Amylin Pharmaceuticals Inc., of San Diego, said it has been selected for addition to the Nasdaq Biotechnology Index, effective May 20. Amylin focuses on the discovery, development and commercialization of drug candidates for the treatment of diabetes and other metabolic disorders.

AlphaRx Inc., of Richmond Hill, Ontario, said studies comparing a number of formulations using AlphaRx's drug delivery system with commercial topical anti-inflammatory creams provided data suggesting AlphaRx's formulations possess enhanced anti-inflammatory activity when compared to marketed brands. The research was conducted under a sponsored research agreement between NeuroProtection Inc., of Toronto, and the University Health Network. AlphaRx's topical drug delivery formulation uses natural and safe carrier components, the company said.

Amersham plc, of London, said its life sciences division, Amersham Biosciences, agreed to acquire a controlling stake in Cimarron Software Inc., of Salt Lake City. Cimarron is an informatics company that supplies software solutions for life science research. Financial terms were not disclosed. Amersham Biosciences has an option to acquire up to 100 percent of Cimarron during the next three years, although the option is subject to achieving a number of financial milestones.

AntiCancer Inc., of San Diego, said its histoculture drug response assay (HDRA) was shown to be an effective method for in vitro drug response assessment of cancer patients. In a study published in the journal Head and Neck, tumor specimens from 41 of 42 patients undergoing treatment for head and neck cancer were evaluated using the assay. The association between HDRA assessment of drug sensitivity and patient survival remained significant with tumors of all stages, as well as recurrent cancer.

Atugen AG, of Berlin, Germany, and Byk Gulden, of Konstanz, Germany, a unit of Altana AG, signed a three-year collaboration to validate a number of genetic targets associated with cancer and immunological diseases. The companies have completed a target evaluation agreement that was signed in 2001. Atugen receives an up-front payment, annual licensing fees, research funding and potential milestone payments, as well as potential royalties on antisense GeneBlocs developed as therapeutics. Atugen will develop GeneBlocs that inhibit expression of specific genetic targets selected by Byk Gulden. The companies will analyze the effects of the GeneBlocs in pharmacological assays and animal models of disease. Atugen will retain rights to the GeneBlocs developed and have an option to perform antisense GeneBloc development on targets not pursued by Byk Gulden.

AVI BioPharma Inc., of Portland, Ore., said two preclinical studies published in Current Opinion in Molecular Therapeutics demonstrate potential for use of AVI's third-generation antisense drug platform, Neugene, in treating prostate cancer and viral infections caused by Caliciviridae, a family of RNA viruses. Separately, AVI's lead cancer agent, Avicine, has completed three Phase II trials in colorectal and pancreatic cancer and is initiating a Phase III trial in pancreatic cancer, with a supporting trial in colorectal cancer.

Caliper Technologies Corp., of Mountain View, Calif., said that, effective July 1, Michael Knapp will become the company's CEO and James Knighton will become president. Daniel Kisner will become chairman and will no longer serve as CEO and president. David Milligan, the current chairman, will become vice chairman. Caliper designs, manufactures and commercializes devices and systems, including its LabChip technology, for research and experiments.

Cell Therapeutics Inc., of Seattle, said it is continuing a Phase II trial of Xyotax (polyglutamate paclitaxel) in non-small-cell lung cancer based on a review of interim results from the study. The study involves high-risk patients, meaning they are more than 70 years of age or are unable to work and unable to get out of bed for nearly half their day. The study is designed to evaluate disease control rate, median survival and safety. Xyotax links paclitaxel to a biodigestible polyglutamate polymer.

Celsion Corp., of Columbia, Md., said the National Institutes of Health, of Bethesda, Md., began a preclinical evaluation to determine whether Celsion's doxorubicin-laden, temperature-sensitive liposomes can be used to improve liver cancer treatment. The objective of the study is to determine if the addition of a cytotoxic drug targeted to the tumor margin by Celsion's heat-activated liposomes will improve therapy. Celsion's drug delivery technology is licensed from Duke University.

Debiopharm SA, of Lausanne, Switzerland, and Dyax Corp., of Cambridge, Mass., said a study was published in the American Journal of Respiratory Cellular and Molecular Biology that demonstrates the protective effect of DX-890, a human neutrophil elastase inhibitor, against acute lung injury in vitro and in an animal model. DX-890 is in development in Europe by Debiopharm for cystic fibrosis under a collaboration agreement with Dyax. The study was conducted in centers in France and Belgium.

Genentech Inc., of South San Francisco, and OSI Pharmaceuticals Inc., of Melville, N.Y., said the FDA designated Tarceva (erlotinib HCl, OSI-774) a fast-track product for the treatment of chemotherapy-na ve Stage III/IV non-small-cell lung cancer patients. Tarceva is a small-molecule epidermal growth factor receptor inhibitor being developed by the companies and F. Hoffmann-La Roche Ltd., of Basel, Switzerland. Tarceva is being studied in non-small-cell lung cancer and in pancreatic cancer through randomized and controlled Phase III studies with survival as the primary endpoint.

Human Genome Sciences Inc., of Rockville, Md., said the FDA cleared the company's investigational new drug application to begin clinical trials of LymphoRad (131). Human Genome Sciences' initial Phase I trial will evaluate the safety and pharmacology of LymphoRad in patients with multiple myeloma. Preclinical studies have shown that LymphoRad, a radio-iodinated form of B-lymphocyte stimulator, binds to receptors found only on B cells and B-cell tumors.

Immuno-Designed Molecules SA, of Paris, and its U.S. subsidiary, IDM Inc., reached agreement with the FDA to begin a Phase III trial in the treatment of ovarian cancer using IDM's Cell Drug Osidem (IDM-1). IDM will conduct the study in association with a number of U.S. teams of cell therapy specialists. The goal of the cellular immunotherapy treatment from IDM is to eliminate residual tumor cells after surgery and chemotherapy. A Phase III trial of Osidem in patients with Stage III ovarian cancer is ongoing in Europe, Canada and Australia, with the aim of prolonging remission after a positive response to a standard protocol consisting of surgery followed by chemotherapy.

Interleukin Genetics Inc., of Waltham, Mass., and Kaiser Permanente's Center for Health Research said the first 581 patients have been enrolled in a study to investigate the importance of genetic differences among patients with Type II diabetes in determining their risk for developing cardiovascular disease. Results of the study will be used to determine if Interleukin Genetics can develop a DNA test to identify those diabetics who are at highest risk for heart disease.

InterMune Inc., of Brisbane, Calif., acquired the interferon gamma-1b patent estate of Amgen Inc., of Thousand Oaks, Calif. The estate has been in question with the interferon gamma-1b patents of Genentech Inc., of South San Francisco. InterMune licenses interferon gamma-1b (Actimmune) from Genentech. Financial terms of the acquisition were not disclosed. Actimmune is marketed for the treatment of chronic granulomatous disease and severe, malignant osteopetrosis, and is being developed in additional indications.

MacroGenics Inc., of Rockville, Md., licensed a therapeutic target induced by Epstein-Barr virus (EBV) from EBVax Inc. and Tufts University. MacroGenics said it will launch a research program to identify treatments for reducing morbidity in patients suffering from the acute and chronic consequences of EBV infection, including mononucleosis and the development of lymphomas. Financial terms were not disclosed.

Sequitur Inc., of Natick, Mass., said it added small interfering RNA to its Functional Genomics Program. The company now offers both blocking and cleaving antisense reagents. Its Functional Genomics Program offers validated reagents, optimized cell transfection protocols and collaborative research, the company said.

Schering AG, of Berlin, said Campath - developed by Millennium Pharmaceuticals Inc., of Cambridge, Mass., and ILEX Oncology Inc., of San Antonio - was shown to double life expectancy for heavily pretreated B-cell chronic lymphocytic leukemia patients, from eight to 16 months in follow-up data from the international Phase II pivotal study published this month in Blood. For those patients who responded to the Campath/MabCampath therapy, the study showed an average life expectancy of 32 months. MabCampath is marketed in Europe by Schering and in the U.S. as Campath by Schering's affiliate, Berlex Laboratories Inc.

Panacea Pharmaceuticals Inc., of Rockville, Md., closed its Series B private placement for about $3 million. Participants included MedImmune Inc., which made an equity investment in Panacea as part of a collaboration and license agreement between the companies related to Panacea's Human Aspartyl (Asparaginyl) Beta-Hydroxylase (HAAH) technology. Prior investors also participated. Proceeds from the offering will be used to further develop the applications of Panacea's HAAH oncology program in cancer diagnostics and to fund development of its Parkinson's disease and Alzheimer's disease programs. (See BioWorld Today, April 22, 2002.)

Peregrine Pharmaceuticals Inc., of Tustin, Calif., said an article published in the current issue of Hybridoma and Hybridomics detailed the successful generation of stable fragments of a tumor necrosis therapy antibody in a mammalian expression system. Tumor necrosis therapy is Peregrine's tumor-targeting platform technology that targets DNA-associated antigens in the nucleus of necrotic cancer cells.

SkyePharma plc, of London, said it intends to enter a strategic collaboration with Kowa Co. Ltd., a Japanese conglomerate. Under a subscription agreement signed Monday, Kowa proposed to make an investment in SkyePharma. The companies signed a separate nonbinding letter of intent to evaluate Kowa's acquisition of a 50 percent interest in SkyePharma's manufacturing facility in Lyon, France. The companies have an active relationship involving the formulation and manufacture of a new lipid-lowering agent, NK-104, to support late-stage development of the drug.

Valentis Inc., of Burlingame, Calif., said it is offering to acquire for cash 16,940 shares, or 55 percent of its outstanding Series A convertible redeemable preferred stock, and 55 percent of the related outstanding common stock purchase warrants, Class A, and common stock purchase warrants, Class B - warrants from both of which are exercisable for shares of common stock and were issued to the holders of Series A preferred stock. The company will pay $1,000 per share of Series A preferred stock and related Class A and Class B warrants tendered. The shares of Series A preferred stock acquired will be retired and related warrants canceled.

Vernalis Group plc, of Berkshire, UK, said it signed a collaboration with F. Hoffmann-La Roche Ltd., of Basel, Switzerland, for drugs to treat depression and anxiety. Roche has an option to license worldwide rights to compounds arising from Vernalis' research and development programs, exercisable on completion of Phase I studies. Roche will pay Vernalis an annual option fee and additional sums for achieving milestones during the option period. If the option is exercised, the parties would establish a joint research collaboration and Roche would provide research funding to Vernalis. Roche would conduct further development of products and Vernalis would have the potential to receive up to a total of $80 million in pre- and post-approval milestones, plus royalties. Also, Roche made a £7 million (US$10.1 million) loan to Vernalis, convertible into Vernalis ordinary shares at a conversion price of 329 pence per share. If not converted, the loan is repayable after five years.