• Acadia Pharmaceuticals Inc., of San Diego, said data published in Journal of Pharmacology and Experimental Therapeutics show ACP-104, the major metabolite of clozapine, is a partial agonist that causes weak activation of dopamine D2 and D3 receptors, whereas clozapine and most other antipsychotic drugs block those receptors. The company, which is developing ACP-104 for schizophrenia with the added potential benefit of improving cognition, said that the partial agonist properties of ACP-104 might lead to less motoric side effects than seen with most other antipsychotic drugs.

• AEterna Zentaris Inc., of Quebec, started a European multicenter Phase II trial of perifosine in combination with radiotherapy in non-small-cell lung cancer. The exploratory, double-blind, placebo-controlled trial will assess the efficacy and safety of a 150-mg daily dose of perifosine when combined with radiotherapy in 160 patients with inoperable Stage III NSCLC. Patients will receive perifosine daily for five to six weeks, starting seven days prior to radiotherapy, and they will be followed for at least 12 months. The product is partnered in North America with Keryx Biopharmaceuticals Inc., of New York.

• Archemix Corp., of Cambridge, Mass., and Nuvelo Inc., of Sunnyvale, Calif., decided to drop their development of ARC183, which was being tested as an anticoagulant for potential use in acute cardiovascular settings, such as coronary artery bypass graft (CABG) surgery, and instead will pursue an optimized second-generation molecule. The partners closed a Phase I trial after preliminary results showed that the amount of ARC183needed to achieve the desired anticoagulation for use in CABG surgery resulted in a sub-optimal dosing profile.

• Cellerant Therapeutics Inc., of San Carlos, Calif., raised $9 million in a second closing of its Series B round, bringing the total to $25 million. The first closing was in May. The company is focused on the regulation of the hematopoietic system. (See BioWorld Today, May 12, 2005.)

• Cel-Sci Corp., Vienna, Va., said that in connection with the settlement of litigation involving a shareholder and three former investors in Cel-Sci, the judge approved a settlement of the lawsuit that is expected to yield Cel-Sci about $630,000. Cel-Sci expects to receive the money within the next 10 days. Cel-Sci is developing new immune system-based treatments for cancer and infectious diseases.

• Cyberonics Inc., of Houston, agreed to sell $125 million in 3 percent convertible senior subordinated notes due 2012 to qualified institutional buyers. The company also granted the initial purchaser a 13-day option for up to $18.75 million in additional notes. Cyberonics intends to use a portion of the proceeds to purchase $10 million in shares of its common stock as part of a stock repurchase program, and to fund separate convertible bond hedge and warrant transactions. The remaining $98 million is expected to go toward general corporate purposes, including the launch of its treatment-resistant depression product in the U.S. and Europe.

• Eiffel Technologies Ltd., of Sydney, Australia, and MAP Pharmaceuticals Inc., of Mountain View, Calif., signed a development and licensing agreement that provides MAP with the exclusive right to apply Eiffel's intellectual property to developing pharmaceutical products for pulmonary delivery of insulin, pulmonary and nasal delivery of steroids, and pulmonary delivery of combinations of long-acting beta agonists and steroids. Under the agreement, Eiffel will receive $600,000 up front, as well as potential milestones and royalties.

• Exelixis Inc., of South San Francisco, began a trio of Phase I studies. A trial of XL844 will be conducted in patients with chronic lymphocytic leukemia, and a study of XL184 will be conducted in patients with solid tumors for whom there are no available therapies. At the same time, a repeat-dose trial of XL784 is under way in healthy volunteers in preparation for a Phase II program to test efficacy in patients with renal failure.

• GenVec Inc., of Gaithersburg, Md., obtained commitments to purchase shares of its common stock in a registered direct offering for gross proceeds of $14.5 million. Under the terms of the transaction, GenVec will sell about 7.3 million of its common stock at $2 per share to a group of institutional investors. The closing of the offering is expected to take place on Monday. GenVec estimates net proceeds from the financing to be approximately $13.4 million after deducting placement agent fees and the estimated costs associated with the offering.

• Genzyme Corp., of Cambridge, Mass., expanded projects in Belgium, Ireland, and the UK to support Genzyme's antibody and protein-based medicines. Together the projects represent capital investments of more than $500 million over several years. Genzyme also announced today that in addition to producing humanized monoclonal antibodies at its new Geel, Belgium, plant, the facility will be used to meet the anticipated demand for Myozyme (alglucosidase alfa), an enzyme-replacement therapy under review with U.S. and European regulatory authorities for the treatment of Pompe disease.

• Geron Corp., of Menlo Park, Calif., said its public offering of 6.9 million shares of common stock, including 900,000 shares issued upon exercise of an option granted to the underwriters to cover overallotments, closed Sept. 21. The public offering price was $9 per share and the aggregate gross public offering price, including the shares issued upon exercise of the overallotment option, was $62.1 million. Concurrent with the closing, Merck & Co. Inc., of Whitehouse Station, N.J., exercised its warrant to purchase 2 million shares of Geron common stock with a total exercise price of $18 million. The offering was originally announced last week. (See BioWorld Today, Sept. 19, 2005.)

• Hana Biosciences Inc., of South San Francisco, received approval to list its common shares on the American Stock Exchange. Hana's common shares will began trading on the AMEX Thursday under the symbol HBX. Hana acquires, develops, and commercializes innovative products to advance cancer care.

• Hemosol Corp., of Toronto, entered an agreement with an agent under which a syndicate will market a private placement of units consisting of one common share and one common share purchase warrant. The syndicate has a mandate to raise up to $10 million, with an agents' option to raise up to an additional $5 million. The company needs to complete the private placement early in the fourth quarter to continue as a going concern.

• IDM Pharma Inc., of San Diego, produced a first lot of Junovan that meets current specifications, as well as the prior specifications for the product to be used in a Phase III study in patients with high-grade non-metastatic osteosarcoma. The company achieved the milestone with its contract manufacturers, Genzyme Pharmaceuticals, of Liestal, Switzerland; NOF Corp., of Tokyo; Ben Venue Laboratories, of Cleveland, Ohio; and Solvias AG, of Basel, Switzerland.

• Illumina Inc., of San Diego, signed a commercial, multiyear genotyping services agreement with GlaxoSmithKline plc, of London. Illumina will use Sentrix Arrays in conjunction with its GoldenGate and Infinium assays to conduct genetic studies for thousands of samples provided by GSK. The blanket agreement enables multiple projects to be conducted over a period of time. Financial terms were not disclosed.

• InSite Vision Inc., of Alameda, Calif., an ophthalmic therapeutics, diagnostics and drug delivery company, signed a manufacturing supply agreement with Cardinal Health for the manufacture of topical AzaSite (1 percent azithromycin) commercial units. Cardinal Health has manufactured the clinical trial supplies being used in InSite Vision's two Phase III bacterial conjunctivitis trials, and also the registration batches to be used for the AzaSite new drug application filing.

• Intarcia Therapeutics Inc., of Emeryville, Calif., said it would withdraw its initial public offering and accompanying registration statement due to market conditions. The company had filed for an $86.25 IPO earlier this year to garner funds for its cancer and hepatitis C virus programs. (See BioWorld Today, Feb. 8, 2005.)

• LAB International Inc., of Laval, Quebec, successfully completed a Phase I trial of its asthma product LAB CGRP (calcitonin gene-related peptide). The double-blind, placebo-controlled study met its primary endpoints, demonstrating safety and tolerability of the drug.

• MediciNova Inc., of San Diego, said its registration statement was declared effective, through which about 67.3 million of its common shares were registered. The stock may be offered for resale by the stockholders identified therein for their own account, and the specialty pharmaceutical company will not receive any proceeds from such sales.

• Myogen Inc., of Denver, completed its $125 million public offering. The company said it would use the $116.4 million in net proceeds to continue the development of its product candidates and research program, including the acceleration and expansion of the darusentan clinical development program, to prepare for the potential commercial launch of ambrisentan and darusentan, as well as to fund working capital and for other general corporate purposes. The transaction included an original 4.7 million newly issued common shares at $23.25 apiece, and another 700,000 shares for an overallotment. Goldman, Sachs & Co. acted as the offering's sole book-running manager. CIBC World Markets Corp., First Albany Capital Inc. and Lazard Capital Markets LLC acted as co-managers. (See BioWorld Today, Sept. 19, 2005.)

• Myriad Genetics Inc., of Salt Lake City, said Phase II findings reported at the Congress of the International Psychogeriatric Association in Stockholm, Sweden, showed that patients with mild Alzheimer's disease who received 800 mg of Flurizan twice daily appeared to stabilize and experience no further decline in cognitive function from months 12 to 15, as measured by the Alzheimer's Disease Assessment Scale cognitive subscale test. Specifically, at 12 months, that dose group had declined an average of 2.8 points on the scale since the beginning of the trial, and after the three additional months on Flurizan, those patients had an average ADAS-cog decline of 2.7 points, indicating that patients did not decline further during the follow-on study and instead demonstrated a small improvement.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., received a favorable opinion in Europe regarding orphan medicinal product (OMP) designation for Altastaph to treat Staphylococcus aureus bacteremia. The company expects to receive formal OMP designation later this year.

• National Center for Genome Resources in Santa Fe, N.M., was awarded $2.7 million by the National Institute of Allergy and Infectious Disease, part of the National Institutes of Health in Bethesda, Md., to develop diagnostic tests for severe sepsis and community-acquired pneumonia. The program, titled Community Acquired Pneumonia and Sepsis Outcome Diagnostics, involves investigators from five other organizations: Duke University Medical Center in Durham, N.C.; Henry Ford Hospital in Detroit; Eli Lilly and Co., of Indianapolis; Indiana Centers for Applied Protein Sciences in Indianapolis; and ProSanos Corp., of La Jolla, Calif.

• Nektar Therapeutics Inc., of San Carlos, Calif., intends to offer $200 million aggregate principal amount of convertible subordinated notes due 2012, in a private offering to institutional buyers. Nektar intends to grant the initial purchasers a 30-day option to purchase up to an additional $50 million of notes to cover overallotments. The notes will be convertible into shares of Nektar's common stock. Proceeds may be used to fund possible repurchases of its outstanding convertible subordinated notes in transactions from a limited number of holders in privately negotiated transactions or in unsolicited open-market transactions, it said. The remaining proceeds will be used for general corporate purposes.

• Neurogen Corp., of Branford, Conn., said its first-in-human, single ascending-dose study of NG2-73, its leading drug candidate for insomnia, produced reports of sleepiness among treated subjects. Also in the Phase I trial, the compound was safe and well tolerated across a broad dose range. NG2-73 selectively modulates receptors of the gamma-aminobutyric acid (GABA) neurotransmitter system. A second study is testing multiple ascending doses in healthy subjects, and a pharmacokinetic/pharmacodynamic study is under way to evaluate its sleep-inducing effects at various dosages in order to establish a range for Phase II.

• NutraCea, of El Dorado Hills, Calif., said its SynBiotics-3 product was approved to be added to the formulary at Mercy Hospital of Folsom as adjunctive therapy in the management of recurrent Clostridia difficile colitis, or antibiotic-associated diarrhea. The product contains bacteria called Saccharomyces, as well as NutraCea's fructo-oligosaccharide-rich stabilized rice bran derivative "RiSolubles" and other "friendly" bacterial strains.

• Ortho Biotech Products LP, of Raritan, N.J., said a study published in the September issue of The Oncologist demonstrated that Procrit (epoetin alfa) increased hemoglobin levels more than Aranesp (darbepoetin alfa) in patients with cancer and anemia caused by chemotherapy. Within four weeks of initiating therapy, 47 percent of patients treated with Procrit achieved the primary endpoint of an increase in hemoglobin of 1 gram or more per deciliter of blood, compared to 33 percent of those treated with Aranesp, which is developed by Amgen Inc., of Thousand Oaks, Calif.

• Osiris Therapeutics Inc., of Baltimore, began distributing Osteocel, a product indicated for the repair, replacement or reconstruction of bone defects. It is an allogeneic bone matrix containing viable stem cells, and provides an alternative to autograft in orthopedic procedures. Blackstone Medical Inc., of Springfield, Mass., will distribute the product under the Trinity brand, while Osiris also will market and distribute the product under the Osteocel brand.

• ReNeuron Group plc, of Guildford, UK, held a formal pre-investigational new drug application meeting with the CBER component of the FDA regarding its lead ReN001 stem cell therapy to treat chronic disability after stroke. The company is maintaining its preclinical development timelines and said it will file an investigational new drug application by mid-2006.

• TransTech Pharma Inc., of High Point, N.C., received a milestone payment from its collaboration partner, Novo Nordisk A/S, of Bagsvaerd, Denmark, as a result of progress made with a drug candidate resulting from their collaboration. The compound was discovered during their collaboration using TransTech's small-molecule discovery engine, TTP Translational Technology.

• Vernalis plc, of London, signed a contract with Diosynth Biotechnology, of Research Triangle Park, N.C., for process development, scale-up and manufacturing of V10153 for Phase III trials. V10153 is a modified version of human plasminogen, a naturally occurring protein, which, when activated, is responsible for dissolving blood clots in the body.

• Verus Pharmaceuticals Inc., of San Diego, said Paladin Labs Inc., of Montreal, has launched Twinject in Canada. The product is an epinephrine auto-injector indicated for the emergency treatment of severe allergic reactions. Verus and Paladin Labs entered an exclusive agreement in July to commercialize Twinject in Canada.

• ViaCell Inc., of Cambridge, Mass., said the FDA placed a clinical hold on its Phase I trial of CB001, an investigational cord blood product for hematopoietic stem cell transplantation, though the action is not in response to any new events in the study. ViaCell said it suspended enrollment in the study earlier this week, and the company and the agency had an agreement to suspend enrollment after two patients experienced Grade IV acute graft-vs.-host disease, or aGVHD. (See BioWorld Today, Sept. 20, 2005.)

• Vical Inc., of San Diego, was awarded funding for a one-year, $500,000 project for the Defense Advanced Research Projects Agency, of the U.S. Department of Defense. The award will fund feasibility studies of a new approach for rapidly manufacturing large quantities of DNA vaccines.

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