* Acacia Biosciences Inc., of Richmond, Calif., and Novartis AG, of Basel, Switzerland, signed a profiling agreement through the latter company's subisidiary, Novartis Crop Protection Inc., of Research Triangle Park, N.C., to use Acacia's Genome Reporter Maxtrix (GRM) to help in the selection and optimization of lead compounds for crop protection products. Acacia will provide chemical and biological profiles on a class of Novartis compounds. Terms were not disclosed. GRM is a tool that provides practical analysis of early stage chemicals by interpreting their effects across entire genomes.
* Amylin Pharmaceuticals Inc., of San Diego, began a Phase I clinical study of AC2993 (exendin-4) for Type 2 diabetes. The synthetic peptide, based on a substance isolated from the salivary secretions of the Gila monster, is being administered subcutaneously to normal human volunteers. It has been shown to exert effects that appear important for metabolic and glucose control.
* ArQule Inc., of Medford, Mass., told investors it expects this year's revenues will fall short of projections, and will be in the range of $22 million to $26 million, with a loss ranging up to $5 million as a result. The revenue shortfall is due primarily to temporary delays by a major collaborator, ArQule said.
* FibroGen Inc., of South San Francisco, said its subsidiary, FibroGen Europe Ltd., of Oulu, Finland, and the government of Finland, through its development arm, the Technology Development Center (TEKES), renewed a potential $28 million deal to fund FibroGen's worldwide recombinant collagen program. Since 1996, TEKES funding has contributed to FibroGen's development of recombinant human collagen and recombinant gelatin for use in medical device, pharmaceutical and industrial applications. The renewed agreement, which should cover expenses through May 1999, calls for TEKES to reimburse FibroGen for 47 percent of its development expenses.
* GeneMedicine Inc., of The Woodlands, Texas, said it has received several proprietary peptide sequences from the University of Texas Southwestern Medical Center at Dallas that demonstrate a high affinity for targeting dendritic cells in vitro. The company intends to develop genetic vaccines that specifically target dendritic cells and deliver unique genetic information for a particular infectious disease or cancer, thereby allowing control and direction of immune response.
* Genentech Inc., of South San Francisco, and Idec Pharmaceuticals Corp., of San Diego, said study results on projected median time to progression of disease for Rituxan (rituximab) were published in the August issue of the Journal of Clinical Oncology. Rituxan, a monoclonal antibody, was cleared by the FDA for marketing in November 1997 for relapsed or refractory low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma. The trial showed a 48 percent overall response rate in 166 intent-to-treat patients.
* LXR Biotechnology Inc., of Richmond, Calif., appointed Paul Hastings president and CEO, to succeed Kirk Raab, who will remain with the company as chairman and who had been interim CEO since April 1998. (See BioWorld Today, April 24, 1998, p. 1.)
* Metra Biosystems Inc., of Mountain View, Calif., said the FDA cleared the company's premarket notification for use of the Pyrilinks-D bone resorption immunoassay to monitor patient response to hormone replacement therapy in the treatment and prevention of osteoporosis. Earlier this year, the FDA gave Metra permission to commercialize Pyrilinks-D for use in monitoring patient response to treatment of osteoporosis with alendronate.
* Millennium Pharmaceuticals Inc., of Cambridge, Mass., said American Home Products Corp., of Madison, N.J., accepted an antibacterial drug target for drug candidate screening. Millennium is collaborating with the company's pharmaceutical research and development division, Wyeth-Ayerst Research. The antibacterial drug target is the fifth discovered at Millennium since the alliance began in 1996, and triggers an undisclosed milestone payment. American Home first launched the collaboration with Cambridge-based ChemGenics Pharmaceuticals Inc., which Millennium acquired last year. (See BioWorld Today, Jan. 22, 1997, p. 1.)
* Nabi, of Boca Raton, Fla., submitted a product license application and a supplement to an establishment license application for the company's reformulated hepatitis B immune globulin (human), the proposed trade name of which is H-BIG. The new formulation for the prevention of hepatitis B contains 5 percent protein, is processed with solvent detergent and nanofiltration viral inactivation/ removal steps, and contains no thimerosal.
* NeXstar Pharmaceuticals Inc., of Boulder, Colo., said the Medicines Control Agency of the U.K. has approved a new indication for AmBisome, the company's liposomal formulation of amphotericin B. The broader label includes empirical treatment for presumed fungal infections in febrile neutropenic patients whose fever is resistant to broad-spectrum antibiotics and where a bacterial or viral cause has not been defined. The antifungal drug now has first-line indications in 17 countries.
* Pangaea Pharmaceuticals Inc., of Cambridge, Mass., said its investigational new drug application for Biotope-CD to treat human papilloma virus-associated cervical dysplasia, has been cleared by the FDA. Pangaea's technology uses a delivery system called Biotopes, which are small circular pieces of DNA encoding a particular peptide and the signals that provide for their intracellular trafficking. Data from the first human trial of Biotope-CD are expected next year. (See BioWorld Today, May 15, 1996, p. 1.)