• Affymetrix Inc., of Santa Clara, Calif., launched 179 NimbleExpress prokaryotic array designs, providing researchers with microarray expression products for basic microbiology and infectious diseases. The arrays offer scientists a tool to conduct whole-genome expression studies on a range of pathogenic organisms, including Bacillus anthracis, Haemophilus influenzae and Mycobacterium tuberculosis.

• Amgen Inc., of Thousand Oaks, Calif., priced an offering of $1 billion in 4 percent senior notes due 2009 and $1 billion in 4.85 percent senior notes due 2014. The sale is expected to close Thursday. Amgen estimated that the net proceeds would be about $1.99 billion. It will use the money for open-market purchases of shares under its stock repurchase program and for general corporate purposes, including capital expenditures and working capital.

• BioAlliance Pharma SA, of Paris, said European regulatory authorities designated its doxorubicin Transdrug an orphan product for hepatocellular carcinoma, primary liver cancer. The product is a nanoparticle formulation being evaluated in a Phase I/II trial at seven French sites. The company said it would file this month an application with the FDA to obtain orphan drug designation in the U.S.

• BioBalance Corp., of New York, began enrolling irritable bowel syndrome patients in a randomized, double-blinded, placebo-controlled trial of Probactrix. The study will include about 210 patients to evaluate the product's ability to reduce symptoms of the disease and improve quality of life.

• Bioxel Pharma Inc., of Sainte-Foy, Quebec, said it completed validation of its large-scale paclitaxel manufacturing process at the FDA-inspected site of Aerojet Fine Chemicals in California. The high-containment facility will produce up to 120 kg per year of USP-grade natural paclitaxel.

• Cephalon Inc., of West Chester, Pa., began an offer to exchange its outstanding zero coupon convertible subordinated notes due 2033, first putable in 2008, and zero coupon convertible subordinated notes due 2033, first putable in 2010, for an equal amount of zero coupon convertible subordinated notes due 2033, first putable in 2008, and zero coupon convertible subordinated notes due 2033, first putable in 2010. The new notes will have substantially similar terms to the old notes, except the new ones will be convertible into a mixture of cash and Cephalon common stock, while the old are convertible solely into Cephalon common stock. Also, the new notes will provide for additional rights upon a change of control and offer conversion-price adjustments for any cash dividends.

• Corautus Genetics Inc., of Atlanta, said Circulation published preclinical results of the company's gene-transfer technology administered in combination with cytokines. The technology is being tested in a Phase IIb trial known as GENASIS (genetic angiogenic stimulation investigational study), which is enrolling up to 404 patients with Class III or IV angina in about 20 U.S. cardiac medical centers. In the trial, doses of vascular endothelial growth factor-2 in the form of naked DNA plasmid, are delivered to diseased heart muscle tissue. Results of the preclinical study demonstrated that the combination of VEGF-2 gene transfer and cytokines led to improved oxygenation and increased growth of supplementary vessels in animal models of chronic and acute myocardial infarction.

• Crucell NV, of Leiden, the Netherlands, discovered a monoclonal antibody product for protection against rabies. Specifically, the company's MAbstract technology was used to produce a combination of two human rabies antibodies, and the antibody product demonstrated protection in a hamster model at least equivalent to human rabies immune globulin. The program was completed in collaboration with the Thomas Jefferson University in Philadelphia and the Centers for Disease Control and Prevention in Atlanta.

• Dragon Pharmaceutical Inc., of Vancouver, British Columbia, said its recombinant erythropoietin (EPO) products were approved in the Dominican Republic and Trinidad-Tobago. Also, the health authority of Kosovo accepted an application for approval and under such a circumstance, Dragon's licensee won a bid for government tender. Initial shipment of the products to all three international markets began this quarter.

• Elixir Pharmaceuticals Inc., of Cambridge, Mass., gained a license to intellectual property from the Medical College of Georgia in Augusta relating to NaCT-1, a human ortholog of the longevity gene, INDY. The school's lead researcher said a drug that inhibits NaCT-1 might provide a pharmacological means to reduce fat and cholesterol synthesis and thus enable control of diseases like hyperlipidemia, hypercholesterolemia and obesity. The company already has been researching the INDY gene through an exclusive license it gained in 2002 from the University of Connecticut in Storrs to intellectual property relating to a discovery that down-regulation of the gene doubled the life span of fruit flies and protected them against a range of stressors. Financial terms of the latest license were not disclosed.

• Evogene Ltd., of Rehovot, Israel, entered an agreement with Mertec LLC, of West Point, Iowa, for the development and marketing of soybean seeds with improved traits. The companies will bring newly developed traits from Evogene to the market in soybean varieties developed by Mertec, which will market the co-developed soybean varieties. Financial terms were not disclosed.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., and Ipsogen, of Marseille, France, signed a co-marketing agreement, under which the companies will jointly offer an integrated package of gene-expression and genotyping technologies to developers and marketers of cancer drugs. It combines Ipsogen's Oncogenomic platform for gene-expression profiling with Genaissance's HAP technology and high-throughput genotyping platform.

• Gene Logic Inc., of Gaithersburg, Md., said its wholly owned subsidiary, Gene Logic KK, officially opened its offices in Tokyo to provide sales support and customer service to pharmaceutical customers in Japan. The company hired two technical support managers and is searching for a general manager. More than 30 percent of Gene Logic revenue is from Japanese-headquartered pharmaceutical companies.

• Inpharmatica Ltd., of London, expanded its three-year-old drug discovery collaboration with Serono SA, of Geneva. The companies are developing new secreted proteins identified using PharmaCarta, Inpharmatica's gene-to-candidate platform, from which more than 200 protein sequences have been identified. The expanded arrangement calls for both companies to commit to their characterization and exploitation. Terms include up-front funding for Inpharmatica's research facilities, plus milestones and royalties on any resulting products. Inpharmatica also received $1.5 million for granting Serono additional rights to new protein sequences delivered under the collaboration.

• Inspire Pharmaceuticals Inc., of Durham, N.C., received about $42.3 million in net proceeds after closing its previously reported public offering of about 2.5 million common shares. The total figure included 330,000 shares sold upon exercise by the underwriter, Deutsche Bank Securities Inc., of its overallotment option in full. The shares were sold to the public at $17.10 apiece. (See BioWorld Today, Nov. 12, 2004.)

• JDS Pharmaceuticals LLC in New York completed a $62 million round of financing. The specialty pharmaceutical company, which was founded by Phillip Satow to acquire and develop products in targeted therapeutic markets, already has acquired Lithobid, a twice-daily, sustained-release lithium carbonate, and a related late-stage developmental compound called JDS 103. The financing was led by AIG Healthcare Partners LP and Galen Partners LP.

• Locus Pharmaceuticals Inc., of Blue Bell, Pa., entered a multistage research collaboration with Dow AgroSciences LLC in Indianapolis focused on agrochemicals and biotechnology innovation. Locus will apply its computational technology to discover and develop new small-molecule compounds to treat fungal targets identified by Dow. Specific terms were not disclosed, though Locus could realize certain milestones and royalties and secured an exclusive option to human therapeutic applications.

• Lorus Therapeutics Inc., of Toronto, signed a commercial supply agreement with Diagnostic Chemicals Ltd. operating as BioVectra dcl, of Charlottetown, Prince Edward Island, for the commercial manufacture of Virulizin. Lorus has completed the technology transfer process to BioVectra, and it will scale up to commercial-batch size by the second quarter of 2005. Virulizin is the subject of a fully enrolled global Phase III pivotal trial to treat advanced pancreatic cancer in combination with gemcitabine. Results are expected in the second half of 2005.

• Manhattan Pharmaceuticals Inc., of New York, said findings reported at the North American Association for the Study of Obesity meeting in Las Vegas showed that Oleoyl Estrone's uptake into blood could be detected within minutes following oral dosing, resulting in dose-related increases in its plasma concentration that last for hours. Even at the highest dose levels administered, 50 mg/kg, blood levels resulting from single doses of Oleoyl Estrone fell to background levels within 24 hours. The orally administered small molecule has been shown to cause weight loss without the need for dietary modifications in preclinical animal studies, the company said.

• Novasite Pharmaceuticals Inc., of San Diego, received a $3.4 million, four-year grant from the National Institutes of Health in Bethesda, Md., to support the scale-up of the company's Single Cell Screening technology for parallel screening of more than 100 G protein-coupled receptors (GPCRs). Novasite is using the technology to develop a new class of drugs within the GPCR family called allosteric modulators.

• PerOs Systems Technologies Inc., of St.-Nicolas, Quebec, said it conducted tests combining its Oralject oral drug delivery technology with the USDA's Agricultural Research Service's vaccine developed against the streptococcal disease for tilapia. The protection conferred by the combination product proved higher than any oral administration tested in the past, the company said, adding that detailed results would be published in the next few months.

• ProMetic Life Sciences Inc., of Montreal, said its Mimetic Ligand technology hit a milestone in the company's collaboration with Serono SA, of Geneva. It achieved the purity and yield requirements of Serono and maintained its performance throughout the scale-up process. The project began in March, and ProMetic said it would deliver a complete technology transfer package to Serono by the end of the year, including the provision of quantities of GMP-grade affinity adsorbent. The material can be used by Serono to manufacture larger quantities of a protein for its ongoing clinical trials program.

• Raven Biotechnologies Inc., of South San Francisco, submitted an investigational new drug application to begin a Phase I trial for RAV12, a therapeutic monoclonal antibody, in advanced-stage adenocarcinoma. The open-label, dose-escalation trial for RAV12 is planned to begin enrolling patients after clearance. The multicenter trial will include patients with colon, stomach or pancreatic cancer, or other target antigen-positive adenocarcinomas, including breast, lung and prostate.

• Spectral Genomics Inc., of Houston, introduced its web-enabled SpectralWare, a software suite for the analysis and reporting of data from array Comparative Genomic Hybridization. The webware concept is designed to allow users of SpectralWare to have the latest version of software as soon as it is available.

• Symbollon Pharmaceuticals Inc., of Framingham, Mass., said Canadian regulatory authorities advised it to seek IoGen's approval in that country following product exposure in at least 500 patients. Applicable regulatory guidelines usually require 1,500 patients be exposed to a drug. The specialty pharmaceutical company is developing IoGen for moderate to severe cyclic pain and tenderness associated with fibrocystic breast disease.

• TriPath Imaging Inc., of Burlington, N.C., said data reported at the American Society of Cytopathology meeting in Chicago support the clinical use of biomarkers for the detection of cervical dysplasia and cancer. Data on an early version of the company's formulation of multiple biomarkers demonstrated a sensitivity of 93 percent, a specificity of 92 percent, a negative predictive value of 97 percent and a positive predictive value of 79 percent for biopsy-proved moderate to severe cervical dysplasia in a retrospective cohort of cervical samples.

• Vasogen Inc., of Toronto, reached full enrollment in its 500-patient Phase III Simpadico trial of Celacade (immune-modulation therapy) for the treatment of peripheral arterial disease (PAD). The primary endpoint of Simpadico is the change in maximal treadmill walking distance after six months, which is a primary efficacy endpoint recognized by the FDA and other regulatory authorities for approving treatments for symptomatic PAD.

• Vivus Inc., of Mountain View, Calif., completed a Phase II study of Testosterone MDTS (metered-dose transdermal spray), which is being developed to treat hypo-active sexual desire disorder. The six-month, multicenter, double-blind, placebo-controlled trial enrolled 260 female patients with HSDD. Results will be announced in the first quarter. MDTS delivers a pre-set dose of a formulation of testosterone to the skin, where it is released into the bloodstream on a sustained basis over 24 hours.

• Xanodyne Pharmaceuticals Inc., of Florence, Ky., said its product to treat heavy menstrual bleeding, known as XP12B, was granted fast-track product status by the FDA. The product is in a Phase III program.

• Zyomyx Inc., of Hayward, Calif., appointed Peter Wagner CEO. The company, which works in the protein biochip technology field, also unveiled its new business strategy. Wagner, a founder of the company who has served as its chief technology officer since 1998, succeeds Robert Monaghan. Under the new business model, Zyomyx will enter development agreements primarily aimed at providing its clients with marketable products and technologies.