• Advancis Pharmaceutical Corp., of Germantown, Md., signed a definitive agreement with Par Pharmaceutical Inc., of Spring Valley, N.J., a subsidiary of Par Pharmaceutical Companies Inc., as its partner to develop and commercialize its most advanced pulsatile product candidate, Amoxicillin Pulsys. The product uses Advancis' once-a-day pulsatile delivery technology called Pulsys and is expected to be commercially available by as early as 2006. The agreement finalizes the letter of intent signed and reported in March.

• Anadys Pharmaceuticals Inc., of San Diego, relocated its facilities to 3115 Merryfield Row in San Diego. Anadys is focused on discovering, developing and commercializing small-molecule, anti-infective medicines for the treatment of hepatitis C, hepatitis B and bacterial infections.

• Cell Signaling Technology Inc., of Beverly, Mass., and Li-Cor Biosciences Inc., of Lincoln, Neb., signed a joint marketing and assay-validation agreement to validate In-Cell Western cellular imaging assays on Li-Cor's Odyssey Infrared Imaging System employing Cell Signaling's antibody reagents. Financial terms were not disclosed.

• ChemBridge Research Laboratories LLC, of San Diego, and Eisai Co. Ltd., of Tokyo, achieved a discovery milestone in their collaboration targeting an undisclosed G protein-coupled receptor. As a result, ChemBridge will receive further discovery support to facilitate the optimization of identified lead molecules, and the company will continue to receive milestone payments if the program progresses. The agreement dates to April 2002.

• Dyax Corp., of Cambridge, Mass., granted a nonexclusive license to its antibody phage display libraries to Genzyme Corp., also of Cambridge, for the discovery of human antibodies, initially for use in research and with options for therapeutic antibody product development. Dyax will receive an up-front technology license fee, potential clinical milestone payments and royalties. The agreement provides Genzyme with a license to Dyax's antibody phage display technology and patent rights, as well as sublicenses to relevant third-party antibody phage display patents that might be used with Dyax's technology.

• EPIX Medical Inc., of Cambridge, Mass., priced its offering of $75 million of convertible senior notes due 2024 to be sold to qualified institutional buyers. The notes will bear interest at a rate of 3 percent. The company also granted initial purchasers a 30-day option to purchase up to an additional $25 million aggregate principal amount of the notes to cover overallotments. The sale is expected to close on June 7. The notes will be convertible into the company's common stock at a conversion rate of about 33.6 shares per $1,000 principal amount of the notes, subject to adjustment in certain circumstances.

• Genesis Bioventures Inc., of New York, filed a secondary registration statement relating to the resale of certain shares of its common stock. The offering contemplates the potential resale of about 2.6 million shares directly owned by certain selling shareholders, about 5.8 million shares underlying shares of recently issued senior convertible notes and about 3 million shares issuable upon the exercise of certain warrants. The company, which is in the process of merging with Corgenix Medical Corp., of Denver, will not receive proceeds from the sale of the shares other than the exercise price, if any, received upon exercise of the warrants.

• Genomatix Corp., of Roanoke, Va., released its Cell-Based Knockins, products to compare the effects of adding new or modified genetic materials into the functional context of a total gene knockout, adding to its list of DNA vector applications.

• GTx Inc., of Memphis, Tenn., reported Phase IIb results for its lead product Acapodene (toremifene citrate) tablets, demonstrating that it was well tolerated and reduced the incidence of prostate cancer in men who are at high risk for prostate cancer. Patients were classified as being at high risk if they had biopsy-proved precancerous lesions of the prostate. GTx plans to initiate a Phase III study this year.

• Hematech LLC, of Sioux Falls, S.D., received an undisclosed milestone payment from Kirin Brewery Co. Ltd., of Tokyo, after reaching a milestone in the development of its bovine production system for the creation of fully human polyclonal antibodies. The company said it produced calves that carry the human heavy and light chain antibody genes but lack both copies of the bovine heavy chain antibody gene (or the immunoglobulin gene). The sequential gene-targeting technology that enabled Hematech to knock out the bovine heavy chain antibody genes will be published in the June 6, 2004, advanced online edition of Nature Genetics.

• Iconix Pharmaceuticals Inc., of Mountain View, Calif., entered an agreement to provide chemogenomic profiling and analytical services for a cancer drug discovery program of AstraZeneca plc, of London. Iconix will use biomarkers of drug pathology and mechanisms from its Drug Signatures library to profile AstraZeneca's compounds. AstraZeneca, which will apply Iconix's chemogenomics platform to understand the mechanisms of toxicity found in specific drug programs, also is seeking to identify genomic biomarkers that could be used as counterscreens in short-term studies. Financial terms were not disclosed.

• ILEX Oncology Inc., of San Antonio, said it would hold a shareholder meeting on July 1 to vote on the proposed merger with Genzyme Corp., of Cambridge, Mass. Shareholders of record on May 28 are entitled to vote. The transaction was reported three months ago and estimated at $1 billion at the time. (See BioWorld Today, March 1, 2004.)

• Indevus Pharmaceuticals Inc., of Lexington, Mass., received a $120 million milestone payment from Pliva dd, of Zagreb, Croatia, related to FDA approval of Sanctura. Two months ago, the companies entered a co-promotion and licensing agreement that called for the overactive bladder product to be co-promoted by a joint sales force of Indevus and Pliva through its Odyssey Pharmaceuticals Inc. subsidiary. Sanctura was approved late last month. (See BioWorld Today, April 8, 2004, and June 1, 2004.)

• Inspire Pharmaceuticals Inc., of Durham, N.C., began a Phase III trial of diquafosol tetrasodium for dry eye. The double-masked, randomized, placebo-controlled safety and efficacy study is the result of an FDA approvable letter and subsequent agency guidance indicating that an additional trial would be required. In the study, which will be conducted in about 500 patients at 36 U.S. sites, diquafosol or placebo will be administered four times daily over six weeks. The company announced its intention to conduct the trial earlier this year. (See BioWorld Today, Feb. 2, 2004.)

• KaloBios Pharmaceuticals Inc., of Palo Alto, Calif., exclusively in-licensed a preclinical therapeutic antibody lead and its commensurate intellectual property for the clinically relevant pathogen Pseudonomas aeruginosa. The antibody was developed by a team of researchers at the Medical College of Wisconsin in Milwaukee and the University of California at San Francisco. KaloBios is using its antibody technology to engineer a high-affinity human antibody against the PcrV protein that is more potent than the original mouse antibody, it said. The company expects to complete the antibody engineering work by mid-2004.

• MDS Proteomics, a unit of MDS Inc., of Toronto, changed its business and financial strategy to focus on providing services for biomarker identification, lead optimization and protein analysis. The company said it plans to discontinue its activities in drug discovery and development.

• Metabolic Pharmaceuticals Ltd., of Melbourne, Australia, completed enrollment in its Phase IIb trial of AOD9604 for obesity. More than one-third of patients have finished treatment in the 300-patient study, with all treatment expected to end in September, followed by results in late November. Its primary efficacy endpoints are to determine the effect of AOD9604 on body-weight reduction, and fat reduction measured from a CT scan. Secondary endpoints are other measures of obesity, such as waist circumference and the effect of AOD9604 on perceived quality of life.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., signed a research agreement with Harvard University and professor E.J. Corey for a family of proteasome inhibitors and a related chemical synthesis process. Millennium intends to use the agreement to enhance its ongoing efforts to develop next-generation proteasome inhibitors, building on the success of its first-in-class proteasome inhibitor Velcade. Harvard granted Millennium certain rights to intellectual property and inventions for development of proteasome inhibitors using a chemical synthesis process developed by Corey. Millennium will pay milestone fees and royalties to Harvard. Additional financial terms were not disclosed.

• Nastech Pharmaceutical Co. Inc., of Bothell, Wash., said the FDA completed its pre-approval inspection of its manufacturing facility for both the Nascobal Nasal Spray product for vitamin B12 deficiencies and the Salmon-Calcitonin Nasal Spray product for osteoporosis. Both products are under FDA review for marketing clearance.

• Phylonix Pharmaceuticals Inc., of Cambridge, Mass., received a $993,463 Phase II Small Business Innovation Research grant from the National Cancer Institute in Bethesda, Md., to develop zebrafish apoptosis assays for drug screening. The company is developing a vital dye assay for high-throughput screening using an automated liquid-handling workstation and a microplate reader.

• Power 3 Medical Products Inc., of The Woodlands, Texas, said it would operate in the protein-based diagnostic and drug-targeting markets as a result of its acquisition of a proteomics company called ProteEx Inc., also of The Woodlands, for an undisclosed amount. Power 3 added that it would seek partners for its protein biomarker products.

• Prana Biotechnology Ltd., of Melbourne, Australia, said that shareholders approved the issuing of securities worth $20 million to institutional and professional investors, led by New York-based global health care fund managers, OrbiMed and XMark Funds. The transaction was originally announced April 28. Investors also purchased five-year warrants to buy an additional 3 million American depository receipts at an exercise price of $8 each. If exercised, that would raise an additional $24 million.

• SkyePharma plc, of London, entered an alliance with Vectura Ltd., of Chippenham, UK, in the area of pulmonary delivery technologies. SkyePharma will acquire rights to use Vectura's Aspirair dry-powder inhaler device for certain macromolecules on a nonexclusive basis. Although detailed commercial terms were not released, SkyePharma has made a £2 million (US$3.7 million) equity investment in Vectura as part of the alliance.

• Structural GenomiX Inc., of San Diego, completed its installation of a high-throughput structural biology facility for Eli Lilly and Co., of Indianapolis, achieving two validation milestones in the process. The company received payments from Lilly as a result of the milestones, which stem from an April 2003 collaboration under which Structural GenomiX agreed to apply its target-to-structure technologies to generate drug leads for Lilly's discovery programs.

• Trillium Therapeutics Inc., of Toronto, licensed exclusive worldwide rights to a series of pro-inflammatory cytokine receptor antagonists. The technology was developed at St. Justine Hospital and the University of Montreal in the laboratories of Sylvain Chemtob and Williams Lubell. Trillium specializes in the development of therapies that restore balance to the immune system in conditions associated with aberrant and harmful immune responses.

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