• Ariana Pharmaceuticals, of Paris, is making its KEM drug development support technology available to third parties under fee-for-service contracts, license agreements or research collaborations. KEM, for Knowledge Extraction and Management, is a computational tool that integrates and mines multiple data sources. It is used by Ariana in combination with other computational, crystallographic and biochemical methods to predict the behavior of novel molecules and expedite the lead identification and optimization process.

• Australian Cancer Technology Ltd., of Sydney, Australia, began a Phase II study of RP101 for metastatic pancreatic cancer. The eight-month trial will include 22 patients in Germany. RP101 tablets are being administered in conjunction with conventional chemotherapy agents, and will be evaluated with gemcitabine. Following the study, the company plans to begin a pivotal Phase IIb/III trial in the U.S. and seek orphan drug status. In two previous pilot studies that included 39 patients, treatment with RP101 demonstrated a reduction of side effects and an improvement in response compared to chemotherapy alone, the company said.

• Avidex Ltd., of Oxford, UK, completed preclinical development of its rheumatoid arthritis treatment, RhuDex, a first-in-class small molecule designed to work by blocking T-cell activation. The drug will move into Phase I trials next year, and the company is in discussion with potential partners.

• Basilea Pharmaceutica AG, of Basel, Switzerland, is negotiating with Ortho-McNeil Pharmaceutical Inc., a subsidiary of Johnson & Johnson, of New Brunswick, N.J., concerning a licensing deal for its cephalosporin antibiotic, ceftobiprole (BAL5788). The companies have received clearance under anti-trust rules on the putative deal.

• BioInvent International AB, of Lund, Sweden, and ThromboGenics Ltd., of Dublin, Ireland, expanded their collaborative research and licensing agreement to jointly develop a new class of anti-angiogenesis agents under investigation at ThromboGenics, based on inhibition of placental growth factor. The program's lead candidate will enter formal preclinical development next year, and the parties will share costs and revenues according to existing agreement terms. The new program will be added to the ongoing collaboration, which is developing anti-Factor VIII monoclonal antibody as an anticoagulant therapy. They expect to bring the programs through clinical proof of concept prior to seeking a pharmaceutical partnership for further development and commercialization.

• bioMerieux SA, of Marcy l'Etoile, France, and Applied NeuroSolutions Inc., of Vernon Hills, Ill., signed a non-exclusive agreement to bring to worldwide markets a biologic test for the diagnosis of Alzheimer's disease. Milestones due Applied NeuroSolutions could be worth more than $5 million, plus what it termed substantial royalties. The agreement grants bioMerieux an option to further evaluate the technology before going forward; if it opts into the deal, bioMerieux would be financially responsible for obtaining regulatory approvals to develop and sell diagnostic tests for Alzheimer's disease using the technology.

• Bionomics Ltd., of Adelaide, Australia, agreed to acquire the French contract research organization business, Neurofit, with the acquisition to be completed in early 2005 and Bionomics taking over operations by March 1. Neurofit's core business is the preclinical testing of developmental therapeutics for central nervous system disorders.

• Biovitrum AB, of Stockholm, Sweden, entered a pact with Discovery Partners International Inc., of San Diego, focused on finding small-molecule candidates for metabolic disease. Terms were not disclosed, but under the agreement, Biovitrum will gain access to Discovery Partners' compound collection and its process and data management tools.

• Crucell NV, of Leiden, the Netherlands, said that Merck & Co. Inc., of Whitehouse Station, N.J., has met a clinical development milestone in connection with the PER.C6 technology licensed to Merck for its investigational HIV vaccine program.

• Cytomics Systems, of Paris, reported favorable preclinical results showing that use of its nosocomial fungal infection treatment resulted in a complete cure in mice infected with a pathogenic fungus. There were no undesirable side effects. The company identified the molecules used in the tests with its high-throughput screening system, UbiScreen.

• Debiopharm SA, of Lausanne, Switzerland, entered an exclusive licensing agreement with Rowfarma S de RL de CV, a subsidiary of Quintiles Transnational Corp., of Research Triangle Park, N.C., to market Decapeptyl Depot 3.75 mg and Decapeptyl LA 11.25 mg in Mexico. Debiopharm will supply Decapeptyl from its FDA-inspected plant in Switzerland exclusively to Rowfarma and will receive royalties on sales in Mexico. The product, an intramuscular injectable formulation of triptorelin pamoate, is registered there for prostate cancer, endometriosis, precocious puberty and breast cancer.

• DeCode Genetics Inc., of Reykjavik, Iceland, signed an agreement under which it will conduct a Phase II trial next year of a third-party compound as part of program in asthma. The compound targets the product of a gene that DeCode has shown plays a role in the development of asthma. Enrollment is expected to begin in early 2005. Neither the name of the company or the compound was disclosed.

• Diamyd Medical AB, of Stockholm, Sweden, obtained regulatory approval in Sweden to move its diabetes therapeutic vaccine, Diamyd, into a Phase II trial in 70 children and adolescents newly diagnosed with Type I diabetes. The study will test whether two immunizations with the candidate vaccine lead to disease remission by preserving the function of the remaining insulin-producing beta cells in the pancreas.

• Diatos SA, of Paris, reported the positive review and regulatory clearance of its lead drug's investigational new drug application by the ethics committee of Toulouse 1 (France). AFSSAPS, the French health products safety agency, was notified and the company will conduct Phase I studies beginning in early 2005. The trials primarily will study the safety and pharmacokinetics of DTS-201, a doxorubicin prodrug that can be delivered selectively to tumors, in patients with advanced or metastatic solid tumors.

• Flamel Technologies SA, of Lyon, France, enrolled the first patient in a Phase I/II study of its Medusa formulation of long-acting interferon-alpha. The company said the study is to evaluate the pharmacokinetic profile of the long-acting interferon for hepatitis and hepatitis C treatment. Also, Flamel enrolled the first patient in a Phase I/II study of its Medusa formulation of long-acting interleukin-2 in comparison with Proleukin. Proleukin is the only treatment approved for renal cancer. Flamel's formulation resulted in measurable increases in levels of lymphocyte CD4 and CD8, as well as CD25, which are considered surrogate markers for stimulation of the body's immune system.

• Genmab A/S, of Copenhagen, Denmark, said that HuMax-CD20 was designated a fast-track product by the FDA. The designation covers patients with chronic lymphocytic leukemia who have failed fludarabine therapy. That patient group includes those who are refractory to available treatment. HuMax-CD20 is in two Phase I/II studies to treat CLL and non-Hodgkin's lymphoma. Separately, Genmab said two of its antibodies were selected as candidates for clinical development by F. Hoffmann-La Roche Ltd., of Basel, Switzerland. The antibodies are for two undisclosed disease areas. If all goals are reached in the 3-year-old collaboration, Genmab could gain $100 million plus royalties. The partners significantly expanded their relationship more than two years ago.

• The German state of Saxony-Anhalt said it would challenge recently passed national laws restricting agricultural biotechnology. The laws were passed in late November over the objections of the parliamentary chamber representing the states. The government asserted that the regulations implement European Union directives on agricultural biotechnology. Some states argue that provisions in the laws, such as liability for losses without proof of culpability, violate the EU directives. Saxony-Anhalt will challenge the national laws in Germany's Constitutional Court and seek to have them overturned. (See BioWorld International, Dec. 1, 2004.)

• GPC Biotech AG, of Martinsried, Germany, and Debiopharm SA, of Lausanne, Switzerland, signed a license agreement for GPC Biotech's preclinical small-molecule MHC Class II antagonist program. Debiopharm will license exclusive global rights to further develop the program, and GPC Biotech will receive an up-front payment plus milestone payments and royalties.

• HemeBiotech A/S, of Hiller d, Denmark, changed its name to Zymenex A/S to reflect its focus on the development of enzyme-replacement therapeutics. The company also named Fredric Price, former chairman and CEO of BioMarin Pharmaceutical Inc., of Novato, Calif., executive chairman, while Ron Cohen, founder and CEO of Acorda Therapeutics Inc., of Hawthorne, N.Y., joined the board.

• Inpharmatica Ltd., of London, signed a contract with Applied InSilico, of Chippenham, UK, to use its Evolutionary Learning Environment to reveal ADME (Absorption, Distribution, Metabolism and Excretion) relationships in complex chemical data sets. Inpharmatica said Applied InSilico's ability to harvest data and provide insight into data sets will enhance Inpharmatica's ability to build more accurate predictive models.

• IsoTis OrthoBiologics SA, of Lausanne, Switzerland, sold its wound-management activities to DFB Pharmaceuticals Inc., of Fort Worth, Texas, for an undisclosed amount. The parties entered a worldwide exclusive licensing agreement in August 2003 for Allox, a cell-based product to treat chronic skin wounds. IsoTis also established that year EpiSource SA, a potential spin-off company for its wound-management portfolio, which includes the lead product Allox, as well as EpiDex and AcuDress. With the transaction with DFB, IsoTis has divested all of its non-core activities and will focus solely on orthobiologics.

• Merck KGaA, of Darmstadt, Germany, said it plans to acquire the Lumitec OLED R&D project from Schott AG, of Mainz, Germany. All 20 employees involved with the project have been offered positions at Merck, which expects the transaction, including an unlimited exclusive license for the business-related patents and associated assets, to be completed in early January. The Lumitec OLED (organic light-emitting diode) project involves indium tin oxide-coated glass substrates owned by a Merck subsidiary.

• MorphoSys AG, of Martinsried, Germany, extended its collaboration with Schering AG, of Berlin, to develop antibody therapeutics and in vivo diagnostics. Originally signed in December 2001, the collaboration will be extended at least until the end of 2006, with the option of a further extension period of one year. MorphoSys receives annual license fees under the revised contract, funding for a team of scientists and royalties and milestone payments. Schering receives access to MorphoSys's HuCAL GOLD technology and exclusive commercial licenses for several collaborative programs.

• Mymetics Corp., of Nyon, Switzerland, received approval from the National Institutes of Health's Institute of Allergy and Infectious Diseases to begin preclinical testing of the company's trimeric gp41 vaccine in nonhuman primates. The study will run through the third quarter of 2005, testing the second generation of HIV vaccines in development. Mymetics expects to conduct advanced toxicology testing by the end of 2005 and file an investigational new drug application in 2006.

• Optinose A/S, of Oslo, Norway, secured €4.5 million in a Series B funding led by existing investor Andromeda-Fund BV. The company plans to use proceeds to continue developing its nasal drug delivery technology, which is designed to assure more focused deposition of vaccines and systemic and topical drugs compared with available devices. The company said it unveiled its first device in the fall and has entered partnering discussions with several biotechnology and pharmaceutical firms.

• Oxford Biomedica plc, of Oxford, UK published preclinical data for SMN1-G for the treatment of spinal muscular atrophy, showing a significant improvement in survival and improved motor neuron survival in a mouse model of the disease. The company said it will start clinical trials in 2006.

• Pepscan Systems, of Lelystad, the Netherlands, entered a research and license option agreement with Cytos Biotechnology AG, of Zurich, Switzerland, for the identification of peptide antigens to generate peptide-based therapeutic vaccines. Pepscan will use its Clips technology to map and reconstruct the receptor interaction site of a cytokine, which Cytos intends to target in one of its Immunodrug development programs.

• Pharmaxis Ltd., of Sydney, Australia, said its shareholders approved the A$16.5 million share placement and the closure of its share purchase plan announced in November. The placement of 22 million shares was made to institutions and investors at 75 cents per share. The share purchase plan closed on Dec. 3 with Pharmaxis raising A$3.27 million through the issuance of about 4.4 million new shares. The proceeds from the placement and share purchase plan enable the company to proceed with a new international Phase III trial for Bronchitol in 2005, it said.

• Pharming Group NV, of Leiden, the Netherlands, updated its development of a recombinant human C1 inhibitor for hereditary angioedema at its investigator meeting. Results from ongoing trials revealed that patients treated with rhC1INH showed rapid time to beginning of relief (15 minutes to four hours) and time to complete resolution (one hour to 48 hours), as well as favorable evaluation of treatment by both patients and physicians.

• Physiomics plc, of Oxford, UK, floated on the Alternative Investment Market in London, netting £750,000 (US$1.35 million). The in silico systems biology company said it will spend the money expanding its technology platform and on development of an in-house portfolio.

• Procognia Ltd., of Maidenhead, UK, and PerkinElmer Inc., of Boston, entered an exclusive distribution and co-marketing agreement to deliver a product for high-throughput and high-resolution analysis of the glycosylation of proteins. To that end, Procognia's U-c fingerprint lectin array-based platform is being combined with PerkinElmer's instrumentation, the Protein Array Workstation and the ProScanArray HT.

• Sareum Holdings plc, of Cambridge, UK, announced a fee-for-service deal with an unnamed pharmaceutical company to provide protein structure determination services. Sareum will receive up-front and success payments.

• Sinovac Biotech Ltd., of Beijing, signed an avian flu vaccine co-development agreement with the China Centre of Disease Control and Prevention, which will be responsible for surveillance of influenza prevalence, a molecular epidemiology study of the virus strain, guidance and establishment of the avian flu vaccine development strategy, plus participation in avian flu vaccine research and development and the design of a technical roadmap. Sinovac is responsible for avian flu vaccine research and development, vaccine application and production. The Chinese CDC is responsible for conducting several tests, including genome analysis on the virus strains used in the vaccine research and development, antigen analysis and immunization protection analysis, among others. The parties intend to apply for government funding, and longer term, all commercial rights will be owned by Sinovac.

• SkyePharma plc, of London, signed a non-binding term sheet to acquire 11.2 million additional shares in Astralis Ltd., of Fairfield, N.J., from two former Astralis directors in exchange for the issuance of about 6 million ordinary SkyePharma share. Completion of the transaction is subject to the negotiation of definitive agreements and the appointment of two directors nominated by SkyePharma to Astralis' board. If the transaction completes, SkyePharma would own 36.4 million shares, or 49.7 percent, of the outstanding common stock of Astralis.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, and Codexis Inc., of Redwood City, Calif., a subsidiary of Maxygen Inc., entered a collaboration to develop improved processes for the manufacturing of a marketed fermented pharmaceutical product. They will use Codexis' MolecularBreeding-directed evolution platform to improve the productivity of the manufacturing process and to reduce capital expenditures. Codexis will receive research and development funding and could receive milestone and royalty payments. Teva gets exclusive commercialization rights to the process.

No Comments