¿ Access Pharmaceuticals Inc., of Dallas, said the FDA cleared it to start Phase III trials of OraDisc for canker sores. The trial will take place at 15 centers in the U.S. and one in Europe. A separate Phase III study is taking place in Northern Ireland evaluating OraDisc for the prevention of canker sores and is now half-completed. OraDisc, a polymer disc formation that adheres to the disease site and slowly erodes, locally releasing the drug, is potentially an improved delivery vehicle for the oral delivery of amlexanox.
¿ Atairgin Technologies Inc., of Irvine, Calif., moved its headquarters to University Research Park in Irvine. The company's headquarters and laboratory area now total 22,000 square feet and allow for expansion of existing programs.
¿ Aviron, of Mountain View, Calif., extended its cooperative research and development agreement for the development of the FluMist vaccine with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health. The agreement is now valid through June 2003. In March 1995, Aviron entered into a five-year agreement to conduct clinical trials designed to explore potential benefits of the FluMist technology. Aviron intends to submit a biologics license application for FluMist in the fourth quarter. FluMist stimulates the mucosal immune system as well as the systemic immune system, resulting in a strong cytotoxic T-cell response.
¿ BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., signed its first option license agreement with ID Biomedical Corp., of Vancouver, British Columbia, for the development of BioSante's calcium phosphate nanoparticle core technology (CAP) vaccine adjuvant. With ID Biomedical, BioSante will test its CAP vaccine adjuvant and delivery system in a vaccine against group A streptococcus (GAS). BioSante will formulate a second-generation vaccine using CAP and proprietary GAS antigens from ID Biomedical, which is conducting a Phase I trial of its GAS vaccine, StreptAvax. ID BioMedical also obtained an option to a worldwide exclusive license to use CAP in future GAS vaccines that may be developed by ID Biomedical.
¿ Bio-Technology General Corp. (BTG), of Iselin, N.J., entered into an agreement with DePuy Orthopaedics Inc., of Warsaw, Ind., for BioHy, BTG's proprietary high-molecular-weight sodium hyaluronate product, for the treatment of pain associated with osteoarthritis of the knee. BioPuy now will have exclusive marketing rights to BioHy in all countries except Japan and Israel. Financial terms were not disclosed.
¿ Charles River Laboratories International Inc., of Wilmington, Mass., raised $224 million in its initial public offering by selling 14 million shares at $16 each. Donaldson, Lufkin & Jenrette Inc. and Lehman Brothers, both of New York, acted as joint lead managers. ING Barings Inc., SG Cowen Securities Corp. and DLJdirect Inc., all of New York, along with U.S. Bancorp Piper Jaffray, of Minneapolis, acted as co-managers. The underwriters were granted an overallotment option on 2.1 million shares.
¿ CuraGen Corp., of New Haven, Conn., and Ono Pharmaceutical Co. Ltd., of Osaka, Japan, entered into a pharmacogenomic collaboration to gain a greater understanding of how genes influence and affect drug efficacy and toxicity using CuraGen's functional genomics technologies. The companies will collaborate in the application of molecular toxicology. No financial terms were released.
¿ Cytogen Corp., of Princeton, N.J., filed to obtain European marketing approval of ProstaScint, a radiolabeled monoclonal antibody, for the imaging of metastatic prostate cancer. ProstaScint has been available in the U.S. since 1997.
¿ Evotec BioSystems AG, of Hamburg, Germany acquired all of the shares of Genion Forschungsgesellschaft mbH, of Hamburg, for DM5 million (US$2.4 million) in an all-stock transaction. Genion has expertise in the field of ion channel assays, particularly potassium channels.
¿ GeneEd Inc., of San Francisco, raised $2 million in its seed round of financing. Principal investors included Incyte Genomics Inc., of Palo Alto, Calif.; Alza Pharmaceuticals Inc., of Mountain View, Calif.; and the law firm of Wilson Sonsini Goodrich & Rosati, of Palo Alto. GeneEd specializes in web-based e-Learning for the life science industry.
¿ Genzyme Corp., of Cambridge, Mass., amended its charter, modifying certain terms applicable to its tracking stocks. The amendment would benefit shareholders in the event that a tracking stock division's assets were sold by allowing them to receive a distribution that more accurately reflects the net after-tax proceeds realized by Genzyme.
¿ InterMune Pharmaceuticals Inc., of Burlingame, Calif., acquired the exclusive rights for a broad range of indications of Actimmune in Canada from South San Francisco-based Genentech Inc. Among the indications are osteopetrosis, idiopathic pulmonary fibrosis and infectious diseases. InterMune will pay royalties to Genentech on all Canadian sales. InterMune markets Actimmune (interferon gamma-1b) injection in the U.S. for the treatment of chronic granulomatous disease and osteopetrosis.
¿ Magainin Pharmaceuticals Inc., of Plymouth Meeting, Pa., and its collaborators said that an article published in the June 2000 issue of American Journal of Respiratory Cell and Molecular Biology, discusses the mechanisms regulating mucin genes in the lung. Excess mucus production is an important clinical feature of chronic obstructive pulmonary diseases, including asthma, chronic bronchitis and cystic fibrosis.
¿ Millennium Pharmaceuticals Inc., of Cambridge, Mass., and Ilex Pharmaceuticals Inc., of Austin, Texas, said the FDA gave a complete response letter related to their filing of a biologics license application for Campath (alemtuzumab), a humanized monoclonal antibody. The FDA noted some deficiencies in the application. Although no timetable was given, the companies said they will respond to the FDA's comments quickly. No details were given concerning the deficiencies.
¿ Nanogen Inc., of San Diego, sold its second NanoChip Molecular Biology Workstation. The sale was made to Egea BioSciences Inc., of San Diego, a genomics company formed by Glen Evans, the principal investigator responsible for one of Nanogen's three successful beta-site tests reported earlier this year. The NanoChip system uses electronically accelerated hybridization under very low salt conditions, potentially avoiding problems with DNA conformation and secondary structures, the company said.
¿ NitroMed Inc., of Bedford, Mass., and the University of Texas at Austin said that NMI-870 has shown significant results in treating female sexual arousal disorder (FSAD) in post-menopausal women. In the Phase II studies, NMI-870, a nitric oxide-enhanced compound of the alpha2 blocker yohimbine, showed the ability to increase vaginal blood flow in post-menopausal women diagnosed with FSAD. The results were presented at the 26th International Academy of Sex Research Conference in Paris.
¿ North American Vaccine Inc., of Columbia, Md., said that its acquisition by Baxter International Inc., of Deerfield, Ill., is complete. The total value of the acquisition was $380 million, with North American Vaccine shareholders receiving $6.73 per share, comprising $6.70 in Baxter common stock and 3 cents in cash. For each share of North American Vaccine common stock, its shareholders will receive .1021 shares of Baxter. North American Vaccine's stock (AMEX:NVX) closed Monday at $6.875, up $1.625, or 31 percent.
¿ Ortec International Inc., of New York, extended the expiration date of its Class B warrants to Sept. 28. The warrants have a $15 exercise price and were set to expire June 30. There are about 1.18 million Class B warrants and 8.3 million common shares outstanding.
¿ Research Corporation Technologies, of Tucson, Ariz, launched a new licensing program to offer widely used gene expression systems and associated technologies. The company will offer a multifaceted collection of basic "expression" technologies available to companies through flexible, non-exclusive licensing terms, it said.
¿ Serono, of Geneva, Switzerland and Norwell, Mass., received FDA approval of a needle-free device to deliver Saizen (somatropin [rDNA origin] for injection) human growth hormone for the pediatric market. Serono will be the first company to provide a needle-free delivery for growth hormone in the U.S. The device, called cool.click, is dispersed through the skin in a fine mist in less than a second. The drug is delivered subcutaneously, distributed by the bloodstream, and is bioequivalent to needle injections. Cool.click was developed for Saizen in a partnership with Bioject Medical Technologies Inc., of Portland, Ore.