Amgen Inc., of Thousand Oaks, Calif., said the European Commission approved Kineret (anakinra) for the treatment of the signs and symptoms of rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone. The FDA approved Kineret in the U.S. in November. Kineret is a direct and selective blocker of interleukin-1. (See BioWorld Today, Nov. 15, 2001.)
Array BioPharma Inc., of Boulder, Colo., entered a drug discovery collaboration with the pharmaceutical division of Japan Tobacco Inc., of Tokyo, to create small-molecule therapeutics against a Japan Tobacco target. Japan Tobacco will fund drug discovery research conducted by Array based on the number of Array scientists working on the research phase of the agreement. Array may receive milestone payments as well as royalties on net sales of products.
Berna Biotech Ltd., of Berne, Switzerland, and Actelion Ltd., of Allschwil, Switzerland, said a clinical development partnership was formed between Berna and Hesperion Ltd., an independent company in which Actelion owns a controlling majority. The companies will pool resources and form the Center of Excellence for Vaccine Development. Berna is a developer and producer of viral and bacterial vaccines. Financial terms were not disclosed.
Biotherapies Inc., of Ann Arbor, Mich., completed the sale of Biomedical Diagnostics, the diagnostic unit it started with Genesis Bioventures in 1998. Genesis was recruited as a joint venture partner since it had shown an interest in the Mammastatin protein technology that Biotherapies was developing for breast cancer. Biotherapies deals with the diagnosis and treatment of specific cancer based on the discovery of a family of naturally occurring human proteins.
BTG, of London, and the Swiss Institute for Experimental Cancer Research said researchers exploited a genetic defect commonly found in colorectal cancer cells to engineer a virus that selectively replicates within and destroys the tumor cells. The data are published in the March issue of Gene Therapy.
Cell Therapeutics Ltd., a wholly owned subsidiary of Cell Therapeutics Inc., of Seattle, said the European Commission granted marketing authorization for Trisenox (arsenic trioxide), indicated for the induction of remission and consolidation in adult patients with relapsed/refractory acute promyelocytic leukemia characterized by the presence of the t(15:17) translocation and/or the presence of the pro-myelocytic leukemia/retinioic-acid-receptor-alpha gene. Previous treatment for the patients should have included a retinoid and chemotherapy. The FDA approved Trisenox for the treatment of relapsed/refractory APL in September 2000. (See BioWorld Today, Sept. 27, 2000.)
Coley Pharmaceutical Group Inc., of Wellesley, Mass., expanded its collaboration with Aventis Pharma AG, of Frankfurt, Germany, to include a drug discovery program to screen and evaluate second-generation immunomodulatory CpG product candidates for the treatment of asthma and allergic rhinitis, triggering a $2 million milestone payment. In the new two-year agreement, Coley will provide Aventis Pharma with CpG product candidates optimized to redirect hypersensitive immune responses into more normal responses. Aventis will evaluate the candidates and select a certain number for development and commercialization. The CpG oligos are in addition to CpG 7929, the lead molecule licensed exclusively to Aventis Pharma in a previous agreement between the two companies. (See BioWorld Today, Aug. 7, 2001.)
Collateral Therapeutics Inc., of San Diego, entered an option agreement to license exclusive worldwide gene therapy rights from the University of Texas Southwestern Medical Center at Dallas for the Endothelial PAS domain protein 1 gene. Collateral expects to evaluate the development and potential commercialization of EPAS1 in its ongoing nonsurgical cardiovascular gene therapy programs. EPAS1 is a naturally occurring hypoxia-inducible transcription factor that is predominantly expressed in endothelial cells.
DiagnoCure Inc., of Quebec, and Compugen Ltd., of Tel Aviv, Israel, said the Canada-Israel Industrial Research and Development Foundation approved a C$800,000 (US$502,028) grant to assist in the research and development of a nucleic acid probe-based diagnostic kit for the early detection of lung cancer. The funding results from an agreement between DiagnoCure and Compugen announced in January for the co-development and commercialization of molecular diagnostic tests for the detection of certain epithelial cancers. The lung cancer test will combine Compugen’s capabilities in identifying novel disease markers and predicting their utility with DiagnoCure’s knowledge of developing, manufacturing and commercializing molecular diagnostic assays.
IGEN International Inc., of Gaithersburg, Md., signed an agreement to sell products to the U.S. Army Space and Missile Defense Command based on IGEN’s Origen technology for the detection of specific biological agents important to the U.S. Department of Defense. Also, IGEN received and filled an order for 20 Origen analyzers for delivery to the Department of Defense. Revenues attributable to these instruments and reagents are anticipated to be at least $2 million dollars.
Isis Pharmaceuticals Inc., of Carlsbad, Calif., initiated a Phase II trial of ISIS 104838, an antisense inhibitor of tumor necrosis factor-alpha, in rheumatoid arthritis (RA). The trial will evaluate ISIS 104838 in RA when administered by subcutaneous injection for three months. This is the second Phase II study of ISIS 104838 in RA. The double-masked, placebo-controlled, randomized Phase II study is expected to enroll 160 patients with RA at 25 sites in the U.S. and Canada.
Myogen Inc., of Denver, published results from a preclinical study of ambrisentan in stent-induced restenosis, demonstrating that ambrisentan administered orally reduced the narrowing of the coronary arteries of pigs following angioplasty and coronary stent implantation. The results were published in the December issue of the Journal of Cardiovascular Pharmacology.
NeoTherapeutics Inc., of Irvine, Calif., raised $5.15 million by selling common stock to a group of institutional investors led by Royal Bank Investment Management Inc. The $2 issue price represents a 4.3 percent discount to the March 12 closing price of $2.09. Also, the company issued warrants to purchase common stock at a price of $2.75 per share that, if exercised, would generate about $1.8 million. NeoTherapeutics said the financing strengthens its cash position prior to unblinding and reporting results from a pivotal study of Neotrofin in Alzheimer’s disease. It also will help fund two Phase II studies of Neotrofin in chemotherapy-induced neuropathy and launch a Phase III study of its lead anticancer drug, satraplatin, in prostate cancer.
Progen Industries Ltd., of Brisbane, Australia, said the Wesley Clinic Research Centre in Brisbane received hospital ethics approval to join the Australian Phase II trial for the cancer drug PI-88. The trial is designed to test PI-88 in 27 volunteer patients with multiple myeloma. Progen focuses on the discovery, development and commercialization of small-molecule pharmaceuticals for the treatment of a variety of diseases.
SciClone Pharmaceuticals Inc., of San Mateo, Calif., said data presented at the World Congress of Gastroenterology in Bangkok, Thailand, this month indicate that, after an additional 12-month follow-up period for difficult-to-treat chronic hepatitis B patients in Turkey, 71 percent of patients who used Zadaxin in combination therapy with interferon continued to show a sustained response, vs. only 10 percent of the patients who used interferon alone. The original data were presented during Digestive Disease Week in May 2001. SciClone’s stock (NASDAQ:SCLN) rose $1.07 Wednesday, or 32.9 percent, to close at $4.32.
SkyePharma plc, of London, acquired 59.8 percent of the outstanding voting shares of RTP Pharma Inc., of Montreal, in return for the issuance of SkyePharma ordinary shares worth $20.6 million, thereby securing ownership. RTP’s nanoparticulate technology is used to improve drug solubility. On Aug. 1, SkyePharma said it paid US$20 million in SkyePharma ordinary shares and acquired $5 million of preferred shares in RTP for its 40.2 percent interest in RTP. Since then, RTP has achieved certain key milestones, and the directors of SkyePharma decided to negotiate with RTP’s remaining shareholders to acquire their holdings. (See BioWorld Today, Aug. 2, 2001.)
Symyx Technologies Inc., of Santa Clara, Calif., said a shareholder class action securities lawsuit against the company’s officers has been dismissed. The plaintiffs filed a notice in the United States District Court for the Southern District of New York voluntarily dismissing without prejudice the claims filed in December. The suit asserted violations of the federal securities laws relating to how the underwriters of Symyx’s initial public offering allegedly allocated IPO shares to underwriters’ customers.
Viventia Biotech Inc., of Toronto, and Clinomics BioSciences Inc., of Pittsfield, Mass., formed an agreement for Clinomics to supply tissue microarray systems for Viventia’s ImmunoMine screening program. Also, Clinomics’ network of consulting pathologists will provide interpretation of the cellular binding profile of selected Viventia antibodies discovered through its Hybridomics discovery platform. Financial details were not disclosed.