¿ Abbott Laboratories, of Abbott Park, Ill., and NaPro BioTherapeutics Inc., of Boulder, Colo., filed an abbreviated new drug application with the FDA for paclitaxel. The ANDA seeks approval for a generic version of Taxol.
¿ AltaRex Corp., of Nashville, Tenn., said nearly half of recurrent ovarian cancer patients treated with OvaRex MAb survived 50 weeks or longer in a Phase II test of the anticancer therapeutic. Trial results showed that six of 13 treated patients survived 50 weeks or longer from entry to the trial, and that more than half the patients enrolled in the study exhibited substantive immune responses following treatment.
¿ Antares Pharma Inc., of Minneapolis, completed the final $3 million of a $10 million private placement. An unnamed Swiss investor purchased 511,945 shares at $5.86 per share. The first $7 million was raised in early February. The company will use the money to further development of its drug delivery technologies, including needle-free injection systems, mini-needle injector systems and advanced gel technologies. Antares develops and commercializes delivery systems, distributing needle-free injection systems for delivery of insulin and growth hormone replacement therapy.
¿ Aquasearch Inc., of Kailua-Kona, Hawaii, and Cyanotech Corp., also of Kailua-Kona, settled the intellectual property litigation between them without admission of liability by either party. Terms were not disclosed, but the companies said Cyanotech agreed to an injunction that prevents it from using any tube system for microalgae production that infringes on Aquasearch's U.S. Patent. No. 5,541,056, and Aquasearch agreed that Cyanotech's microalgae production process, PhytoDome, does not infringe on that patent. Cyanotech will pay undisclosed royalties to Aquasearch as a part of the settlement.
¿ Atrix Laboratories Inc., of Fort Collins, Colo., said results from a Phase I/II trial of Atrisone dapsone topical gel in SMP technology for moderate to severe acne indicated that the maximum blood concentration of dapsone administered topically twice daily was over 600 times lower than the systemic safety concern level for orally administered dapsone. Though the study was not designed to evaluate efficacy, the company said, Atrisone appeared to reduce both inflammatory and noninflammatory lesions by about one half over the 28-day study.
¿ Bio-Rad Laboratories Inc., of Hercules, Calif., renewed its collaboration with the Institut Pasteur in Paris for an additional four years. The collaboration was begun in 1990, and gives Bio-Rad exclusive commercialization rights to the institute's research developments in virology, microbiology, physiology, biochemistry, parasitology and mycology.
¿ British Biotech plc, of Oxford, UK, said E21R development partner BresaGen Ltd., of Adelaide, Australia, commenced patient recruitment for a Phase II study investigating the effectiveness of E21R in chronic myleomonocytic leukemia. The companies last year entered the development agreement granting British Biotech an exclusive worldwide license to commercialize E21R for all indications. British Biotech agreed to equity, cash and conditional milestone payments of $8 million to BresaGen for development of E21R in acute myeloid leukemia and further conditional milestone payments of up to $6 million for successful development of E21R for nonleukemic indications. BresaGen also stands to get a royalty stream from the eventual sale of the drug.
¿ Cellegy Pharmaceuticals Inc., of South San Francisco, filed for marketing approval in South Korea for Rectogesic (nitroglycerin ointment) for treatment of anal fissures. Cellegy expects approval for the treatment in South Korea, the third-largest pharmaceutical market in Asia, within 12 months.
¿ Helix BioPharma Corp., of Aurora, Ontario, raised C$3.93 million (US$2.56 million) of new equity through the exercise of 1.23 million Series A warrants. The warrant exercise resulted in the issuance of 1.23 million common shares at C$3.50 per share.
¿ COR Therapeutics Inc., of South San Francisco, lowered its guidance for first-quarter and year-end 2001 worldwide sales of Integrilin. COR dropped its estimates for 2001 worldwide sales from $250 million to $270 million to a range of $245 million to $260 million. First-quarter sales estimates were dropped to between $37 million and $39 million. The company also said it would have a corresponding loss for the first quarter of 5 cents to 7 cents per share instead of the projected 3-cent net income, and that it had dropped its projection for net income per share for the year from 40 cents per share to between 35 cents and 37 cents. COR said an unanticipated reduction in wholesale inventory levels - fallen from 1.3 months at 2000's end to 0.3 months to 0.4 months - is responsible for the lowered projections.
¿ GlaxoSmithKline plc, of Brentford, UK, entered a multiyear strategic relationship with Golden Helix Inc., of Bozeman, Mont., for the development of software. Glaxo acquired 15 percent of privately held Golden Helix through the deal. The companies have collaborated for two years on the development of Golden Helix's HelixTree software, which the companies anticipate will more rapidly identify genetic factors that contribute to the safety and efficacy of compounds in development.
¿ IGEN International Inc., of Gaithersburg, Md., said an investigational genetic test based on its Origen technology identified micrometastases in nearly half of colon cancer patients who showed no signs of metastatic disease from conventional detection methods. A separate study, the company said, demonstrated the sensitivity of another Origen-based test in the detection of metastatic cancer cells in the blood or other tissues of people with breast, skin or colorectal cancers.
¿ Ligand Pharmaceuticals Inc., of San Diego, said investigators presented data from a pilot study demonstrating response of patients with moderate to severe psoriasis treated with Ontak (denileukin diftitox) with low-dose schedules. The company said the study confirmed Ontak's anti-psoriatic activity with a low-dose schedule. All six patients in the pilot study achieved the response criteria of at least a 30 percent decrease in Psoriasis Area and Severity Index (PASI).
¿ LigoCyte Pharmaceuticals Inc., of Bozeman, Mont., reported that data shows the efficacy of its ProteoFlow system in identifying new targets for anti-infective therapeutics and vaccines. The flow-based assay allows for the analysis of ligands that pathogens use to attach themselves to hosts.
¿ LION Bioscience AG, of Heidelberg, Germany, extended its bioinformatics collaboration with Intervet International GmbH, of Boxmeer, the Netherlands. The extension includes licenses for the data integration technology SRS and the automated gene and genome annotation system bioSCOUT, in addition to new licenses for genomeSCOUT gene comparison software and SRS everEST, a product for EST clustering.
¿ MediGene AG, of Munich, Germany, said subsidiary MediGene Inc., of San Diego, submitted a final study report of its Phase I trial of G207, its novel anticancer therapeutic for treatment of brain tumors. MediGene is preparing a Phase II trial of the compound. The Phase I study, designed to analyze toxicity in patients for whom all known treatments have failed, produced a survival rate of 10 percent two years after treatment ended. The study identified no evidence of long-term toxicity from the treatment.
¿ Paradigm Genetics Inc., of Research Triangle Park, N.C., said it exceeded its fourth consecutive milestone in its commercial partnership with Monsanto Co. The partnership entails Paradigm discovering gene function for Monsanto genes through Paradigm's GeneFunction Factory. Paradigm will share revenues generated through the collaboration from royalties. The milestone triggered an undisclosed payment from Monsanto to Paradigm.
¿ Pharmagenesis Inc., of Palo Alto, Calif., completed a funding round for an undisclosed amount from a group of investors that included biomerieux-Pierre Fabre, of Paris; The Dassault Group, of France; AXA; and an unnamed Hong Kong investment group. Pharmagenesis said it will use the funding for development of its anticancer agent PG490-88 and its hematopoiesis enhancer, PG2-2000.
¿ Rosetta Inpharmatics Inc., of Kirkland, Wash., launched version 2.0 of its Rosetta Resolver Expression Data Analysis system, a bioinformatics solution for deciphering gene expression data. Version 2.0 has advanced capacity for accepting and analyzing data from single-color DNA chip technologies and a utility that enables automated processing of Affymetrix Inc. GeneChip array data files. The update also converts, imports and exports data in Gene Expression Markup Language (GEML).
¿ Serono SA, of Geneva, Switzerland, said the FDA granted its U.S. affiliate marketing authorization for multi-dose Gonal-F (follitropin alfa for injection), a gonadatropin for treatment of infertility. The new multidose presentation is designed for more flexible dosing and greater ease of preparation. Gonal-F was approved in October 1997. (See BioWorld Today, Oct. 1, 1997.)
¿ Supratek Pharma Inc., of Montreal, said its melanoma DNA vaccine formulated with SP1017 increased survival rates by more than 10-fold compared to the non-formulated DNA vaccine. Supratek's platform for gene delivery enhances the performance of gene-based medicines, the company said, through the recruitment of large numbers of dendritic cells.
¿ Teva Neuroscience, of Kansas City, Mo., said Copaxone (glatiramer acetate for injection) showed rapid effect on almost all MRI-monitored disease activities in relapsing-remitting multiple sclerosis (RRMS) patients. The study found Copaxone produced a 29 percent reduction in enhancing lesions compared to placebo and reduced the number of relapses in RRMS patients by 33 percent compared to placebo (p=0.012).
¿ The American Foundation for AIDS Research, of New York, awarded basic research grants totaling $1.17 million to 13 projects to identify cellular and viral targets for the development of novel anti-HIV drugs. The projects will examine genes and gene products of HIV as well as the cellular components needed by HIV to thrive.
¿ Theratechnologies Inc., of Saint-Laurent, Quebec, began enrollment in a trial for ThGRF in chronic obstructive pulmonary disease. The trial is designed to enroll 90 patients and assess the growth hormone-releasing factor analogue's safety and efficacy for three months. The trial will also evaluate the compound's effect on lean body mass, peripheral skeletal muscle strength, respiratory muscle strength and quality of life as secondary endpoints.
¿ Vasogen Inc., of Toronto, received approval from Health Canada to proceed with a multicenter trial of its immune modulation therapy for treatment of moderate to severe psoriasis. The 105-patient, four-site trial is designed to study the impact of optimized dosing schedules and further evaluate efficacy. Vasogen anticipates completing the trial in the fourth quarter.