• Abbott Laboratories, of Abbott Park, Ill., submitted a supplemental biologics license application with the FDA and a Type II Variation with European authorities to market Humira (adalimumab) as a treatment for ankylosing spondylitis. Abbott also said the FDA approved Humira for reducing the signs and symptoms of active arthritis in patients with psoriatic arthritis and as a first-line treatment for patients with moderate to severe rheumatoid arthritis. The European Medicines Agency granted similar approvals in August.

• Acura Pharmaceuticals Inc., of Palatine, Ill., received notice from the FDA recommending that certain nonclinical studies be conducted prior to starting further clinical testing of its product, Candidate No. 2. The company said it is suspending the initiation of future trials for this product until it is able to fully evaluate the basis for, and the implications of the FDA's recommendations.

• Adventrx Pharmaceuticals Inc., of San Diego, licensed from SD Pharmaceuticals Inc., of Carlsbad, Calif., certain rights to ANX-530, an emulsion formulation of vinorelbine tartrate that has demonstrated in preclinical testing a reduction in vein irritation following repeated I.V. injections, compared with Navelbine (GlaxoSmithKline plc). Under the terms, Adventrx gets exclusive U.S. rights to the product and all future intellectual property related to vinca alkaloid formulations. Further financial details were not disclosed. Adventrx said it plans to pursue a 505(b)2 regulatory path for ANX-530, and has initiated discussions with the FDA for the clinical trial design. A pre-investigational new drug application meeting is set for December.

• Affibody AB, of Stockholm, Sweden, and Funakoshi Co. Ltd., of Tokyo, formed an agreement in which Funakoshi will promote and distribute Affibody's biotechnology products in Japan. Affibody has a new class of affinity ligands Funakoshi will sell in Japan. Financial terms were not disclosed.

• Affymetrix Inc., of Santa Clara, Calif., reported that GlaxoSmithKline plc, of London, selected the Affymetrix GeneChip Human Mapping 500K Array Set to find the genetic variations associated with diseases. GSK will use the arrays to perform whole-genome association studies.

• Astellas Pharma Inc., of Tokyo, and MerLion Pharmaceuticals Pte. Ltd., of Singapore, formed a collaborative agreement to discover and develop new drug candidates derived from natural products chemistry. MerLion will receive a pipeline of validated drug targets from the Astellas portfolio and will use its extensive natural sample collection and other technology for the identification of new chemical seeds.

• Avexa Ltd., of Victoria, Australia, said it received encouraging feedback during a meeting with the FDA regarding the development plan for its HIV/AIDS drug candidate, AVX754. The company expects to be able to move into Phase III after completing an ongoing Phase IIb trial, the results of which are expected during the first quarter of 2006.

• Bavarian Nordic A/S, of Copenhagen, Denmark, submitted a proposal to the U.S. Department of Health and Human Services to manufacture and supply 20 million doses of its Imvamune smallpox vaccine to the strategic national stockpile. The HHS provided requirements in August for companies to submit vaccine supply proposals, and is expected to make a decision on the contract award or awards in February 2006. Imvamune is a third-generation smallpox vaccine that has received fast-track status from the FDA.

• Benitec Ltd., of Mountain View, Calif., said the lawsuit with Nucleonics Inc., of Horsham, Pa., has been dismissed without prejudice to future rights. Benitec filed a motion to dismiss the suit in light of the Supreme Court's recent decision in Merck KGaA vs. Integra Lifesciences Ltd. In March 2004, Benitec sued Nucleonics for infringement of U.S. Patent No. 6,573,099 covering Promega.

• BioGenex Laboratories Inc., of San Ramon, Calif., received pre-market approval from the FDA for its InSite HER-2/neu monoclonal antibody for use in tests to identify breast cancer patients eligible for treatment with Herceptin (trastuzumab). The product is available as a ready-to-use reagent, in manual and automated formats, and is allowed for use with BioGenex Super Sensitive Detection Systems.

• Calando Pharmaceuticals Inc., of Duarte, Calif., a majority-owned subsidiary of Arrowhead Research Corp., said collaborators using its siRNA delivery technology published data showing in vivo demonstration of sequence-specific gene inhibition in tumors from the systemic administration of targeted formulations of siRNA. Systemic delivery through the bloodstream enables RNAi therapeutics to target metastatic cancer located throughout the body. The research appears in Cancer Research.

• Caliper Life Sciences Inc., of Hopkinton, Mass., closed its planned $22 million acquisition of NovaScreen BioSciences Corp., of Hanover, Md. The acquisition combines NovaScreen's screening, profiling and assay development services with Caliper's LabChip and advanced liquid handling products to provide the pharmaceutical and biotechnology industry with a central resource for drug discovery solutions. In addition to the $22 million, which is subject to future adjustment based on certain financial parameters, NovaScreen shareholders also can earn up to $8 million on the achievement of revenue milestones over a 30-month period. (See BioWorld Today, Sept. 9, 2005.)

• CardioVascular BioTherapeutics Inc., of Henderson, Nev., said the independent data and safety monitoring committee gave approval to proceed to the final dosing group for an ongoing Phase I trial of Cardio Vascu-Grow in heart patients who are not eligible for traditional therapies, such as bypass or stenting procedures. The trial is designed to evaluate the safety and tolerability of Cardio Vascu-Grow, a protein drug candidate designed to induce angiogenesis, though the company also is collecting efficacy data to use in planning future studies.

• Codexis Inc., of Redwood City, Calif., achieved the second technical milestone in just more than three months in its collaboration with New York-based Pfizer Inc. The achievement triggered the second milestone payment from Pfizer since June. Established in July 2004, the collaboration applies Codexis' process research and development platform to some of Pfizer's small-molecule therapeutics. (See BioWorld Today, July 27, 2004.)

• Depomed Inc., of Menlo Park, Calif., said it delivered notice to Toronto-based Biovail Corp., and its subsidiary, Biovail Laboratories Inc., outlining Biovail's material breaches of the companies' 2002 license agreement for Glumetza, a once-daily extended-release formulation of metformin approved to treat Type II diabetes. Depomed said the breach involves the failure of Biovail to make the first commercial sale of 500-mg Glumetza within 120 days of approval in both Canada and the U.S., as required by the license agreement, and failed to use diligent efforts in the marketing and selling of the 500-mg strength version. Glumetza was approved May 31 in Canada and approved in the U.S. on June 3. (See BioWorld Today, May 30, 2002.)

• Genesis Bioventures Inc., of New York, said the American Stock Exchange received the company's plan to bring itself back into compliance with the exchange's rules, but AMEX decided to proceed with the filing to revoke Genesis' common stock from listing. The company is restructuring, reorganizing and relocating to California. It may petition the exchange to further review the compliance plan and list the company on an alternative exchange in the meantime.

• Genome Canada, of Ottawa, Ontario, said the Canadian government will contribute more than $3 million toward a $6 million genomics research project at the University of Saskatchewan to examine cold tolerance in wheat, barley and rye. The aim is to identify, characterize and use the biological mechanisms governing low temperature adaptation in wheat, barley and rye to improve cold-hardiness in those crops.

• Gentium SpA, of Villa Guardia, Italy, entered definitive agreements for a $10.9 million private placement of about 1.6 million shares of its American depository shares at $7.05 each. Subject to shareholder approval, investors also will receive warrants to purchase 620,452 ADSs at $9.69 per share. Net proceeds are expected to cover costs relating to the company's upcoming Phase III trial of Defibrotide to treat severe VOD, as well as the recently announced Phase I/II trial of Defibrotide in multiple myeloma. Other funds will go toward developing additional product candidates and for general corporate purposes. Great Point Partners LLC, of Greenwich, Conn., acted as the lead investor in the transaction. New York-based Rodman & Renshaw LLC served as the lead placement agent, while Maxim Group LLC, also of New York, and Southlake, Texas-based I-Bankers Securities Inc. were co-placement agents.

• Innovive Pharmaceuticals Inc., of New York, said the FDA approved its investigational new drug application, allowing the company to enter Phase I trials with INNO-105 to treat adult patients with advanced solid malignancies. INNO-105 is a naturally occurring peptide that has recently demonstrated antitumor activity in a Phase I pancreatic cancer study. The company said INNO-105 inhibits cell growth and division by interacting with OGFr, a receptor found on the nuclear membrane of a range of malignant cells.

• Life Therapeutics Ltd., of Sydney, Australia, retired the $6.8 million note held by Atlanta-based Serologicals Corp., finalizing its December 2003 purchase of the Therapeutic Plasma business from Serologicals. The business now is in the Life Sera division of Life Therapeutics. Under the terms of the transaction, the debt was discounted to $6 million in return for early payment and a royalty-bearing, nonexclusive commercial license to the Life Therapeutics' Gradiflow technology.

Meditech Research Ltd., of Melbourne, Australia, held its first formal meeting with the FDA to understand what data would be needed to support an investigational new drug application for its lead cancer product, HyCAMP. The company intends to submit an IND application in the first half of 2006. The meeting confirmed that Meditech's current Phase II trial in colorectal cancer could support initiation of an IND-based pivotal study.

• MGI Pharma Inc., of Minneapolis, closed its previously announced acquisition of Baltimore-based Guilford Pharmaceuticals Inc. Under the terms, all shares of Guilford were exchanged for 5.3 million shares of MGI Pharma stock, plus $53.9 million in cash, which represents $3.75 per Guilford share, as determined based on MGI's five-day average stock price ending Sept. 25, or total consideration of $179.6 million. As part of this transaction, Dean Mitchell, formerly president and CEO of Guilford, has joined MGI's board. Through the purchase, MGI gains several products, including the marketed Gliadel Wafer and the Phase III candidate Aquavan. (See BioWorld Today, July 22, 2005.)

• MultiCell Technologies Inc., of Lincoln, R.I., and Australian company Living Cell Technologies Ltd., entered a joint venture to develop therapeutic liver cell applications. The collaboration will focus on creating liver-cell based technologies and products that lead to the development of new medicines and treatments for liver-related diseases. Under the terms, MultiCell will develop extended functionality of its adults liver stem cells and immortalized human hepatocytes using LCT's encapsulation technology called biocapsules. Financial details were not disclosed.

• NeoPharm Inc., of Lake Forrest, Ill., said that pursuant to new SEC regulations, which will become effective on Dec. 1, the company's current shelf registration will be extended through Dec. 1, 2008. The company has about $46 million remaining in its existing shelf-registration statement, which had been due to expire on Dec. 17. NeoPharm is focused on cancer drugs.

• Osta Biotechnologies Inc., of Montreal, said researchers David Goltzman, Andrew Karaplis and Dengshun Miao have discovered a key role of specific segments of the parathyroid hormone related peptide on growth retardation and early aging in mice. They found that the expression of tumor-suppressing genes p16 and p21 was significantly increased, but the expression of oncogene Bmi-1 was reduced in the skeleton of the animal model compared to the normal control.

• Peptech Ltd., of Sydney, Australia, appointed John Chiplin CEO, effective January 2006. Chiplin previously served as CEO of ITI Life Sciences, of Dundee, Scotland, and as CEO for California-based Geneformatics. Chiplin will take over for Mel Bridges, who will stay on at Peptech as nonexecutive chairman.

• Perlegen Sciences Inc., of Mountain View, Calif., said that it will assist Merck & Co., of Whitehouse Station, N.J., in conducting a high-density whole-genome analysis of more than 1,000 individuals with important clinical characteristics. Using Affymetrix GeneChip technology, Perlegen scientists will assay up to 675,000 genetic variations in DNA samples provided by Merck.

• PharmaMar SA, of Madrid, Spain, said that PM02734, a marine-derived compound, began Phase I trials for the treatment of solid tumors. PM02734 is a chemical entity resulting from PharmaMar's internal research program for derivatives of marine natural compounds. It is a new depsipeptide of the kahalalides family.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., said the delisting of its common stock from Nasdaq has been stayed pending a decision by the Nasdaq panel. Savient is a specialty pharmaceutical company dedicated to developing, manufacturing and marketing therapeutic products.

• StemCells Inc., of Palo Alto, Calif., filed a registration statement to sell, from time to time, up to $100,000 of its common stock. Proceeds from any offerings would go toward working capital and general corporate purposes, as well as for potential acquisitions. StemCells focuses on developing therapies that would use stem and progenitor cells to treat neurodegenerative diseases, multiple sclerosis, spinal cord injuries, stroke, chronic liver failure and diabetes.

• Synthetic Blood International Inc., of Costa Mesa, Calif., plans to initiate Phase II trials with its perfluorocarbon blood substitute and therapeutic oxygen carrier, Oxycyte, in patients with traumatic brain injury and with sickle cell anemia. The company expects to complete both trials and report trial data before the end of 2005, subject to its ability to obtain additional funding. In an effort to advance Oxycyte through clinical development, the company has temporarily suspended patient enrollment in its Phase II trial in patients with hip revision surgery to allocate resources to the smaller, faster Phase II studies, it said.

• Tm Bioscience Corp., of Toronto, formed a license agreement with Abbott Laboratories, of Abbott Park, Ill., for certain intellectual property in the areas of human and pathogen genotyping, among others. The nonexclusive license is worldwide, expires co-terminously with the associated patents and covers Tm's current and future products in all fields of use.

• Urigen Inc., of Vancouver, British Columbia, said the FDA accepted the company's investigation new drug application to initiate a Phase IIb trial with its lead product, U101. U101 is an intravesical formulation of FDA-approved components that has been demonstrated to provide relief of symptoms associated with interstitial cystitis. The results of a Phase IIa study were published in the Journal of Urology in February 2005.

• Xechem International Inc., of New Brunswick, N.J., said that its wholly owned subsidiary, Xechem UK Ltd., received orphan drug designation from the European Medicine Evaluation Agency for Niprisan (now known as Nicosan/Hemoxin), a phytopharmaceutical product that has shown efficacy in the treating sickle cell disease.