• aaiPharma Inc., of Wilmington, N.C., retained Rothschild Inc. to assist the management team in its evaluation of potential asset divestitures. The company plans to divest businesses and assets that no longer meet its long-term business plan. AaiPharma cut its headcount by more than 10 percent during the second quarter, and had a delayed regulatory filing, a near Nasdaq delisting and several changes in its senior management this year due to an SEC investigation on unusual sales in its Brethine and Darvocet product lines. The company has made adjustments to the recognition of revenue for those products.

• Agilent Technologies Inc., of Palo Alto, Calif., and Vanderbilt University Medical Center in Nashville, Tenn., said Agilent has donated cDNA microarray kits valued at $66,000 to the medical center. The center plans to use the kits to improve and develop undergraduate and graduate courses in genomics and bioinformatics.

• Alliance Pharmaceutical Corp., of San Diego, said Duane Roth agreed to assume the role of executive director of UCSD Connect, an organization founded by the University of California at San Diego, to foster entrepreneurship in the San Diego region. Roth will remain chairman and acting CEO until a replacement is named. Also, Alliance received clarification from the European Agency for the Evaluation of Medical Products regarding development recommendations for Oxygent as an alternative to blood transfusions. The agency recommended that the company pursue an initial indication that would not require direct comparison to allogeneic blood transfusion as they believe it would not be possible to conduct a clinical trial comparing blood transfusion with Oxygent that was of sufficient size to show that Oxygent is as safe or safer than transfusion of allogeneic blood. Alliance has determined that it will pursue another indication for Oxygent that would exploit its oxygen delivery capability to enhance tissue oxygenation.

• Allos Therapeutics Inc., of Westminster, Colo., said radiographic response in the brain at three months is a statistically significant predictor of prolonged survival in brain metastases patients undergoing whole-brain radiation therapy. The findings were drawn from Allos' Phase III trial of Efaproxyn. Results also showed a statistically significant improvement in response rate at three months for patients in the Efaproxyn arm compared with the control arm. Study results were presented at the 46th annual meeting of the American Society for Therapeutic Radiation Oncology.

• Altachem Pharma Ltd., of Edmonton, Alberta, made a public apology to its former president and CEO, Warren Jackson, for any slanderous or defamatory comments contained in open letters to shareholders. The company apologized for any embarrassment or other harm that the letters caused, including suggestions of impropriety, lack of fiduciary duty, inappropriate actions or mismanagement. Jackson has agreed to withdraw his legal claims filed against the company, and Altachem is paying his legal expenses as well as $15,000 to settle the litigation. Jackson will serve as the company's executive vice president of international business and a member of the board.

• AVI BioPharma Inc., of Portland, Ore., said its president and chief operating officer, Alan Timmins, will testify in a joint hearing before the Senate Committee on Health, Education, Labor and Pensions and the Committee on the Judiciary focusing on government's role in sponsoring drug development efforts to combat bioterrorism. The company is working with the U.S. Army Medical Research Institute of Infectious Diseases on its Neugene compounds against viruses including Marburg and Ebola.

• Biolex Inc., of Pittsboro, N.C., expanded its collaboration with Malvern, Pa.-based Centocor Inc. to include two additional proteins. The additions bring to six the number of Centocor antibodies being expressed using Biolex's LEX System. Biolex will carry out a commercial line creation project for the proteins. At Centocor's option, Biolex may scale-up and manufacture the proteins following the commercial line creation phase.

• BioVision, of Hannover, Germany, said improvements of its clinical Peptidomics technologies were presented at the Protein Biomarkers Conference in Philadelphia. Peptidomics comprises methods and technologies for analyzing small proteins and peptides in clinical research and development and for accompanying studies. The company was able to increase the sensitivity of analysis methods and accelerate research projects by integrating a new generation of mass spectrometers, improving internal process chains and providing sample preparation.

• Chromos Molecular Systems Inc., of Burnaby, British Columbia, said it is not proceeding with the private placement announced in July due to current market conditions. The company had intended on raising C$7 million (US$5.3 million) in gross proceeds after completing a private placement of up to about 10.8 million units at C65 cents apiece. Chromos is developing immune-based cell therapies.

• Ciphergen Diagnostics, of Fremont, Calif., a division of Ciphergen Biosystems Inc., said initial results of its ongoing study to validate biomarkers for ovarian cancer confirmed the down-regulation of specific variants of transthyretin and apolipoprotein A1. The results, which were presented at the International Gynecologic Cancer Society meeting, were achieved using a newly developed assay specifically designed for the markers and read on Ciphergen's new ProteinChip System 4000. Data also indicated that the markers were responsive to therapy.

• Computer Sciences Corp., of El Segundo, Calif., said its biopharmaceutical company DVC entered a Phase I trial for its recombinant botulinum neurotoxin vaccine candidate. The trial will evaluate the vaccine in healthy volunteers between the ages of 18 and 40. Testing is under way and will continue into 2005 at the University of Kentucky Chandler Medical Center in Lexington.

• Cryo-Cell International Inc., of Clearwater, Fla., signed a 20-year definitive license and royalty agreement with Asia Cryo-Cell Private Ltd. in India to establish and market its U-Cord program in India. Asia Cryo-Cell also has an option to expand into Singapore and Malaysia. Cryo-Cell is the world's largest U-Cord stem cell banking firm.

• Debiopharm SA, of Lausanne, Switzerland, said researchers presented data at the 11th international symposium on hepatitis C and related viruses held in Heidelberg, Germany, on the inhibition effect of DEBIO-025 on the replication of the hepatitis C virus. Using the luciferase activity in Huh-5-2 cells, the compounds were about 10-fold more potent than cyclosporine A. Debiopharm started Phase I studies this year with DEBIO-025, which demonstrated a favorable toxicological profile and was well tolerated in healthy volunteers.

• Evotec OAI AG, of Hamburg, Germany, signed an agreement with Altana Pharma AG, a division of Altana AG, of Konstanz, Germany, to advance the discovery on one of their kinase targets. The companies will seek to identify and optimize lead compounds that interact with the target by applying Evotec's drug discovery engine. Financial terms were not disclosed.

• Genaissance Pharmaceuticals Inc., of New Haven, Conn., signed a cooperative agreement with the Agricultural Research Service (ARS) to determine the distribution of known bovine SNPs in different types of beef and dairy cattle. The parties will construct and validate assays for the SNPs. ARS will make the panel of assays available to trace the origin or parentage of cattle. The Animal Plant Health and Inspection Service has awarded Genaissance a contract to conduct genotyping services to determine the susceptibility of sheep to scrapie as part of the National Scrapie Eradication Program.

• Gilead Sciences Inc., of Foster City, Calif., is calling for redemption on Nov. 20 all its outstanding 2 percent convertible subordinated notes due Dec. 15, 2007. The notes are being called as a provisional redemption based on the market price of Gilead common stock exceeding certain thresholds. The aggregate principal amount outstanding of the notes is $345 million. Gilead focuses on anti-infectives.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., initiated a multidose Phase I trial of aminocandin, under development as a treatment for systemic, invasive fungal infections. The trial will test the product in 32 healthy volunteers. Aminocandin is a member of the echinocandin class of anti-fungal agents.

• Magistral Biotech Inc., of Montreal, launched two new multicenter clinical studies. The objective of the first study will be to demonstrate the effectiveness of Libracol when taken concomitantly with Lipitor, made by Pfizer Inc. Adding Libracol to the statin is expected to improve the treatment's effectiveness, without increasing the risk of adverse effects. The purpose of the second study is to gather the information required for marketing approvals from Canada and U.S. regulatory authorities.

• Medarex Inc., of Princeton, N.J., received orphan drug status for its fully human anti-CD30 antibody, MDX-060, for Hodgkin's disease. The company is conducting an expanded dose-ranging Phase II trial in CD30+ lymphomas. CD30 has been found to be present on malignant cells of Hodgkin's disease and anaplastic large-cell lymphoma, as well as other CD30+ lymphomas.

• Medical Discoveries Inc., of Twin Falls, Idaho, said the FDA received the last research report for MDI's investigational new drug application for MDI-P in cystic fibrosis. The report focused on MDI-P as an adjunct therapy to Tobramycin (TOBI) in juvenile New Zealand rabbits with pulmonary infection. No inhibitory effects were seen in rabbits given both compounds intranasally. Applied alone, TOBI reduced the severity of Pseudomonas aeruginosa pulmonary infection compared to saline-treated controls and measured by broncheoaveolar lavage analysis of infection in the lungs. Applied in sequence, the drugs produced satisfactory reductions in infection.

• Medicure Inc., of Winnipeg, Manitoba, said preliminary results showed potential for MC-45308 in preventing blood clots. The compound demonstrated a property that displayed anti-platelet and anti-coagulant effects, which might be effective against myocardial infarction, stroke, pulmonary emboli and peripheral arterial disease, it said. To advance MC-45308, the company entered a research agreement with Jawed Fareed, a professor in the departments of pathology and pharmacology at Loyola University Stritch School of Medicine in Illinois.

• MethylGene Inc., of Montreal, initiated a two-step Phase II trial with MG98 in combination with interferon alpha for the treatment of metastatic renal-cell cancer. The first part of the trial will involve about 30 to 50 patients who have not previously received chemotherapeutic treatment. Patients will be randomly assigned to two dosing schedules that will combine MG98 with interferon alpha. The second step will involve 200 patients at up to 35 sites in North America and Europe. The patients will be randomized to treatment with either a combination of MG98 and interferon alpha or interferon alpha alone.

• Miikana Therapeutics Inc., of Fremont, Calif., raised $3 million in an extension of its Series A financing, which has raised a total of $7.25 million. The additional funds will enable the company to complete validation and preclinical lead selection for its first internal cancer agent. Investors included 5AM Ventures, Aravis Ventures, Novartis Venture Fund and Queensland Asset Management.

• Miravant Medical Technologies Inc., of Santa Barbara. Calif., decided on Photrex as the new brand name for SnET2, a proposed PDT drug for the treatment of wet age-related macular degeneration. The company also said the United States Adopted Name Council designated "rostaporfin" as the drug's unique generic name. Last week the company received an approvable letter from the FDA for the product, although the letter asked for a confirmatory study. (See BioWorld Today, Oct. 4, 2004.)

• Mirus Bio Corp., of Madison, Wis., was awarded a $1.3 million, multiyear Phase II SBIR grant from the National Institutes of Health to develop a gene-therapy product to treat anemia. The product will be the third in Mirus' portfolio to be based on its gene delivery platform, Pathway IV, a method to deliver genes to muscle via the bloodstream. The award follows completion of a Phase I grant under which researchers demonstrated therapeutic proof of concept by eliminating anemia in a small-animal model. The goal of the new grant will be to refine dosing and delivery parameters in larger animals.

• NeoPharm Inc., of Lake Forest, Ill., said Akorn Inc., of Buffalo Grove, Ill., defaulted on its $3.25 million promissory note to NeoPharm, which originally provided the financing to help Akorn fund the completion of a manufacturing facility. The facility was supposed to provide lyophilization manufacturing services for NeoPharm's lyophilized drug product candidates. As a result of the default, outstanding principal and interest under the note became immediately due and payable.

• PharmaMar SA, of Madrid, Spain, received orphan drug status for Aplidin, its second marine-derived compound, now in Phase II development. Aplidin has twice been granted orphan designation - the first time in June for acute lymphoblastic leukemia. The antitumor agent derived from the marine tunicate Aplidium albicans is designed to induce apoptosis and inhibit secretion of VEGF.

• Protein Design Labs Inc., of Fremont, Calif., said preclinical data for F200, its anti-alpha5beta1 integrin antibody fragment for the treatment of ocular disorders, showed it suppressed hemorrhaging and leakage in a rabbit choroidal neovascularization model. Targeting alpha5beta1 integrin might provide advantages over targeting a single growth factor, such as VEGF, in that it disrupts a common pathway for endothelial cell survival and acts downstream of multiple pro-angiogenic growth factor pathways. The data were presented at the 37th annual scientific meeting of the Retina Society in Baltimore.

• Sanguine Corp., of Pasadena, Calif., in anticipation of funding activities to support an animal trial program for its red blood cell substitute, PHER-02, completed reorganizing its financial statements. Management members opted to forgive their salary accruals and remove their related party debt as part of Sanguine's efforts to reduce its obligations. That also included the satisfaction of debt for stock issuance, issuance of securities for certain convertible debt and contribution to capital of other debt.

• Saqqara Consultants, of Carlsbad, Calif., entered an agreement with Cellular Genomics Inc., of Branford, Conn., to develop structure-based drug design within Cellular Genomics' discovery process. Saqqara will provide crystallization know-how and downstream support. Financial terms were not disclosed.

• Stanford University, of Palo Alto, Calif., said researchers at the school of medicine uncovered details about distinct molecular effects precipitated by the smallpox virus. In one of two articles published in this week's online issue of the Proceedings of the National Academy of Sciences, the researchers, using DNA microarrays, identified which genes are activated and which are suppressed in the circulating blood cells of infected monkeys. Certain critical molecules that control immune response were shut down in smallpox infection but not Ebola, suggesting smallpox might produce inhibitors of those molecules and underlying events that characterize early infection. The study was funded by the National Institutes of Health and the Howard Hughes Medical Institute.

• The Leukemia & Lymphoma Society, of White Plains, N.Y., awarded two Specialized Center of Research grants to advance the development of targeted cancer therapies. The grants bring funding from the program past the $77 million mark in the five years since its inception. The grants will go to John Bushweller, of the University of Virginia, who will develop novel, highly specific inhibitors of proteins that play a critical role in the development of acute and chronic myelogenous leukemia, and to Tak Mak, of the University of Toronto, who is studying signaling pathways in leukemia and lymphoma genesis.

• VioQuest Pharmaceuticals Inc., of Monmouth Junction, N.J., is opening a new production facility in Jiashan, China, that will expand the company's capabilities for the manufacture of raw material and basic building blocks to complement its chiral technologies from its subsidiary Chiral Quest Inc. The company said the 40,000-square-foot facility near Shanghai should be fully operational by the end of the year. It will initially employ about 20 professionals.

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