Amgen Inc., of Thousand Oaks, Calif., said the European Committee on Proprietary Medicinal Products recommended approval of Aranesp for the treatment of anemia associated with chronic renal failure. The recommendation will be forwarded to the European Commission for marketing authorization. Aranesp has been submitted to the FDA for approval for the same indication.
Amylin Pharmaceuticals Inc., of San Diego, signed a license agreement with the National Institutes of Health, of Bethesda, Md., giving Amylin worldwide rights to patent applications directed to a novel use of exendin-4 to convert noninsulin-producing cells into insulin-producing cells. Amylin agreed to pay license fees to the NIH and will perform research relating to this use.
AnorMED Inc., of Vancouver, British Columbia, initiated a Phase I trial in healthy volunteers to study the white blood cell count-increasing effects of AMD-3100, an inhibitor of the CXCR4 chemokine receptor. The study is being conducted at the University of Washington, Seattle, and will enroll up to 10 volunteers. The product will be administered subcutaneously.
Arrow Therapeutics Ltd., of London, said formulation, pharmacokinetic and toxicity studies have begun on its compound, A358, and it should get into the clinic late in 2001. A358 has shown it may have activity against Gram-positive organisms.
Atlantic Technology Ventures Inc., of New York, and Fusion Capital Fund II LLC, of Chicago, entered a common stock purchase agreement, with Fusion buying $6 million of Atlantic's common stock. The funds will be used for general corporate purposes, acquisitions and other corporate opportunities. Funding of the $6 million will occur from time to time after the SEC declares a registration statement effective.
Axys Pharmaceuticals Inc., of South San Francisco, said Bay City Capital, of San Francisco, acting through its funds Bay City Capital Fund I LLC (BCC) and The North American Nutrition & Agribusiness Fund LP (NANAF), acquired about 2.4 million shares of Axys common stock through the exercise of options granted in connection with the BCC and NANAF funding of Akkadix Corp., of La Jolla, Calif. Axys now has an ownership percentage of approximately 43.8 percent of a fully diluted basis. The shares were issued in a private placement and are subject to a registration rights agreement between Axys, BCC and NANAF.
Celera Genomics Inc., of Rockville, Md., said Vita Genomics, of Taiwan, signed a multiyear subscription agreement, giving its researchers access to the Celera Discovery System to use Celera's integrated database products, bioinformatics systems and other discovery tools to conduct genomics research. Financial terms were not disclosed.
Deltagen Inc., of Menlo Park, Calif., said it is participating as a founding member of the Centre for Modeling Human Disease, based in Toronto. The research goal is to generate data, resources and technologies from genome-wide functional analysis and to establish phenotyping tools to exploit the mouse as a model for understanding and affecting human biology and disease. Consortium members will have certain rights to access and use the mouse model systems, data and intellectual property arising from CMHD's research and development programs.
Digene Corp., of Gaithersburg, Md., withdrew its proposed public offering, originally announced Feb. 7, citing unfavorable market conditions. It filed to sell about 2.5 million shares, about 2.1 of which were to be sold by the company. Its stock (NASDAQ:DIGE) on the day of announcement was trading at $36.875. It rose $1.625 on Monday, or about 10 percent, to close at $17.375.
GeneData AG, of Basel, Switzerland, entered a licensing agreement with the Japanese National Institute of Technology and Evaluation (NITE) to use GeneData Phylosopher for the computational analysis of the genome sequence data being generated in NITE's sequencing factory. Financial terms were not disclosed.
Genomics One Corp., of Laval, Quebec, closed a two-year agreement with Alpha Helix AB, of Uppsala, Sweden, to market a cloning kit that combines Genomics One's TrueBlue Technology with Alpha Helix's liquid dispensing system, MicroCartridge. The kit was been co-developed with Mirador DNA Design, of Montreal.
IDEC Pharmaceuticals Corp., of San Diego, presented results of its Phase I trial of its agent, IDEC-152, a primatized anti-CD23 monoclonal antibody, at the 57th Annual Meeting of the American Academy of Allergy, Asthma and Immunology in New Orleans. In the study, 30 patients with allergic asthma were given either a single intravenous infusion on one of several dosage levels of IDEC-152, or placebo. Reductions in IgE levels were noted along with an encouraging safety profile, the company said.
Isis Pharmaceuticals Inc., of Carlsbad, Calif., extended its research collaboration with Merck & Co. Inc., of Whitehouse Station, N.J., to discover drug candidates to treat patients infected with the hepatitis C virus. The one-year extension on the original three-year deal will pay Isis research support for an additional year, as well as clinical development milestone payments from compounds that arise from the collaboration and royalties from product sales. (See BioWorld Today, June 10, 1998.)
Lorus Therapeutics Inc., of Toronto, said its investigational new drug application has been accepted by the FDA to begin a Phase I trial for its anticancer drug GTI-2501. Lorus also has GTI-2040 in the clinic and its product Virulizin will advance to Phase III later this year.
Matrix Therapeutics Ltd., of Nottingham, UK, received a #2 million (US$2.8 million) syndicated investment from Technomark Medical Ventures, of London, Generics Asset Management, Interlkea Finance SA and Sopartec. Matrix has also entered a research collaboration with Sopartec, the transfer affiliate of the University of Louvain-la-Neuve, Belgium. It develops products for the treatment, prevention and diagnosis of human diseases.
Message Pharmaceuticals Inc., of Malvern, Pa., is collaborating with Aventis Pharmaceuticals Inc., of Bridgewater, N.J., to investigate post-transcriptional regulatory mechanisms associated with a number of genes of interest to Aventis. Message will apply its Scribe technology (Specific Control of RNA Interaction and Binding Events) to the collaboration. Financial terms were not disclosed.
NeoPharm Inc., of Lake Forest, Ill., initiated two Phase I/II trials of LE-AON for cancer patients. One study involves LE-AON as a single agent in cancer patients with various solid tumors and the second involves using it in combination with radiation therapy in cancer patients with radiation-resistant tumors. LE-AON is an electrostatic liposome encapsulated antisense cRaf oligonucleotide designed to block the expression of the cRaf protein in radiation resistant tumors.
Pharmacia Corp., of Peapack, N.J., launched a multinational Phase III trial to evaluate the addition of semaxanib (SU5416), an investigational angiogenesis signaling inhibitor, to the combination of Camptosar (irinotecan), fluorouracil (5-FU) and leucovorin. The trial will enroll about 1,300 patients with untreated, advanced colorectal cancer. Semaxanib is also being studied in solid tumors, hematologic cancers and more than 28 National Cancer Institute trials for various tumor types.
Pharmagenesis Inc., of Palo Alto, Calif., said PG2, a plant-derived hematopoiesis enhancer that restores blood cells after destruction of bone marrow cells induced by chemotherapy, passed clinical trials in China. The company said PG2 was more efficient in stimulating growth of blood cell lines during chemotherapy than G-CSF, the positive control product used in the trials. The trials were regulated by the State Drug Administration. PG2 will be sold in China once authorization is granted.
Scios Inc., of Sunnyvale, Calif., initiated a new study with Natrecor to investigate its potential pharmacoeconomic impact in improving treatment and outcomes for acute congestive heart failure patients. On Jan. 10, Scios submitted an amendment to its new drug application for Natrecor to the FDA, requesting approval to market it for the treatment of acute CHF.
The Medicines Co., of Cambridge, Mass., withdrew its proposed public offering of 4 million shares, originally filed in January, citing unfavorable market conditions.
The University of Utah School of Medicine, Department of Dermatology, of Salt Lake City, reported on a trial studying alefacept (human LFA-3, IgG, fusion protein, Amevive - a product of Cambridge, Mass.-based Biogen Inc.) in patients with psoriasis who had previously been treated with alefacept. The trial reported that successive treatments with alefacept demonstrated positive results similar to that of the initial course of treatment and that patients maintained their clinical improvement between five and 17 months after a course of therapy. Detailed study results are scheduled for publication within the next six months.
Vernalis Group plc, of London, reached an agreement with Eli Lilly and Co., of Indianapolis, for Vernalis to undertake clinical trials of VML 670 as a treatment for sexual dysfunction. The studies will focus on patients taking selective serotonin re-uptake inhibitors for depression who experience sexual difficulties. Phase I studies should begin soon, Vernalis said, and Phase IIa studies are expected to begin at the end of 2001.
XTL Biopharmaceuticals Ltd., of Rehovot, Israel, received multiple milestone payments from an undisclosed corporate partner based on products advancing into clinical testing for the treatment of the hepatitis C virus. Its partner submitted an investigational new drug application for two products that were evaluated in XTL's proprietary Trimera animal model, triggering the payments. No further details were disclosed.