Advanced Tissue Sciences Inc., of La Jolla, Calif., and Inamed Corp., of Santa Barbara, Calif., said Inamed subsidiary McGhan Medical Corp. filed a premarket approval amendment with the FDA seeking to change McGhans injectable collagen for treatment of wrinkles from a bovine collagen to a human-based collagen developed by ATS. ATS and Inamed have collaborated on the development of human-based collagen for wrinkle treatment.
Agilent Technologies Inc., of Palo Alto, Calif., and Merck & Co. Inc., of Whitehouse Station, N.J., said they will continue the strategic alliance begun in 1999 by Agilent and Rosetta Inpharmatics Inc., of Kirkland, Wash., to develop technologies for gene expression research. Rosetta and Merck last week entered an agreement to merge in a $620 million deal. (See BioWorld Today, May 14, 2001.)
Applied Genetics Inc. Dermatics, of Freeport, N.Y., formed an alliance with Elan Corp., of Dublin, Ireland, to commercialize AGI Dermatics drug, Dimericine, a topical product containing a DNA repair enzyme that reverses the damage to skin DNA caused by solar ultraviolet exposure, the company said. The companies will jointly develop the drug and they will license marketing rights. Elan will make a $4 million equity investment in AGI Dermatics and additional equity investments upon achievement of milestones.
BioMedicines Inc., of Alameda, Calif., said it completed enrollment in a Phase II trial of its product, omega interferon, in patients with chronic hepatitis C that is resistant to current treatments. Also, it is conducting a multicenter trial in Europe in patients being treated for chronic hepatitis C for the first time. The company expects to report results later this year.
Bionomics Ltd., of Adelaide, Australia, said it linked a genetic abnormality to the most common form of epilepsy. The abnormality is in a gene associated with a receptor for the brain chemical GABA, or gamma-aminobutyric acid, which stops nerve cells from functioning. The research linking GABA receptor mutation to epilepsy was presented at the 24th International Epilepsy Congress in Buenos Aires, Argentina, and was published in the May 2001 issue of Nature Genetics.
BioTransplant Inc., of Charlestown, Mass., and the Massachusetts General Hospital said they detected mulitlineage microchimerisms in animals that have successfully accepted donor kidneys following transplantation of hematopoietic stem cells. BioTransplant said the study findings reinforce the correlation between mixed chimerism and the induction of transplantation tolerance. The study used a prototype of BioTransplants AlloMune System and a 30- to 60-day course of cyclosporin as a conditioning for a high-dose peripheral blood stem cell transplant from haploidentical donors in miniature swine. The blood stem cell transplant was intended to induce a mixed chimerism so the animals accepted donor cells as self.
BioTransplant Inc., of Charlestown, Mass., said it completed its acquisition of Eligix Inc., of Medford, Mass., in a stock-for-stock merger valued at $55 million, following the satisfaction of closing conditions. (See BioWorld Today, Dec. 12, 2000.)
International Wex Technologies Inc., of Vancouver, British Columbia, signed a letter of intent with Canaccord Capital Corp., also of Vancouver, for a proposed financing. No further details were disclosed.
Celgene Corp., of Warren, N.J., said it will pursue a major trial intended to evaluate Thalomid as a potential therapy for late-stage renal cell carcinoma with time to disease progression and survival as endpoints. The company plans to initiate that trial on the strength of data presented at the meeting of the American Society of Clinical Oncology in San Francisco.
Cepheid Inc., of Sunnyvale, Calif., said its SmartCycler TD System for portable, real-time gene detection is on exhibit at the 13th Annual California Association of Professional Scientists State Scientists Day for early detection of Pierces disease in grape vines. Scientists can use the system to detect the lethal disease before symptoms appear, Cepheid said, allowing vintners to remove the infected vines before the disease spreads.
Epigenomics AG, of Berlin, said it will play a pivotal role in a DM5.34 million (US$2.4 million) research project funded in part by the German Ministry of Education and Research. The three-year project aims to further develop high-throughput technology to detect methylation patterns in human DNA.
Focal Inc., of Lexington, Mass., said it reached written agreement with the FDA on key aspects of its clinical study plan for FocalSeal-S, its neurosurgical sealant. FocalSeal-S neurosurgical sealant was approved for sale in Europe in November 1999. Genzyme Corp., of Cambridge, Mass., is expected to acquire Focal in the second or third quarter of this year and include its operations with Genzyme Biosurgery. Genzyme owns 22 percent of Focal now and will acquire the remaining percentage in an exchange of Genzyme Biosurgery Division common stock, Focal said.
Genzyme Transgenics Corp., of Framingham, Mass., said it accepted the resignation of Sandra Lehrman as president, CEO and a director. It will name an executive committee of the board of directors to oversee the companys direction as it seeks a successor.
ID Biomedical Corp., of Vancouver, British Columbia, said it completed its acquisition of Intellivax International Inc., of Montreal, through a 4-million-share issue to Intellivax shareholders. The companies announced their intent to merge in a $12.75 million deal in March. (See BioWorld Today, March 28, 2001.)
Incellico Inc., of Research Triangle Park, N.C., said it will release both its Arrayex web-based software for gene expression analysis and its Coded Electronic Life Library, a data cross-referencing and integration toolkit. Arrayex was released in beta form in January, and will be released commercially late this quarter.
Incyte Genomics Inc., of Palo Alto, Calif., said Agilent Technologies Inc., also of Palo Alto, launched the first in a series of human gene expression microarrays based on Incytes sequence-verified, non-redundant cDNA clone sets characterized in the LifeSeq Gold human gene sequence database and the ZooSeq animal model database. The licensing and supply agreement between the companies allows Agilent to use Incytes portfolio of gene transcripts, databases and cDNA clones to develop and commercialize arrays.
Ligand Pharmaceuticals Inc., of San Diego, said results of Phase I/II studies suggesting Targretin capsules administered front-line in combination with chemotherapy may prolong survival in patients with non-small-cell lung cancer were published in the May 15, 2001, issue of The Journal of Clinical Oncology. The information also was presented at the meeting of the American Society of Clinical Oncology in San Francisco.
Memorec Stoffel GmbH, of Cologne, Germany, received a EUR12.8 million (US$11.3 million) investment, led by 3i Germany. Other investors were KSK Wagniskapital, Nordrhein-Westfalen Fonds, tbg Technologie-Beteiligungs-Gesellschaft, TechnoMedia Kvln and Delbr|ck & Co. Privatbankiers. Memorec focuses on drug target discovery and validation and biochip technology.
NeuroSearch A/S, of Ballerup, Denmark, said NS2389, developed in collaboration with GlaxoSmithKline plc, of London, is being studied in safety trials expected to be completed by the fourth quarter. The data will then be discussed with the FDA with the intent of continuing clinical development of NS2389. In August 2000, Phase II trials were suspended for clarification of preclinical safety studies, NeuroSearch said.
Organogenesis Inc., of Canton, Mass., appointed Michael Sabolinski president and CEO and added him to the board of directors. Sabolinski was senior vice president of medical and regulatory affairs at the company and joined Organogenesis in 1992. He led the development of its lead product, Apligraf, from the start of clinical trials to commercialization.
Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Cytogen Corp., of Princeton, N.J., said preclinical studies of their prostate cancer vaccine indicated the vaccine generated a potent dual-immune response against prostate-specific membrane antigen. The therapeutic vaccine yielded both antibodies and T cells. The findings were presented Tuesday at the meeting of the American Society of Clinical Oncology in San Francisco. Cytogens stock (NASDAQ:CYTO) gained $1.57 Wednesday, or 44 percent, to close at $5.14.
XTL Biopharmaceuticals Ltd., of Rehovot, Israel, began a Phase II study of XTL-001 in combination with lamivudine for treatment of chronic hepatitis B virus infection. The dose-ranging, multicenter, double-blind, 60-patient study will administer the combination therapy for a year, and safety and antiviral effects also will be evaluated.
Serono SA, of Geneva, and Alkermes Inc., of Cambridge, Mass., said they intend to proceed with clinical development of the long-acting formulation of recombinant human follicle stimulating hormone (rhFSH) for treatment of infertility. The formulation is based on Alkermes ProLease injectable sustained-release drug delivery technology. A Phase I trial has been completed for rhFSH, and it triggered an undisclosed milestone payment to Alkermes.
Telik Inc., of South San Francisco, said the National Institutes of Health awarded it a second Small Business Innovation Research grant to apply Teliks TRAP chemogenomics technology to the discovery of a new class of potential anticancer compounds. Telik will use the funding to identify small molecules that selectively antagonize the functions of proteins that inhibit apoptosis.