• Aerogen Inc., of Mountain View, Calif., said it is realigning resources to focus on the execution of its specialty pharmaceutical business. It is reducing its staff by 26 people, about 30 percent of its work force. The company is developing inhaler and nebulizer products based on its aerosol-generator technology. It said in June it was cutting employees to conserve cash, dropping 32 employees at the time. (See BioWorld Today, June 10, 2002.)

• Applied Molecular Evolution Inc., of San Diego, reported two lead candidates in its internal development program: AME-527, which binds to and neutralizes tumor necrosis factor alpha to treat rheumatoid arthritis, and AME-133, which binds to cells expressing CD20 to treat non-Hodgkin's lymphoma. AME-527 and AME-133 are both next-generation, humanized and optimized monoclonal antibody products that demonstrated improved activity in preclinical studies conducted by AME, compared with the currently marketed, first-generation treatments, Remicade by Malvern, Pa.-based Centocor Inc., and Rituxan by South San Francisco-based Genentech Inc., respectively, the company said.

• Ariad Pharmaceuticals Inc., of Cambridge, Mass., said the investigational new drug application for AP23573, its lead anticancer product candidate, was filed with the FDA in late December in support of initiating Phase I trials. The drug is designed to inhibit the protein mTOR and shrink tumors by cancer cell starvation (metabolic arrest) through inhibition of nutrient uptake and growth factor stimulation.

• CancerVax Corp., of Carlsbad, Calif., said that data published in the Journal of Clinical Oncology in an article titled "Prolonged Survival After Complete Resection of Disseminated Melanoma and Active Immunotherapy with a Therapeutic Cancer Vaccine" indicated that treatment with its experimental Canvaxin therapeutic cancer vaccine increased overall survival significantly in patients with American Joint Committee on Cancer Stage IV melanoma. In an analysis of 263 patients who underwent complete resection of clinically detectable AJCC Stage IV melanoma, 150 received post-surgical treatment with the Canvaxin in Phase II protocols and 113 received other or no adjuvant therapy. In patients who received Canvaxin, median overall survival and five-year overall survival were significantly increased (p=.0001).

• Enzon Inc., of Bridgewater, N.J., said it will suspend its PEG-paclitaxel development program. The decision to suspend the Phase I program was based on a strategic analysis of its potential investment returns against the associated costs, competitive risks, resource allocation and development time, the company said.

• GTC Biotherapeutics Inc., of Framingham, Mass., and Merrimack Pharmaceuticals Inc., of Cambridge, Mass., agreed to expand their relationship to include purification of Merrimack's MM-093, a recombinant human alpha-fetoprotein for use in clinical studies. That is in addition to a previously announced agreement for GTC to produce rhAFP in the milk of transgenic goats. GTC expects to deliver purified rhAFP during 2003 for use in clinical trials.

• Iomai Corp., of Gaithersburg, Md., raised $54 million through the issuance of Series C preferred stock. The round was co-led by New Enterprise Associates and Essex Woodlands Health Ventures. Iomai's technology, transcutaneous immunization (TCI), allows delivery of vaccines to the skin using a patch. TCI combines the use of immune stimulants, or adjuvants, that target Langerhans cells.

• Novartis AG, of Basel, Switzerland, said the European Commission approved Gleevec (imatinib) as a first-line treatment for adult and pediatric patients with Philadelphia chromosome-positive chronic myeloid leukemia. Gleevec is approved in the U.S. for the chronic myeloid leukemia indication in the blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., and Eli Lilly and Co., of Indianapolis, restructured a five-year-old agreement centered on hepatitis C viral protease inhibitors. Vertex will take the lead in developing and commercializing VX-950, an oral hepatitis C viral protease inhibitor. Lilly was to have maintained preclinical, clinical and global marketing responsibility for any resulting drugs. But Lilly said it is reprioritizing its research portfolio, and Vertex said it wants to focus on specialty pharmaceutical markets and retain greater downstream rights to its own compounds. As a result, Vertex has obtained the worldwide rights to compounds identified during the collaboration. Lilly will retain a financial interest in VX-950 and other HCV protease compounds through royalties on future net product sales. Specific financial terms were not disclosed. Vertex said it plans to begin clinical testing in the second half of this year for VX-950, a small-molecule protease inhibitor from a new class of antiviral drugs that inhibits hepatitis C NS3-4A protease, an enzyme considered essential for HCV viral replication. Calling its compound distinct, the company said it has shown excellent in vitro potency, with high levels of drug achieved in both plasma and liver in animal studies. (See BioWorld Today, June 13, 1997.)

• ViroPharma Inc., of Exton, Pa., and Wyeth, of Madison, N.J., initiated Phase I trials of HCV 371, the lead compound from a chemical series that is being developed under their hepatitis C collaboration. ViroPharma also said it is considering the development of Picovir to treat patients suffering from severe or life-threatening enteroviral infections as part of an effort to explore alternative uses for the drug. It said it will also explore ways to maximize the value of Picovir by evaluating an intranasal approach to treating the common cold. ViroPharma said it is discontinuing the development of its Phase I and preclinical respiratory syncytial virus compounds.