• Affymetrix Inc., of Santa Clara, Calif., granted Veridex LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, long-term access to its GeneChip technology to create and market in vitro diagnostics for cancer. Veridex gains nonexclusive rights to Affymetrix's arrays, instrumentation systems and planned improvements to the technologies.

• Axonyx Inc., of New York, completed the last six-month patient treatment period in its Phase III trial with Phenserine for Alzheimer's disease. The trial began in June 2003 and involved 375 mild to moderate AD patients who were randomly assigned Phenserine, in either 15-mg or 10-mg twice-daily doses, or a placebo, and evaluated with memory and cognition tests for required efficacy endpoints. Axonyx expects to announce results by the end of March. The company initiated two additional Phase III trials in late 2004. Phenserine is a dual-action acetylcholinesterase and beta-APP inhibitor.

• CancerVax Corp., of Carlsbad, Calif., secured an $18 million loan from Silicon Valley Bank to expand the production capacity of its biologics manufacturing facility in the Los Angeles area. The company said it will use the funds to create additional warehouse and laboratory space for manufacturing Canvaxin, a therapeutic cancer vaccine undergoing evaluation in two Phase III trials involving patients with Stage III or Stage IV melanoma. CancerVax previously announced a partnership with Geneva-based Serono SA to develop and market Canvaxin. CancerVax received an initial $37 million payment and is eligible to receive up to $253 million through development and regulatory and commercial milestones. (See BioWorld Today, Dec. 17, 2004.)

• Gen-Probe Inc., of San Diego, said the FDA granted marketing clearance for the company's APTIMA Chlamydia Trachomatis assay, an amplified nucleic acid test that detects the bacterium that causes the infection. The assay can be run on Gen-Probe's semi-automated DTS instruments. The company also has filed for clearance of its stand-alone APTIMA GC assay for Neisseria gonorrhoeae, and it expects approval in the first quarter.

• Halozyme Therapeutics Inc., of San Diego, received CE mark approval for Cumulase to treat oocytes to facilitate certain in vitro fertilization (IVF) procedures. The company anticipates launching Cumulase in the European Union in the first quarter. Cumulase is an ex vivo formulation of rHuPH20 (recombinant human PH20 hyaluronidase) to replace bovine and ovine extracts used for the preparation of oocytes prior to IVF during the process of intracytoplasmic sperm injection. Halozyme also has a pending 510(k) application for Cumulase before the FDA.

• Myriad Genetics Inc., of Salt Lake City, submitted an investigational new drug application to begin a Phase I trial with MPC-2130 (previously referred to as MPI-176716), a product designed as an inducer of apoptosis in cancer cells. The study is expected to evaluate the safety and pharmacokinetic profile of MPC-2130 in patients with advanced metastatic tumors or blood cancers, as well as refractory cancer that had progressed despite chemotherapy. Myriad reported that preclinical testing showed apoptosis in ovarian cancer, prostate cancer and two lymphoma cell lines, Burkitt's lymphoma and T-cell lymphoma.

• Pharming Group NV, of Leiden, the Netherlands, said it will acquire ProBio International Holdings Pte. Ltd., of Melbourne, Australia, to expand Pharming's commercial opportunities with recombinant human lactoferrin and to enhance its protein product technology platform. Pharming already owns about 45 percent of ProBio's shares, but it will gain control of the intellectual property portfolio through the acquisition. It also will gain rights to the non-pharmaceutical applications of recombinant human lactoferrin, and it will benefit from ProBio's relationships with pan-Asian entities. The total consideration for the acquisition will be paid in shares and accounts for about 1.5 percent of the company's capitalization. Detailed terms were not disclosed.

• Sonus Pharmaceuticals Inc., of Bothell, Wash., and Synt:em SA, of Nimes, France, revised the terms for a proposed acquisition of Synt:em originally announced in November. Under the new agreement, Sonus will issue a maximum of 5.4 million shares, instead of 7.6 million to 8.9 million shares, to acquire all of the outstanding shares of Synt:em. The new terms state that Sonus' shares at closing will have a value of about $12 million, and additional shares will be issued at certain milestones met by Synt:em's product candidates entering Phase II trials, instead of Phase I trials. Synt:em shareholders will own 20 percent, as opposed to 25 percent to 29 percent, of the combined entity if the milestone payments are earned. The new agreement also includes a mechanism to reallocate a portion of the Sonus shares issued at the closing to the contingent milestone pool if Sonus reaches an agreement with the FDA on Phase III testing or if it enters a partnership for Tocosol Paclitaxel, a cancer product. The transaction is expected to close in the first quarter. The terms were amended following an end-of-Phase II meeting with the FDA regarding Tocosol Paclitaxel. (See BioWorld Today, Nov. 5, 2004.)

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