Access Pharmaceuticals Inc., of Dallas, signed letters of intent to exclusively license OraRinse, amlexanox cream and amlexanox gel, to Laboratorios Dr. Esteve SA and affiliate Isdin for marketing in Portugal, Spain and Greece. Esteve and Isdin will make up-front licensing payments in addition to milestone payments and a percentage of product sales revenue. Esteve wil also make an equity investment in Access and fund European clinical research.
Alexion Pharmaceuticals Inc., of New Haven, Conn., in conjunction with researchers from Yale University School of Medicine, also of New Haven, said transplanting genetically modified pig cells into damaged rodent spinal cords leads to the regeneration of axons in the spinal cord. Results of a study published in the September issue of Nature Biotechnology showed that immunoprotected transgenic pig cells survived and contributed to spinal repair by engrafting and regenerating the myelin sheath around axons, regenerating the axon and restoring electrical conductance across the lesion.
Applied Biosystems Inc., of Foster City, Calif., said it released an improved mass spectrometry system for proteomics research, the optional oMALDI ion source for the API QSTAR Pulsar Hybrid LC/MS/MS system. The company said the improvement will allow users to routinely perform higher-throughput analysis of peptides and proteins with high sensitivity and mass accuracy.
BioTime Inc., of Berkeley, Calif., submitted an application for European approval for Hextend, the company's proprietary physiologically balanced plasma volume expander. The application submitted to the Swedish Medical Products Agency would grant the company marketing approval in all 16 European Union countries under the EU's mutual recognition process.
Catholic University, of Leuven, Belgium, released one-year follow-up data on tenecteplase, a single-bolus thrombolytic tested in the ASSENT II clinical trial, that indicates the compound has a similar efficacy to alteplase (Actilyse or Activase) in life preservation in heart attack patients. After a year, the mortality rate of tenecteplase in heart attack patients matches that of alteplase, 9.7 percent each. Tenecteplase is marketed in the U.S. by Genentech Inc., of South San Francisco, as TNKase.
Cerus Corp., of Concord Calif., closed the sale of 1.2 million newly issued shares to an institutional investor at $50 each, giving the company cash and investments of about $106 million. The $60 million private placement is earmarked for research and development funding, to include clinical trials, general and administrative expenses, capital expenditures and working capital. Cerus is developing blood substitutes based on its Helinx technology, which prevents replication of viruses, bacteria and other pathogens. Clinical trials are under way to evaluate the company's pathogen-inactivated platelets, fresh frozen plasma and red blood cells in collaboration with Baxter Healthcare Corp., of Deerfield, Ill.
CIBA Vision Corp., of Atlanta, said the FDA assigned priority review status to a supplemental new drug application for Visudyne (verteporfin for injection), the company's age-related macular degeneration compound. The sNDA requests expansion of the product's indications to include ocular conditions characterized by choroidal neovascularization, including pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, and CNV due to certain retinal abnormalities.
Discovery Laboratories Inc., of Doylestown, Pa., began trading its shares on German stock exchanges in Berlin, Frankfurt, Munich and Stuttgart. The biopharma company will trade in Germany under the symbol DYB and the Cusip number 918436.
Enchira Biotechnology Inc., of The Woodlands, Texas, entered a follow-on agreement with Genencor Inc., of Palo Alto, Calif., for research and development work on improved proteins. The deal includes $1 million in funding by Genencor for Enchira over the next two years. The companies partnered in May, granting Genencor access to Enchira's RACHIT (random chimeragenesis on transient templates) gene-shuffling technology for gene-based product development for the industrial chemicals sector.
Genaissance Pharmaceuticals Inc., of New Haven, Conn., said underwriters have exercised their overallotment option to purchase an additional 900,000 shares of Genaissance stock at the IPO price of $13 per share. The overallotment exercise raises the value of the IPO to $89.7 million. (See BioWorld Today, Aug. 3, 2000, p. 1.)
Geron Corp., of Menlo Park, Calif., and Merix Bioscience Inc., of Research Triangle Park, N.C., said Duke University researchers have demonstrated use of telomerase as an antigen to stimulate an immune response inhibiting tumor growth in animals and killing human tumor cells in vivo. The research, reported in the September issue of Nature Medicine, shows that RNA encoding the catalytic reverse transcriptase protein component of telomerase (hTERT RNA), when introduced into dendritic cells, can stimulate the immune system to recognize and destroy telomerase-positive cancer cells. In response to the findings, Geron and Merix said they will collaborate to assess the clinical and commercial potential of hTERT RNA as an antigen for cancer immunotherapy using a Merix delivery system. Merix holds the exclusive license for the ex vivo RNA-modified antigen-presenting cell technology. Geron will sponsor preclinical studies on the safety and efficacy of the hTERT RNA-modified dendritic cells, and Merix will perform similar studies in parallel. The companies will jointly determine the clinical development plan for the technology. Financial terms were not disclosed.
LI-COR Biotechnology Inc., of Lincoln, Neb., agreed to license AFLP reagent kits, genome analysis kits using DNA marker technology, from Keygene N.V., of Wageningen, the Netherlands. Financial terms of the development and marketing agreement were not disclosed.
Matritech Inc., of Newton, Mass., said preliminary testing confirmed the presence of colon-cancer-specific proteins in the blood of patients with that disease. The discovery process for the colon cancer markers was the same used by Maritech scientists to discover cancer-specific proteins relating to breast cancer that led to a test for that disease, and Maritech said it intends to apply the technique to other cancer types in the future.
Meridian Diagnostics Inc., of Cincinnati, will expand into biotechnology, research reagent development and other services aimed toward pharmaceutical discovery and marketing through a series of licensing agreements and targeted acquisitions. Meridian is established as an antibody science, immunoassay and test formatting company.
Operon Technologies Inc., of Alameda, Calif., said it will release a set of arrayable oligonucleotides for the entire P. falciparum malaria genome. The array makes use of Operon's sequence optimization and hybridization temperature normalization techniques designed to increase specificity and sensitivity as compared to other microarray techniques.
PathoGenesis Corp., of Seattle, began enrollment for a Phase I open-label study of TOBI (tobramycin solution for inhalation) in patients with ventilator-associated pneumonia. The trial aims to find out how TOBI deposits in the lungs when administered via a nebulizer connected to a ventilator, and to evaluate the safety of that administration method as an adjunct to other antibiotics.
Rosetta Inpharmatics Inc., of Kirkland, Wash., said underwriters for the company's initial public offering have exercised their overallotment option to purchase an additional 1.08 million shares of Rosetta stock. The overallotment exercise brings the IPO's total to 8.28 million shares valued at $115.92 million. (See BioWorld Today, Aug. 4, 2000, p. 1.)
Sequenom Inc., of San Diego, said it reached an agreement with Integrated DNA Technologies Inc., of Coralville, Iowa, for the sale of two MassARRAY systems. The Iowa company will use the technology as an ultra high-throughput quality control method for its high-volume oligonucleotide production process.
Viron Therapeutics Inc., of Rome, said its lead viral protein compounds SERP-1 and CBPI, showed potential to reduce kidney transplant rejection in animal models. The preclinical data showed the viral protein compounds, in combination with cyclosporine, significantly decreased symptoms of chronic kidney transplant rejection.
Watson Pharmaceuticals Inc., of Corona, Calif., completed the acquisition of Schein Pharmaceutical Inc., of Florham Park, N.J. through a two-step transaction comprised of a cash tender offer followed by a taxable stock merger. The cash tender was at $19.50 per share of Schein stock. Each share of Schein stock not tendered was converted to the right to receive 0.42187 of a share of Watson stock. Watson will issue about 5.3 million shares in exchange for the remaining outstanding shares of Schein. Schein is now a wholly owned subsidiary of Watson.
Zonagen Inc., of The Woodlands, Texas, was awarded a $96,843 Phase I Small Business Innovation Research Grant to study enhanced formulations of topically applied alpha-interferon for treatment of genital herpes. The grant is the second SBIR awarded the company this year. Separately, the company said it has agreed to receive supplies of the genital wart treatment, Omiferon, from Viragen Inc., of Plantation, Fla. Financial terms were not disclosed.