• Amgen Inc., of Thousand Oaks, Calif., received support for its product Enbrel. A study published in the Nov. 20, 2003, issue of the New England Journal of Medicine indicated that people with moderate to severe plaque psoriasis treated with etanercept (Enbrel) experienced significant clearing of skin lesions within the first two weeks of taking the medication. The study showed, among other things, that 49 percent of people taking a high dose of Enbrel (50 mg twice weekly) achieved clear or almost-clear skin at week 12, which was the primary endpoint. Clear or almost clear skin is similar to an improvement of at least 75 percent from baseline in the PASI scoring system, also known as PASI 75. The results continued to improve, with nearly 60 percent of patients taking that dose achieving clear or almost-clear skin at six months. The study involved a total of 652 psoriasis patients. Enbrel targets tumor necrosis factor. It was first approved for rheumatoid arthritis.

• Amrad Corp. Ltd., of Melbourne, Australia, said it received its first $3 million milestone payment under its exclusive license and research collaboration with Merck Sharp & Dohme Pty Ltd., the Australian subsidiary of Merck & Co. Inc., of Whitehouse Station, N.J. That brings the total amount received by Amrad to $8 million since the agreement was signed in June 2003. At that time, the companies entered one of the largest biotechnology collaborations in Australian history with potential milestones of up to $112 million, plus royalties. The collaboration is to develop drugs with therapeutic potential in areas such as asthma and other types of respiratory disease and oncology.

• Avant Immunotherapeutics Inc., of Needham, Mass., received notification from the U.S. Department of Agriculture of the licensure of its MeganEgg vaccine for use in breeding and laying hens. MeganEgg is a double gene-modified vaccine for use in commercial breeders and egg-layers to protect against infection from Salmonella bacteria that is known to contaminate eggs. Lohmann Animal Health International will distribute MeganEgg exclusively in North America. The primary objective of the vaccine is elimination or reduction of Salmonella enteriditis levels in chickens, particularly found in eggs, the birds and their poultry house.

• BCY LifeSciences Inc., of Toronto, said analysis of its Phase II trial designed to evaluate the efficacy and safety of DCF 987 in the treatment of cystic fibrosis shows the candidate is well tolerated and might have shown positive trends in lung function and reduction of Pseudomonas aeruginosa bacterial load in patient sputum. The Phase II trial assessed twice-daily 500- or 1,000-mg doses of inhaled DCF 987 on pulmonary function in adult patients.

• BioMarin Pharmaceutical Inc., of Novato, Calif., said it expects to begin clinical trials next year to study Phenoptin (6R-BH4), an enzyme cofactor that is a second-generation, oral form of tetrahydrobiopterin, for phenylketonuria (PKU). To support such development, BioMarin entered a development and manufacturing agreement with Merck Eprova AG, a wholly owned subsidiary of Merck KGaA, of Darmstadt, Germany. Merck Eprova will supply Phenoptin to BioMarin for clinical trials and potential commercial operations. The partners will share process development and clinical manufacturing costs, and BioMarin will own and develop the 6R-BH4 product for PKU and other genetic disease indications. BioMarin will pay Merck Eprova a royalty on commercial sales of Phenoptin for PKU or related indications.

• Devgen NV, of Ghent, Belgium, was awarded €1.9 million (US$2.3 million) from the Flemish government. The Flemish Institute for the Promotion of Industrial Scientific and Technological Research awarded the grant to further develop Devgen's technology to identify the mechanism of action of human drugs.

• Enzon Pharmaceuticals Inc., of Bridgewater, N.J., will collaborate with the National Institutes of Health in Bethesda, Md., in a Collaborative Research and Development Agreement. The CRADA is in the final stages of approval at the NIH, Enzon said. The program will center on the recombinant immunotoxin SS1P. Enzon and the National Cancer Institute (NCI) plan to initially develop SS1P in pancreatic and ovarian carcinomas. Phase II trials are set to start in the second half of 2004. The compound is in Phase I development at the NCI. Responsibility for development of the SS1P compound will be shared between Enzon and the NCI. Financial terms were not disclosed.

• Genentech Inc., of South San Francisco, and Xoma Ltd., of Berkeley, Calif., said study results to be published in the Nov. 20, 2003, issue of the New England Journal of Medicine show patients with moderate to severe plaque psoriasis receiving 12 weeks of treatment with Raptiva (efalizumab) experienced a significant reduction in the signs and symptoms associated with psoriasis. Also, most patients who received extended treatment to 24 weeks continued to benefit. Raptiva is approved to treat continuous control of chronic moderate to severe plaque psoriasis. The results are from one of four randomized, placebo-controlled Phase III studies that were included in the companies' marketing application.

• Gen-Probe Inc., of San Diego, and DiagnoCure Inc., of Quebec City, Canada, signed a license and collaboration agreement under which they will develop a urine test to detect a new, highly specific genetic market for prostate cancer. The test will detect a recently described gene called PCA3(DD3) that has been shown in studies to be overexpressed only in malignant prostate tissue. Gen-Probe will pay DiagnoCure an up-front fee of $3 million and future fees and contract development payments of up to $7.5 million over the next three years. Gen-Probe will receive exclusive worldwide rights to diagnostic products resulting from the agreement, and will pay DiagnoCure royalties of 8 percent on cumulative net product sales of up to $50 million, and royalties of 16 percent on cumulative net sales above $50 million. Gen-Probe will market the test.

• Icagen Inc., of Research Triangle Park, N.C., and Abbott Laboratories, of Abbott Park, Ill., extended their research and development agreement to discover and develop small-molecule drugs that target a specific ion channel for the treatment of neuropathic and inflammatory pain. The renewal provides for continued research and development funding by Abbott. The deal was originally signed in 1997. (See BioWorld Today, Dec. 9, 1997.)

• Incara Pharmaceuticals Corp., of Research Triangle Park, N.C., said its stockholders approved a reorganization of the company. The reorganization consists of the merger of Incara into one of its wholly owned subsidiaries. The reorganization will result in the conversion of Incara's Series C preferred stock into common stock of the merged company, conversion of a $3 million bridge loan into common stock of the merged company, and conversion of Incara's Series B preferred stock into nonvoting common stock equivalent shares of the merged company. Incara common stock will be converted into common stock of the merged company, which will continue to trade as Incara Pharmaceuticals Corp. under the same symbol "INCR." Shares outstanding after the reorganization will total about 52.4 million shares of common stock and common stock equivalent shares. The company has had ongoing financial difficulty. (See BioWorld Today, Oct. 23, 2002, and Jan. 16, 2003.)

• Inveresk Research Group Inc., of Cary, N.C., priced a public offering of 10 million shares of its common stock at $20 per share. The offering is composed of 9 million shares being offered by various selling shareholders and 1 million shares being offered by Inveresk. The underwriters have been granted a 30-day option to purchase up to an additional 1.5 million shares from certain of the selling stockholders to cover overallotments. Inveresk is a provider of drug development services to companies in the pharmaceutical and biotechnology industries.

• Isolagen Inc., of Houston, received data from an independent clinical research organization demonstrating positive results from patients treated with the Isolagen Process in the UK. Isolagen collected response data from 59 patients randomly chosen from a total of about 400 patients treated to date in the UK with the process. Results indicated that 73 percent of sampled patients tested demonstrated positive results even in the first two months of therapy while still receiving injections. All patients who received the process for six months or longer had positive results.

• Kos Pharmaceuticals Inc., of Miami, raised net proceeds of about $157 million through an offering of 5 million common shares priced at $44.25 apiece. As previously reported, the company sold 3.75 million shares, with the remainder offered by a selling shareholder. In addition, the underwriters have an option to purchase, at the offering price, up to another 650,000 shares from Kos and 100,000 shares from another selling shareholder. Kos will not receive any proceeds from the sale of shares by the selling shareholder. The offering is scheduled to close Nov. 25.

• Medicure Inc., of Winnipeg, Manitoba, received FDA and Canadian regulatory approval to begin a Phase II study to treat up to 900 patients with its lead compound, MC-1. The study, to be called MEND-CABG, will evaluate the ischemic reperfusion and neuroprotective effects of MC-1 in patients undergoing high-risk coronary artery bypass graft surgery. The primary efficacy endpoint is the reduction of the combined incidence of cardiovascular death, nonfatal heart attack and nonfatal stroke, up to and including postoperative day 30. Separately, Medicure said patient enrollment in its Phase II trial of MC-4232 for hypertension was progressing well, with results expected during the first quarter of next year.

• MedImmune Inc., of Gaithersburg, Md., said animal data published in the Nov. 15, 2003, issue of Cancer Research demonstrated proof of principle for using antibodies targeting the protein EphA2 as a potential treatment for certain cancers. More specifically, data showed that certain antibody-binding sites on EphA2 are selectively available on cancerous cells but are not accessible on normal cells. The study also showed that delivering anti-EphA2 antibodies at a level of 6 mg/kg results in substantial decreases in tumor growth in mice models.

• Mpex Pharmaceuticals Inc., of San Diego, and Mixture Sciences Inc., also of San Diego, entered a research collaboration that uses Mixture's combinatorial libraries to identify lead compounds appropriate for antibacterial development by Mpex. Mpex is pursuing the discovery of broad-spectrum antibiotics that meet the need created by multidrug-resistant bacterial pathogens. To identify the agents, Mpex is using its assay technology to screen sources of diversity to identify agents that have activity against the Mpex targets.

• Nanoscience Technologies Inc., of New York, licensed certain DNA nanotechnology inventions and intellectual property from New York University in exchange for at least about $1.7 million through 2007, and additional fees and expenses. An initial payment of $300,000 has been paid to NYU, which granted Nanoscience an exclusive worldwide license to develop, manufacture, use, lease or sell any licensed products and/or processes related to the research project, together with the right to grant sublicenses. Nanoscience, which will pay NYU a royalty fee of a varying amount from sales of products and for sublicenses, also issued common shares to the school.

• Norak Biosciences Inc., of Research Triangle Park, N.C., reported scientific validation of Transfluor technology for use in deorphanizing G protein-coupled receptors. An article describing the role of Transfluor in ligand identification of three Drosophila melanogaster orphan GPCRs was published in the Oct. 10, 2003, issue of the Journal of Biological Chemistry.

• NPS Pharmaceuticals Inc., of Salt Lake City, said preliminary results from a two-year rat carcinogenicity study of Preos helped it identify a noncarcinogenic dose of the full-length human parathyroid hormone drug candidate being developed for osteoporosis. The study was a component of a standard toxicology package for submission with the product's new drug application. More specific data showed no difference in the incidence of osteosarcoma seen in the low-dose and control arms of the study. NPS also found that a dose-related increase in the incidence of osteosarcoma occurred in the mid- and high-dose arms of the study, but at rates that appear to be lower than those observed in published carcinogenicity studies using teriparatide (Forteo, Eli Lilly and Co.). NPS added that the findings also confirm the positive effects of Preos on bone seen in other animal studies and in clinical trials. The company said it continues to compile its Phase III results and plans to submit its NDA next year.

• Orphan Medical Inc., of Minneapolis, met with the FDA concerning an investigational new drug application. The company will now write a protocol to accompany an investigational new drug application to the FDA for Xyrem to treat fibromyalgia syndrome. Orphan expects IND approval in the first quarter of 2004, with patient enrollment beginning in the second quarter.

• Paradigm Genetics Inc., of Research Triangle Park, N.C., signed a fungicide evaluation agreement with Bayer CropScience AG, of Leverkusen, Germany, whereby Bayer will test a select number of chemical compounds validated in Paradigm's fungicide screening program. The testing will take place at Bayer's research headquarters in Monheim, Germany. Financial terms were not disclosed. If the screening tests are successful, Bayer has the option to enter an exclusive licensing agreement with Paradigm to develop the lead chemicals into commercial fungicides.

• Peplin Biotech Ltd., of Brisbane, Australia, acquired a portfolio of potential therapeutic products comprising new, synthetic, engineered polyunsaturated fatty-acid compounds. The compounds are the product of an extensive research program at the Women's & Children's Hospital in Adelaide, Australia. In the deal, Peplin secures the rights to 44 compounds and 41 patent filings, represented by seven patent families, including five granted U.S. patents covering molecular structures and their use as human therapeutics.

• Plexxikon Inc., of Berkeley, Calif., and Phenomix Corp., of San Diego, formed a drug discovery collaboration focused on the development of small-molecule drugs for the treatment of oncology, inflammation and other diseases. The companies will jointly develop a series of new compounds that inhibit c-Kit, a gene target in the protein kinase family. Plexxikon will apply its Scaffold-Based Drug Discovery platform to develop the small molecules and Phenomix will evaluate potential leads for early demonstration of in vivo efficacy, pharmacology, preclinical analysis and compound re-profiling.

• Pluristem Life Systems Inc., of Haifa, Israel, said its scientific team has identified new information about the company's 3-D culture technology for stem cell expansion without differentiation vs. the conventional 2-D cultures presently used in research. The scientists documented success in building a 3-D replica of the physiological bone marrow environment and in proving that the 3-D structure is essential for the support of hematopoietic stem cells (HSCs). The company's core technology is designed to expand HSCs for bone marrow transplantations using its 3-D PluriX bioreactor.

• Reliant Pharmaceuticals LLC, of Liberty Corners, N.J., signed a definitive agreement to acquire the U.S. rights to the Rythmol (propafenone HCl) product family from Abbott Laboratories, of Abbott Park, Ill. Rythmol is an anti-arrhythmic that has been on the market for more than 12 years. A new extended-release formulation, Rythmol SR, was approved by the FDA in September. In patients without structural heart disease, Rythmol is indicated to prolong the time to recurrence of symptomatic paroxysmal atrial fibrillation and symptomatic paroxysmal supraventricular tachycardia. Financial terms were not disclosed.

• SkyePharma plc, of London, submitted an application to the UK Medicines and Healthcare Products Regulatory Agency for approval of DepoMorphine, its sustained-release injectable formulation of morphine for control of moderate to severe post-operative pain. If granted approval, SkyePharma intends to seek approval in other European countries under the EU's mutual recognition procedure. SkyePharma submitted a new drug application for DepoMorphine to the FDA in July.

• Tm Bioscience Corp., of Toronto, said the Mayo Foundation in Rochester, Minn., signed a five-year master purchase agreement for the company's line of genetic tests. The foundation agreed to purchase the Tag-It Mutation Detection Kit for CFTR (cystic fibrosis gene). The kit is designed to identify the 40 most common genetic mutations in the gene. The agreement also will enable Mayo to purchase additional tests from Tm as they are commercialized. The tests will be used by Mayo Medical Laboratories, which is a lab testing and interpretive service for Mayo and medical centers and hospitals, and Mayo's Molecular Genetics Laboratory, which is an international reference laboratory.