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May 1, 2010 (Vol. 30, No. 9)

Hungary Bids for Prime Spot in EU Biotech

Country Ranks First in Development Capacity Index for Central and Eastern Europe

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    AMRI Hungary serves as the center of AMRI's European operations and provides discovery services. It is fully integrated with AMRI's locations in the United States and Asia.

    AMRI focuses on drug discovery, development, and manufacturing of active ingredients and pharmaceutical intermediates for healthcare companies. Headquartered in Albany, NY, with facilities in India, Singapore, and the U.K., AMRI became established in Hungary through its purchase of ComGenex. The company recently opened a new 32,300 sq. ft. chemistry R&D facility in Budapest, with a scale-up lab for non-GMP synthesis up to 25 L capacity.

    The development meets the company’s planned expansion in synthetic chemistry services and underpins its presence in the European marketplace. It will now offer more parallel synthesis and specialized medicinal chemistry, including fragment-based discovery services. “Increasingly, we are becoming  a collaborative partner to our customers,” observes Gergely Makara, Ph.D., managing director of AMRI’s Hungarian operations.

    Part of the income from the ComGenex sale went to set up ThalesNano, which specializes in development of microreactors, lab-on-a-chip, and flow chemistry. The company has built a market in flow chemistry and continuous processing. By 2008, the top 20 big pharmas, the top three fine chemical companies, and the top three agrochemical companies had adopted ThalesNano’s technology, the firm reports.

    Its first product was the H-Cube™ continuous-flow hydrogenation reactor. H-Cube is used in hundreds of labs and generated U.S./Europe revenues of $3.3 million in 2008, says CEO László Ürge, Ph.D. Customers include AstraZeneca, GSK, Takeda, Roche, BASF, Novartis, Boston University, Cambridge University, and Imperial College, London.

    “We have the most comprehensive benchtop continuous process technology and instrument portfolio with 70% market share,” says Dr. Ürge. “This technology solves R&D bottlenecks because transfer of a method to large scale is very fast.” He believes that these systems increase the productivity of researchers 50-fold and represent a good alternative to outsourcing chemistry to India or China. Continuous processing is also carbon neutral, he says, and it is safer than conventional approaches, and fulfills FDA PAT requirements.

    ThalesNano works closely with NanGenex, which specializes in nanoformulation. The company’s NanoActive™ technology reportedly enhances the solubility and bioavailability of active ingredients through creation of nanoparticles. With 90% of NMEs being poorly soluble, NanoActive can turn them into effective nanodrugs, and therefore, decrease dosage and side effects, the firm claims. The technology is also applicable in agriculture, and the company has deals with two major agrochemical companies.

    “If we are successful, we could rewrite the way we use these poisons in the environment,” says CEO Gábor Heltovics. He also envisions the technology being used in fragrances and foods. “It increases the opportunity space by increasing solubility without inventing a new active.” In one case, the solubility of a marketed drug could be increased from 0.0035 mg/mL to 27.6 mg/mL. NanGenex is exploiting the technology through a number of programs, including NanoLead™, NanoRescue™, and NanoReform™, which can help to extend expired patents with new formulations or rescue failed compounds by improving their properties.

    Also in Budapest is N-Gene, a New York-headquartered drug discovery and development company formed by Hungarians in 1997. N-Gene’s lead compound, BGP-15, a small molecule to treat insulin resistance, is in Phase IIb for type 2 diabetes and in Phase I for schizophrenia-induced metabolic disorder.

    Vichem has a kinase platform which provides discovery services, including a unique library of more than 12,000 kinase inhibitors (the Nested Chemical Library™). Partners select a kinase target, and Vichem delivers a lead compound. The firm is involved in lead/preclinical programs in TB, influenza, AIDS, and cancer. KinaTor™ is another Vichem platform, which is a chemoproteomic technology for selectivity profiling of kinase inhibitors.

    Meanwhile, ChemAxon offers chemical software development for drug discovery. “Pharmaceutical companies have millions of compounds in their databases. We provide all the tool kits you would need to manage them,” explains CEO Alex Drijver. “We also provide tools for drug design itself—that is, building virtual libraries and screening virtually.”

    ChemAxon’s market share has been rising rapidly, with revenue doubling in the last year, according to Drijver. Several big pharmas, including Pfizer, are customers. “The platform integrates well into customers’ architecture,” Drijver observes. “It also enables a search of the patent literature from the desktop, which saves time and money.”

    Hungary is a good location for clinical trials, so HungaroTrial, a CRO for Phases I to IV, is doing well. It has been profitable from the start and has carried out 63 clinical trials in CEE countries, CEO Lajos Sarosi, M.D., says. It is also developing business in the U.S. and counts Roche, GSK, Wyeth, and Sanofi-Aventis among its customers. It will soon start work in Ukraine, Kazakhstan, and Russia. “These countries are to play a significant role in clinical research,” predicts Dr. Sarosi.

    Finally, Solvo Biotechnology is one of Hungary’s most established biotechs. Berend Oosterhuis, business development director, explained that Solvo is focused on the phenomena behind drug absorption and excretion that often cause drug-drug interactions. “We deal with transporter proteins, which are a hot topic now,” he notes.

    Hungarian biotech companies largely generate revenues by offering services. “This financing model is better than having government throw money at drug discovery,” says Duda. “Local VCs do not have sufficient experience and want a lead investor. They see that, apart from ComGenex, there is a lack of successful exits in the region. But the first VC to set up a $100 million fund here will make a lot of money.”

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