Abmaxis Inc., of Santa Clara, Calif., and MaimoniDex RA Ltd., of Jerusalem, signed an agreement to jointly develop a therapeutic human monoclonal antibody for the treatment of rheumatoid arthritis and other inflammatory diseases. Based on its discovery of a disease-causing molecule found only in the joints of RA patients, MaimoniDex has developed a murine monoclonal antibody that has shown bioactivities both in vitro and in vivo. Abmaxis will humanize and optimize the murine antibody to develop a drug suitable for therapeutic use. MaimoniDex will pay Abmaxis an up-front technology license fee and Abmaxis also is entitled to receive future milestone payments and royalties.
Acambis plc, of Cambridge, UK, after a 30-day review period of a complaint, is the subject of an investigation by the U.S. International Trade Commission in Washington. The investigation relates to alleged patent infringement on MVA smallpox vaccine products marketed by Acambis plc, and the complaint was filed by Bavarian Nordic A/S, of Copenhagen, Denmark, stating that Acambis imported and sold, and/or offered to sell in the U.S., MVA smallpox vaccines that infringe patents owned by Bavarian Nordic. The complaint further alleges misappropriation of Bavarian Nordic's MVA-BN proprietary technology. Bavarian Nordic is requesting the ITC to issue a permanent cease and desist order, which would prohibit Acambis from importing, selling or offering for sale in the U.S. its MVA smallpox vaccine or other products that infringe Bavarian Nordic's patents. The firms are involved in a bidding process to supply doses of MVA smallpox vaccine products to the U.S. Department of Health and Human Services under the BioShield program.
Amarin Corp., of London, said patient enrollment and first dosing began in the U.S. Phase III trial of Miraxion in Huntington's disease by The Huntington Study Group. The company expects to begin a European trial later in the year. The Miraxion Phase III trials are being conducted under a special protocol assessment procedure approved by the FDA.
Amaxa GmbH, of Cologne, Germany, entered an agreement with the American Type Culture Collection in Manassas, Va., for ATCC to supply cell lines for developing and optimizing protocols using Amaxa's Nucleofector technology. Nucleofector is designed to allow the transfer of nucleic acids, even into primary cells and difficult-to-transfect cells, in a reproducible way.
Amrad Corp. Ltd., of Melbourne, Australia, is proposing to change its name to Zenyth Therapeutics Ltd. to reflect the company's focus on developing therapeutic antibodies for cancer and inflammation. Amrad recently sold its anti-infective business to Avexa Ltd., also of Melbourne. The name change proposal will be put to shareholders at the annual meeting Oct. 27.
Ardana plc, of Edinburgh, UK, said the launch of its lead compound, Teverelix, a long-acting Gonadatrophin-Releasing Hormone for treating benign prostatic hyperplasia could be two years earlier than anticipated, following a pre-investigational new drug meeting with the FDA. The FDA said that improvements in symptoms, as measured by the International Prostate Symptom Score, can serve as a single endpoint for therapeutic and regulatory success. Ardana is planning to submit its first IND within the next few months.
Avantogen Ltd., of Sydney, Australia, and Innovate Oncology Inc., of New York, said pancreatic cancer results on RP101 reported at the International Conference on Tumor Progression and Therapeutic Resistance in Burlington Mass., showed that the product extends survival beyond previous results of RP101 co-administered with standard chemotherapy. The new data showed that 10 of 13 original patients survived at least one year following treatment; median survival was 447 days. Time to progression was 280 days, and presently, four of the original 13 remain alive for nearly two years. Avantogen, formerly called Australian Cancer Technology, and Innovate have jointly licensed RP101 from RESprotect GmbH, of Dresden, Germany, and plan to sponsor clinical trials in the U.S. starting early next year.
Can-Fite BioPharma Ltd., of Petach Tikvah, near Tel Aviv, Israel, aims to raise ILS45 million (US$9.8 million) at a company pre-money value of US$25 million via an initial public offering on the Tel-Aviv Stock Exchange, scheduled for Sept. 29. The main underwriters are I.B.I Poalim, Apex Mutavim, and D.I.M. The offering will consist of 133,334 units at ILS337.5 each for 300 common shares (or LIS 1.125 per share). Can-Fite's lead product, CF101, a small oral drug for the treatment of rheumatoid arthritis, is in Phase II trials.
CellCentric, of Cambridge, UK, and Cancer Research Technology Ltd., of London, began an anticancer co-development program to validate CellCentric's epigenetic-related lead cancer target, and to develop monoclonal antibody therapeutic products. Both parties will share the costs and rewards of the collaboration, which could be followed by the co-development of other targets identified by CellCentric.
Cellectis SA, of Romainville, France, entered a research collaboration and license agreement with Biogen Idec Inc., of Cambridge, Mass., to develop a custom Meganuclease Recombination System designed to enable reproducible high-yield production of target proteins in mammalian cells. Cellectis will engineer a meganuclease and DNA targeting matrix to induce site-specific homologous recombination. Financial terms were not disclosed.
Eiffel Technologies Ltd., of Sydney, Australia, and MAP Pharmaceuticals Inc., of Mountain View, Calif., signed a development and licensing agreement that provides MAP with the exclusive right to apply Eiffel's intellectual property to developing pharmaceutical products for pulmonary delivery of insulin, pulmonary and nasal delivery of steroids, and pulmonary delivery of combinations of long-acting beta agonists and steroids. Under the agreement, Eiffel will receive $600,000 up front, as well as potential milestones and royalties.
Elan Corp plc, of Dublin, Ireland, and Biogen Idec Inc., of Cambridge, Mass., expect the safety evaluation of Tysabri in Crohn's disease and rheumatoid arthritis will be completed in the coming weeks. It also said it would submit a supplemental biologics license application for Tysabri in multiple sclerosis to the FDA. In February, the companies had suspended ongoing clinical trials based on three reports of multifocal leukoencephalopathy or PML, a demyelinating disease of the central nervous system. A previous safety evaluation of Tysabri to treat multiple sclerosis did not show any new confirmed cases of PML.
Evolutec Group plc, of Reading, UK, announced positive results in a U.S. Phase II study of its lead product, rEV131, in treating allergic rhinitis. In the 112-patient study, rEV131 met its primary endpoint, a statistically significant difference in the mean sum of symptom scores at 15 minutes post-allergen challenge in the 62 patients who completed the trial. rEV131 showed a dose dependent effect enabling Evolutec to select the optimum dose for further research to determine the onset of action and the duration of effect. rEV131 is a recombinant version of a naturally occurring immunosuppressive and immunomodulatory protein found in the saliva of ticks.
Flamel Technologies SA, of Lyon, France, announced positive preliminary data from a Phase I/II trial of IFN-alpha-XL in patients infected with chronic hepatitis C virus. IFN-alpha-XL is a long-acting interferon formulation based on Flamel's Medusa drug delivery system and is designed to have enhanced efficacy and reduced toxicity, compared with unmodified or PEG-modified interferon formulations. The trial demonstrated the safety, tolerability and long-acting nature of the product. It also showed that IFN-alpha-XL had a positive impact on viral load and interferon activity biomarkers, and no serious adverse events were reported.
Gentium SpA, of Villa Guardia, Italy, is beginning an independent Phase I/II study at 10 cancer centers in Italy of Defibrotide to treat multiple myeloma. The study is a Phase I/II study designed to assess the safety and the efficacy of Defibrotide with MPT regimen as a salvage treatment in advanced refractory multiple myeloma patients. Defibrotide is a single-stranded DNA that protects the vascular endothelial cells, particularly those of small vessels, from damage and activation, Gentium said.
Glycominds Ltd., said its MS predictor test, based on novel biomarkers detectable in a blood can predict if a patient will develop an active form of multiple sclerosis within two years after the first neurological event. Results will be presented at upcoming conferences. The Glycominds technology predicted future course of the disease.
GW Pharmaceuticals plc, of Salisbury, UK, said Neurology published data from a randomized, placebo-controlled trial showing that its cannabis-based therapy, Sativex, is effective in reducing central neuropathic pain and sleep disturbance in people with multiple sclerosis. The study included 66 patients with moderate to severe pain that was inadequately treated by their existing medication.
Innovata plc, of Nottingham, UK, said the previously unnamed partner for its dry powder delivery system Clickhaler in Europe is Merck KgaA, of Darmstadt, Germany, which recently announced the formation of an international respiratory business unit to consolidate its expertise in this field. Innovata has to date received £6 million (US$10.6 million) in milestones from Merck, and the formation of the new business unit triggered an unspecified payment.
Institute of Systems Biology in Seattle, and Kreatech Biotechnology, of Amsterdam, the Netherlands, have formed an arrangement between Kreatech and the institute for the use of its commercial products. Kreatech's platinum based "Universal Linkage System" (ULS), a non-enzymatic way of labeling nucleic acids with detectable molecules such as fluorophores, has been adopted by a research group and now is the preferred labeling method for both bacterial gene expression profiling and chip on chip assays that have been developed at the ISB.
KeyNeurotek AG, of Magdeburg, Germany, received a certificate from the respective authorities of the State of Saxony-Anhalt to qualify analytical work performed in line with preclinical and clinical programs of its development program, including work done with its Telomics platform technology, according to international good laboratory practice. KeyNeurotek develops treatments for neurodegenerative diseases of the central nervous system.
Large Scale Biology Corp., of Vacaville, Calif., and Icon Genetics AG, of Munich, Germany, completed the research phase of their collaborative program to co-develop a biopharmaceutical product for enzyme-replacement therapy and began its commercial phase. They had been working to apply their gene expression and biomanufacturing resources for such a product, by way of their plant-based platforms. Future details of the agreement were not disclosed.
MerLion Pharmaceuticals Pte. Ltd., of Singapore, and Cancer Research Technology Ltd., of London, entered a large-scale screening program to identify new cancer drug candidates derived from natural product chemistry. MerLion will screen its natural compound collection against high-throughput screens developed by scientists at CRT in order to isolate new therapeutic compounds against validated cancer targets. The results of the collaboration will be jointly owned.
Mesoblast Ltd., of Melbourne, Australia, enlisted Cambrex Corporation Inc., of East Rutherford, N.J., for large-scale production of its proprietary adult stem cells. The cells are being evaluated for the treatment of a range of orthopedic and cardiovascular conditions and will be used in U.S.-based clinical trials. Mesoblast also reported approval to commence the first human orthopedic trial of its adult stem cell technology. Approval from The Royal Melbourne Hospital's Human Research Ethics Committee is for a pilot trial in up to 10 patients suffering from non-union of long bone fractures, which affects up to 2 million people each year in developed countries. The trial will be an independent assessment of the safety of the technology.
Novagali Pharma, of Paris, completed a Phase I trial of Nova12005, its oral, self-micro-emulsifying formulation of paclitaxel, which it is developing for the treatment of taxane-sensitive tumors. The trial was conducted at the Netherlands Kancer Institute in Amsterdam on patients suffering from advanced cancer and showed not only that the product was safe and well tolerated, but also that it was quickly absorbed and had high bioavailability.
OctoPlus Technologies NV, of Leiden, the Netherlands, and Singapore-based SingVax Pte Ltd. are co-developing a single-short Japanese encephalitis vaccine, and hope to begin clinical trials in the next two years. The work will use OctoPlus' delivery systems for the controlled release of drugs and antigens, along with the PER.C6 technology licensed by SingVax from Dutch biotechnology company Crucell NV for the manufacturing of viral particles. Financial terms were not disclosed.
Protherics plc, of London, said it received preliminary approval from the Nasdaq Stock Market to establish a Level II American Depository Receipt program in the U.S. The Bank of New York has been appointed as the depositary bank to administer the ADR program. Trading is expected to begin Tuesday under the ticker symbol "PTIL." The ADRs will trade on the basis of 10 Protherics ordinary shares for every one ADR. Protherics focuses on critical care and oncology.
Qiagen NV, of Venlo, The Netherlands, entered into an agreement to purchase all outstanding shares of Shenzhen PG Biotech Co. Ltd., of Shenzhen, China, a developer, manufacturer and supplier of polymerase chain reaction-based molecular diagnostic kits in China. The transaction is pending Chinese government approval. Qiagen will acquire all of PG Biotech's outstanding shares for about US$14.5 million in cash.
ReNeuron Group plc, of Guildford, UK, held a formal pre-investigational new drug application meeting with the CBER component of the FDA regarding its lead ReN001 stem cell therapy to treat chronic disability after stroke. The company is maintaining its preclinical development timelines and said it will file an investigational new drug application by mid-2006.
Sareum Holdings plc, of Cambridge, UK, entered a collaborative agreement with Infinity Pharmaceuticals Inc., of Cambridge, Mass., to provide protein structure determination capabilities to accelerate Infinity's research. Sareum will provide high-throughput protein expression, purification and structure determination to show how Infinity's drug candidates interact with their target protein receptors. Financial terms were not disclosed.
Synairgen plc, of Southampton, UK, received authorization for a UK Phase I trial of inhaled interferon beta in treating exacerbations of asthma induced by rhinovirus. The trial is based on observations by academic and clinical collaborators at Southampton University that the epithelial cells of asthmatics lack the ability to express interferon beta, which normally eliminates virally infected cells before the virus can replicate and spread. In vitro studies have shown that the addition of interferon beta to asthmatic epithelial cells restores their ability to prevent rhinovirus replicating.
Transgene SA, of Strasbourg, France, voluntarily delisted its American depository shares from the Nasdaq market due to their low trading volume and the growing costs of a dual listing with shares also on the Paris Eurolist markets. They represented less than 1 percent of the company's share capital at the end of last month, it said.
Vernalis plc, of London, signed a contract with Diosynth Biotechnology, of Research Triangle Park, N.C., for process development, scale-up and manufacturing of V10153 for Phase III trials. V10153 is a modified version of human plasminogen, a naturally occurring protein, which, when activated, is responsible for dissolving blood clots in the body.
Viron Therapeutics Inc., of London, initiated the first Phase II trial of its lead anti-inflammatory drug, VT-111, for the treatment of acute coronary syndromes. The trial will enroll 72 patients, with the primary objective of assessing safety though the measurement of major adverse cardiac events, and the detection of any signs and symptoms of drug toxicity. VT-111 is a virally derived biologic that has shown efficacy in preclinical studies against inflammatory-based conditions, including ACS, transplantation and rheumatoid arthritis.
XTL Biopharmaceuticals Ltd., of Rehovot, Israel, closed its license and asset purchase agreement with VivoQuest Inc., of Valley Cottage, N.Y., giving XTL an exclusive license to VivoQuest's intellectual property and technology, including hepatitis C virus compounds and VivoQuest's compound library. Also XTL made a $1.4 million up-front payment by way of issuing about 1.3 million shares. All other amounts to be paid to VivoQuest will be subject to the achievement of certain milestones. Also, members of the VivoQuest's U.S.-based research and development team joined XTL, along with a pair of scientific advisers.