• Acadia Pharmaceuticals Inc., of San Diego, initiated Phase I trials of ACP-103, a small-molecule drug candidate that represents a new approach to amelioration of treatment-induced dysfunction in Parkinson's disease, as well as a range of neuropsychiatric disorders. ACP-103 originates from Acadia's internal discovery and development efforts and represents the first of two small-molecule drugs that Acadia plans to move into testing this year. ACP-103 acts as a selective inverse agonist at the 5-HT2A receptor.

• Affymetrix Inc., of Santa Clara, Calif., and Boston University Medical Center entered a collaboration using Affymetrix's GeneChip technology to develop a less-invasive sample acquisition method and to identify predictive molecular signatures that may enable screening and early detection of lung cancer in at-risk individuals. Using GeneChip microarrays, researchers will study the use of airway gene expression signatures for early detection, prognosis, therapy selection and monitoring of lung cancer - potentially less invasive than today's standard of removing tissue from inside the lung. Financial terms were not disclosed.

• AnorMED Inc., of Vancouver, British Columbia, said it was notified by its licensee, North American Scientific Inc., of Chatsworth, Calif., that its Theseus Imaging subsidiary has withdrawn a pending investigational new drug application for clinical studies of Hynic-Annexin V, a kit used for the in vivo imaging of apoptosis and necrosis, following recent discussions with the FDA. North American Scientific said it plans to submit a new filing within the next few months that will provide additional data requested by the agency.

• Aphton Corp., of Miami, said it received notification that the Committee for Orphan Medicinal Products recommended to the European Commission of the European Union that Aphton's anti-gastrin immunogen, G17DT, be granted orphan drug status for both pancreatic cancer and gastric cancer indications.

• BioVision AG, of Hanover, Germany, said since entering a cooperation project with Roche Diagnostics GmbH, of Mannheim, Germany, in 1999, that it has identified a number of proteins that may enable early diagnosis of Alzheimer's disease and distinguish it from other forms of dementia. The cooperation between BioVision and Roche is therefore entering a new phase, the company said. Roche decided to test large groups of patients for the presence of the most promising of those peptides in serum and is developing an appropriate testing system.

• Cambrex Corp., of East Rutherford, N.J., said Claes Glassell resigned as its president and chief operating officer, as well as from its board, to pursue other opportunities. Current Chairman and CEO James Mack will take on the additional title and duties of president of Cambrex, which develops products and services for drug discovery.

• Cell Genesys Inc., of Foster City, Calif., said it received $15 million in cash from Transkaryotic Therapies Inc., of Cambridge, Mass., stemming from an agreement under which Cell Genesys licensed to TKT intellectual property related to Cell Genesys' gene activation technology for certain therapeutic proteins. Through the deal, Cell Genesys received $11 million in cash and was scheduled to receive $15 million in TKT stock. A registration statement for the sale of stock had not yet been declared effective, and the companies agreed for TKT to substitute $15 million in cash in place of TKT stock. On the day the deal was made public in June, TKT's stock (NASDAQ:TKTX) closed at $34.97. It closed Wednesday at $5.89. (See BioWorld Today, June 11, 2002.)

• Cel-Sci Corp., of Vienna, Va., said in a letter to update corporate goals to shareholders that it plans to submit to the FDA an application to begin Phase III trials of its non-toxic immunotherapy drug Multikine in head and neck cancer. Funding sources for such a trial could come from a deal with a pharmaceutical company, through a government sponsorship or from internal funds. Cel-Sci said it plans to allocate the most funding to developing Multikine in head and neck cancer. It plans to seek government and/or partner funding to continue development of the drug in cervical dysplasia.

• Compugen Ltd., of Tel Aviv, Israel, granted to Diagnostic Products Corp., of Los Angeles, a license to develop and commercialize diagnostic assays based on two prostate-specific proteins for the screening, detection and monitoring of prostate and other cancers. The agreement couples Compugen's recent discoveries of a PSA-linked molecule (PSA-LM) and an hK2-linked molecule (K-LM), with Diagnostic Products' development, manufacturing and marketing of diagnostic immunoassay-based products worldwide. Compugen will receive undisclosed milestone payments and royalties based on the commercialization of its intellectual property, including Diagnostic Products' sales of any immunoassay-based products. More specific financial terms were not disclosed.

• Introgen Therapeutics Inc., of Austin, Texas, said a preclinical study published in Molecular Cancer Therapeutics demonstrated that mebendazole exhibits antitumor activity in in vitro and in vivo models of lung cancer. Treatment of lung cancer cell lines with mebendazole caused the arrest of mitosis and resulted in apoptosis. Oral administration of mebendazole in mice elicited an antitumor effect in a subcutaneous cancer model, as well as in a mouse model of metastatic lung cancer. Introgen has exclusive rights to patent applications describing the use of the mebendazole family of drugs for cancer and hyperproliferative disorders.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said its GeneTrove division entered a target-validation agreement with Pfizer Inc., of New York. Pfizer will obtain access to Isis' antisense inhibitors and acquire a license to specific patents within Isis' intellectual property estate for use in its internal antisense-based functional genomics program. Financial terms were not disclosed.

• Labopharm Inc., of Laval, Quebec, reported positive results from the multicenter European Phase III trial of its lead in-house product, a once-daily formulation of the analgesic tramadol. Tramadol is indicated for the treatment of moderate to severe pain. In the Phase III trial, Labopharm's formulation achieved the primary endpoint of the study, providing a statistically and clinically significant reduction in pain associated with osteoarthritis, Labopharm said.

• LION bioscience AG, of Heidelberg, Germany, entered a two-year global licensing agreement for its SRS integration technology with Johnson & Johnson Pharmaceutical Research & Development LLC, a unit of Johnson & Johnson, of New Brunswick, N.J. J&J will access LION's SRS7.0 software, which integrates life science data from public and private databases for analysis, as well as SRS Prisma, which automatically updates internal databases as new information becomes available. Financial terms were not disclosed.

• OraPharma Inc., of Warminster, Pa., said that Arestin was approved for sale in Sweden. The product is a time-released antibiotic encapsulated in microspheres designed to combat periodontal disease. The Swedish approval may help expedite obtaining approval in other European Union member countries, as the company files for those approvals by using the mutual recognition process. On Nov. 13, OraPharma entered an agreement with Johnson & Johnson, of New Brunswick, N.J., under which J&J agreed to acquire all the outstanding stock of OraPharma for $7.41 in cash per share.

• Palatin Technologies Inc., of Cranbury, N.J., reported results of a Phase IIa trial designed to evaluate the efficacy of PT-141 in patients with erectile dysfunction and a history of inadequate response to sildenafil citrate (Viagra). Data showed that PT-141 had a highly significant effect on both the primary efficacy endpoint, total time of penile base rigidity greater than 60 percent of full base rigidity vs. placebo (p<0.001), and the secondary efficacy endpoint, time of penile base rigidity greater than 80 percent of full base rigidity vs. placebo (p<0.003). A base rigidity of 60 percent is generally considered sufficient for sexual intercourse.

• QuatRx Pharmaceuticals Co., of Ann Arbor, Mich., said the FDA accepted the investigational new drug application for the company's vitamin D analogue, QRX-101. QuatRx is initiating a Phase II study of a topical formulation of the compound in patients with mild to moderate psoriasis, the first indication that will be sought. The study will involve 120 patients. QuatRx acquired the exclusive license to QRX-101 in 2002 from Deltanoid Inc., of Madison, Wis.

• SangStat Medical Corp., of Fremont, Calif., said it filed a marketing authorization application in an undisclosed European country for Acceptine (cyclosporine capsules), SangStat's branded formulation of the generic immunosuppressive frequently taken throughout the life of a transplant patient after surgery to prevent organ rejection. SangStat said its formulation is about half the size of the most commonly used cyclosporine capsules in Europe, a market the company estimated at about $350 million. Given approval, SangStat said it intends to file other such applications throughout Europe as part of a mutual recognition process.

• Sun Microsystems Inc., of Tokyo, said the Human Genome Center, a branch of the Institute of Medical Science of the University of Tokyo, deployed Sun Fire 15K servers as the basis of its human genome analysis system. Powered by Sun's high-end 64-bit servers, the system went fully operational on Jan. 1, the company said.

• The Genetics Co. Inc., of Zurich, Switzerland, said it acquired a set of core assets from CallistoGen AG, of Berlin. The Genetics Co. acquired CallistoGen's portfolio of small-molecule candidates against Alzheimer's disease and its lead-generation platform. The Genetics Co. also will gain access to a number of international customers. Financial terms were not disclosed. The Genetics Co. said it will focus its drug discovery and development efforts on cancer and neurodegenerative disease and it plans to out-license its noncore assets, including its work in diabetes.

• Tularik Inc., of South San Francisco, said it filed a registration statement with the SEC relating to the possible resale of up to about 11.4 million shares of Tularik common stock owned by ZKB Pharma Vision AG, of Glaris, Switzerland. Tularik is engaged in the discovery and development of a range of orally available medicines that act through the regulation of gene expression in three therapeutic areas: cancer, immunology and metabolic disease.

• Viragen Inc., of Plantation, Fla., said its majority owned subsidiary, Viragen International Inc., entered an agreement to introduce its natural human alpha interferon drug, Multiferon, into the Chinese market with Genesis Technology Group Inc., of Boca Raton, Fla. Viragen said Genesis is the first U.S. Trust Member of the Shanghai Technology Stock Exchange, which provides services in property rights transactions and equity financing for high-tech and growth enterprises in China. Multiferon offers an alternative interferon therapy to treat many viral and malignant diseases. Financial terms were not disclosed.

• Zapaq Inc., of Oklahoma City, said it was awarded $250,000 in follow-on funding from the Institute for the Study of Aging in New York. The start-up is working to develop drugs that inhibit a family of enzymes called aspartic proteases to treat Alzheimer's disease. Its first in-licensed technology was developed at the Oklahoma Medical Research Foundation in Oklahoma City, and the University of Illinois.