• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., and collaborators from the Swiss Federal Institute of Technology published data related to mechanisms for in vivo delivery of small interfering RNAs. Lipid-conjugates of siRNAs that facilitate in vivo systemic delivery were found to associate with circulating lipoprotein particles and to achieve cellular uptake through receptors for low-density lipoproteins and high-density lipoproteins, in addition to the mammalian homologue for a channel-like cell surface protein that mediates transport of siRNAs in nematodes and fruit flies. Results were published in Nature Biotechnology.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said it reached a favorable agreement with Conor Medsystems, a subsidiary of New Brunswick, N.J.-based Johnson & Johnson, to settle all outstanding patent litigation with respect to Conor's CoStar paclitaxel stent. Details were not disclosed, but Angiotech said it expects that the resources needed to defend and enforce its intellectual property should decrease. At the time of the settlement, there was ongoing litigation in three jurisdictions: the UK, the Netherlands and Australia.

• BioMarin Pharmaceutical Inc., of Novato, Calif., said it licensed to Asubio Pharma Co. Ltd., a subsidiary of Tokyo-based Daiichi Sankyo Co. Ltd., exclusive rights to data and intellectual property contained in the Kuvan (sapropterin dihydrochloride) new drug application. Asubio will use the data to supplement its current filing for approval in Japan of its BH4 product for the treatment of phenylketonuria. The application is for a label extension for its current BH4 product marketed in Japan for primary BH4 deficiency. BH4 is the active ingredient in Kuvan. Asubio already held exclusive rights to its own data to commercialize BH4 for all indications in Japan. BioMarin is entitled to a milestone payment for product approval as well as double-digit royalties on resulting sales of BH4 for PKU in Japan.

• BioServe, of Beltsville, Md., said it bolstered its Global Repository of tissue, DNA and serum samples through a joint distribution deal with NeoCodex SL, of Seville, Spain. BioServe gets access to clinically annotated human specimens from the uniquely homogenous Spanish population. In return, NeoCodex gains access to BioServe's Global Repository.

• Celera Group, an Applera Corp. business in Rockville, Md., entered a research collaboration with Merck & Co. Inc., of Whitehouse Station, N.J., to develop biomarker and pharmacogenomic tests for cancer patients. Celera will evaluate the use of certain gene expression profiles identified by Merck, with the goal of developing diagnostic predictors for use in Merck's clinical trials, and potentially to form the basis for commercial companion diagnostic tests for oncology therapies. Celera will receive an undisclosed payment for the collaboration, which is expected to be completed by the end of Celera's fiscal 2008. Celera would be eligible for an additional payment should Merck decide to transfer a Celera-validated gene expression assay to a clinical reference laboratory upon completion.

• CellCyte Genetics Corp., of Kirkland, Wash., entered a research agreement with physician scientists at the Cleveland Clinic. The goal is to investigate the presence and regulation of heart receptors involved in stem cell trafficking in normal and diseased human hearts, using CellCyte compounds. CellCyte is developing stem cell-enabling products designed to allow more efficient delivery and significantly increased retention of adult stem cells to diseased organs. Clinic scientists will analyze heart tissue samples of heart failure patients for the presence of surface receptors that may play an important role in the interaction of stem cells with the heart. Terms of the deal were not disclosed.

• Cephalon Inc., of Frazer, Pa., said it finalized and shared with health care professionals revisions to the label for Provigil (modafinil) tablets, its wake-promoting agent. The changes were necessary to make the Provigil label consistent with that of Nuvigil (armodafinil) tablets.

• Depomed Inc., of Menlo Park, Calif., said it is reducing its work force by about 25 percent. Specific numbers were not disclosed. The move followed failed results in July of a Phase III trial of the pain tablet Gabapentin GR in postherpetic neuralgia. The company said the staff reduction is in addition to other ongoing cost-cutting initiatives. (See BioWorld Today, July 11, 2007.)

• Immutep SA, of Orsay, France, published data showing its lead product, IMP321, induces activation of a range of human effector cytotoxic cells. The product, ImmuFact IMP321, is a natural human immunostimulatory factor designed to amplify the T-cell immune response. Research data showed the principal antitumor immune response is mediated through the activation of Type I cytotoxic CD8+ T cells, NK cells and monocytes/macrophages. Data were published in the Journal of Immunology.

• Ligand Pharmaceuticals Inc., of San Diego, said data from a preclinical study of LGD-3303, a selective androgen-receptor modulator, showed that repeated oral doses of the drug were more effective than alendronate (Fosamax, Merck & Co. Inc.) for increasing bone mineral density in the femur. Additional results from the three-month study in ovariectomized, osteopenic rats demonstrated that LGD-3303 appeared to increase bone mineral density by the deposition of new bone and was capable of increasing the bone strength of bone in the femur and the spine. Combining LGD-3303 and alendronate demonstrated greater effectiveness than either treatment alone at increasing lumbar bone mineral density. Those data were presented at a bone and mineral research meeting in Honolulu.

• MicroIslet Inc., of San Diego, and Progenitor Cell Therapy LLC, of Hackensack, N.J., signed a manufacturing agreement for MicroIslet-P, a product consisting of microencapsulated islets for implantation into the abdominal cavity that is designed to provide self-regulating blood glucose control. Under the terms, MicroIslet-P will be manufactured at PCT's California facility under cGMP for use in MicroIslet's ongoing preclinical studies and planned clinical programs. Financial terms were not disclosed.

• Pervasis Therapeutics Inc., of Cambridge, Mass., published animal data from its Vascugel product, which is under investigation to aid in healing, function and remodeling of traumatized veins and arteries. The study suggested Vascugel, a matrix of endothelial cells placed directly on damaged blood vessels to stimulate natural repair and regeneration, was instrumental in significantly increasing the diameter of injured vasculature, and reduced vascular narrowing, in tests using a porcine model of arteriovenous grafts. In August, Pervasis completed patient enrollment for two Phase II trials of Vascugel in end-stage renal disease. The preclinical data were published in the Journal of Vascular Surgery.

• Pipex Pharmaceuticals Inc., of Ann Arbor, Mich., received a $57,000 Michigan Economic Development Job Training Grant to support the training of Pipex employees involved in the cGMP pharmaceutical production of Coprexa (oral tetrathiomolybdate), its lead program for neurologically presenting Wilson's disease, and other potential product candidates. The grant will assist in the costs of training company personnel in such areas as standard operations procedures intended to assure cGMP compliance.

• Sontra Medical Corp., of Franklin, Mass., and privately held Echo Therapeutics Inc., of Durham, N.C., merged their transdermal technologies to form a publicly held company that will operate under the Echo name. Sontra issued 6.25 million shares in the deal, giving Echo about 35 percent of the combined company. Sontra uses ultrasound and skin-permeation methods in transdermal science, while Echo is developing topical formulations of approved products using Azone dermal-penetration technology. They will develop improved formulations of specialty pharmaceuticals and new applications of transdermal diagnostics. The merged company will have corporate offices in Philadelphia, with R&D facilities in Franklin and Durham. Patrick Mooney and Shawn Singh, both formerly of Echo, will serve as CEO and interim president, respectively. Harry Mitchell of Sontra will continue to serve as chief operating officer and chief financial officer.

• StemCells Inc., of Palo Alto, Calif., said it will begin a patent-reexamination process with the U.S. Patent and Trademark Office. The move follows the PTO decision to preliminarily reject all claims in the company's four patents that are the subject of its lawsuit against Neuralstem Inc., of Rockville, Md. In June, StemCells said the four patents were pending reexamination by the PTO based on petitions from Neuralstem. The company said it expected the PTO's preliminary decision, adding that is not uncommon as the PTO shifts responsibility of proof back to the patent holder.

• Trana Discovery Inc., of Cary, N.C., said it and collaborator Southern Research Institute in Birmingham, Ala., developed of a high-throughput screening assay for identification of HIV compounds. The assay allows screening to identify compounds that interrupt the lifecycle of HIV through inhibition of transfer RNA.

• Vermillion Inc., of Fremont, Calif., said it received notification from Nasdaq that the company has regained compliance with certain listing standards that were noted in August. The matter is now closed, said Vermillion, which previously was known as Ciphergen Biosystems Inc.

• Viragen Inc., of Plantation, Fla., and majority-owned subsidiary Viragen International Inc. said Viragen International's wholly owned subsidiary, ViraNative AB, of Umea, Sweden, filed an application seeking protection under bankruptcy laws of Sweden. ViraNative manufactures Multiferon, a multi-subtype, human alpha interferon. The application was filed because ViraNative was unable to pay taxes and other debts, Viragen said, adding that it does not intend to fund further operations of ViraNative during the bankruptcy process.

• Xenomics Inc., of New York, signed a licensing agreement with Ipsogen SAS, of Marseille, France, for co-exclusive rights to develop, manufacture and market research and diagnostic products for the stratification and monitoring of patients with acute myeloid leukemia. Testing focuses on the nucleophosmin, or NPM1, gene. Terms of the deal were not disclosed.

• XTL Biopharmaceuticals Ltd., of Valley Cottage, N.Y., presented data on small-molecule inhibitors of hepatitis C virus affecting the NS5A target. In a replicon assay, the company's most advanced compounds had single-digit nanomolar potency against hepatitis C genotype 1b and low-double-digit nM potency against genotype 1a. XTL also presented data indicating an additive effect with certain other HCV treatments.

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