Acambis plc, of Cambridge, UK, said its partner Intervet NV, of Boxmeer, the Netherlands, achieved 100 percent seroconversion to West Nile virus neutralizing antibodies in horses, following vaccination with Acambis' ChimeriVax West Nile veterinary vaccine. The horses resisted infection when they were subsequently challenged with the virus. Intervet intends to launch the vaccine in 2005. Gordon Cameron, CEO of Acambis, said this would be of limited financial impact.
Affitech AS, of Oslo, Norway, and Dyax Corp., of Cambridge, Mass., signed a cross-licensing agreement covering their respective patents in the area of antibody phage display. Financial terms were not disclosed. Under the agreement, Affitech gains access to Dyax's Ladner patents, which already have a total of 60 licensees. In return, Dyax becomes the first licensee of Affitech's Breitling patents, originally obtained from the German Cancer Research Center in Heidelberg.
Ark Therapeutics Group plc, of London, completed recruitment in its Phase II study of EG005 in lipodystrophy in HIV patients. After completing the initial 12-week blinded study, 45 of 50 subjects elected to go into a one-year, open-label extension trial. Results are due in the second quarter. EG005 also is in Phase III in the treatment of cancer cachexia.
Artemis Pharmaceuticals GmbH, of Cologne, Germany, and Schering AG, of Berlin, signed a cooperation agreement in mouse genetics and genomics. Artemis will generate various genetically engineered mouse models for Schering. Schering will use the mice in its drug discovery research activities to identify compounds and therapies for the treatment of various diseases. The generation of the mouse models will be based on Artemis' ArteMice and ArteMice Conditional technologies. Financial details were not disclosed.
BioPartners GmbH, of Zug, Switzerland, filed for European approval of Valtropin (somatropin), its recombinant human growth hormone developed in collaboration with LG Life Sciences Ltd., of Seoul, South Korea. The application is for the treatment of pediatric and adult growth hormone deficiency, and other growth disorders.
BioXell SpA, of Milan, Italy, commenced enrollment of patients in a Phase IIa trial of BXL628 in overactive bladder. The study, which will be coordindated by the urology division at San Raffaele Hospital in Milan, will investigate the efficacy of the molecule in 120 patients at 13 centers in Italy. The compound, a vitamin D3 analogue, also is scheduled to enter a Phase IIb trial in benign prostatic hyperplasia in the first half of next year. BXL628 also is due to enter Phase IIa trials in interstitial cystitis and chronic prostatitis next year.
Boehringer Ingelheim Austria GmbH, of Vienna, Austria, and Avidia Research Institute, of Mountain View, Calif., entered a multiyear development and manufacturing agreement under which Boehringer will develop manufacturing technology for Avidia's Maxybody proteins. The company also will supply Avidia with Maxybody proteins for use in clinical studies and commercial sale.
Cambridge Bioscience Partnership Ltd., of Cambridge, UK, agreed to provide assay development and screening services to NeurAxon Inc., of Mississauga, Ontario, for research on undisclosed targets. Financial terms were not disclosed.
Cellectis SA, of Romainville, France, entered an agreement to grant a worldwide, nonexclusive license to Lexicon Genetics Inc., of The Woodlands, Texas, to a patent family relating to a process for the specific replacement or insertion of a gene in a eukaryotic genome. The deal allows Lexicon to expand its intellectual property portfolio for creating and using genetically modified mice in its research activities. Financial terms were not disclosed.
Crucell NV, of Leiden, the Netherlands, signed a PER.C6 research license agreement with Edwards Lifesciences Corp., of Irvine, Calif. The nonexclusive agreement allows Edwards to use the PER.C6 cell line for research and development of gene therapeutics based on adenoviral vectors. Crucell also granted Edwards access to technical and regulatory support. Financial terms were not disclosed.
Daiichi Suntory Pharma Co. Ltd., of Tokyo, and BioMarin Pharmaceutical Inc., of Novato, Calif., entered a partnership for Phenoptin (sapropterin hydrochloride), an investigational oral enzyme cofactor for the genetic disease phenylketonuria (PKU). BioMarin will receive preclinical and clinical data on 6R-BH4, the product's active ingredient, and access to commercial-grade 6R-BH4. The assets will allow BioMarin to begin a Phase II trial in PKU patients by the end of the year. BioMarin will pay Daiichi Suntory approval milestones and a royalty on Phenoptin's sales outside of Japan, while Daiichi Suntory will retain PKU rights in Japan. Specific financial terms were not disclosed.
DeCode Genetics Inc., of Reykjavik, Iceland, formed a three-year collaboration with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, to develop and commercialize phosphodiesterase 4 (PDE4) inhibitors for the prevention and treatment of vascular disease, including stroke. The alliance calls for DeCode to use its structure-based drug-design capabilities to optimize lead compounds and begin development. The companies will share drug discovery and clinical trials costs, and DeCode is eligible to receive milestone payments and royalties. Specific financial terms were not disclosed.
Eiffel Technologies Ltd., of Sydney, Australia, signed a material transfer agreement with an undisclosed major international pharmaceutical company to evaluate the potential for Eiffel's drug re-engineering technology to improve the performance of two of the pharmaceutical company's drugs. The drugs, one already on the market and the other still in development, both are administered orally.
Elan Corp. plc, of Dublin, Ireland, stated on its website that the wholesale acquisition cost of Tysabri (formerly Antegren) to treat multiple sclerosis will be about $1,808 per vial. With each patient requiring about 13 infusions a year, the new MS drug will cost a patient about $23,500 annually. At that price, the drug could reach peak sales of more than $3.5 billion, according to some analysts. The FDA approved the use of Tysabri for relapsing forms of MS last week. The product is partnered with Biogen Idec Inc., of Cambridge, Mass.
EMD Biosciences Inc., a division of Darmstadt, Germany-based Merck KGaA, said it is adding the first in vitro-derived recombinant antibody to its catalogue of research reagents. The antibody is targeted against human cyclophilin A and is produced by Martinsried, Germany-based MorphoSys AG's Antibodies by Design division.
Eurogentec SA, of Liege, Belgium, signed a license with SuperArray Bioscience Corp., of Frederick, Md., allowing it to use SuperArray's cDNA GEArray-focused DNA microarray platform for product development. Eurogentec can purchase cDNA microarray and accessory-kit inventory from SuperArray under a regionally exclusive agreement. Eurogentec then can repackage the raw material as a Eurogentec product and independently promote, market, sell and distribute the product in the European Union. Financial terms were not disclosed.
Gamidor Diagnostics, of Petach Tikva, Israel, a distributor of clinical diagnostics in Israel, and Tm Bioscience Corp., of Toronto, signed a distribution agreement. Gamidor will have exclusive rights to distribute the Tag-It menu of genetic tests in Israel for a minimum three-year term that can be extended annually. As Tm launches new products, they can be rolled into the agreement upon approval of both parties.
GeneMedix plc, of Newmarket, UK, was granted a U.S. patent for monomeric analogues of human insulin discovered by its partner, the Shanghai Institute of Biochemistry and Cell Biology in China. The company intends to develop the compound to the end of Phase I before finding a commercial partner.
Geneva Bioinformatics (GeneBio) SA, of Geneva, entered a distribution agreement with the Bioinformatics Institute for Global Good, of Tokyo. The partnership combines Phenyx, GeneBio's protein-identification software platform, with the institute's Japanese market position. The institute will establish a distribution campaign for Phenyx in Japan in coordination with GeneBio's Japanese branch. The software platform is used for the identification and characterization of proteins and peptides from mass spectrometry data.
GenOway SA, of Lyon, France, and Charles River Laboratories International Inc., of Wilmington, Mass., established a European collaboration aimed at speeding up the availability of genetically modified research models to their pharmaceutical, biotech and academic research customers. The companies expect models developed in 45 percent less time with the same budget as a classic model.
Golden Hand Resources Inc., of Tel Aviv, Israel, changed its name to BrainStorm Cell Therapeutics Inc. to better communicate its focus as a cell-therapy firm. Specifically, the company is developing NurOwn cell-therapy products sourced from adult stem cells for treatment of neurodegenerative diseases, with an initial focus on bone marrow-derived, neural-like cells for Parkinson's disease. BrainStorm will be traded on the Over-the-Counter Bulletin Board as "BCLI."
IP2IPO Group plc, of London, launched a new £20 million (US$37.9 million) venture capital trust, UniVen VCT, to specialize in financing university spinout companies. UniVen will be managed by Top Technology Ventures Ltd., a venture capital management company that was acquired recently by IP2IPO.
Medical Marketing International (MMI), of Oxford, UK, said it signed a contract with start-up Cambridge Theranostics Ltd. (CTL), of Cambridge, UK, to use MMI's bioincubator LabHotel. CTL used LabHotel on a test basis for seven months in 2003. LabHotel is designed to provide start-ups with access to high-cost industrial-standard equipment without incurring capital costs. CTL is developing a diagnostic test and treatments for atherosclerosis.
Micromet AG, of Munich, Germany, said the FDA will allow MT201, an antibody targeting the Ep-CAM antigen, to begin a Phase II trial in metastatic breast cancer in the U.S. Micromet added that the antibody's target is overexpressed in a range of tumors, including prostate, colon, lung, breast, stomach, pancreas, head and neck and ovary cancers.
NeuroSearch A/S, of Ballerup, Denmark, said GlaxoSmithKline plc, of London, reported data on a partnered product as part of a presentation on central nervous system diseases. The product, labeled NS2359 by NeuroSearch and GSK372475 by GSK, is in development for depression. It enhances the function of the neurotransmitters serotonin, noradrenaline and dopamine. GSK, which is funding the product's further development under a year-old licensing deal, next year plans to begin Phase II studies with the product in major depressive disorder.
PharmaMar SA, of Madrid, Spain, moved Aplidin into Phase II trials in hematological malignancies such as multiple myeloma, non-Hodgkin's lymphoma (both aggressive and indolent) and adult acute lymphoblastic leukemia. The product already is in Phase II trials in a number of solid-tumor indications, with results expected next year. The company noted that the marine-derived antitumor agent does not present limiting bone marrow toxicity.
Pharming Group NV, of Leiden, the Netherlands, placed 3 million new shares with professional long-term investors for gross proceeds of |6 million. The proceeds will be used to accelerate development of Pharming's recombinant human lactoferrin and fibrinogen. The issuance represents about 4 percent of the total outstanding shares after the transaction. The new shares were placed through Amsterdams Effectenkantoor BV.
PhotoCure ASA, of Oslo, Norway, named Kjetil Hestdal president and CEO. Hestdal, currently chief operating officer, will succeed Vidar Hansson on Jan. 1. Hansson is retiring after eight years at PhotoCure.
Sinovac Biotech Ltd., of Beijing, reported that the American Stock Exchange approved Sinovac's application for listing its common stock. That approval is contingent upon the company being in compliance with all applicable listing standards on the date it begins trading on the exchange. Shares are expected to begin trading under the symbol "SVA" soon. Sinovac specializes in human vaccines for illnesses such as hepatitis A and hepatitis B, influenza, severe acute respiratory syndrome and avian flu.
Swiss voters endorsed government proposals to permit human embryonic stem cell research using embryos left over from in vitro fertilization procedures. In a referendum, a 66.4 percent majority backed the government's legislation. Therapeutic cloning, research on embryos and trade in embryos remain illegal.
Symphogen A/S, of Copenhagen, Denmark, will present its Symplex technology at the IBC Antibody Engineering Conference in San Diego on Dec. 2. The technology enables the isolation of naturally occurring antibodies from plasma cells obtained from human donors. It eliminates the problem of cross-reactivity that can arise with antibodies derived using earlier approaches, such as transgenic mice.
Trigen Ltd., of London, and Eurand International SpA, of Milan, Italy, entered a collaboration to develop controlled-release formulations of Trigen's clinical-stage oral anticoagulant, TGN 167. Eurand is bringing its delivery and formulation technologies to the table, while Trigen will retain all the product's commercialization and development rights. Financial terms were not disclosed.
Vernalis plc, of Reading, UK, started recruitment in a confirmatory Phase III study of Frova (frovatriptan) in treating menstrually related migraine. Coupled with an ongoing safety study, the study should lead to a submission to the FDA in the first half of 2006. Around 600 patients will be recruited and treated for three consecutive months.
Zilip-Pharma, of the Netherlands, and the biological products division of Bayer HealthCare LLC, of Research Triangle Park, N.C., signed an exclusive, global technology license for the development and commercialization of a new, longer-acting version of Kogenate. Zilip-Pharma will apply its liposome technology to the hemophilia product and could receive up to $100 million in up-front and milestone payments, followed by royalties should the new product reach the market.