• Aeolus Pharmaceuticals Inc., of San Diego, raised $5 million through the sale of newly issued shares of common stock and warrants to selected institutional investors. The company expects to use its net proceeds to advance the clinical development of AEOL 10150, a catalytic anti-oxidant now expected to move into Phase II, to complete toxicity and other work necessary to file investigational new drug applications for at least one more compound, as well as for general administrative expenses and working capital. The financing, which was led by Efficacy Capital, included the sale of 10 million common shares and five-year warrants to purchase up to an additional 7 million shares for 75 cents apiece. The company also issued 4 million warrants exclusively to Efficacy Capital, which are exercisable for 50 cents apiece and carry a 12-month term.

• Alexza Pharmaceuticals Inc., of Palo Alto, Calif., started a Phase IIb trial with AZ-001 (Staccato prochlorperazine), an inhalation product candidate, in patients with migraine headaches. The trial is an outpatient, multicenter, randomized, double-blind, single-dose, placebo-controlled study in about 400 migraine patients with or without aura. The study will evaluate placebo and three doses of AZ-001 (5 mg, 7.5 mg and 10 mg).

• Aspreva Pharmaceuticals Corp., of Victoria, British Columbia, and Hoffmann-La Roche Inc., of Nutley, N.J., said the FDA has granted orphan drug designation for CellCept (mycophenolate mofetil) in the treatment of pemphigus vulgaris (PV). Aspreva is evaluating CellCept for the treatment of PV in a global Phase III study.

• Biovest International Inc., of Worcester, Mass., filed for regulatory approval to open up to 30 new clinical sites for its pivotal Phase III trial of BiovaxID for follicular non-Hodgkin's lymphoma. Contract research organizations will manage the work in Ukraine and Russia, taking responsibility for monitoring patient recruitment and overseeing all aspects of the investigations there. The opening of the sites is expected to dramatically increase the number of patients being treated with BiovaxID during the next year to 18 months. BiovaxID is a targeted therapeutic that stimulates the immune system to seek out and destroy only cancerous B-cell lymphocytes without causing damage to normal B-cell lymphocytes or to other cells.

• Cell Signaling Technology Inc., of Danvers, Mass., entered a new partnership agreement with Bio-Rad Laboratories Inc., of Hercules, Calif., under which CST will develop antibodies for kinase activation and protein phosphorylation assays that will be commercialized in Bio-Rad's multiplex bead-based assays for the Bio-Plex suspension array system. CST's expertise will be leveraged to develop a broader array of antibodies for Bio-Rad's Bio-Plex platform, enabling multiplexed measurement of phosphoproteins and signaling pathways.

• Collegium Pharmaceutical Inc., of Cumberland, R.I., achieved a development milestone through its reformulation and new product agreement with Cypress Bioscience Inc., of San Diego. In January 2004, Collegium received a milestone payment when Cypress exercised its option to license all of the intellectual property rights to novel reformulations and new analogues of milnacipran developed by Collegium. The goal is to extend Cypress' milnacipran franchise and the category of drugs known as norepinephrine serotonin reuptake inhibitors. The deal includes the payment of development milestones up to $5.4 million. Milnacipran is approved to treat non-pain indications and is being developed for fibromyalgia.

• CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, began patient dosing in a Phase II trial evaluating the activity of PXD101, a small-molecule histone deacetylase (HDAC) inhibitor, for acute myelogenous leukemia. The trial is being sponsored by the National Cancer Institute, part of the National Institutes of Health in Bethesda, Md., and will be conducted throughout the U.S. Up to 55 patients will be enrolled. The primary endpoint for the study is response rate, with secondary endpoints measuring overall survival and time to treatment failure. Correlative pharmacodynamic studies also will be conducted to evaluate the potential inhibition of HDACs in these cancer cells from patients treated with PXD101. Evaluation of the genes regulating proliferation and apoptosis, as well as differential gene expression in the cells obtained both prior to and following treatment with PXD101, also will be performed.

• Dharmacon Inc., of Lafayette, Colo., and Amaxa GmbH, of Cologne, Germany, formed an agreement to co-promote data generated using Dharmacon's siRNA libraries with Amaxa's Nucleofector technology. Some RNAi gene silencing research has been hampered by the insufficient delivery of siRNA into primary cells and non-standard cell lines. Nucleofection gives researchers the ability to transfer nucleic acids into the cells and use them for gene silencing experiments. Amaxa's Nucleofector 96-well Shuttle system allows parallel processing of a large number of transfection experiments.

• Gentium SpA, of Villa Guardia, Italy, completed a $22.1 million private placement of 1.9 million American depository shares at $11.39 each. Investors also received warrants to buy 388,705 ADSs at $14.50 each. ThinkEquity Partners LLC acted as the lead placement agent, while Rodman & Renshaw LLC and I-Bankers Securities Inc. were the co-agents. Net proceeds will be used to fund the continued development of Gentium's product candidates, including defibrotide for severe veno-occlusive disease in recipients of stem cell transplants, and for general corporate purposes.

• Ingenium Pharmaceuticals AG, of Munich, Germany, and Asinex Ltd., of Moscow, conducted a lead optimization project that resulted in the generation of novel active compounds, which will expand Ingenium's pipeline of pain and inflammatory disease treatments. The companies plan to continue their collaboration throughout this year.

• Locus Pharmaceuticals Inc., of Blue Bell, Pa., agreed to apply its computational technologies to design small molecules with activity against a target identified by Amgen Inc., of Thousand Oaks, Calif. Locus said it has applied its technology in six external collaborations to date. Financial terms were not disclosed.

• Millipore Corp., of Billerica, Mass., said it intends to offer $550 million in convertible senior notes due 2026 to qualified institutional buyers who will receive a 13-day option to buy an additional $82.5 million in notes to cover overallotments. The notes will be convertible, in certain circumstances, into a combination of cash and Millipore common stock. Millipore plans to use net proceeds to fund a portion of its $1.4 billion acquisition of Serologicals Corp., of Atlanta, which was announced in April. Remaining funds will go toward working capital and be used for general corporate purposes.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., entered an agreement with Procter & Gamble Pharmaceuticals Inc., a division of The Procter & Gamble Co., of Cincinnati, to manufacture and supply PTH1-34 nasal spray for osteoporosis. The deal follows a development and commercialization agreement between the companies reported earlier this year. Going forward, Nastech will be the exclusive manufacturer of the PTH1-34 nasal spray for P&G and will be responsible for the chemistry, manufacturing and controls sections of the FDA regulatory submission. Nastech will supply the product to P&G at a transfer price that includes a manufacturing profit, though specific financial terms were not disclosed.

• Oncolytics Biotech Inc., of Calgary, Alberta, completed patient enrollment in the dose-escalation portion of its Phase I systemic administration trial investigating the use of Reolysin in patients with advanced cancers. A total of 30 were treated to a maximum daily dose of 1x10(11) TCID(50), but a maximum tolerated dose was not reached and the treatment appears to have been well tolerated. Interim results reported at this week's American Society of Clinical Oncology meeting in Atlanta indicated that Reolysin can be delivered systemically to various tumor types and cause virus-mediated tumor responses.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Wyeth Pharmaceuticals, a division of Wyeth, of Madison, N.J., said they said they plan to submit methylnaltrexone's new drug application to the FDA early next year for opioid-induced bowel dysfunction. The NDA will be for the subcutaneous formulation. Next quarter, Progenics plans to begin pivotal Phase III study of an intravenous form in patients at high risk for developing post-operative bowel dysfunction, and Wyeth plans to begin additional studies abroad. Also to begin next quarter are global pivotal studies for an oral formulation for opioid-induced bowel dysfunction, to be conducted by Wyeth. The companies have partnered on the drug since late last year.

• Sequenom Inc., of San Diego, closed its $33 million private placement of about 20 million shares and warrants to purchase an additional 12 million shares with four institutional investors. Oppenheimer & Co. Inc. was the placement agent. The investors were Pequot Private Equity Fund IV LP, CornVest Investment Partners II LLC, LB I Group Inc. and Siemens Venture Capital GmbH. Net proceeds will be used for general working capital and to execute new management strategies to strengthen and expand the company's core product sales and services business, while pursuing new opportunities in the field of non-invasive prenatal diagnostics.

• SuperGen Inc., of Dublin, Calif., said a contract was executed to terminate the distribution of its hairy cell leukemia drug Nipent (pentostatin for injection) by Madison, N.J.-based Wyeth. SuperGen paid Wyeth a $2.1 million early termination fee and now holds all distribution rights. The two parties will collaborate to ensure uninterrupted distribution services during the transition period. Distribution and marketing for Nipent in Europe will be managed by SuperGen's subsidiary, EuroGen Pharmaceuticals Ltd., of Cheltenham, UK.

• Xechem International Inc., of New Brunswick, N.J., said the FDA named the five-membered heterocyclic anti-sickling compound known as 5-HMF an orphan drug for treating patients suffering from sickle cell disease. 5-HMF not only is a natural product with very little toxicity, but it also has a high affinity for sickle cell hemoglobin, the company said. Xechem is preparing the product's investigational new drug application for submission to the FDA in the coming months.

• YM BioSciences Inc., of Mississauga, Ontario, began a Phase II trial combining tesmilifene with Taxotere (docetaxel, from Sanofi-Aventis). The trial is a collaborative effort between both companies to investigate the drug combination's effect in women with rapidly progressing metastatic breast cancer. The primary endpoint of the trial is pharmacokinetic, assessing the effect of adding tesmilifene on the plasma concentration of docetaxel. YM expects to complete enrollment in the fourth quarter, with that pharmacokinetic data available early next year. Secondary endpoints are overall survival and progression-free survival.

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