• Anadys Pharmaceuticals Inc., of San Diego, said it and partner Novartis Pharma AG, of Basel, Switzerland, have decided to discontinue development of ANA975, a Phase Ib compound for the treatment of hepatitis C virus infection. The partners determined that results to date from the ongoing 13-week toxicology study, together with the results in the previous 13-week toxicology study, do not support further clinical evaluation of chronic daily dosing of ANA975 in hepatitis C patients. Anadys will continue development of ANA773, another TLR7 agonist prodrug, and expects to file an investigational new drug application by the end of 2007. It plans to evaluate ANA773 in Phase I trials for the treatment of advanced cancer. That program is independent of the Novartis collaboration and is not affected by the decision to discontinue development of ANA975.

• AspenBio Pharma Inc., of Castle Rock, Colo., said it received its investigational new animal drug application file number for BoviPure FSH (bovine follicle stimulating hormone) to officially start the FDA approval process. BoviPure FSH is a single-chain recombinant FSH analogue designed to aid in super-ovulation for embryo transfer in dairy and beef cows. Separately, AspenBio entered a deal with AppTec Laboratory Services Inc., of St. Paul, Minn., for GMP manufacturing and validation of the product.

• Bioenvision Inc., of New York, said it was named as a defendant in a class-action lawsuit filed in the U.S. District Court for the Southern District of New York. The suit alleges, among other things, that the company made material misstatements and omissions in connection with the agreement and plan of merger entered into with Genzyme Corp., of Cambridge, Mass., on May 29. The company said it believes all the allegations in the complaint are without merit and that it intends to vigorously defend them. A vote by shareholders on the deal is expected by the end of the year.

• BioForce Nanosciences Inc., of Ames, Iowa, said it received the second year of funding under a National Institutes of Health Small Business Innovation Research grant for nearly $200,000, bringing total funding under the grant to $400,000. Funds will be used to construct and evaluate a nanobiosensor capable of detecting protein biomarkers from just a few cells. The nanobiosensor device is named Chip-on-a-Tip. The grant will fund work through April.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp., of Dublin, Ireland, saw their shares fall Friday after FDA briefing documents released prior to Tuesday's joint meeting of the Gastrointestinal Drugs and Drug Safety and Risk Management advisory committees suggested that the multiple sclerosis drug Tysabri (natalizumab) might not be effective enough against Crohn's disease to outweigh potential risks. Tysabri sales were suspended in 2005 after the drug was linked to cases of the fatal brain disease progressive multifocal leukoencephalopathy, though the drug was allowed back on the market last year in limited uses. The advisory committees will pass a recommendation onto FDA reviewers following Tuesday's meeting. Though not binding, the agency generally follows the recommendations of its advisory panels. Biogen's stock (NASDAQ:BIIB) dropped $1.18 to close at $57.01, while shares of Elan (NYSE:ELN) fell 73 cents to close at $19.

• BrainStorm Cell Therapeutics Inc., of New York, said it met conditions to receive the first portion of the equity financing transaction from ACCBT Corp., a company under the control of BrainStorm President Chaim Lebovits. ACCBT will provide $1 million of its previous $5 million commitment. The closing condition was met when BrainStorm completed the restructuring of certain contract matters with Ramot, the technology transfer company of Tel Aviv University in Israel. BrainStorm is developing adult stem cell therapeutic products, derived from autologous bone marrow cells, for treatment of neurodegenerative diseases.

• CSL Behring, of King of Prussia, Pa., said the FDA granted marketing approval for Privigen (immune globulin intravenous [human], 10 percent liquid). The intravenous immunoglobulin was approved for treating patients diagnosed with primary immunodeficiency. Privigen also is indicated for the treatment of chronic immune thrombocytopenic purpura to rapidly raise platelet counts to prevent bleeding. CSL Behring plans to launch Privigen in the first quarter of 2008.

• Genaera Corp., of Plymouth Meeting, Pa., presented new data from preclinical studies of trodusquemine (MSI-1436) for the treatment of obesity. Studies demonstrated that MSI-1436 is a potent, highly selective and reversible inhibitor of protein tyrosine phosphatase 1B, or PTP-1B, an enzyme central to the function of both the leptin and insulin pathways, the company said. Data also indicated that MSI-1436 crossed the blood-brain barrier and is both centrally and peripherally active.

• Gene Logic Inc., of Gaithersburg, Md., said GL1001, its clinical-stage drug candidate, showed indications of efficacy in in vivo testing for inflammatory bowel disease. Based on those results, the company is seeking a partner for the clinical development of GL1001. Gene Logic discovered the new potential use for GL1001 using its Drug Repositioning Platform. The work was performed under its agreement with Millennium Pharmaceuticals Inc., of Cambridge, Mass.

• Medicure Inc., of Winnipeg, Manitoba, said data from its MR PCI head-to-head study comparing the platelet-inhibition effects of the approved products Aggrastat (tirofiban hydrochloride) and Integrilin (eptifibatide) will be published in the August edition of the American Heart Journal. It said a higher degree of platelet inhibition was seen with high-dose Aggrastat vs. double-bolus Integrilin at 10 minutes (p=0.003), and at six to eight hours (p<0.001) in patients undergoing elective high-risk percutaneous coronary intervention. In addition, the study demonstrated that significantly more patients achieved greater than 95 percent inhibition of platelet aggregation with the high-dose Aggrastat regimen.

• Mirus Bio Corp., of Madison, Wis., said it developed a technique to target specific cells with RNA interference, which is designed to block the production of disease-causing proteins inside those cells. In a first proof-of-concept demonstration, Mirus scientists targeted liver cells and switched off their ability to produce "bad" cholesterol. Mirus said its researchers overcame targeting and clearance problems by assembling tiny synthetic molecules, called Dynamic PolyConjugates, that shield their genetic cargo as they home in on target cells. Details of the work were published in the online early edition of the Proceedings of the National Academy of Sciences.

• OSI Pharmaceuticals Inc., of Melville, N.Y., entered an agreement to divest its anti-platelet-derived growth factor (PDGF) aptamer program to Ophthotech Corp., of Newton Centre, Mass., in exchange for undisclosed up-front, equity, milestone and royalty payments. Ophthotech gains all rights to the PDGF aptamer program, including preclinical compound E10030, which has demonstrated the potential to regress neovascularization when used in combination with vascular endothelial growth factor inhibitor. The deal follows OSI's decision to divest its eye disease business. The transaction is expected to close next month.

• Point Therapeutics Inc., of Boston, further reduced its management staff, part of which included terminating its chairman and CEO along with other top officials. The company is seeking a buyer or partner for its technology and related intellectual property and other assets, in bankruptcy or otherwise. The moves stem from the halting in May of two Phase III trials of its only clinical candidate, talabostat, in non-small-cell lung cancer due to the determination that that neither trial was likely to meet the primary endpoint of median progression-free survival. Earlier this month, the company cut its work force from 33 to eight employees.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said it is evaluating various financing options to bridge it to milestones anticipated later this year or in the first quarter of 2008. As part of cash-conservation efforts, the company reduced planned third-quarter cash expenses by 30 percent, in part by a 50 percent reduction in payroll (with no change in headcount). The company had $2.4 million in cash on June 30, and expects its cash operating expense in the third quarter to be about $1.2 million. Upcoming expected milestones include completion of the 505 (b)(2) submission with the FDA seeking approval of Davanat as an adjuvant therapy for the treatment of cancer; preliminary results from the ongoing Phase II biliary and colorectal cancer trials; and the finalization of a commercialization deal.

• ReNeuron Group plc, of Guildford, UK, entered an agreement to acquire the business assets of AmCyte Inc., a cell therapy company based in Santa Monica, Calif., for $4 million in stock. ReNeuron is acquiring AmCyte's cell encapsulation technology, together with its U.S. laboratories and staff. ReNeuron intends to combine its pancreatic cells with AmCyte's cell encapsulation system, in order to produce an islet cell therapy for Type I diabetes. ReNeuron said the deal also will give it an operational presence in California, and allow it to explore other therapeutic cell types. AmCyte's alginate-based cell-encapsulation system is designed to enable the delivery of therapeutic cells of varying types, and has been shown in preclinical transplantation studies to maintain cell function. It has run initial safety studies in the U.S. and Canada in a small number of severely diabetic patients. ReNeuron will issue about 9.3 million shares in the deal. In addition, it is raising $3.1 million through the sale of about 7.18 million shares.

• Silence Therapeutics plc, of London, appointed Jeffery Vick CEO. He has worked in the health care industry in both Europe and the U.S., and spent time as a business analyst and biotechnology venture capitalist. Silence Therapeutics is developing products based on RNA interference.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said the European Medicines Agency accepted for review the marketing authorization application submitted for satraplatin in combination with prednisone for the treatment of patients with metastatic hormone-refractory prostate cancer who have failed prior chemotherapy. The filing was made by Pharmion Corp., of Boulder, Colo., a partner of Spectrum licensee GPC Biotech AG, of Martinsried, Germany. Acceptance of the MAA triggered a milestone payment to Spectrum. The companies suffered a setback in the U.S. last week when FDA advisers recommended additional data be submitted before consideration of approval. Separately, GPC said it was sued in the U.S. District Court for the Southern District of New York, a move related to the satraplatin setback. (See BioWorld Today, July 23, 2007, July 25, 2007, and July 26, 2007.)