• Active Biotech AB, of Lund, Sweden, said it stood to gain a payment of up to US$10 million from PowderJect Pharmaceuticals plc, of Oxford, UK, following a positive review of the travelers' diarrhea vaccine Dukoral by the Committee for Proprietary Medicinal Products of the London-based European Medicines Evaluation Agency. Provision for the payment was a condition of the sale of its SBL Vaccin AB unit to PowderJect in 2001. Active Biotech also would receive royalties on annual sales above US$40 million, subject to a maximum amount of US$20 million.
• Ben Gurion University professor Leslie Lobel, of the department of virology, initiated an international collaboration to control deadly infectious diseases like smallpox and the Ebola virus through the use of human antibodies. It has gained "substantial funding" from New York-based Acceptys Inc., which is immortalizing antibody-producing human lymphocytes through its human hybridoma technology; and, from Ben Gurion University-affiliated B.G. Negev Technologies in Beer-Sheva. Robert Downing, a research physician in the Uganda Virology Research Institute, is collecting peripheral blood lymphocytes from survivors of the Ebola outbreak in Gulu, Uganda; and research at Columbia University in New York that Lobel started with colleague Ilya Trakht and his research team before coming to Israel continues.
• Biotie Therapies Oyj, of Turku, Finland, said it was seeking a new development partner for its bioheparin project, following the recent termination of an agreement with Inalco SpA, of Milan, Italy. Biotie and Inalco have entered a "freedom-to-operate" agreement, which allows each company to operate independently and to exploit commercially the intellectual property rights associated with the program. As part of the agreement, Biotie said it gained royalty-free, global, nonexclusive access to three Inalco patents.
• BTG plc, of London, said its licensed rights to two compounds to treat anxiety and depression to Abiogen Pharma SpA, a private Italian company, for an initial £2 million (US$3.2 million) and development milestones and royalties on sales. The compounds are the first in a new class of nonsedating, nonaddictive drugs that BTG acquired, along with several others, from the universities of Bradford, Reading, Southampton and Sussex. BTG1640 recently entered Phase I at Abiogen for the treatment of clinical anxiety states, including panic disorder, while BTG 1675A is in preclinical development for the treatment of depression.
• Cardion AG, of Erkrath, Germany, licensed its product CRB-15 to Hoffmann-La Roche Inc., of Nutley, N.J., for up-front and milestone payments that could total $90 million. The compound has not yet entered clinical testing, but Cardion has been investigating its potential in both transplant rejection and rheumatoid arthritis. Cardion has said that the compound has potential in other autoimmune diseases as well. Roche will develop CRB-15 and hold global commercial rights. The companies declined to specify the financial details of the deal, but beyond up-front and milestone payments, Cardion would receive royalties on future sales.
• Codon AG, of Berlin, has suspended Chairman Karl-Gerd Fritsch. Following the resignation of one of its supervisory board members earlier this month, the chairman's suspension will be formally addressed at an extraordinary shareholders' meeting called for Aug. 11. That meeting will also vote on appointing Bernd Wegener to the open supervisory board position, restoring the legal minimum number of members to the board. Wegener is chairman of Brahms AG and also chairman of the German Pharmaceutical Industry Association. Codon was founded in 1993 and specializes in cell-based biomedical products for the regeneration of cartilage, bone and intervertebral discs.
• The Genopole, France's national biotechnology science and business park in Evry, has signed a collaboration agreement with two Taiwanese organizations, the Industrial Technology Research Institute (ITRI) and Phalanx Biotech Group Inc., covering the exchange of information on research and development into DNA chips. ITRI and Phalanx Biotech will inform the Genopole about their DNA chip development programs and take advantage of its high-density DNA chip verification and testing know-how. Genopole Managing Director Pierre Tambourin said gaining access to Taiwanese know-how will enable French companies to accelerate the development of new DNA chips.
• Medarex Inc., of Princeton, N.J., increased its shareholding in Genmab A/S, of Copenhagen, Denmark, to 32 percent, following the issue of 246,914 new shares in a directed offering to the former company's subsidiary GenPharm International Inc. The transaction arises from a technology licensing agreement the companies entered in 2000, concerning Medarex's transgenic mouse platform. That requires Genmab to pay Medarex US$2 million in cash or an equivalent amount in shares annually, through 2004. Medarex now holds about 7.35 million of Genmab's 22.96 million outstanding shares.
• MedPharma plc, of Charlbury, UK, said its initial public offering, originally touted for May and then postponed until July, has been further delayed. A spokeswoman told BioWorld International the placing on London's Alternative Investment Market to raise £8 million "doesn't seem likely to go ahead in the immediate future." MedPharma has six sexual dysfunction and urology products in its portfolio, including Roche BDM, a treatment for bladder dysfunction in males and females, being developed in a joint venture with F. Hoffmann-La Roche Ltd.
• ML Laboratories plc, of Warrington, UK, said it entered a research license agreement with Antisoma plc, of London, giving Antisoma the right to use its gene expression technology, Ubiquitous Chromatin Opening Elements (UCOE), to accelerate and improve expression of a number of Antisoma's preclinical product candidates. UCOEs are DNA elements that enhance and stabilize the expression of proteins in mammalian cells by preventing gene silencing. Terms were not disclosed.
• MorphoSys AG, of Munich, Germany, reported positive results from its research cooperation with Schering AG, of Berlin, into the effectiveness in animal models of an antibody from MorphoSys against an oncology target provided by Schering. The antibody showed effects in in vitro tests, and it also showed tumor-specific accumulation in mice. The tests were part of a collaboration between the companies begun in December 2001. The collaboration encompasses five different antibody programs and concentrates on oncology.
• NeuroSearch A/S, of Ballerup, Denmark, said it commenced a U.S. Phase II clinical trial of NS2359 in 100 adults with attention deficit hyperactivity disorder. Trial participants will receive either placebo or 0.5 mg of NS2359 per day over an eight-week period. NS2359, according to NeuroSearch, improves the functioning of the neurotransmitters dopamine, noradrenaline and serotonin in regions of the brain associated with attention, concentration and memory. Existing therapy, which is mainly confined to children, is based on the administration of amphetamine or methylphenidate. The market for this indication was worth approximately US$1 billion in 2001, but is expected to increase considerably, the company said, as clinical studies have shown that adult patients can also benefit from treatment.
• Newron Pharmaceuticals SpA, of Bresso, Italy, received an FDA IND approval for evaluating safinamide in Parkinson's disease. The company plans to conduct a Phase I clinical trial in 12 healthy volunteers, under the direction of Hans Georg Eichler of the University of Vienna, Austria. The main purpose of the study is to confirm that no dietary restrictions are required during safinamide treatment. Efficacy studies would then follow in the U.S. The compound has several modes of action, including inhibition of monoamine oxidase B, dopamine reuptake inhibition, sodium channel-blocking activity and calcium channel modulation. It is already undergoing several Phase II clinical trials in Parkinson's disease and epilepsy in Europe.
• Pieris Proteolab AG, of Freising, Germany, and the Technical University of Munich began a research alliance to investigate lipocalins and anticalins. The latter are a new class of engineered proteins based on the lipocalin scaffold, and offer a potential alternative to antibodies. Arne Skerra, who invented the technology, is head of the university's department of biochemistry and a co-founder of Pieris. The university has assigned the company two key patents, and additional intellectual property will either be licensed or granted to Pieris. The company will make milestone and royalty payments to the university.
• Protherics plc, of Runcorn, UK, saw its shares rise 8 percent last week to 27.25 pence after the company announced strong growth of its two marketed antibody products, CroFab for the treatment of rattlesnake bites and DigiFab for the treatment of toxic effects of the heart drug digoxin. Sales of CroFab were up 70 percent to £8.5 million (US$13.8 million) in the year ended March 31, while in its first full year on the market DigiFab sales reached £1.2 million. Overall turnover was up by 64 percent at £11.3 million, and the company traded profitably in the second half of the year.
• Serono SA, of Geneva, reported a 33.8 percent jump in revenues (to $508.4 million) in the first half of 2003, leading it to revise up its forecasts for revenue and earnings growth in 2003 to 20 percent (from 15 percent to 20 percent). Its strong first-half performance was largely due to a 62.3 percent jump in sales of Rebif, its multiple sclerosis drug, which were $199 million worldwide. Separately, Serono announced positive results from two studies that evaluated the long-term safety and efficacy of Raptiva (efalizumab) as a treatment for moderate to severe plaque psoriasis in adults. Data at 24 weeks from a randomized, double-blind, placebo-controlled Phase III trial indicated that 44 percent of patients receiving continuous weekly Raptiva treatment showed a 75 percent or greater improvement in Psoriasis Area and Severity Index scores (and 67 percent after 84 weeks of treatment).
• Sygen International plc, a specialist in applying genetics and biotechnology to animal breeding, said it is relocating its head office from Berkeley, Calif., to the UK, and changing its board structure to reflect its increasing focus on the use of genomics in animal breeding. Sygen is listed on the London Stock Exchange, with most of its shareholders in the UK. CEO Phil David and CFO John Adams are to relocate from the U.S. to the new headquarters in Oxfordshire, UK.
• Techno Venture Management, of Munich, Germany, and Boston, promoted two principals to partners in the firm. David Poltack, part of the company's finance team in Boston, has been made one of 13 general partners. Poltack joined TVM in 2000 from PricewaterhouseCoopers' office in Boston. Axel Polack, part of TVM's life science team in Munich, is a venture partner. Polack also joined the company in 2000, coming from Innovative Technologies Neuherberg GmbH, where he had been general manager. In addition to his work with TVM, Polack is an assistant professor at the Ludwig Maximilian University of Munich.
• Xenova Group plc, of Slough, UK, gave an update on the restructuring of its R&D operation that was precipitated by the axing of Phase III studies of its lead product, tariquidar, in May 2003. Staff has been cut from 107 to 66, and all preclinical programs, apart from those funded by a partner, have been parked. Xenova's partner, QLT Inc., of Vancouver, British Columbia, is still in the process of conducting a review of the unblinded clinical data on more than 300 cancer patients who were treated with tariquidar, an adjunctive treatment designed to reverse resistance to chemotherapy. QLT also announced it was terminating a Phase II study of tariquidar in breast cancer after recruiting 17 patients. Preliminary analysis of 11 patients showed that reversal of resistance was achieved in only one.
• XTL Biopharmaceuticals Ltd., of Rehovot, Israel, received US$1.2 million from the Office of the Chief Scientist of the Ministry of Industry and Trade, the first installment of its approximately $4.3 million award that had been suspended two months ago on fears that XTL would be taken over by the foreign entity, Shore Capital. The reinstatement of the award, including scheduled payments of the remainder of the grant, was confirmed by the OCS since the young company had shown in writing that it had not only repelled the hostile bid but was clearly focused, trimmed down and ready to follow through on bringing its Israel-based research discoveries to the medical market, and that its R&D and intellectual property were remaining in Israel, said XTL CEO Martin Becker. He pointed out that XTL's first two HepeX proto-drugs for viral hepatitis were in Phase II clinical trials.