¿ Abbott Laboratories, of Abbott Park, Ill., received accelerated FDA approval to market its antiretroviral Kaletra (lopinavir/ritonavir), formerly known as ABT-378/r, for the treatment of HIV infection in adults and children 6 months and older in combination with other antiretroviral medications. Kaletra will be available in capsule and liquid formulations within the next week. Kaletra is the only protease inhibitor approved for use in children as young as 6 months.
¿ Agouron Pharmaceuticals Inc., of La Jolla, Calif., initiated an additional trial of the capravirine for the treatment of HIV infection as part of combination therapy in people who have failed previous therapy. This trial is in addition to several trials under way designed to evaluate the safety and efficacy of capravirine in two populations: HIV-infected patients who have either failed previous treatment or have never been treated. Capravirine generally has been well tolerated in clinical studies to date.
¿ Avant Immunotherapeutics Inc., of Needham, Mass., plans to initiate a controlled Phase IIb study of its lead complement inhibitor, TP10, in infants undergoing cardiac surgery. The study should begin before the end of the year and will be double blind and placebo controlled. TP10 is being studied as a potential treatment to improve post-operative outcomes in infants undergoing cardiac surgery.
¿ Biomira Inc., of Edmonton, Alberta, stated at the Stephens Inc. Anti-Cancer Biopharmaceutical Investment Conference that it surpassed 700 patients in its pivotal Phase III trial with Theratope vaccine for metastatic breast cancer and should have full enrollment by year's end. The study is designed to measure time to disease progression and survival as measures of efficacy.
¿ Chiron Corp., of Emeryville, Calif., said the 2000 Albert Lasker Award for Clinical Medical Research will be awarded to Chiron's Michael Houghton for his work with hepatitis C virus. Houghton is being cited for his discovery of the hepatitis C virus in 1987 and the development of blood supply screening technologies.
¿ EntreMed Inc., of Rockville, Md., said the first Phase I clinical trial of 2-methoxyestradiol (2ME2) combined with cytotoxic chemotherapy has begun. 2ME2 is an orally active compound and is an antiproliferative and antiangiogenic agent. The study will focus on the safety of simultaneously administrating 2ME2 and the cytotoxic docetaxel in patients with advanced breast cancer. A Phase I study on 2ME2 as a single agent began in March and is ongoing.
¿ InforMax Inc., of Rockville, Md., released GenoMax 3.0, the next generation of its bioinformatics system, including modules for sequence analysis, gene expression analysis and protein 3D structure.
¿ Isotechnika Inc., of Edmonton, Alberta, said its common stock will commence trading on the Toronto Stock Exchange today under the symbol ISA. Isotechnika has been listed on the Canadian Venture Exchange for the past 20 months and is a life sciences company developing drugs and diagnostic products.
¿ Life Medical Sciences Inc., of Edison, N.J., extended the expiration of the Class A and Class B redeemable warrants originally issued in conjunction with its initial public offering in 1992. Unless previously redeemed, the warrants are now exercisable at any time until 5 p.m. on March 21, 2002.
¿ Maxim Pharmaceuticals Inc., of San Diego, will have its lead drug candidate Maxamine reviewed by the Oncology Drugs Advisory Committee (ODAC) panel at its December meeting. The ODAC panel advises the FDA as part of its evaluation of NDAs. The company completed its U.S. Phase III trial in stage-IV malignant melanomas in March.
¿ Medical Alliance Inc., of Irving, Texas, signed an agreement with ICN Pharmaceuticals Inc., of Costa Mesa, Calif., for ICN to purchase the medical business assets of Medical Alliance for $14.4 million in cash. The closing of the deal is dependent on approval of Medical Alliance's shareholders and subject to other certain conditions.
¿ MetaPhore Pharmaceuticals Inc., of St. Louis, was awarded a $290,000 Small Business Innovation Research grant to study potential new treatments for managing both acute and chronic pain. The National Institutes of Health awarded the six-month grant. The funding allows MetaPhore to proceed with studies on pain using its metal-based compounds. The compounds mimic the body's primary defense mechanism against oxidative damage from the free radicals derived from oxygen known as superoxide.
¿ NaPro BioTherapeutics Inc., of Boulder, Colo., along with its licensee, Abbott Laboratories, filed a lawsuit in the U.S. District Court against Bristol-Myers Squibb Corp. alleging patent infringement. NaPro and Abbott allege infringement upon U.S. Patent Nos. 5,972,992 and 5,977,164, which relate to paclitaxel, the active ingredient in Bristol-Myers Squibb's anticancer drug Taxol.
¿ Orchid BioSciences Inc., of Princeton, N.J., and Tecan, of Hombrechtikon, Switzerland, entered into a strategic partnership in which Tecan will allow Orchid to use its automated DNA processing solution for use in the manufacture of SNPware consumable kits and in support of Orchid's genotyping operations in its high-throughput MegaSNPatron facility. Financial terms were not disclosed.
¿ Protein Design Labs Inc., of Fremont, Calif., signed a second antibody humanization agreement with Eli Lilly and Co., of Indianapolis, under which PDL will humanize one or more murine antibodies directed to a single target. PDL will receive a non-refundable, non-creditable up-front signing fee of $1.36 million, milestone payments upon the achievement of specified objectives, annual maintenance fees and royalties on sales of the humanized antibody.
¿ Sangamo BioSciences Inc., of Richmond, Calif., signed an agreement with Merck & Co. Inc., of Whitehouse Station, N.J., to provide its Universal GeneTools to Merck for internal use. Sangamo's products are customized transcription factors designed to further the understanding of individual genes roles in various diseases.
¿ SangStat Medical Corp., of Fremont, Calif., said Thymoglobulin, marketed by SangStat in both the United States and Europe, has been granted orphan drug designation for the treatment of myelodysplastic syndrome by the FDA. Thymoglobulin is a pasteurized anti-thymocyte rabbit immunoglobulin indicated for the treatment of renal transplant acute rejection, in conjunction with concomitant immunosuppression.
¿ SignalGene Inc., of Montreal, withdrew its $5.4 million offer to purchase Nova Molecular Inc., also of Montreal, previously announced on Aug. 23. SignalGene reviewed NMI and concluded that the acquisition was not appropriate. (See BioWorld Today, Aug. 24, 2000, p. 1.)