Ablynx NV, of Ghent, Belgium, appointed Edwin Moses nonexecutive chairman. Moses previously was CEO and chairman of Oxford Asymmetry and is a nonexecutive director of several biotechnology companies.
Acrongenomics Inc., of Athens, Greece, said it would raise $1 million through a private placement of 400,000 shares at $2.50 apiece. Proceeds will be used to fund the company's ongoing validation studies for its first product, the NeoEpCAM Detection Kit, for new product research and development and for general corporate purposes. Acrongenomics is developing products for genomics, proteomics and diagnostics, with a focus on a platform of molecular human diagnostic tools for various diseases.
Alliance Pharmaceuticals, of Basingstoke, UK, and Valeant Pharmaceuticals International, of Costa Mesa, Calif., entered a co-promotion deal on two brands. The Valeant product, Mestinon, is indicated for myasthenia gravis, while Alliance's Symmetrel is targeted at dyskinesia associated with Parkinson's disease. Valeant sales specialists will promote Symmetrel to neurologists alongside Mestinon, while the Alliance sales team will promote the benefits of it in addition to Symmetrel. Also, Valeant sold its Spanish manufacturing operations to Labiana Group, of Barcelona, Spain. Terms were not disclosed. The company expects to reduce its holdings to five manufacturing sites by 2006.
Antisense Therapeutics Ltd., of Melbourne, Australia, will conduct a proof-of-concept study of ATL1101 in patients with psoriasis. ATL1101 is a second-generation antisense drug designed to block the synthesis of the IGF-1 receptor, a protein involved in the regulation of cell overgrowth in psoriasis. It is based on Carlsbad, Calif.-based Isis Pharmaceuticals Inc.'s second-generation antisense chemistry, called 2-0-methoxyethyl, and is being developed as a cream for the topical treatment of mild to moderate cases of psoriasis.
BioAlliance Pharma SA, of Paris, said European regulatory authorities designated its doxorubicin Transdrug an orphan product for hepatocellular carcinoma, primary liver cancer. The product is a nanoparticle formulation being evaluated in a Phase I/II trial at seven French sites. The company said it would file this month an application with the FDA to obtain orphan drug designation in the U.S.
Biocon Ltd., of Bangalore, India, and Vaccinex Inc., of Rochester, N.Y., formed a partnership to discover and co-develop at least four therapeutic antibody products. The collaboration combines Vaccinex's capabilities to discover fully human monoclonal antibodies using its antibody discovery technology and Biocon's knowledge in clinical research and biologics manufacturing. The companies will focus on antibodies directed at cancer, inflammation and autoimmune disease. Biocon also will make an equity investment in Vaccinex.
BioTie Therapies Oyj, of Turku, Finland, said it obtained |3.3 million (US$4.3 million) in financing commitments from Tekes, Finland's national technology agency, to fund its VAP-1 SSAO small-molecule inhibitor program. The funding, which comprises a loan of |2.3 million, plus an R&D subsidy of |1 million, is intended to cover half of the project's costs from August 2004 through July 2006. The program aims to find molecules that inhibit the semicarbazide-sensitive amine oxidase domain of the Vascular Adhesion Protein-1 receptor, in order to reduce the formation of hydrogen peroxide during the inflammatory response.
Brain AG, of Zwingenberg, Germany, and Sandoz GmbH, of Kundl, Austria, reported positive results from their collaboration to find new enzymes to aid in the production of beta-lactam antibiotics, such as penicillin and cephalosporin. The companies said they will build on the results to produce the enzymes in quantities sufficient to support industrial-scale antibiotic production.
Chroma Therapeutics Ltd., of Oxford, UK said dosing began in a Phase I trial of its lead product, CHR-2797, in patients with advanced or metastatic solid tumors that are refractory to standard therapy. The objective is to assess safety and tolerability of an ascending dose as a monotherapy dosed orally once daily in up to 40 patients.
Crucell NV, of Leiden, the Netherlands, and allied contract manufacturer DSM Biologics, of Sittard, the Netherlands, signed a PER.C6 research license agreement with Micromet AG, of Munich, Germany. The agreement allows Micromet to use the technology to evaluate the expression of certain recombinant monoclonal antibody products and for subsequent preclinical manufacturing. Also, Crucell discovered a monoclonal antibody product for protection against rabies. Specifically, the company's MAbstract technology was used to produce a combination of two human rabies antibodies, and the antibody product demonstrated protection in a hamster model at least equivalent to human rabies immune globulin. The program was completed in collaboration with the Thomas Jefferson University in Philadelphia and the Centers for Disease Control and Prevention in Atlanta.
Eiffel Technologies Ltd., of Sydney, Australia, signed an agreement with an undisclosed U.S.-based specialty pharmaceutical company to develop an asthma treatment using Eiffel's re-engineered drugs and the partner's delivery device. Eiffel will receive an up-front payment of $150,000 and could receive milestone-related payments of A$1 million (US$782,577) over the next 18 months. The drug will employ Eiffel's Supercritical Fluid technology for use in an inhalation delivery device.
Evogene Ltd., of Rehovot, Israel, entered an agreement with Mertec LLC, of West Point, Iowa, for the development and marketing of soybean seeds with improved traits. The companies will bring newly developed traits from Evogene to the market in soybean varieties developed by Mertec, which will market the co-developed soybean varieties. Financial terms were not disclosed.
ExonHit Therapeutics SA, of Paris, plans to initiate a Phase IIa proof-of-concept trial of its lead compound, EHT 0202, in Alzheimer's disease early in 2005, a little earlier than originally scheduled. A Phase I study entailing the oral administration of a single dose has been completed and confirmed that the drug is well tolerated and well absorbed. Preclinical studies demonstrated protection from cell death following induction of different stresses (ischemia or toxic treatment), as well as improved learning and cognitive performance in aged rats. Two months ago, ExonHit announced that its previous lead compound, a treatment for amyotrophic lateral sclerosis, had failed to attain its primary efficacy endpoint in a Phase III trial.
FIT Biotech Oyj, of Tampere, Finland, and Inovio AS, of Oslo, Norway, entered a research collaboration and option agreement to develop an HIV vaccine. It will be based on FIT Biotech's Gene Transport Unit (GTU) technology, a plasmid construct containing an insert encoding Nuclear Anchoring Protein, which boosts protein production by ensuring that the plasmids are bound to the active portion of the nuclear chromatin and by activating the promoters driving transcription. The companies will evaluate the GTU technology in combination with Inovio's Elgen electroporation method for delivering naked DNA into mammalian cells. FIT Biotech has obtained an option to negotiate a license or co-development agreement for moving the program into clinical trials.
Galapagos Genomics NV, of Mechelen, Belgium, and Celgene Corp., of Warren, N.J., entered a multiyear target-discovery collaboration. Galapagos' wholly owned services unit, Galadeno, will provide Celgene with its adenoviral siRNA and cDNA libraries, SilenceSelect and FLeXSelect. Celgene will use the libraries across research programs to study disease pathways and identify new drug targets. Financial terms were not disclosed.
Gene Logic Inc., of Gaithersburg, Md., said its wholly owned subsidiary, Gene Logic KK, officially opened its offices in Tokyo to provide sales support and customer service to pharmaceutical customers in Japan. The company hired two technical support managers and is searching for a general manager. More than 30 percent of Gene Logic revenue is from Japanese-headquartered pharmaceutical companies.
GPC Biotech AG, of Martinsried, Germany, and co-development partner Spectrum Pharmaceuticals Inc., of Irvine, Calif., said new data on satraplatin in prostate cancer showed the treatment resulted in tumor-cell death accompanied by a concomitant reduction in the amount of secreted prostate-specific antigen (PSA) levels in cell culture medium. Investigators concluded that the reduction in PSA levels was a result of the cytotoxic effects of satraplatin or its active metabolite and was not a result of the pharmacologic effects on PSA expression or secretion. The data were presented at the American Association for Cancer Research's Basic, Translational and Clinical Advances in Prostate Cancer meeting, held in Bonita Springs, Fla.
Ipsogen, of Marseille, France, and Genaissance Pharmaceuticals Inc., of New Haven, Conn., signed a co-marketing agreement under which the companies will jointly offer an integrated package of gene-expression and genotyping technologies to developers and marketers of cancer drugs. It combines Ipsogen's Oncogenomic platform for gene-expression profiling with Genaissance's HAP technology and high-throughput genotyping platform.
Karolinska Institute in Stockholm, Sweden, and IBM, of Armonk, N.Y., teamed up to build what they described as Sweden's first "IT-enabled" biobank, which will link environmental and genetic data to human tissue samples in an effort to understand disease mechanisms. The project, which is part of a wider collaboration between the institute and IBM's life sciences business, will integrate existing biobank projects across Sweden, and will promote the development of standardized data-collection methods. Its promoters hope it will help researchers across the country to comply with the legislation governing the area.
Ludesi AB, of Lund, Sweden, entered a proteomics research collaboration with WITA GmbH, of Teltow, Germany, to provide access to more information about protein functions in human, animal and plant cell cultures and tissues. The companies plan to combine their respective technologies, merging WITA's high-resolution, 2-D gel electrophoresis process, which allows for up to 10,000 different proteins to be separated, with image analysis through Ludesi's software systems.
Medical Marketing International Group plc, of Cambridge, UK, said its joint venture Viratis Ltd. was granted a European patent on its ribozyme-based AIDS therapy.
Merck KGaA, of Darmstadt, Germany, said it is encouraged by results from the Phase I study of the angiogenesis inhibitor cilengitide in glioma sponsored by the National Cancer Institute. Data presented at the annual meeting of the Society for Neuro-oncology showed that out of 51 patients, two showed complete response, three exhibited partial response and four had stable disease for more than six months. Merck began a Phase II proof-of-concept study in October in patients with recurrent glioblastoma multiforme receiving cilengitide after failing first-line chemotherapy.
Morphochem AG, of Munich, Germany, and Probiodrug AG, of Halle, Germany, began a multiyear research collaboration to develop small-molecule drugs. The companies will begin by focusing on inhibiting the serine protease dipeptidyl peptidase IV to treat anxiety and depression. The companies will use Morphochem's discovery approach and Probiodrug's in vivo and in vitro models. Both firms will retain ownership interests in any intellectual property developed during the project. They declined to specify financial terms of the collaboration.
NeuroSearch A/S, of Ballerup, Denmark, realized a profit of DKK27 million (US$4.8 million) during the first nine months of 2004 from the sale of 148,050 shares in Bavarian Nordic A/S, of Kvistgard, Denmark. It halved its shareholding in the company during that time, and now holds a 3.2 percent stake, which, as of Nov. 16, was worth DKK73.6 million, it said. NeuroSearch reported a net profit of DKK30.4 million for the third quarter and raised its guidance for the full year from a loss of DKK25 million to a loss of DKK10 million. It held DKK505.5 million in cash at Sept. 30.
Onyvax Ltd., of London, said it has discovered an immunological signature that can be used to predict responders and non-responders to its Onyvax-P prostate cancer vaccine. The technique involves using a neural network to analyze data derived from blood samples taken throughout a clinical trial.
PharmaMar SA, of Madrid, Spain, said that Aplidin, its second marine-derived compound in clinical development, was granted orphan drug status by the European Commission for the treatment of multiple myeloma, following adoption of a positive opinion by the Committee for Orphan Medicinal Products.
PowderMed Ltd., of Oxford, UK, reported positive results in a Phase I trial of a prophylactic DNA influenza vaccine. All three doses passed the Committee for Proprietary Medicinal Products criteria at 56 days and the maximum dose passed the criteria at 21 days and was well tolerated.
Prana Biotechnology Ltd., of Melbourne, Australia, said its previous issuance of ordinary shares was approved at its annual meeting, pursuant to resolution of a patent dispute regarding PBT-1. The product is in development for Alzheimer's disease. Also approved were up to an aggregate of 12 million ordinary shares or American depository shares issuable under option plans.
Sareum Holdings plc, of Cambridge, UK, said it agreed to a fee-for-service contract with Millennium Pharmaceuticals Inc., of Cambridge, Mass., to generate chemical compound libraries to screen against Millennium's drug targets. Sareum is focused on structure-based drug design.
Viragen Inc. and Viragen International Inc., of Plantation, Fla., reported the approval of Multiferon, natural human alpha interferon, for sale in Bulgaria. The Bulgarian regulatory authorities approved an application filed by Viragen's distribution partner, Arriani Pharmaceuticals SA, of Athens, Greece, which holds the exclusive rights to distribute the drug in Greece and designated Balkan countries. Multiferon is approved in Bulgaria for the second-line treatment of any and all diseases in which recombinant interferon therapy failed or the patient was unable to tolerate the regimen.
YM BioSciences Inc., of Mississauga, Ontario, said its European licensee, Oncoscience AG, of Wedel, Germany, initiated a rolling Phase I/II trial in Europe for YM's TheraCIM hR3, in patients with metastatic pancreatic cancer. The trial will enroll 60 patients who have failed first-line treatment with chemotherapy. Initial results are expected in the third quarter of 2005. Six German hospitals are participating in the trial. TheraCIM hR3, which is called Theraloc in Europe, is a humanized monoclonal antibody that targets the epidermal growth factor receptor.