• American Oriental Bioengineering Inc., of Hong Kong, signed a legally binding letter of intent to acquire Heilongjiang Songhuajiang Pharmaceutical Ltd., a Chinese state-owned pharmaceutical company located in Heilongjiang province. Heilongjiang, which employs about 500 people, has a line of antiviral products. American Oriental said it expects the acquisition to add about $6 million in revenue annually and roughly $15 million in net assets.

• AOP Orphan Pharmaceuticals AG, of Vienna, Austria, entered a licensing and commercialization agreement for the European development of Moli1901, an investigational treatment for cystic fibrosis from Lantibio Inc., of Chapel Hill, N.C. AOP, which is planning to begin Phase II trials in Germany, will assume full responsibility for the clinical and nonclinical development in Europe. Lantibio will be responsible for technical development activities to support regulatory filings in the European Union, and will have access to resulting European data to support regulatory filings in the U.S. Terms include undisclosed up-front and milestone payments to Lantibio, as well as royalties on Moli1901's eventual European sales.

• Cellectis SA, of Paris, signed a license agreement granting four German academic research centers nonexclusive licenses under its patent family covering a process for the specific replacement or insertion of a gene in a eukaryotic genome by homologous recombination. The agreement gives the institutions a sublicense under the patents for internal scientific research and the commercialization of materials resulting from such research, such as mice models and transgenic services for industry and academia. Financial terms and conditions were not disclosed. The deal was brokered by Ascenion GmbH, of Munich, Germany, a life science intellectual property-asset management company acting on behalf of the four research establishments. The four research centers are the German Research Center for Biotechnology, the National Research Center for Environment and Health, Max Delbrück Center for Molecular Medicine Berlin-Buch and the German Cancer Research Center.

• CeNeS Pharmaceuticals plc, of Cambridge, UK, said Addex Pharmaceuticals SA, of Geneva, is to commence a Phase II U.S. smoking cessation trial of CeNeS's dopamine D1 selective antagonist. The license to Addex entitles CeNeS to milestone and royalty payments of up to $4.5 million over several years.

• Ernst & Young's 2004 report on biotechnology in Germany showed that Munich led the sector in number of companies, employees and compounds in the development pipeline. Regarding companies, Munich topped Berlin-Brandenburg, its closest competitor, 63 to 50. But those 63 firms had more than twice as many compounds in development, with 65, compared to 30 for Berlin companies. On the whole, the German biotech sector had lower revenues in 2004 compared with the previous year (€960 million in 2003 against €1 billion in 2002). Investments in research and development also fell, dropping from about €1.1 billion to €966 million.

• Gamida-Cell Ltd., of Jerusalem, said preclinical studies show that an injection of an expanded population of cord blood-derived AC133 cells directly into the pancreas of mice reversed diabetes. More specifically, the data demonstrated that the expanded population of stem cells helped to restore normal blood glucose levels, as well as the ability to maintain a stable blood sugar level. The expression of the human C peptide, the marker for the production of insulin, also appeared.

• Genmab A/S, of Copenhagen, Denmark, said that HuMax-CD4 for the treatment of cutaneous T-cell lymphoma (CTCL) was designated an orphan drug by the European Agency for the Evaluation of Medicinal Products. Filing for the status was completed as part of an overall plan to obtain orphan drug protection to treat CTCL. At present, Genmab's primary rights for HuMax-CD4 are in North and South America. Genmab does not hold rights to the drug in Europe.

A national Human Embryonic Stem Cell Resource Centre was formed at Sheffield University in the UK to provide researchers with access to expertise, facilities and training related to stem cell research. Funding is part of a new £16.5 million (US$31.1 million) investment in stem cell research announced last week, under which 57 research grants were awarded.

• Innogenetics NV, of Ghent, Belgium, entered an agreement to gain access to a microarray technology platform from PamGene International BV, of s-Hertogenbosch, the Netherlands, for the development of next-generation nucleic acid and protein-based tests. The exclusive license covers the PamStation 12 instrumentation in areas in which Innogenetics is active - infectious diseases, genetic testing and neurodegeneration - with an optional extension for applications in oncology. The agreement includes an up-front payment, staged development milestone fees as new tests reach the market and royalties.

• Microsens Ltd., of London, developed a technology called Seprion to directly identify abnormal prion proteins that could form the basis of a diagnostic test for Creutzfeldt-Jakob disease and for screening blood donations. Microsens said its test is sensitive enough to detect abnormal prions in infected animals that are presymptomatic.

• Mologen AG, of Berlin, named Gregor Kunz and Hans Lutz to its supervisory board. Kunz is an accountant and tax adviser, and a partner with Dr. Roever & Partner KG, of Berlin. Lutz is a professor of internal medicine at the University of Zurich and also director of the university's veterinary lab.

• NeuroSearch A/S, of Ballerup, Denmark, said it completed enrollment in a Phase II study of NS2359 for attention deficit hyperactivity disorder. The trial includes 126 adult patients, with half treated with 0.5 mg of the compound once a day and the other half getting placebo. The U.S.-based study is expected to be completed this fall. NS2359 is part of an alliance with GlaxoSmithKline plc, of London, which will conduct additional clinical studies this year.

• Opperbas Holding BV, of Amsterdam, the Netherlands, is conducting a Phase II trial of its PEGylated liposomes to prolong the half-life and hemostatic efficacy of recombinant Factor VIII, a protein used to treat hemophilia A. The delivery technology showed encouraging results in a Phase I/II trial completed last year. Opperbas technology has the potential of reducing the number of infusions to a third of what is currently used, while retaining clinical efficacy. It might lead to improved convenience for patients, enabling them to prevent bleeding episodes. The company plans to out-license the first indication to a pharmaceutical company and to further develop its technology in other indications.

• Oxford BioMedica plc, of Oxford, UK, announced the results of a preclinical study of MoNuDin in amyotrophic lateral sclerosis (ALS). MoNuDin uses Oxford's LentiVector system to deliver a vascular endothelial growth factor gene. The research, in collaboration with the Flanders Interuniversity Institute for Biotechnology in Leuven, Belgium, showed that MoNuDin delayed onset and slowed progression of the disease in a mouse model of ALS, leading to a 30 percent increase in life expectancy.

• Protherics plc, of Runcorn, UK, is now profitable, recording its first full-year profit for the 12 months leading up to March 31. The company made a pre-tax profit of £800,000 (US$1.5 million), compared to a loss of £600,000 for the previous year on turnover up from £11.3 million to £21 million.

• responsif GmbH, of Erlangen, Germany, began the first clinical trials of an immunotherapy it has developed for renal-cell carcinoma. The new therapeutic concept, which is made of tumor cells collected from patients during routine operations, is designed to activate a body's endogenous immune defenses against tumor cells via immunization. After being harvested, the collected tumor cells are first inactivated, deep frozen and kept in cold storage. Shortly before treatment, the cells will be coated with an immunostimulating protein called Annexin V, and subsequently injected subcutaneously.

• Sanofi-Synthelabo SA, of Paris, said the expiration date of its U.S. offer for Aventis SA, of Strasbourg, France, was extended to June 30. Holders of Aventis securities eligible to participate in the U.S. offer may tender, or withdraw their tendered, Aventis securities at any time until then.

• Serono SA, of Geneva, said its board authorized the repurchase of up to CHF750 million (US$591 million) worth of bearer shares through a share buyback program expected to start in June. Lasting a maximum of five years, the shares will be purchased on the open market via a second trading line and subsequently cancelled. The authorization applies only to the bearer shares traded on the virt-x, which is a pan-European blue-chip exchange, and excludes the American depository shares traded on the New York Stock Exchange. It is subject to the approval of the Swiss Takeover Board and the Swiss Stock Exchange.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, and Strasbourg, France-based Aventis SA's multiple sclerosis drug Copaxone was the subject of a review by the Cochrane MS Group, which concluded the therapy might provide no significant benefit in either slowing the progression of MS or substantially affecting the risk of clinical relapses over time. A Cochrane researcher said there is insufficient evidence to support future routine use of Copaxone (glatiramer acetate) in clinical practice, and that more clinical data are needed. The review incorporated the results of 646 patients with relapsing-remitting and chronic progressive MS who participated in four randomized, placebo-controlled clinical trials. Glatiramer acetate is a random mixture of polypeptides derived from the synthesis of four amino acids that is prescribed as an alternative to beta interferon. Copaxone was FDA approved in December 1996 to reduce flare-ups in relapsing MS.

• Vectura Ltd., of Chippenham, UK, announced positive results for VR004 (inhaled apomorphine) in erectile dysfunction. VR004 was absorbed following inhalation with onset of effect between 3 minutes and 8 minutes. All treatment-related adverse events were of mild to moderate severity. Vectura said it plans to carry out further trials during 2004.

• Wilex AG, of Munich, Germany, and Fox Chase Cancer Center in Philadelphia began a Phase I trial of WX-UK1 to target tumor-cell invasion, metastasis and primary tumor growth. It marks the first of two clinical trials of the company's compound at Fox Chase, funded by a $3.9 million grant from the Department of Defense to study the compound's potential as a breast cancer therapeutic. In animal models, Wilex said the non-cytotoxic small molecule blocks tumor-cell invasion, metastasis and primary tumor growth by inhibiting the urokinase Plasminogen Activator system.

• Xerion Pharmaceuticals AG, of Munich, Germany, reported positive results from its investigation into the role that heat-shock protein 90 (hsp 90) plays in tumor invasion. Researchers from Xerion, together with collaborators from the Tufts University School of Medicine and the National Cancer Institute in Bethesda, Md., found a direct physical and functional interaction between hsp 90 and a protease that is a key factor in tumor invasion. Xerion is building a pipeline of targets and antibodies to treat various forms of cancer and immune disorders.

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