• Actelion Ltd., of Allschwil, Switzerland, said guidelines published in the Journal of the American College of Cardiology graded Tracleer (bosentan) with the highest level of evidence for treating patients with idiopathic pulmonary arterial hypertension Class III and pulmonary arterial hypertension related to connective tissue disease. The guidance stemmed from an international symposium on pulmonary arterial hypertension. Separately, Actelion and Celltech Group plc, of Slough, UK, modified their license agreement covering Zavesca (miglustat), which is approved for Type I Gaucher's disease in the European Union, U.S., Canada and Israel. Actelion will manage the ongoing or planned clinical trials in the approved indication and trials exploring Zavesca in other glycolipid storage disorders. It also will be responsible for all regulatory and marketing activities, while Celltech will handle manufacturing and receive undisclosed royalties on sales.

• AGT Biosciences Ltd., of Melbourne, Australia, and ChemGenex Therapeutics Inc., of Menlo Park, Calif., completed their merger transaction. Stockholders of both companies approved the merger and merger-related proposals, and closing conditions were satisfied. The combined company will be named ChemGenex Pharmaceuticals Ltd. and will continue trading on the Australian Stock Exchange. In April, the companies said AGT would issue about 28 million shares valued at $10.2 million to ChemGenex shareholders.

• Amrad Corp. Ltd., of Melbourne, Australia, said it would spin out its anti-infectives portfolio into a company called Avexa Ltd. in a demerger to Amrad shareholders, who will be entitled to about 80 percent of the shares of the demerged company, while Amrad will retain about 19.9 percent. It will invest $12 million as initial working capital to complete proof-of-concept animal trials of its three anti-infective research projects. Avexa is planned to list on the Australian Stock Exchange later this year with a market capitalization of $24 million.

• Ardana Bioscience Ltd., of Edinburgh, Scotland, received an exclusive license from Senetek plc, of Napa, Calif., to manufacture and market Senetek's erectile dysfunction drug treatment in the European Union and European Free Trade Area. Ardana assumes full responsibility for completing the European regulatory process for Invicorp and seeking national marketing approvals throughout Europe. The product is approved in Denmark, which has been chosen as the reference member state for mutual recognition in Europe. Senetek will receive royalties based on net sales plus milestone payments upon regulatory approvals in specified major markets and achievement of unspecified cumulative net sales in Europe.

• Ark Therapeutics Group plc, of London, was granted European orphan drug status for Trinam, its vascular endothelial growth factor gene delivery system for preventing blood vessel blocking after vascular graft access surgery for hemodialysis. Trinam consists of a biodegradable collar that is fit around the outside of the vein where it has been joined to the access graft. The product is in Phase II trials in the U.S.

• Basilea Pharmaceutica AG, of Basel, Switzerland, received a second fast-track designation from the FDA for its broad-spectrum, first-in-class antibiotic BAL5788. The additional designation covers hospital-acquired pneumonia including ventilator-associated pneumonia due to suspected or proved methicillin-resistant Staphylococcus aureus (MRSA). BAL5788 is a broad-spectrum cephalosporin antibiotic and has a combination of features resulting in bactericidal activity toward MRSA and penicillin-resistant Streptococcus pneumoniae, in addition to a broad-spectrum profile toward other Gram-positive and Gram-negative pathogens.

• BioMérieux SA, of Lyon, launched an initial public offering on the Premier Marché of the Euronext stock exchange in Paris. Up to 11.5 million existing shares (including an overallotment option of almost 1.5 million shares) are being offered for sale - 10 percent through an open-price public offering in France and the rest through an institutional placement in France and other countries. The company is offering just more than 1 million new shares to its employees at a 20 percent discount off the offer price. An indicative price range of €26.90 to €31.25 per share is proposed for the offering, and at the mid-point figure of about €29.08, the operation would give BioMérieux a capitalization of about €1 million to €1.2 million. BioMérieux and its chairman, Alain Mérieux, have a 70 percent holding in the Strasbourg-based gene therapy company Transgene SA.

• Crucell NV, of Leiden, the Netherlands, and DSM Biologics, of Groningen, the Netherlands, signed a PER.C6 research license agreement with Chiron Corp., of Emeryville, Calif. The license allows Chiron to research and preclinically develop its portfolio of recombinant monoclonal antibody products using Crucell's PER.C6 technology. Crucell and DSM Biologics will receive an up-front payment and annual maintenance fees. Further financial details were not disclosed.

• Debiopharm SA, of Lausanne, Switzerland, and Labopharm Inc., of Laval, Quebec, entered an agreement to conduct research on the oral delivery of a current intravenous cancer drug using Labopharm's polymeric nano-delivery systems technology to address the delivery challenges of water-insoluble compounds, and, potentially, proteins and peptides. The systems are composed of block co-polymers developed specifically for delivery of water-insoluble compounds and poorly bioavailable compounds.

• DeCode Genetics Inc., of Reykjavik, Iceland, completed enrollment in its Phase IIa trial of DG031 for the prevention of heart attack. The trial is designed to examine the effect of various doses of the compound on biomarkers such as C-reactive protein and myeloperoxidase and on the production of leukotrienes. DG031 is designed to inhibit the activity of the FLAP, or 5-lipoxygenase activating protein, which modulates the activity of the leukotriene pathway. The 10-week trial is scheduled to conclude in late August, and the company expects to present results in the fall.

• Evotec OAI AG, of Hamburg, Germany, reported a successful general GMP audit and FDA pre-approval inspection of its cGMP manufacturing facilities to manufacture an undisclosed active pharmaceutical ingredient. Evotec is a drug discovery company that also provides chemical and pharmaceutical development resources.

• ExonHit Therapeutics SA, of Paris, developed an improved formulation of Ikomio, its drug candidate in Phase III trials for the treatment of amyotrophic lateral sclerosis (ALS). The new patented formulation is based on microgranules that ensure a more controlled release of the active ingredient and make the drug easier to swallow. It is the formulation that ExonHit intends to commercialize, and the company has embarked on a bioequivalence study to confirm that it is equivalent to the non-microgranule formulation being used in the Phase III trial. But the study will be initiated only if the initial trial results, expected in the fourth quarter, are positive. ExonHit is planning to file Ikomio for regulatory approval in Europe in the first half of 2005.

• Genmab A/S, of Copenhagen, Denmark, said the FDA accepted its investigational new drug application to start an open-label, dose-escalation Phase I/II study of HuMax-CD20 to treat patients with relapsed or refractory chronic lymphocytic leukemia. Thirty-two patients will be treated for four weeks. The total follow-up period is 12 months from treatment start, and the primary endpoint of the trial is objective response over the period from screening to week 19. Genmab will initiate the study this summer.

The German Ministry of Education and Research allocated an additional €18 million over the next two years for research in the national network for the investigation of microorganism genomes, a program known as GenoMik. The research aims to develop new antibiotics or other therapies against infectious diseases such as tuberculosis. The GenoMik network includes 12 companies and more than 30 academic institutions.

• GW Pharmaceuticals plc, of Salisbury, UK, announced positive preliminary results in two Phase III trials of Sativex, a cannabis extract. In a 125-patient neuropathic pain study there was a statistically significant improvement in pain relief in comparison to placebo. Positive results were obtained also in secondary endpoints including pain disability index, quality of sleep and patients' impressions of improvements. In the 189-patient multiple sclerosis trial there was a statistically significant improvement in comparison with placebo. Another trial is under way in patients with bladder dysfunction due to MS. Sativex is under review by regulators in the UK and Canada, with further information due to be submitted to UK regulators in July to answer outstanding questions.

• H. Lundbeck A/S, of Copenhagen, Denmark, sold its central nervous system product Buronil (melperone hydrochloride) to Ovation Pharmaceuticals Inc., of Deerfield, Ill. Financial terms were not disclosed. Ovation assumes all of Lundbeck's responsibilities for Buronil in Europe, where Lundbeck markets the drug to treat schizophrenia and other central nervous system conditions in 12 countries. Ovation will assess the opportunity to seek approval for Buronil in other European countries, as well as in the U.S.

• Hovione, of Loures, Portugal, and CyDex Inc., of Lenexa, Kan., formed an alliance to develop and commercialize improved formulations of drugs that are off-patent or soon will be off-patent. The collaboration will use CyDex's Captisol technology to develop formulations offering advantages such as improved bioavailability, dissolution and stability. The companies will develop Captisol-enabled formulations of six drugs initially. Hovione is a fine chemicals company that specializes in the process development and manufacture of active pharmaceutical ingredients and regulated intermediates.

• Immuno-Designed Molecules SA, of Paris, postponed its proposed initial public offering. The company, which is developing inmmunotherapeutic products to treat and control cancer, said current market conditions influenced its decision to pull out of its listing on the Nouveau Marche.

• Karo Bio AB, of Huddinge, Sweden, said it would receive a milestone payment as part of its joint collaboration with Wyeth, of Madison, N.J. Wyeth advanced a lead compound from the three-year-old collaboration into predevelopment for atherosclerosis, and the partners agreed to extend the agreement an additional year until Aug. 31, 2005, to discover new treatments for atherosclerosis targeting the liver X receptor.

• NascaCell IP GmbH, of Munich, Germany, won €2.5 million from the European Commission for parallel optimization of new technologies for post-genomics drug discovery. The research project will last three years, and the financial support is part of the European Union's Sixth Research Framework Program. NascaCell is part of a consortium undertaking the research, and the project aims to optimize drug discovery technologies for parallel, rather than sequential, application in developing new oncology targets.

• Nautilus Biotech, of Evry, France, and Serono SA, of Geneva, entered an agreement to develop next-generation therapeutic proteins with improved biological, pharmacological and clinical profiles. Nautilus will apply its technology for improving biotherapeutics to design new protein variants and validate them in vitro and in vivo. Serono would select protein variants created and validated by Nautilus and bring them through preclinical and clinical development to market. Financial terms were not disclosed.

• Oncoscience AG, of Wedel, Germany, the European licensee for Mississauga, Ontario-based YM BioSciences Inc.'s TheraCIM hR3 enrolled the first patient in a 47-patient Phase I/II trial in pediatric glioma. TheraCIM hR3 is a humanized monoclonal antibody targeting the epidermal growth factor receptor. The trial will examine the efficacy of TheraCIM hR3 monotherapy in treating recurring, highly malignant brain gliomas in children.

• Oxford BioMedica plc, of Oxford, UK, said its research collaboration with Viragen Inc., of Plantation, Fla., demonstrated that Oxford BioMedica's lentiviral vectors can be used to generate transgenic chickens with an efficiency 10- to 100-fold higher than other previously published methods. Viragen is working with the Roslin Institute in Edinburgh to develop the technology for the manufacture of pharmaceutical proteins in the eggs of transgenic chickens.

• ReGen Therapeutics plc, of London, released further animal data on its Alzheimer's disease treatment Colostrinin, showing the product enhances memory in newly hatched chickens. The research, carried out at the Open University, will be presented at the Federation of European Neurological Societies meeting in Lisbon, Portugal, in July.

The Royal Society, the UK's national science academy, is putting pressure on the government to strengthen legislation against animal rights extremists. It has written to all UK universities asking how much money they are spending protecting animal research facilities from extremists in order to highlight what the Royal Society says are "the huge costs" nationally of protecting such facilities.

• SanguiBioTech GmbH, of Witten, Germany, said it would jointly develop a hemoglobin wound spray based on its artificial oxygen carrier with an undisclosed German pharmaceutical company. The pharmaceutical firm will acquire knowledge, rights and patents from Sangui, while both partners plan to prepare and promote international regulatory clearance of the wound spray. It would be internationally marketed by the pharmaceutical company, and Sangui would participate in future sales through royalties.

• Sirenade Pharmaceuticals AG, of Munich, Germany, began a Phase I study of its compound SRN-001, a new formulation of dihydroergocryptin (DHEC), an established dopamine agonist with neuroprotective properties. Sirenade is developing the formulation to treat Alzheimer's disease, Parkinson's disease and migraines. The company expects to begin a Phase II study by the end of 2004.

• Sosei Co. Ltd., of Tokyo, received permission to start a Phase I trial in the UK of SOU-001 in oral formulation for stress urinary incontinence. The trial will evaluate the safety, tolerability and pharmacokinetics of single oral doses of SOU-001 in healthy female volunteers. Sosei acquired exclusive worldwide rights for commercialization of the compound. SOU-001 is from Sosei's drug reprofiling platform.

• Teva Pharmaceutical Industries Ltd., of Jerusalem, and Aventis SA, of Strasbourg, France, said the multiple sclerosis therapy Copaxone (glatiramer acetate injection) now is available in Europe in a pre-filled, ready-to-use syringe. Copaxone PFS contains the same active ingredient and dose as the lyophilized form of Copaxone. Aventis said Copaxone has demonstrated sustained effect on both reducing relapse rate and preserving physical function.

The UK Medical Research Council (MRC) announced a £1.5 million (US$2.8 million) funding toward a new center to develop stem cell-based treatments. The center, at Cambridge University, will be co-funded by the Juvenile Diabetes Research Foundation and be directed by Roger Pederson, an American academic who moved to the UK because he considers it a better climate for stem cell research.

• Xenova Group plc, of Slough, UK, received regulatory authorization for its clinical trials manufacturing facility in Cambridge, UK. The approval applies to the company's own products and those manufactured under contract for clients, allowing Xenova to manufacture and release investigational medicinal products in compliance with the new clinical trials directive released last month.

No Comments