• Acrux Ltd., of Melbourne, Australia, closed a deal with Vivus Inc., of Mountain View, Calif., involving a transdermal spray delivery technology for female sexual dysfunction and menopause. Privately held Acrux will receive $13 million in licensing fees and royalty payments upon the commercialization of each product, to which Vivus gained exclusive U.S. rights with the ability to sublicense. Acrux, which is free to license the products elsewhere in the world, was advised by Burrill & Co., of San Francisco.

• Artemis Pharmaceuticals GmbH, of Cologne, Germany, and Aventis Pharma R&D, a unit of Aventis SA, of Strasbourg, France, signed several agreements in the area of mouse genetics. More specifically, Artemis will use its ArteMice platform to generate genetically engineered mice for Aventis, which will use the mice in drug research activities for gene function analysis and for the testing of drug candidates. In addition, Artemis is providing Aventis with licenses to certain cre transgenic mice, including the CreER-gene switch mouse. Aventis will use the mice to elucidate gene function in vivo by altering gene expression in certain tissues, or in all tissues in the adult mouse. Financial terms were not disclosed.

• Asterand Inc., of Detroit, is offering six new cell lines for prostate cancer research. The human tissue bank developed the products through a two-year collaboration with Onyvax Ltd., of London. Researchers at Wayne State University and the Karmanos Cancer Institute, both in Detroit, also participated in the development and characterization of the new lines.

• Barrier Therapeutics Inc., of Princeton, N.J., began enrollment in a Phase III trial for Hyphanox (itraconazole) in patients with vaginal candidiasis. The trial will compare the efficacy of a single dose, a 200-mg tablet formulation, of Hyphanox to a single 150-mg dose of the antifungal fluconazole. Fluconazole is sold in the U.S. by New York-based Pfizer Inc. as Diflucan. Barrier expects to enroll about 900 patients at 40 centers across the U.S. in the double-blinded trial.

• BioCrossroads, of Indianapolis, established a protein center of excellence called the Indiana Centers for Applied Protein Sciences. James Ludwig, the head of proteomics programs at Eli Lilly and Co., also of Indianapolis, will lead the center as the founding CEO. BioCrossroads, the Central Indiana Life Sciences Network, is a public-private collaboration that supports the region's research and corporate strengths while encouraging new business development.

• Bone Care International Inc., of Middleton, Wis., named Herbert Conrad its chairman. Formerly the chairman of GenVec Inc., of Gaithersburg, Md., he is replacing Founder Richard Mazess, who will remain on the board. Bone Care International is developing improved vitamin D hormone therapies to treat secondary hyperparathyroidism in patients with kidney disease, osteoporosis and psoriasis.

• Boston Life Sciences Inc., of Boston, received the FDA's response to its latest special protocol assessment submission for Altropane for the indication of differentiating Parkinsonian from non-Parkinsonian syndromes in patients with tremors. The FDA requested further modification to the statistical presentation section of the protocol relating to statistical methodologies. The agency also provided statistical guidance regarding the circumstances under which the single Phase III study would be sufficient to achieve approvability for that indication, and the company is seeking clarification on that point. The company said it believes that the requested changes do not pose a significant obstacle to obtaining the special protocol assessment and already has made the requested modifications to the statistical plan in order to satisfy the conditions for a SPA agreement.

• Chemicon International Inc., of Temecula, Calif., and Promega Corp., of Madison, Wis., entered a sublicense agreement for the use and application of DNA-directed, RNA interference technology. Promega is the exclusive global licensee in certain fields for ddRNAi technology from Benitec Ltd., of Queensland, Australia. Chemicon will have the right to use the technology to develop and sell ddRNAi-based products and reagents for life science research. Promega will provide Chemicon with materials to support development of enabling products for the study of the role of genes in mammalian physiology.

• Encysive Pharmaceuticals Inc., of Houston, reported the publication of an article in the Feb. 15, 2004, issue of the American Thoracic Society's American Journal of Respiratory and Critical Care Medicine. The study is based on Encysive's Phase IIb/III Stride-1 (Sitaxsentan To Relieve Impaired Exercise) in pulmonary arterial hypertension. The 178-patient Stride-1 trial included a broader range of patients than previously studied in the comparable multicenter trial with the marketed, nonselective endothelin receptor antagonist bosentan. Sitaxsentan is a selective endothelin A receptor antagonist.

• Gene Bridges GmbH, of Dresden, Germany, completed a nonexclusive license agreement of its Red/ET Recombination technology with Merck & Co. Inc., of Whitehouse Station, N.J. Red/ET Recombination, also known as ET cloning or Lambda-mediated cloning, allows DNA constructs to be designed and created without size or site restrictions. The license includes the use of Red/ET Recombination technologies for numerous applications in DNA engineering.

• Genomics Collaborative Inc., of Cambridge, Mass., signed a DNA and serum banking agreement with Sention Inc., of Providence, R.I., a company focused on drugs to treat memory impairment and other central nervous system disorders. GCI will provide expertise in sample collection, processing and management. It also will oversee a blood-sample/DNA collection and banking effort for research in an unspecified disease area. GCI will collect and store serum, isolate DNA from whole blood samples collected by Sention, and manage the DNA bank.

• GenVec Inc., of Gaithersburg, Md., said Phase I data of TNFerade showed at least a 25 percent tumor shrinkage rate in 21 of 30 patients across 12 tumor types. Patients also underwent radiation therapy. Data also showed a positive safety profile. The results were published in the Feb. 15, 2004, issue of the Journal of Clinical Oncology.

• Hawaii Biotech Inc., of Honolulu, was awarded a $5.6 million Phase II SBIR bioterrorism grant from the Small Business Biodefense Program of the National Institute of Allergy and Infectious Diseases in Bethesda, Md. The work will focus on optimizing the ability of two classes of compounds discovered by Hawaii Biotech to inhibit the lethal toxin secreted by anthrax bacteria. The grant also will be used to examine the ability of those inhibitors to affect potential bioterrorism agents including botulinum/A, a cause of botulinum.

• Immunotherapeutics Inc., of Needham, Mass., said it plans to start a placebo-controlled Phase II trial of TP10 in about 300 female patients undergoing cardiopulmonary bypass (CPB) surgery. The double-blind Phase II trial will examine the effect of a 30-minute infusion of TP10 vs. placebo. The study's objective is to assess the ability of TP10 to reduce the incidence of death and heart attack that occurs in cardiac surgery patients on CPB. The study will be conducted at about 15 U.S. sites and will conclude at the end of the year.

• Intercell AG, of Vienna Austria, and Aventis SA, of Strasbourg, France, signed a commercial license agreement for the development of bacterial vaccines. Intercell will apply its Antigen Identification Program to identify relevant antigens, which will allow Aventis' vaccines unit Aventis Pasteur to develop a next-generation protein-based vaccine. Intercell will receive up-front payments, license fees, research and development funding, milestone payments and royalties on product sales. Aventis Pasteur will receive exclusive worldwide rights to commercialize the vaccines developed.

• La Jolla Pharmaceutical Co., of San Diego, said the company's new drug application for Riquent was accepted for review by the FDA. Riquent is designed to treat lupus patients with renal disease, a primary cause of sickness and death among those patients. La Jolla began filing its NDA in May. (See BioWorld Today, May 6, 2003.)

• Merck KGaA, of Darmstadt, Germany, will receive about $1.7 billion for the sale of its laboratory distribution business, VWR International, to Clayton, Dubilier & Rice Inc., a global private equity firm. Merck said the sale allows it to better focus on its core businesses of pharmaceuticals and chemicals, and will combine its analytics and reagents and life science products divisions into a new life science and analytics division, which will enter a long-term distribution agreement with West Chester, Pa.-based VWR. The agreement remains subject to regulatory approval.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said the FDA accepted its abbreviated new drug application for a generic calcitonin-salmon nasal spray for the treatment of osteoporosis. The company said worldwide sales of an existing calcitonin-salmon nasal spray totaled about $389 million last year, of which the U.S. accounts for an estimated $240 million.

• OSI Pharmaceuticals Inc., of Melville, N.Y., declared effective its resale registration statement pertaining to its 3.25 percent convertible notes due in 2023 issued in September. The statement allows holders of the notes to resell the securities covered by the registration statement. OSI will not receive any proceeds from the resale.

• PPD Inc., of Wilmington, N.C., opened an office in Mumbai, India, as a drug development site to provide patient recruitment and clinical monitoring for Phase II through Phase IV studies in key therapeutic areas. PPD provides discovery and development services and products to the biotech and pharmaceutical fields.

• Purely Proteins Ltd., of Cambridge, UK, and Abcam Ltd., also of Cambridge, reported a set of collaborative programs leading to the development of protein-antibody pairs that have relevance in pharmaceutical development and span the entire human proteome. The companies formed a collaboration that covers the focused production of families of therapeutically relevant proteins and proteins domains together with their corresponding antibodies. Purely Proteins' TargetBASE database product is being used to provide information about known members of specific, therapeutically relevant protein families. Both companies will immediately launch a number of Protein Tyrosine Phosphatase proteins.

• Qualyst Inc., of Research Triangle Park, N.C., reported the closing of its Series A preferred stock offering. Burton Advisers Ltd., of London, acted as the exclusive financial adviser and placement agent in the offering. Financial details were not disclosed. Qualyst is focused on technologies for drug discovery and development.

• Targeted Genetics Corp., of Seattle, the not-for-profit International AIDS Vaccine Initiative (IAVI) and Columbus Children's Research Institute are partnering with a pair of German universities to begin that country's first human trial of a vaccine candidate designed to prevent AIDS. The trial, which will be conducted at the Universitaetsklinikum Bonn and Universitaetsklinikum Eppendorf in Hamburg, will evaluate tgAAC09, a vaccine candidate designed by Targeted Genetics and the children's research institute to elicit immune system responses to prevent people from becoming infected with HIV and developing AIDS.

• Third Wave Technologies Inc., of Madison, Wis., reported that its Invader technology platform was successfully extended to chromosomal analysis. Third Wave's new approach to chromosomal analysis is designed to provide clinicians with same-day results. Third Wave also reported that it is providing Invader analyte-specific reagents for prenatal chromosomal analysis to the University of California at Los Angeles and other institutions under an early adopter program.

• Vicuron Pharmaceuticals Inc., of King of Prussia, Pa., filed a shelf registration statement with the SEC to offer and sell up to $200 million of equity and/or debt securities in one or more public offerings in the future. The terms will be established at the time of sale. Vicuron has filed a new drug application with the FDA for its lead antifungal product, anidulafungin. It also has another product, dalbavancin, in Phase III trials for Gram-positive infections.

• Xcyte Therapies Inc., of Seattle, said it would offer 4 million shares through its initial public offering, to be priced at a range between $13 and $15. The company, which is developing a T-cell product for use against cancer, autoimmune disorders and infectious diseases, filed for its IPO in the fall. (See BioWorld Today, Oct. 14, 2003.)

• ZLB Bioplasma Inc., of Glendale, Calif., said the FDA approved Rhophylac, a liquid Rh0 Immune Globulin Intravenous product that can be administered intramuscularly or intravenously to prevent hemolytic disease of the fetus and newborn. ZLB Bioplasma manufactures Rhophylac using the ChromaPlus process, which results in a pure therapeutic product making it possible to administer the product intravenously. In the past, U.S. obstetricians have had to deliver the shots intramuscularly, making it more painful for women, the company said.