• Access Pharmaceuticals Inc., of Dallas, and SpePharm Holding BV, of Amsterdam, the Netherlands, have signed a definitive licensing agreement under which SpePharm will market Access's product MuGard in Europe. MuGard is Access' proprietary product for managing oral mucositis, a debilitating side effect of many anticancer treatments. MuGard has received marketing allowance from the FDA under a 510(k) procedure. SpePharm will be responsible for marketing MuGard throughout the European Union plus Switzerland, Norway and Iceland, as well as for manufacturing and for obtaining the necessary regulatory approvals for the product in the territory. SpePharm will pay Access an upfront fee and substantial royalties on net sales, but specific terms were not disclosed.

• Alimera Sciences, of Atlanta, and pSivida Ltd., of Perth, Australia, said they have started enrollment for the first human pharmacokinetic study of fluocinolone acetonide.

• Antisoma plc, of London, said results from a single arm Phase II trial of ASA404 in non-small-cell lung cancer undergoing chemotherapy supported earlier data that showed one of the largest increases in median survival data reported in patients with the condition. In the earlier trial, the median survival was 14 months in patients who received a 1,200 mg/m2 dose of ASA404 combined with chemotherapy and of 8.8 months in patients who received chemotherapy alone. Patients in the recent trials received 1,800 mg/m2 dose of ASA404 in combination with chemotherapy.

• Apollo Life Sciences, of Sydney, Australia, entered an agreement to produce human Leukemia Inhibitory Factor (hLIF) for Millipore Corp., of Billerica, Mass.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said it has submitted a marketing authorization application for ceftobiprole for the treatment of complicated skin and soft tissue infections to Swissmedic by its license partner Janssen-Cilag AG, a Johnson & Johnson company.

• Diamyd Medical AB, of Stockholm, Sweden, said it has a pre-investigational new drug meeting with the FDA scheduled later this week to discuss NP2, a pain drug that uses the nerve targeting drug delivery system gene therapy platform. Pending a favorable outcome, Diamyd plans to begin a 12-patient, Phase I trial in cancer pain later this year. The company also plans to begin a Phase III trial with its diabetes vaccine later this year.

• Enigma Diagnostics, of Proton Down, UK, signed an exclusive license agreement with the publicly-funded Defence Science and Technology Laboratory (Dstl), covering a range of real time PCR technologies, for the rapid detection and identification of infectious micro organisms in clinical, environmental and biological samples. This follows the initial license between the two in 2004. The new agreement enables Enigma to sub-license any of the technologies and allows it to develop its own patent portfolio. The deal covers 25 patents and patent applications.

• Gene Logic Inc., of Gaithersburg, Md., entered a drug repositioning and development agreement with Solvay Pharmaceuticals Inc., a division of the Brussels, Belgium-based Solvay Group. Gene Logic will seek alternative development paths for multiple Solvay drug candidates that were discontinued or de-prioritized in clinical trials for reasons other than safety. Gene Logic is entitled to undisclosed milestone and royalty payments in the deal. Gene Logic also has an option to exclusively license any drug candidate for which it identifies a potential new therapeutic use that Solvay chooses not to develop.

• Genentech Inc., of South San Francisco, and partner F. Hoffmann-La Roche Ltd., of Basel, Switzerland, gained approval of Avastin in Europe for the first-line treatment of patients with advanced non-small-cell lung cancer, in combination with platinum-based chemotherapy. Avastin, an antibody designed to specifically inhibit vascular endothelial growth factor, was first approved in 2004 for metastatic colorectal cancer and went on to gain approvals in other indications.

• Kiadis Pharma BV, of Groningen, the Netherlands, enrolled the last patient in its Phase I/II trial of Rhitol in steroid-resistant or intolerant chronic graft-vs.-host disease following bone marrow transplantation. A total of 20 patients were randomized to receive either low or high doses of Rhitol, a small-molecule drug designed to selectively accumulate in reactive immune cells and to eliminate those cells upon photo-activation. So far, 10 patients have completed the six-month treatment period, and the company reported no treatment-related toxicities so far. An end-of-enrollment survey also indicated that Rhitol treatment was beneficial to about 90 percent of the patients who completed therapy. Final results from the study are expected in early 2008.

• MaxCyte Inc., of Gaithersburg, Md., said Yokohama, Japan-based Medinet Co. Ltd. signed an exclusive license, developing and supply agreement to use MaxCyte's cell loading system to support clinical studies and commercialization of Medinet's cancer immunotherapy service in Japan. Under the terms, MaxCyte will provide the right to use its technology in the closed-system manufacturing of Medinet's immuno-cell therapy service in multiple cell processing centers based on optimized protocols developed under the companies' August 2006 collaboration. Financial terms were not disclosed.

• MedImmune Inc., a Gaithersburg, Md., unit of AstraZeneca plc, licensed its reverse genetics technology to Novartis AG, of Basel, Switzerland. Novartis will use the technology to support development and construction of new vaccine strains to produce inactivated human seasonal, pre-pandemic and pandemic influenza vaccines. Reverse genetics is a method by which viruses such as influenza can be generated from segments of DNA, potentially useful tool when dealing with highly infectious pandemic strains. MedImmune will receive an up-front payment and potentially could receive royalty payments under the nonexclusive deal. Separately, MedImmune unveiled new pilot laboratory facility located on the same Gaithersburg site as its headquarters. The facility will provide additional capacity and flexibility.

• Navamedic ASA, of Lysaker, Norway, is acquiring Vitaflo Scandinavia AB, of Gothenburg, Sweden, for SEK90 million (US$13.1 million), comprising SEK54 million in cash and the remainder in shares. The move is the first step in Navamedic's strategy to build an international specialty pharma business. Vitaflo Scandinavia, which markets a portfolio of products throughout the Nordic region, reported earnings before interest taxes, depreciation and amortization (EBIDTA) of SEK3.4 million on revenues of SEK21.9 million during the first half of 2007. Navamedic plans to fund the transaction via a share issue and debt financing.

• Optimer Pharmaceuticals Inc., of San Diego, and Chinese firm C&O Pharmaceutical Technology (Holdings) Ltd. signed a nonbinding memorandum of understanding for the exploration of potential business collaborations in the U.S. and China. The companies intend to jointly explore possible areas of cooperation, including sharing information on preclinical and clinical studies, as well as screening and synthesizing new compounds.

• ProMetic Life Sciences Inc., of Montreal, said its UK-based subsidiary, ProMetic BioSciences Ltd., has achieved key performance milestones for its new MAbsorbent ligands targeted at the purification of monoclonal antibodies and recombinant antibody fragments. The performance of ProMetic's new ligands against set targets was validated in collaboration with seven antibody producer companies in the U.S. and Europe. The ligands are small synthetic molecules engineered to specifically capture and purify antibodies.

• Rosetta Genomics Ltd., of Rehovot, Israel, received U.S. Patent No. 7,250,496, which relates to human microRNA miR-492.

• Speedel Holding AG, of Basel, Switzerland, said partner Novartis AG, also of Basel, received European Union approval of SPP100 (Rasilez) as a treatment for high blood pressure. The European Commission approved Rasilez alone or in combination with other high blood pressure therapies. The approval applies to all 27 EU member states, plus Iceland and Norway. SPP100 was approved in the U.S. by the FDA in March under the trade name Tekturna to treat hypertension both as monotherapy and in combination with other anti-hypertensives. SPP100 (aliskiren) is an oral direct renin inhibitor.

• Virax Holdings Ltd., of Australia, said it has received $1 million from Transgene SA, of Strasbourg, France, under a Transgene-Roche licence agreement for immunotherapeutic product TG4001. Payment was under the terms of the Virax-Transgene agreement announced by Virax in March.

• Vivalis, of Nantes, France, licensed intellectual property and technology from North Carolina State University for producing undifferentiated avian cell cultures using avian primordial germ cells. The deal is Vivalis' third with the university. Terms were not disclosed.

• Digilab Peptidomics GmbH, of Hanover, Germany, was granted a U.S. patent for a panel of biomarkers for the diagnosis of chronic dementia or a predisposition to such diseases using its Peptidomics Technologies.

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