* Anika Therapeutics Inc., of Woburn, Mass., received notification from the FDA's Center for Devices and Radiological Health that the company's pre-market approval (PMA) application for its Orthovisc therapy has been accepted for filing. Orthovisc, to be used in treating osteoarthritis of the knee, is an injectable form of hyaluronic acid. The PMA application was submitted earlier this year. (See BioWorld Today, Jan. 6, 1998, p. 1.)
* Aviron Inc., of Mountain View, Calif., said a clinical trial of its intranasal influenza vaccine showed positive results in consistency of manufacture. The trial — a randomized, double-blind, placebo-controlled study of 500 children — is required by the FDA prior to approval of the vaccine, and Aviron intends to file its new drug application with the agency in the middle of this year. Last year, the vaccine tested favorably in a Phase III trial. (See BioWorld Today, July 15, 1997, p. 1.)
* Centocor Inc., of Malvern, Pa., increased the size of its offering of convertible subordinated debentures to $460 million from $335 million, after taking into account exercise in full of the overallotment option. The debentures, due in 2005, have an annual coupon of 4.75 percent, are convertible into common stock at $49.261 per share and are not redeemable for three years. The offering will be used to finance purchase of the clot-busting drug Retavase for $335 million from Roche Holding Ltd., of Basel, Switzerland. (See BioWorld Today, Feb. 17, 1998, p. 1.)
* Diversa Corp., of San Diego, received a $100,000 Phase I Small Business Innovative Research grant from the National Cancer Institute to further its search for pharmaceutical compounds from uncultivated microorganisms inhabiting diverse environments. Diversa's technology explores extreme environments, where it has identified numerous new enzymes from previously undiscovered microorganisms. (See BioWorld Today, Feb. 13, 1998, p. 1.)
* T Cell Sciences Inc., of Needham, Mass., said a Phase I trial of the humanized monoclonal antibody ATM027 showed positive results in patients with multiple sclerosis (MS). The drug, licensed by Astra AB, of Sodertalje, Sweden, is derived from the company's T Cell Antigen Receptor program. Astra, conducting the development of ATM027, said Phase I data showed an effect on target cells with no serious adverse reactions.
* Unigene Laboratories Inc., of Fairfield, N.J., received a $2 million milestone payment from Warner-Lambert Co., of Morris Plains, N.J. The payment is for Unigene's achievement of a benchmark in developing an oral calcitonin product for treating osteoporosis. Under terms of the licensing agreement, Unigene is eligible to receive up to $46.5 million more in milestone payments, of which another $13.5 million would come before Phase I trials are begun in the U.S. (See BioWorld Today, July 3, 1997, p. 1.)
* Genzyme Transgenics Corp., of Framingham, Mass., received a milestone payment from Fresenius AG, of Bad Homburg, Germany, triggered by the former's demonstration of a proprietary process for purifying recombinant human serum albumin (rHSA) from the milk of transgenic cows. A program was begun in March 1997 to develop and commercialize rHSA. (See BioWorld Today, March 17, 1997, p. 1.)
* Interferon Sciences Inc., of New Brunswick, N.J., completed preliminary analysis of data from its Phase III trial of Alferon N Injection (natural alpha interferon) in HIV-infected patients. Another meeting, prior to the filing of a new drug application, is slated with the FDA for mid-March. Alferon N Injection already is approved for sale in Mexico, Germany, Singapore and Hong Kong.
* Tripos Inc., of St. Louis, entered a collaboration with Sepracor Inc., of Marlborough, Mass., to discover improved HIV protease inhibitors. The companies will jointly develop computer-aided research methods and new therapeutics to target resistant strains of HIV. They will share profits that may arise from co-invented drug candidates or technology.
* Apollo BioPharmaceutics Inc., of Cambridge, Mass., exercised its option for exclusive licenses to certain technologies arising from research programs sponsored by Apollo at the University of Florida Research Foundation, in Gainesville. The new licenses cover novel steroid compounds that resulted from discovery of a specific structure on the estrogen molecule that blocks nerve cell damage. Apollo also licensed a newly discovered drug mixture that can augment cell protection activity by as much as 1,000-fold, the company said.