• Abbott Laboratories, of Abbott Park, Ill., supported a study recently published in The Journal of Rheumatology, which showed that Humira (adalimumab) is a safe and effective therapeutic option in patients with active rheumatoid arthritis who have had an inadequate response to standard antirheumatic therapy, including one or more traditional disease-modifying antirheumatic drugs, corticosteroids, nonsteroidal anti-inflammatory drugs and analgesics. The study, called STAR (Safety Trial of Adalimumab in Rheumatoid Arthritis), evaluated the safety and efficacy of the fully human monoclonal tumor necrosis factor-alpha antibody when given with standard antirheumatic therapy. Primary endpoints of adverse events produced no statistically significant differences between the adalimumab and placebo groups. Secondary endpoints, determined by American College of Rheumatology (ACR) response criteria, showed that adalimumab-treated patients compared with placebo-treated patients achieved statistically superior ACR20 (52.8 percent vs. 34.9 percent), ACR50 (28.9 percent vs. 11.3 percent), and ACR70 (14.8 percent vs. 3.5 percent) response rates at week 24 (p=0.001).

• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., said its affiliate, Ribopharma AG, of Kulmbach, Germany, granted RNAx GmbH, of Berlin, a nonexclusive license to provide research services under a fundamental patent in RNA interference. The licensed patent is the first and only issued patent covering the use of short double-stranded RNAs to elicit RNAi, Alnylam said. RNAx will pay initial and annual license fees, as well as royalties on sales of licensed services.

• Athersys Inc., of Cleveland, entered an agreement with Johnson & Johnson, of New Brunswick, N.J., and its 3-Dimensional Pharmaceuticals subsidiary to provide cell lines expressing drug targets for use in certain pharmaceutical development programs. Athersys will provide human cell lines optimized for use in high-throughput screening programs produced with its RAGE (Random Activation of Gene Expression) technology platform. In addition, Athersys and J&J will wind down certain co-development projects established through an earlier alliance between Athersys and 3-Dimensional. Athersys, which intends to use its internal chemistry and pharmacology capabilities to advance its compounds in oncology, asthma and obesity, received a one-time fee related to the agreement.

• AVI BioPharma Inc., of Portland, Ore., said that several institutional investors exercised warrants for the purchase of 1.6 million shares of its common stock at $4.62 per share for gross proceeds of $7.5 million. The warrants had been issued pursuant to a direct equity placement of the company's common stock in December 2003 under its effective shelf registration. The company raised $15 million in gross proceeds in December. (See BioWorld Today, Dec. 5, 2003.)

• ChondroGene Ltd., of Toronto, received a C$1.3 million (US$1 million) payment from Pfizer Inc., of New York, in conjunction with achieving the second research milestone in their joint drug target identification program for osteoarthritis (OA). The first milestone payment was received in April. That payment is in addition to the initial equity investment and the regular quarterly payments being made by Pfizer to support and accelerate ChondroGene's OA biomarker program. ChondroGene entered the collaboration with Pfizer to identify therapeutic targets and biomarkers for OA in October 2002.

• Endomatrix Inc., of Santa Rosa, Calif., reported data from an initial human proof-of-concept study of its first product, Provasca, showing that the oral supplement produced positive effects among healthy, nonsymptomatic subjects. Among the findings, use of Provasca reduced high-sensitivity C-reactive protein levels by 43 percent, lowered blood pressure by an average of 10 mmHg, raised HDL levels by 7 percent and reduced triglyceride levels by 17 percent.

• Enhance Biotech Inc., of New York, completed a 30-patient Phase IIa trial of LI 301 in premature ejaculation. The trial was completed in Europe in collaboration with an international contract research organization with a placebo-controlled, double-blind, randomized crossover design. LI 301 met the endpoint of demonstrating substantial effect against the placebo, the company said. Enhance Biotech is developing a product portfolio focused on two areas of drug development: sexual dysfunction and dermatological indications.

• Exact Sciences Corp., of Marlborough, Mass., said it plans to offer 6 million common shares in a public offering pursuant to an effective shelf registration statement. The company also plans to grant the underwriters an overallotment option to purchase up to an additional 900,000 shares within 30 days after the offering. Merrill Lynch & Co. and UBS Securities LLC are acting as joint book-running managers, while co-managers include Thomas Weisel Partners LLC and Leerink Swann & Co. Exact's stock (NASDAQ:EXAS) fell $2 Tuesday, or 20 percent, to close at $8.

• Genta Inc., of Berkeley Heights, N.J., said terms of its Genasense (oblimersen sodium) commercialization and licensing agreement with Aventis SA, of Strasbourg, France, allow for assignment of work to a successor in the event of a change of control of Aventis, such that the terms of the agreement remain unchanged. Aventis is the subject of a $60 billion takeover plan by Sanofi-Synthelabo SA, of Paris.

• Geron Corp., of Menlo Park, Calif., said the Board of Patent Appeals and Interferences of the U.S. Patent and Trademark Office issued a final judgment ending the patent interference proceeding between Geron and Infigen Inc., of DeForest, Wis. The board awarded judgment in Geron's favor on all counts in the interference. The patent interference was over claims to nuclear transfer technology used to clone animals.

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., said that Pharmatel, a pharmaceutical company focused on gastroenterology and oncology, based in Sydney, Australia, licensed the exclusive rights to register, manufacture, sell, market and distribute Visicol for use in Australia and New Zealand. Pharmatel paid an undisclosed up-front license fee, with additional royalties due to InKine on future sales.

• Insmed Inc., of Richmond, Va., said it was granted a nonexclusive license to patent rights pertaining to the use of an insulin-like growth factor-I therapy for the treatment of extreme or severe insulin-resistant diabetes from Fujisawa Pharmaceutical Co. Ltd., of Osaka, Japan. Insmed will obtain worldwide rights in territories (excluding Japan) where a valid patent claim exists, including the U.S. and Europe. Financial terms were not disclosed.

• Martek Biosciences Corp., of Columbia, Md., entered a new $85 million revolving credit facility, replacing its $10 million revolving line of credit that was set to expire next month. The new credit facility is scheduled to expire on Feb. 1, 2007. Martek develops fluorescent markers for diagnostics, rapid miniaturized screening, and gene and protein detection, among other products.

• NanoCure Corp., of Ann Arbor, Mich., was awarded a contract from the Michigan Economic Development Corp. that provides $187,075 over three years. The contract is part of a $1.2 million award to the University of Michigan at Ann Arbor from the MEDC to develop a drug delivery platform based on patented dendrimer technology exclusively licensed by NanoCure from the university. The funds provided to the company will support costs related to commercialization, including developing applications for clinical testing of the platform and funding to support clinical trials. NanoCure is developing cancer treatments based on dendrimer-targeted drug delivery.

• NicOx SA, of Sophia-Antipolis, France, said that following a review of results from the full Phase II programs of AZD3582, the lead compound in the Cinod class, an independent U.S. clinical consultant advisory board recommended further development in osteoarthritis. The panel agreed that AZD3582 at 375 mg twice daily is an effective treatment for patients with osteoarthritis with analgesic efficacy equivalent to rofecoxib (25 mg once daily) and similar to naproxen (500 mg twice daily). The results also indicated that AZD3582 has an improved gastrointestinal safety profile compared to naproxen.

• Seattle Genetics Inc., of Bothell, Wash., said it plans to offer 7 million common shares in an underwritten public offering pursuant to an effective shelf registration statement. The company also plans to grant the underwriters an overallotment option to purchase another about 1.1 million shares. CIBC World Markets Corp. and Banc of America Securities LLC will act as joint book-running managers, with co-management from WR Hambrecht + Co. Seattle Genetics' stock (NASDAQ:SGEN) rose 4 cents Tuesday to close at $10.70.

• Synthetic Blood International Inc., of Costa Mesa, Calif., said that a preliminary analysis of results from the completed Oxycyte Phase I trial was finished. Oxycyte is a perfluorocarbon-based blood substitute and therapeutic oxygen carrier under development by the company. In line with previous reports, the results showed an excellent safety profile, the company said. The principal adverse reactions that have been seen with PFC-based blood substitutes as a drug class are flu-like symptoms.

• Viral Therapeutics Inc., of Ithaca, N.Y., acquired development rights to a recombinant human protein that inactivates 31 strains of the influenza virus, or all that have been tested, Viral said. Its patent protection extends to parainfluenza and coronaviruses, including severe acute respiratory syndrome. The company said its product, Virusorb, also prevents influenza infection in animal studies, and the company is planning human testing next year.

• Vivascience AG, of Hannover, Germany, said findings published in Proteome Science point to a new method for sample fractionation prior to 2D-Page, showing that its Vivapure prefractionation protocol leads to the detection of three times as many protein spots on 2D-Page when analyzing a fission yeast lysate proteome. The reproducible sample fractionation protocol is based on its Vivapure centrifugal ion-exchange columns. The Vivapure anionic ion exchanger was used to fractionate lysate proteins based on differences in charge.

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