British Biotech plc, of Oxford, UK, announced the start of a Phase I trial of its peptide deformylase (PDF) inhibitor, BB-83698, the first of a potential new class of antibiotics. PDF and other metalloenzymes are essential for bacterial survival, and PDF has shown high activity against pneumonia and other serious infections in preclinical studies. Starting the Phase I trial, which is being carried out in collaboration with British Biotech's partner, GeneSoft Pharmaceuticals Inc., of South San Francisco, entitles British Biotech to a milestone payment of US$1 million and a 3.45 percent equity stake in GeneSoft.
Cellestis Ltd., of Melbourne, UK, bought exclusive rights to use proteins specific to tuberculosis developed by Statens Serum Institut in Copenhagen, Denmark, for use in a tuberculosis test developed by Cellestis. The terms of the deal have not been disclosed.
CellFactors plc, of Cambridge, UK, said it received a notice of allowance from the U.S. Patent Office for its Skeletex bone-repair technology. The patent covers the use of human bone-forming cells to produce the cellular mixture of protein growth factors and collagens that comprise Skeletex. As such, the patent protects key steps in the manufacture of Skeletex.
Cerep SA, of Rueil-Malmaison, France, and F. Hoffmann-La Roche Ltd., of Basel, Switzerland, entered a research agreement providing for the Swiss pharmaceutical company to have access to Cerep's proprietary database, BioPrint, and for Cerep to use its BioPrint informatics tools on behalf of Roche. In addition, Cerep will profile Roche compounds in a panel of in vitro biological assays. The financial terms of the deal were not disclosed. Cerep's CEO, Thierry Jean, told BioWorld International that it had already provided Roche with a subset from the BioPrint database as part of Roche's molecular modeling program for determining the mechanisms of action of compounds, and that Cerep will test products selected by Roche. The companies signed a three-year drug discovery agreement in February 2001 that called for Cerep to use its technology in the areas of high-throughput screening, pharmacological and pharmaceutical profiling, and classic pharmacology to identify and select drug candidates coming from Roche.
Enact Pharma plc, of Salisbury, UK, said it filed a patent on the use of titanium-based organometallic compounds as antitumor drugs. The compounds overcome the problems of water insolubility and instability normally associated with transition metal metallocenes and are active against tumor cell lines that are resistant to platinum drugs.
GenOdyssee SA, of Paris, announced positive results for its proprietary interferon-alpha variants in the treatment of hepatitis C and cancer. Studies conducted by independent French laboratories found that GenOdyssee's nine variants were up to 100 times more effective and had far more specific therapeutic activity than interferons 2a and 2b, which are currently used to treat cancer and hepatitis. Founder and CEO Jean-Louis Escary said that using its "expertise in genetic variability and its understanding of proteins . . . to select naturally occurring variants of existing therapeutic proteins that demonstrate a higher therapeutic index and fewer side effects" is one of the key elements in the company's drug discovery strategy.
GPC Biotech AG, of Martinsried, Germany, signed an agreement with NeoTherapeutics Inc., of Irvine, Calif., granting GPC Biotech an exclusive worldwide license to satraplatin, an orally administered anticancer agent that is in the late stages of clinical development. Under the licensing and co-development agreement, NeoTherapeutics will receive a license fee that consists of an immediate US$2 million payment and a payment of $1 million plus a $1 million equity investment when the first patient receives a dose of satraplatin in a registrational study. GPC Biotech will pay additional milestones totaling up to $18 million, the first of which is anticipated to be the acceptance of the NDA filing by the FDA. NeoTherapeutics would receive royalties on net sales. Phase II studies for satraplatin have been successfully completed for treating hormone-resistant prostate cancer, as well as other tumor types.
Gyros AB, of Uppsala, Sweden, which develops CD-based microlaboratories, said it appointed Claes Wilhelmsson, former head of R&D at AstraZeneca plc, of London, as chairman of the board. Wilhelmsson is currently a senior adviser to Investor Growth Capital, a subsidiary of Investor AB, of Stockholm. He retired from his post at AstraZeneca in June.
Igeneon AG, of Vienna, Austria, and Novartis AG, of Basel, Switzerland, have signed a worldwide licensing agreement for a vaccine against epithelial cancers. The agreement paves the way for Igeneon to pursue clinical development of the vaccine designated IGN301. Novartis has completed Phase I tests on the vaccine, and Igeneon will continue the program of clinical trials in the U.S. and Europe. In exchange, Novartis receives an up-front fee, milestone payments and licensing fees on future sales. The agreement follows an option agreement concluded between the companies at the end of 2000, but exact financial terms were not disclosed. Hans Loibner, Igeneon's CEO, had been responsible for IGN301 when he was an executive at Novartis.
KS Biomedix Holdings plc, of Guildford, UK, appointed Medison Pharma Ltd., of Petach-Tikva, Israel, to distribute its TransMID brain cancer treatment in Israel. Under the terms of the agreement, Medison will make an undisclosed equity investment in KSB and contribute clinical support to the pivotal Phase III trial that is due to begin later this year. That is the third license KSB has signed for TransMID.
Meridian Bioscience Inc., of Cincinnati, said it is continuing pre-acquisition due diligence of diagnostics firm Biotrin Holdings plc, of Dublin, Ireland, and is concurrently negotiating a definitive stock purchase agreement. The expected date for the closing of the transaction has been extended. In May, when the deal was initially disclosed, Meridian said it anticipated the merger to be consummated within 45 days. It said Monday that it expects to complete the deal in the fourth quarter.
Phytopharm plc, of Godmanchester, UK, announced the successful completion of a Phase I repeat-dose study of P58, an oral treatment for age-related cognitive dysfunction. In the placebo-controlled study of 30 healthy volunteers over 55, the product was safe and biologically active blood levels were achieved. The results will be used to design the Phase II study in 150 subjects, due to begin in 2003. P58, based on a plant extract, stimulates the release of neuronal growth factors and reverses the loss of neuronal receptors in the aging brain.
The European Agency for the Evaluation of Medicinal Products (EMEA), is reducing its budget for 2002 to €65.4 million from €70.5 million because of the sharp decrease in the number of new drug applications. Only 25 applications had been received by the end of September, compared to 58 at the same point in 2001. EMEA, based in London, said the decline in applications appears to confirm a trend observed by other regulators, including the FDA.
The German Association of Biotechnology Industries elected Peter W. Stadler as its new chairman. Stadler is managing director of Artemis Pharmaceuticals GmbH, of Cologne, Germany, which he co-founded in 1998 with Nobel laureate Christiane Nuesslein-Volhard. The chairmanship of the DIB rotates every three years, and Stadler succeeds Dieter Wissler, president of Novartis Deutschland GmbH. The DIB represents more than 210 companies that are active in biotech production, research or services.
Xenova Group plc, of Slough, UK, said the FDA granted fast-track status to its lead product, tariquidar, for the treatment of multidrug resistance in first-line treatment of non-small-cell lung cancer. Tariquidar, which is licensed to QLT Inc., of Vancouver, British Columbia, is currently in two pivotal Phase III trials as an adjunctive treatment in combination with chemotherapy in lung cancer.
Xention Discovery Ltd., of Cambridge, UK, entered a two-year collaboration with BioFocus plc, of Sittingbourne, UK, to develop candidate drugs against an ion channel target for atrial fibrillation, the most common type of cardiac arrhythmia. BioFocus will exclusively license to Xention a range of compounds already identified as ion channel modulators, which Xention will screen using its AutoPatch technology for the automated screening of molecules against ion channel targets. BioFocus will then provide medicinal and computational chemistry expertise for lead optimization.