¿ Advanced Magnetics Inc., of Cambridge, Mass., said a study shows its Combidex contrast agent has significant potential for the local staging of infiltrating breast cancer, and may improve the capability for interventional breast MRI procedures. The study also found that the prolonged enhancement effect of Combidex (24 to 72 hours) allows it to more accurately define tumor borders when compared to Gadolinium-enhanced images. Combidex is under review by the FDA for the diagnosis and staging of lymph node disease.
¿ AMBI Inc., of Purchase, N.Y., signed an exclusive licensing agreement that gives ImmuCell Corp., of Portland, Maine, worldwide rights to develop and market new antibacterial drugs for animals using AMBI¿s nisin and lysostaphin technologies. AMBI will receive milestone payments and royalties on any sales.
¿ Avax Technologies Inc., of Kansas City, Mo., said its Australian subsidiary, Avax Australia Pty. Ltd., signed a contract manufacturing agreement with Bio Enterprises Pty. Ltd., of Sydney, for the manufacture of Avax¿s autologous cell vaccine M-Vax for the Australian market. In 1999, Avax received notice that M-Vax for the treatment of Stage III melanoma may be available for commercial sale in Australia, subject only to licensure of a manufacturing facility.
¿ BioQuest Inc., of Houston, signed an agreement with Biovector Therapeutics SA, of Labege, France, in which the companies will evaluate and develop an HIV vaccine candidate to be used as a therapeutic immune system stimulant capable of fighting HIV infection. The agreement also has a goal of examining its use as a protective vaccine, and includes milestone payments and potential royalties for BioQuest.
¿ Chromagen Inc., of San Diego, and DuPont Pharmaceuticals Co., of Wilmington, Del., entered into the second extension of an assay development and drug screening agreement begun in May 1998. Chromagen will develop biological assays and screen chemical compounds generated by DuPont Pharmaceuticals Research Laboratories Inc. in its internal drug discovery program. Financial terms were not disclosed.
¿ Diversa Corp., of San Diego, and Aventis Animal Nutrition SA, a subsidiary of Aventis SA, of Strasbourg, France, extended their research agreement beyond the initial six-month period to develop a biocatalytic process used to manufacture a key Aventis product for animal nutrition. The extension resulted in additional research funding to Diversa. Specific financial terms were not disclosed.
¿ Dura Pharmaceuticals Inc., of San Diego, said it invented a new technology for dispersing powder formulations of drugs to create aerosols for inhalation. The new technology is designed to deliver a uniform drug dose with low inspiratory effort, without the need for a battery-powered motor. The company has applied for broad patent coverage of the technology. The new inhalers are designed to deliver small and large molecules to the lungs for topical and systemic applications.
¿ Endorex Corp., of Chicago, completed a private placement of common stock and warrants with domestic and foreign institutional investors, raising $8.6 million. New York-based Paramount Capital Inc. acted as financial adviser in the offering. The placement consisted of 1.81 million common shares priced at $4.725 per share, plus warrants to purchase about 455,000 shares of common stock. The warrants, which will expire in April 2005, are exercisable at $5.91 per share. Endorex, a drug delivery company focused on oral and mucosal delivery of drugs and vaccines, will use proceeds to fund development of its drug delivery technologies and to take its first oral products into clinical development.
¿ Genetronics Inc., of San Diego, said it developed an efficient, non-invasive method for the transfer of plasmid DNA into skin cells. The method uses the electroporation technology of Genetronics Biomedical Ltd. The data demonstrate that electroporation could offer a safe and effective alternative to other methods of gene delivery.
¿ Genset SA, of Paris, signed an agreement with Sanofi-Synthelabo, also of Paris, to pursue a pharmacogenomics collaboration aimed at lead selection and optimization for an undisclosed central nervous system disease. Sanofi-Synthelabo will provide research funding and research milestone fees to Genset, and will pay clinical milestones and royalties on any drugs developed through an active use of the data and clones provided by Genset. Genset will grant Sanofi-Synthelabo an exclusive worldwide license to use the data and clones generated to develop and commercialize drugs to treat the undisclosed disease.
¿ Genzyme Tissue Repair, of Cambridge, Mass., said it obtained from privately held Sentron Medical Inc. an exclusive worldwide license and related intellectual property rights that include Autologous Chondrocyte Graft technology to grow preformed cartilage tissue on a 2-dimensional, or flat, surface. Sentron will receive an undisclosed up-front payment and milestone payments, as well as royalties on products that use the licensed technology.
¿ Hemispherx Biopharma Inc., of Philadelphia, said its European subsidiary, Hemispherx Biopharma Europe NV/SA, is withdrawing its CFS treatment application in order to submit an application with a new manufacturing format and under new regulations for orphan medicinal products guaranteeing 10 years of market exclusivity.
¿ InterMune Pharmaceuticals Inc., of Burlingame, Calif., said a post-study analysis of a Phase II trial in Austria using interferon gamma-1b, the active ingredient in Actimmune, to treat idiopathic pulmonary fibrosis confirmed the diagnosis of pulmonary fibrosis in patients and showed positive results. All nine patients treated with Actimmune had clinically significant improvement in pulmonary function. In the control group, none of the nine patients improved. Four remained stable, and five showed significant disease progression.
¿ La Jolla Pharmaceuticals Co., of San Diego, said it will file a registration statement to register for resale the underlying shares of common stock for its privately held warrants. The company registered the underlying shares for the publicly held warrants following its initial public offering in 1994. The warrants will expire June 3, and the board does not plan to extend the expiration date. The company¿s public warrants have an exercise price of $3 per one-half share.
¿ Matrix Pharmaceutical Inc., of Fremont, Calif., said the FDA granted orphan drug status to its cisplatin/epinephrine product candidate, IntraDose, for the treatment of squamous cell carcinoma of the head and neck.
¿ Procyon BioPharma Inc., of Montreal, and IMI International Medical Innovations Inc., of Toronto, signed a letter of intent to form a joint initiative to develop and commercialize a series of products to screen colorectal cancer and associated pathologics. The companies will consolidate their respective colorectal cancer tests. IMI will lead the product development, clinical trials and commercialization of the combined technologies, and Procyon will provide scientific support and funding of the initiative.
¿ SciClone Pharmaceuticals Inc., of San Mateo, Calif., said Zadaxin was approved in South Korea as an influenza vaccine adjuvant for individuals with weakened immune systems. The approval is expected to be expanded to include use for treatment of hepatitis B and hepatitis C.
¿ Sepracor Inc., of Marlborough, Mass., said the Federal Trade Commission closed its investigation of the license agreement that allows Eli Lilly & Co., of Indianapolis, to exclusively develop and globally commercialize fluoxetine, a modified form of an active ingredient found in Prozac. Upon closing of the transaction, Sepracor will receive an up-front milestone payment and license fee of $20 million, and it also will receive up to $70 million in additional milestone payments.
¿ The Immune Response Corp., of Carlsbad, Calif., said Remune, its immune-based therapy to treat HIV infection, appears to boost CD4 helper T-cell activity against HIV in chronically infected patients on antiviral drug therapy. Immune cell function was measured in 18 patients with chronic HIV infection before and after quarterly injections of Remune. Baseline responses against HIV were undetectable or low in the group studied before treatment, but significant increases, ranging from three- to 20-fold on average, in CD4 helper T-cell activity specifically against HIV were detected after treatment with Remune. The research is published in the current issue of AIDS Research and Human Retroviruses.
¿ Universal Preservation Technologies Inc., of San Diego, received a research and development grant of about $844,000 from the U.S. Office of Naval Research for the preservation of platelets, using its VitriLife stabilization technology, a method for preserving industrial-scale biological suspensions.
¿ Viacord Inc., of Boston, and t. Breeders Inc., of Worcester, Mass., closed a merger agreement forming a new cellular medicine company called ViaCell Inc. ViaCell will leverage its cord blood banking service infrastructure and patented stem cell expansion technology to build a cellular pharmaceutical company providing products and services to treat diseases using stem cells. Upon closing the agreement, ViaCell received $11 million in new equity capital from three investors.
¿ Viragen Inc., of Plantation, Fla., said it was approved for listing its common shares on the American Stock Exchange. Trading is scheduled to begin on Monday under the symbol VRA.