• Alltracel Pharmaceuticals plc, of Dublin, Ireland, agreed to acquire London-based Westone Products Ltd. through a reverse takeover. Alltracel's shares were temporarily suspended pending the publication of an Alternate Investment Market admission document. Alltracel said the document was published and is being posted for all shareholders. The shares will begin trading again on AIM.

• Antisense Therapeutics Ltd., of Melbourne, Australia, and Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated a Phase IIa trial of ATL1102 in patients with multiple sclerosis. ATL1102 is a second-generation antisense inhibitor of VLA-4, which has demonstrated positive effects in multiple animal models of inflammatory diseases, including MS. The trial will enroll about 60 patients with relapsing-remitting MS. They will receive 400 mg of ATL1102 or placebo weekly by a subcutaneous injection over eight weeks.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, initiated a head-to-head study comparing the safety and efficacy of Tysabri (natalizumab) to Rebif (interferon beta-1a) in relapsing-remitting multiple sclerosis. The randomized study will enroll more than 1,000 MS patients in North and South America, Europe, Australia, Turkey and Israel. Patients will either receive treatment with Rebif, administered subcutaneously at 44 mcg three times a week, or receive treatment with Tysabri, administered as a 300-mg intravenous infusion once every four weeks. The primary endpoint will compare the effect of Tysabri to Rebif on the rate of clinical relapses. Secondary endpoints include analysis of the proportion of patients remaining relapse-free, MRI brain scans, safety, tolerability and quality of life. Tysabri gained FDA approval in November. (See BioWorld Today, Nov. 29, 2004.)

• Crucell NV, of Leiden, the Netherlands, signed a second PER.C6 license agreement with Chiron Corp., of Emeryville, Calif. The nonexclusive agreement allows Chiron to use the PER.C6 technology in manufacturing alphavirus vectors for its vaccine research programs. Financial details were not disclosed. Separately, Crucell said it received a grant of up to €2 million (US$2.7 million) from the Dutch Ministry of Economic Affairs' SenterNovem program for malaria research and AdVac technology development. SenterNovem is a stimulation program consisting of more than 100 subsidy schemes targeting high technology, energy, the environment, exports and international collaboration.

• Epigenomics AG, of Berlin, identified a set of DNA-methylation biomarkers that correlate with prostate cancer aggressiveness. The research is part of a program to develop a prostate cancer classification test in partnership with Roche Diagnostics, a unit of F. Hoffmann-La Roche Ltd., of Basel, Switzerland. Meeting the milestone triggered an undisclosed payment to Epigenomics, which now has identified biomarkers for all five initial products in its diagnostic collaboration with Roche.

• Flamel Technologies SA, of Lyon, France, signed an agreement with London-based GlaxoSmithKline plc, to provide its Micropump formulation of a marketed GSK drug. Provisions of the agreement include undisclosed payments, and Flamel will not have cash outlays in connection with the equipment used. Flamel's Micropump technology was licensed to GSK for the drug in March 2003.

• Generex Biotechnology Corp., of Toronto, ended its buccal morphine joint venture with Elan Corp. plc, of Dublin, Ireland. As a result, a related agreement will result in the conversion of $14.3 million of Generex preferred stock owned by Elan into Generex common stock at a voluntary conversion ratio of about $25.28 per share, specified in the original terms of the preferred stock. Shares of Generex closed Monday at 65 cents, increasing the company's net worth by $14.3 million.

• GPC Biotech AG, of Martinsried, Germany, announced the achievement of several milestones in its multiyear alliance with Altana Pharma AG, of Bad Homburg, Germany, working with the Altana Research Institute in Waltham, Mass. Payments to GPC Biotech total $1.2 million and will be listed as revenue this quarter. Research milestones included successful performance of LeadCode screens on compounds of interest and the generation of specialized reagents for use in the drug discovery collaborations that are part of the ARI alliance.

• Innogenetics, of Ghent, Belgium, said it achieved its first milestone under a May 2001 research and development collaboration with Roche Diagnostics, a unit of F. Hoffmann-La Roche Ltd., of Basel, Switzerland, regarding the development of a rapid molecular microbiology testing assay. Innogenetics is set to receive a payment of ]5 million from Roche before the end of the year. The agreement also provides for additional milestones to Innogenetics upon completion of specified deliverables defined in the development program, and it would receive royalties.

• Insmed Inc., of Richmond, Va., said it believes recent allegations by South San Francisco-based Tercica Inc. are "without merit," and Insmed intends to "vigorously defend" its "position and right to make SomatoKine." Tercica brought legal action in the UK against Insmed and its contract manufacturer, Avecia Ltd., of Billingham, UK, challenging Insmed's right to make, use and sell its IGF-replacement hormone SomatoKine in the UK. Tercica said the companies are infringing a European patent under which Tercica holds an exclusive license. Insmed also received a cease and desist letter from Tercica regarding certain activities the company is conducting in the U.S. Tercica's legal actions are not expected to delay the filing of Insmed's new drug application for SomatoKine to treat growth hormone insensitivity syndrome.

• MorphoSys AG, of Martinsried, Germany, extended its agreement with Centocor Inc., a Johnson & Johnson company based in Malvern, Pa., until the end of 2007 to develop fully human therapeutic antibodies using MorphoSys' HuCAL GOLD technology. The agreement, initially signed in December 2000 and expected to end December 2005, calls for the companies to begin at least two new antibody development programs in 2005. MorphoSys will receive an up-front payment, and the company said it stands to receive licensing and milestone payments and royalties on any marketed product.

• Norwood Immunology Ltd., of London, filed an investigational new drug application to test its approach to "re-booting" the immune system following bone marrow transplantation. Assuming FDA approval, the Phase II study will start in the first quarter. Norwood's technology revolves evidence that gonadatrophin-releasing hormone (GnRH) encourages the growth of the thymus, leading to increased production of immune-stimulating T cells. The company has partnered with TAP Pharmaceuticals Inc., of Lake Forest, Ill., the largest vendor of GnRH analogues in the U.S. In the trial, Lupron Depot, TAP's GnRH treatment for prostate cancer, will be administered as an adjunctive treatment to assess its ability to rejuvenate the immune systems of patients recovering from bone marrow transplants.

• Pharming Group NV, of Leiden, the Netherlands, said the FDA approved its investigational new drug application for recombinant human C1 inhibitor (rhC1INH). Based on the approval, the company has expanded the clinical development of rhC1INH for the treatment of hereditary angioedema to the U.S. Pharming will assess the safety and efficacy of rhC1INH to treat acute attacks of hereditary angioedema in its U.S. clinical trials; the protocol involves a randomized, double-blinded, placebo-controlled trial. Pharming will test two doses of rhC1INH.

• QLT Inc., of Vancouver, British Columbia, its development partner MediGene AG, of Martinsried, Germany, and its marketing partner Tokyo-based Yamanouchi Pharmaceuticals Co. Ltd. completed the mutual recognition procedure and gained approvals in 24 of 26 countries throughout Europe for the Eligard one-month, 7.5-mg, and three-month, 22.5-mg, products. Each of the European Union member states gained market approval for the product using the approvals obtained for Eligard a year ago in Germany as a reference. Yamanouchi launched the products in Germany in May. Eligard works by lowering the levels of testosterone in the body, which might result in a reduction of symptoms related to prostate cancer.

• Sinovac Biotech Ltd., of Beijing, entered a financial advisory agreement with Credit Suisse Advisory Partners AG for the subsidiary of the Zurich, Switzerland-based Credit Suisse Group to act as the company's financial adviser. Sinovac has three vaccines that have completed all clinical trials, including a flu vaccine for which the company will seek approval in 2005, and a vaccine designed to prevent severe acute respiratory syndrome that is undergoing clinical testing.

• SkyePharma plc, of London, issued a filing stating its intention to acquire nearly 11.2 million shares of Fairfield, N.J.-based Astralis Ltd., which would give it a 49.8 percent interest, and its intention to seek the right to appoint two members to the company's board. Astralis said its board opposes SkyePharma's filing and released a statement that the board is committed to protecting the best interest of its stockholders. Astralis' product, Psoraxine, designed to treat psoriasis, is in Phase II trials.

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