* Advanced Tissue Sciences Inc., of La Jolla, Calif., said it is the target of a shareholder lawsuit. The lawsuit, filed on behalf of investors who bought shares between Jan. 13, 1997, and June 11, 1998, alleges that Advanced Tissue Sciences and two company officers violated federal securities laws by issuing false and misleading statements about clinical data related to Dermagraft for treatment of diabetic foot ulcers. The FDA issued a non-approvable letter June 12 to Advanced Tissue Sciences for Dermagraft, a bioengineered, living, metabolically active skin implant derived from discarded foreskin tissue. The company's stock fell 44 percent the day the FDA's action was disclosed. Advanced Tissue said the lawsuit "is without merit" and it will fight the allegations.
* Cypress Bioscience Inc., of San Diego, said it is on schedule to complete submission of a premarket approval application to the FDA this summer to expand use of its Prosorba column to include treatment of rheumatoid arthritis. The device, a disposable filter that uses protein A to remove circulating immune complexes believed to be responsible for autoimmune diseases, was approved more than five years ago for idiopathic thrombocytopenic purpura (ITP), an immune-mediated bleeding disorder.
* Digital Gene Technologies Inc., of La Jolla Calif., will make available its Toga technology to Douglas Feinstein, an associate research professor at the University of Illinois, in Chicago, as part of the company's academic research collaboration program. Feinstein will use the Toga technology to isolate genes whose expressions block inflammatory responses of the brain to a variety of neuropathies, infections and diseases, such as multiple sclerosis, Alzheimer's disease and AIDS dementia. Toga (Total Gene Expression Analysis) is a method of identifying and determining the concentration of nearly all of the genes active in a sample cell or tissue.
* Endorex Corp., of Chicago, said the FDA granted orphan drug status to the company's ImmTher for treatment of Ewing's sarcoma, a bone cancer that strikes children and young adults. The drug, a muramyl dipeptide immunomodulator, is designed to stimulate a patient's immune system to kill cancer cells. ImmTher is being tested in Phase II trials as an adjuvant therapy to prevent recurrence of tumors following surgery and chemotherapy.
* Immunex Corp., of Seattle, said the FDA assigned priority review status to Enbrel for treatment of rheumatoid arthritis. Enbrel is a tumor necrosis factor (TNF) receptor that regulates inflammation by blocking the interaction of the proinflammatory cytokine TNF with the cells that respond to its signal. Immunex's partner in development of Enbrel is American Home Products Corp., of Madison, N.J. Immunex also revealed the FDA accepted for review the biologics license application submitted for the drug in May. (See BioWorld Today, May 11, 1998, p. 1.)
* Mylan Laboratories Inc., of Pittsburgh, agreed to acquire Penederm Inc., of Foster City, Calif., in a stock swap worth $205 million. For each Penederm share, stockholders will receive 0.68 Mylan shares, valued at $21.89. Penederm develops and markets topically administered drugs.
* Reliable Biopharmaceutical Corp., of St. Louis, received a two-year, $654,000 Phase II Small Business Innovation Research grant from the National Institutes of Health, in Bethesda, Md., for development of heparinoids to produce an orally administered drug to replace the anticoagulant heparin. The company said its most active heparinoid is synthesized from maltobionic acid.
* Rhone-Poulenc Rorer Inc., of Collegeville, Pa., said the FDA expanded the label for its anti-cancer drug, Taxotere, to include first-line treatment of metastatic breast cancer in patients whose disease has recurred despite adjuvant therapy. The drug, a taxoid, previously was approved for advanced and metastatic breast cancer in patients who failed other chemotherapies.
* Sibia Neurosciences Inc., of La Jolla, Calif., started dosing in a Phase I trial SIB-1553A , under development for treatment of cognitive deficits in a number of diseases, including the initial focus, Alzheimer's dementia. The trial will evaluate the safety and pharmacokinetics of SIB-1553A in a rising dose tolerance study in healthy men. Animal studies have shown SIB-1553A improves short- and long-term memory deficits caused by neuronal loss, drugs or aging. The drug is a subtype-selective nicotinic acetylcholine receptor agonist, activating subtypes of nicotinic receptors within the brain.