the cell through the adenovirus, Galapagos studies the role of that protein in the disease. This way, it can rapidly identify and validate diseasemodifying drug targets. Once a target has been selected, its focused smallmolecule collections can be applied to generate 'hits' – molecules with drug-like properties and activities. These hits can then be further optimised through Galapagos' expertise in medicinal chemistry and ADMET. "From the start we've made use of this technology that allows us to quickly insert a piece of human DNA into a human cell, through the common cold virus that acts as courier," Mr. van de Stolpe adds. "The inserted DNA triggers the cell to produce a specific protein that is then analysed if it plays a role in a specific disease. But that's just the first step in the technological process and we've since advanced the technology. The second step is to shut down the protein that's causing the disease. So we're basically identifying what protein can form the starting point for the development of new medicine. We're currently developing a drug for diabetes, a condition where not enough insulin is produced, for example. In our research we're taking beta cells from the pancreas of deceased people. We use our technology to shut down specific protein, to find out if that results in insulin production going up." Pharmaceutical companies and academic institutions have shown an interest in Galapagos' platform technology from the start, and the company continues to generate revenues from partnering. This gives them a solid financial position, allowing for the advancement of their own portfolio. "The pharmaceutical companies that we partner our technology to essentially finances our own research," Mr. van de Stolpe adds. He explains that they've always had this rational, business-like approach. "When you're based in California where investors throw lots of money at biotech companies, it might not be that important to think about generating revenues from the start. But we're listed on the Euronext in the Netherlands, which places us in a different position and which has forced us to adopt a business model that is not typical of a biotech company. " Galapagos continues to form alliances and partnerships, just recently with Charley's Fund Inc. and the Nash Avery Foundation. The three companies announced that they will collaborate to investigate the potential effectiveness of Galapagos' SARM candidate drug, G100192, in treating Duchenne muscular dystrophy. G100192 is an orally-available small molecule therapeutic, which has demonstrated successful Proof of Concept in pre-clinical studies for cachexia (the loss of weight and muscle mass that AIDS patients notably suffer from). Galapagos also continues its partnership with Morphosys in the field of antibodies. "At Galapagos we focus uniquely on small molecules, in other words pills and tablets," Mr. van de Stolpe comments. "But for certain indications, antibodies are better suited. As that's not our area of specialisation, we have partnered with Morphosys."Galapagos last month issued 10% new shares to institutional investors and raised €18.5 million. Mr. van de Stolpe seems confident that their alliances with some of the top names in the pharmaceutical world will continue to assure the company's financial future, whereby the company is no longer dependent on the financial markets for continuation of its research programs. top - home