• Archemix Corp., of Cambridge, Mass., and Isis Pharmaceuticals Inc., of Carlsbad, Calif., entered a broad license agreement and research collaboration. Archemix gained access to Isis patents covering chemistries, analytical methods and manufacturing methods related to discovery and development of oligonucleotide-based therapeutic drugs based on Archemix's SELEX technology. Additionally, the companies will share their respective expertise in oligonucleotide therapeutic discovery and development. Isis is entitled to milestone and royalty payments on resulting aptamer therapeutics developed by Archemix that incorporate Isis technologies. Also, Isis would receive a percentage of revenue generated through Archemix sublicenses. Specific terms were not disclosed. Separately, Archemix and SomaLogic Inc., of Boulder, Colo., expanded their alliance focused on the use and development of aptamers for therapeutic, diagnostic and other applications. Archemix received exclusive rights to therapeutic uses of aptamers discovered by SomaLogic for a limited number of targets, and will have the option to provide targets to SomaLogic for the generation of aptamers. SomaLogic will receive rights to all ex vivo uses of aptamers it did not previously hold, including the use of aptamers for affinity purification. Terms were not disclosed.

• AVI BioPharma Inc., of Portland, Ore., disclosed a refocusing of its clinical pipeline and a reprioritization of its programs. AVI will focus on advancing Neugene product candidates targeting cardiovascular and genetic diseases, optimizing compounds targeting infectious diseases and testing new technologies that leverage the Neugene antisense platform. As part of the move, AVI is discontinuing its planned dose-escalating trial of AVI-4065 in hepatitis C virus. Instead, it will work to develop a more commercially viable product. Internal programs planned to be advanced include the ongoing Neugene trial in coronary artery bypass graft surgery and a new trial using its exon-skipping pre-RNA interference technology in Duchenne muscular dystrophy.

• Biomira Inc., of Edmonton, Alberta, and partner Merck KGaA, of Darmstadt, Germany, amended their collaboration and supply agreements relating to the Phase III lung cancer vaccine Stimuvax, as contemplated in a letter of intent in January. In the amended agreement, Merck will be responsible for worldwide development and commercialization and would pay Biomira milestones and royalties. Biomira retains responsibility for manufacturing the drug and would receive a $2.5 million payment when the transaction clears U.S. antitrust authorities. In the previous agreement, signed in 2001, Biomira held U.S. co-promotion rights. Biomira said the restructured deal will provide it with sufficient cash resources for six months, and through 2008 based on anticipated milestone payments.

• Biovail Corp., of Toronto, said its Biovail Laboratories International SRL subsidiary entered a license and development agreement with an undisclosed, privately held company for exclusive global rights to BVF-324. Biovail said BVF-324 is a novel product for the treatment of a prevalent sexual dysfunction, and has completed Phase II trials. Biovail said it may be able to initiate Phase III studies in the first half of 2008. The undisclosed licensor is entitled to an up-front payment along with potential milestone and royalty payments.

• Biovitrum AB, of Stockholm, Sweden, entered a new agreement with Wyeth, of Madison, N.J., to co-promote BeneFIX, a coagulation factor IX for hemophilia B, in the Nordic countries of Denmark, Finland, Iceland, Norway and Sweden. Wyeth markets BeneFIX elsewhere around the world. Under the terms of the agreement, Biovitrum will receive a commission on BeneFIX sales, including an additional incentive if certain sales targets are exceeded, for up to five years, with possible one-year extensions thereafter. BeneFIX uses recombinant DNA technology to replace clotting factor IX to stop or prevent bleeding in people with hemophilia B who do not have enough factor IX of their own.

• CytoDyn Inc., of Santa Fe, N.M., said its preclinical study of experimental DNA vaccines for the bird flu showed that three of the vaccines given at a relatively low dose caused mice to develop antibodies against the bird flu at a significant level. The three vaccines consisted of one that the firm obtained from the University of Massachusetts Medical School; another based on the UMMS product that the company had enhanced using the latest method of improving DNA vaccines (CpG motif); and a third, similarly enhanced vaccine from a company that makes DNA vaccines for protecting animals. All three appeared equally effective in terms of the quantity of antibodies produced, although the UMMS vaccine, not enhanced, appeared to be somewhat less potent in other respects.

• FermaVir Pharmaceuticals Inc., of New York, reported preclinical data indicating FV-100 exhibited positive safety, tolerability and pharmacokinetic properties. The product is an orally bioavailable bicyclic nucleoside analogue being developed for treating herpes zoster infection (shingles). Prior published preclinical data demonstrated the antiviral activity of the compound. An investigational new drug application filing is expected in the near term.

• Galapagos NV, of Mechelen, Belgium, said its service division, BioFocus DPI, entered a drug discovery collaboration with AstraZeneca plc, of London, that builds on earlier deals. The new arrangement involves BioFocus performing medicinal chemistry, computational chemistry and supporting biology and ADMET services for AstraZeneca's infection discovery program based in Boston. The total contract value for Galapagos will be €680,000 (US$938,530). It is the companies' third deal, in a relationship that began in the summer of last year.

• Genaera Corp., of Plymouth Meeting, Pa., said interim data from the first Phase I trial of trodusquemine (MSI-1436) for treating obesity demonstrated safety and tolerability. The company presented data from initial cohorts in the double-blind, randomized, placebo-controlled trial that included results from 20 treated subjects and eight controls. Trodusquemine is designed to act both centrally and peripherally to selectively inhibit the enzyme target protein tyrosine phosphatase 1B.

InNexus Biotechnology Inc., of Vancouver, British Columbia, reported that monoclonal antibodies can be enhanced through its cross-linking technology, with laboratory studies of its anti-CD20 antibody for non-Hodgkin's lymphoma indicating greater potency, binding affinity and related characteristics when enhanced with the DXL technology. Data were presented at the IBC Life Science Drug Discovery and Development of Innovative Therapeutics conference in Boston.

Nutra Pharma Corp., of Boca Raton, Fla., said subsidiary ReceptoPharm successfully completed a preclinical study of RPI-78, its lead drug candidate being studied for the treatment of pain. Studies have shown long-lasting pain control. Data also confirmed that the drug did not use an opioid mechanism. The company said the data from may be sufficient to allow it to commence a Phase I trial in subjects with severe pain.

Open Biosystems Inc., of Huntsville, Ala., and Abcam plc, of Cambridge, UK, entered an agreement for Open Biosystems to sell Abcam's primary antibodies alongside its libraries of cDNA, ORF and shRNA clones to expand its resource for gene function analysis. Tools allow researchers to conduct analyses expressing genes, knocking down genes and detecting genes. Financial terms were not disclosed.

• Phosphagenics Ltd., of Melbourne, Australia, said a Phase Ib trial demonstrated the ability of its TPM technology to deliver insulin into the bloodstream in a noninvasive manner. The trial in Australia showed the needle-free TPM/Insulin formulation safely penetrated through human skin and delivered insulin into the bloodstream over a sustained period, without causing adverse reactions, the company said. It is preparing for a Phase II trial, also to be conducted in Australia.

• Protalix BioTherapeutics Inc., of Carmiel, Israel, licensed rights to develop a plant cell-based acetylcholinesterase and its molecular variants for use in several therapeutic and prophylactic indications, including a biodefense program. The license was granted by Yissum Research and Development Co., the technology transfer arm of the Hebrew University of Jerusalem, and the Boyce Thompson Institute for Plant Research at Cornell University. Protalix said in vitro experiments have shown that the AChE protein expressed in its plant-cell ProCellEx system demonstrated promising biological activity at both the biochemical and the cellular levels. Terms of the license deal were not disclosed.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., said the FDA accepted for filing and granted priority review status to the biologics license application for rilonacept, or Interleukin-1 Trap, for the long-term treatment of cryopyrin-associated periodic syndromes. The FDA previously granted orphan drug status and fast-track designation to rilonacept for the treatment of CAPS, a group rare inherited inflammatory conditions. Regeneron said the FDA is expected to take action on the rilonacept application by the end of November. Regeneron completed submission of its rolling BLA in June. (See BioWorld Today, June 11, 2007.)

• Regimmune Corp., of Tokyo, received a one-time grant from the Japanese Ministry of Economy, Trade and Industry to help fund development of cedar allergy drugs using the company's immune-regulating reVax (reverse vaccination) technology. Regimmune said the grant is similar to a Small Business Innovation Research grant.

• Santarus Inc., of San Diego, and its licensor, the University of Missouri, received a Paragraph IV Certification Notice from Par Pharmaceutical Cos. Inc., of Woodcliff Lake, N.J., advising about Par's submission of an abbreviated new drug application for omeprazole and sodium bicarbonate capsules, 20 mg/1100 mg and 40 mg/1100 mg. Par's letter claims that U.S. Patent Nos. 6,645,988; 6,489,346; and 6,699,885 are invalid, unenforceable and/or will not be infringed by Par's manufacture, use, or sale of the product for which the ANDA is submitted. The expiration date for those patents is July 2016. Santarus has 45 days to sue Par in an effort to block the FDA from approving the ANDA for 30 months or until a district court decision that is adverse to Santarus, whichever comes first. The patents are designed to protect Santarus' proton pump inhibitor Zegerid (omeprazole) for heartburn-related indications. Santarus' stock (NASDAQ:SNTS) closed Wednesday at $2.60, down 36 cents, or 12.2 percent.

• Summit Corp. plc, of Oxford, UK (formerly Vastox plc), said data generated by its zebrafish screening platform were used by an undisclosed biotechnology company to obtain regulatory clearance to begin Phase I clinical trials in the UK. The zebrafish platform provides whole-organism data regarding the safety and efficacy of drug-like molecules, and can be used for target validation or to predict clinical responses.