• aaiPharma Inc., of Wilmington, N.C., said it would file its 2003 annual report late with the SEC. The filing deadline will be extended to March 30. AaiPharma's board indicated earlier this month that an ongoing inquiry by a committee of independent directors could result in a delay in the filing. The company is focused on pain management.

• Advanced Bio/Chem Inc., of The Woodlands, Texas, signed a patent and technology license agreement with the University of Texas M.D. Anderson Cancer Center in Houston. The agreement provides for the detection, diagnosis and monitoring of breast cancer through proteomic analysis of breast ductal fluids obtained from the regions of the breast where most breast cancers originate. Terms were not disclosed.

• Altana AG, of Bad Homburg, Germany, said additional efficacy results of Daxas (roflumilast) in patients with chronic obstructive pulmonary disease were presented at the 45th Congress of the German Society of Pulmonology in Frankfurt. The study enrolled more than 1,400 patients in 11 countries. They were treated for 24 weeks with either placebo or a dose of Daxas at 250 micrograms or 500 micrograms. Results showed that the exacerbation rate was reduced at a statistically significant level. The drug, a selective phosphodiesterase-4 inhibitor, is for the treatment of chronic obstructive pulmonary disease and asthma. Altana is developing it worldwide with New York-based Pfizer Inc., expect in Japan, where it is partnered with Tanabe Seiyaku Co. Ltd. In February, Altana filed for marketing approval in Europe.

• Applied Biosystems Group, of Foster City, Calif., and MDS Inc., of Toronto, will receive $18.1 million from Waters Technologies Corp., of Milford, Mass., after entering an agreement resolving outstanding litigation between them. The settlement provides for the resolution of patent-infringement claims made by certain of the parties against the other in the U.S., and of international cases brought by Applied Biosystems and MDS against Waters Technologies in the UK, Canada and Japan. All parties entered royalty-paying license agreements, cross-licensing the use of the technology described in the parties' respective patents at issue. Applied Biosystems is in a partnership with MDS Sciex, the analytical instrumentation and technology solutions division of MDS.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., is planning a 6 million-share public offering after filing a prospectus supplement with the SEC related to an underwritten offering under an existing shelf registration statement. The underwriters, which include sole book-running manager Lehman Brothers Inc., as well as co-managers Lazard Freres & Co. LLC; Adams, Harkness & Hill Inc.; JMP Securities LLC and Rodman & Renshaw LLC, have been granted an overallotment option to purchase up to an additional 900,000 shares. Ariad is selling all the shares.

• Avanir Pharmaceuticals Inc., of San Diego, discovered a series of orally active small molecules that reduce the fatty deposits in blood vessel walls typically associated with atherosclerosis. The compounds also showed favorable effects on plasma cholesterol levels in the experimental animal models. Avanir designated the lead molecule as AVP 26452. The compounds were discovered through a research program targeting Apolipoprotein A1, a mediator of the reverse cholesterol transport pathway.

• Ceres Inc., of Los Angeles, is one of several companies sharing their corn genome sequence data through the National Corn Growers Association (NCGA). The data will be available to research scientists through a searchable database on the Internet, and is intended to be hosted at the Donald Danforth Plant Science Center, a not-for-profit research institute. To gain access to the data, scientists must complete a licensing agreement that can be downloaded on the NCGA website, www.ncga.com. Other companies supplying sequence data include Monsanto Co., of St. Louis, and Pioneer Hi-Bred International Inc., of Des Moines, Iowa. The latter is a subsidiary of DuPont.

• CytoGenix Inc., of Houston, entered an agreement with scientists at the Louisiana State University Health Sciences Center in Shreveport for preclinical experiments using the company's ssDNA expression vector technology to silence a gene that has been shown to cause malignant transformation of tumor cells. The studies are designed to determine the effect the silencing system has on solid-tumor cancer cells.

• DevCo Pharmaceuticals Ltd., of London, completed a confirmatory safety trial of lexipafant, which is being developed to protect from organ dysfunction associated with coronary artery bypass graft, to treat HIV-associated cognitive/motor dysfunction, and to treat acute pancreatitis. The confirmatory trial was conducted in 24 people at a single site in the UK. Subjects tolerated intravenous infusions of 400 mg and 800 mg per day for three days. Plasma levels achieved resulted in 70 percent inhibition of platelet activating factor activated neutrophil function during the fusion period.

• DOR BioPharma Inc., of Miami, closed on its $3.25 million private financing announced earlier this month. Cardinal Securities LLC acted as the placement agent. DOR BioPharma is developing vaccines against ricin and botulinum toxins, and has a Phase III product, orBec, to treat intestinal graft-vs.-host disease.

• enGene Inc., of Vancouver, British Columbia, named Eric Adams president and CEO. Most recently, he was the director of marketing for oncology at QLT Inc., also of Vancouver. Adams replaces Anthony Cheung, a co-founder who will assume the role of chief scientific officer. Both have seats on the board of enGene, which is working to commercialize a platform technology for the systemic delivery of therapeutic proteins within the body through genetic modification of gut cells.

• EraGen Biosciences Inc., of Madison, Wis., signed a distribution agreement with Inter Medico, of Toronto. The deal, which is centered on molecular diagnostic assay systems, calls for Inter Medico to distribute EraGen's products in Canada. Terms were not disclosed.

• Exelixis Inc., of South San Francisco, said the FDA granted orphan drug designation to XL119 to treat bile duct tumors. The company expects to begin a pivotal Phase III trial in the second quarter. The company reached an agreement in September with the FDA through the special protocol assessment for the Phase III program.

• ID Business Solutions, of Guildford, UK, entered several collaborations to provide its ActivityBase software suite to organizations in Australia. Australia's Commonwealth Scientific and Industrial Research Organization (CSIRO), the Walter and Eliza Hall Institute and Alchemia Ltd. adopted the software to manage their chemical and biological drug discovery data.

• Inex Pharmaceuticals Corp., of Vancouver, British Columbia, and Enzon Pharmaceuticals Inc., of Bridgewater, N.J., submitted the final section of a rolling new drug application for Onco TCS to the FDA. The companies are seeking approval of Onco TCS as a single-agent treatment for patients with relapsed aggressive non-Hodgkin's lymphoma who were previously treated with at least two combination chemotherapy regimens. Inex requested a priority review of the NDA. The company began the filing last September. (See BioWorld Today, Oct. 1, 2003.)

• InKine Pharmaceutical Co. Inc., of Blue Bell, Pa., withdrew its public offering for 6 million shares of common stock, priced at $5 per share. The offering was scheduled to close March 15, but was withdrawn when the company became aware that its certificate of incorporation does not contain any provision exempting it from providing pre-emptive rights in connection with certain securities offerings. Typically those preemptive rights are eliminated when a corporation becomes public, but in 1995 when InKine filed for its initial public offering, the former management and board did not amend the certificate of incorporation to eliminate those rights. The company is working with independent counsel to determine its level of exposure. If shareholders with pre-emptive rights claim damage from prior offerings, InKine expects to receive reimbursement from third parties for any resulting liabilities. The company does not expect the withdrawal to adversely effect its current operations.

• MGI Pharma Inc., of Minneapolis, began sales and marketing of the Salagen (pilocarpine hydrochloride) 7.5-mg tablet in the U.S. The FDA approved the tablet as an alternative strength to the currently marketed Salagen 5-mg tablet. The tablets are indicated to treat symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck, and for dry mouth in patients with Sjogren's syndrome.

• MycoLogics Inc., of Denver, received a Phase I Small Business Innovation Research grant from the Department of Health and Human Services to derive a new vaccine against Aspergillus fumigatus, a spore-bearing fungus that causes multiple diseases including allergic asthma, aspergillomas and invasive pulmonary disease in those with predisposing underlying conditions. The company said its vaccine delivery system is low in cost, flexible and able to accommodate potential cocktails. MycoLogics is collaborating on the project with the California Institute for Medical Research.

• Protein Design Labs Inc., of Fremont, Calif., reported positive results from an initial study of daclizumab in patients with chronic persistent asthma whose disease is not well controlled with high doses of inhaled corticosteroid therapy. The humanized antibody was generally well tolerated and met its primary endpoint, which was a percent change in FEV1 from baseline to 12 weeks. Patients receiving daclizumab also demonstrated a statistically significant increase in the time to asthma exacerbation requiring oral corticosteroid rescue, as well as lower peripheral eosinophil counts. The Phase II randomized, double-blind, placebo-controlled trial was conducted at 24 centers in the U.S. and treated 114 patients.

• Spectral Genomics Inc., of Houston, acquired Bacterial Barcodes Inc., also of Houston. Both companies were founded based on technology from Baylor College of Medicine and have been focused on the application of advanced molecular biology methods to genomics. Bacterial Barcodes developed the DiversiLab System based on rep-PCR technology for bacterial strain identification and infection control. Simultaneous to the merger, Spectral Genomics raised $9.3 million through its Series B round of financing. The added funds will allow the company to scale-up its production capacity for its genomic array products and to accelerate the development of its next-generation products. Techxas Ventures led the financing, with additional investments from Burrill & Co., Baylor College of Medicine and BioTex Finance Ltd.

• Vion Pharmaceuticals Inc., of New Haven, Conn., entered a worldwide nonexclusive license agreement for its Melasyn technology with Johnson & Johnson Consumer Companies Inc., of New Brunswick, N.J. Melasyn is a synthetic form of melanin that dissolves readily in water. The agreement does not include up-front or milestone payments. If products including Vion's technology are developed, Vion will receive a royalty based on sales in countries where it has issued patents. Vion is focused on developing treatments for cancer.