• Aethlon Medical Inc., of San Diego, said researchers have discovered the Aethlon Hemopurifier is effective in capturing particles that suppress the immune response in cancer patients. The particles, known as exosomes, are released by solid tumors, lymphomas and leukemia. Exosomes induce T-cell apoptosis and block T-cell signaling, proliferation and cytokine production. High concentrations of circulating exosomes correlate with reduced T-cell production and tumor progression in cancer patients. In studies, 60 percent of circulating exosomes were removed from the blood of ovarian cancer patients during first pass (approximately 10-minutes) through a small-scale Hemopurifier. The capture data were consistent over the course of five different studies.

• Arpida Ltd., of Basel, Switzerland, entered an agreement to acquire privately held TLT Medical Ltd., of Reinach, Switzerland. TLT is developing a therapy to treat onychomycosis, or fungal infections of the nails of the fingers and toes. It is a novel formulation of terbinafine (the active ingredient of Lamisil) that is expected to enter a pivotal Phase III trial in Europe in the near term. The deal would entail an up-front payment to TLT as well as potential milestone payments that together could total up to CHF57 million (US$47.5 million). Up to CHF5 million of that would be paid in Arpida shares, with the remainder in cash. The deal is expected to close by mid-August. Earlier this week Arpida reported positive Phase III data on intravenous iclaprim, a broad-spectrum antibiotic for treating complicated skin and skin structure infections. A new drug application filing is expected later this year. (See BioWorld Today, July 17, 2007.)

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, said U.S. and European regulatory authorities accepted its new drug application and marketing authorization application for ceftobiprole (BAL5788) in the treatment of complicated skin and skin structure infections. The applications were submitted by Basilea's partners Johnson & Johnson Pharmaceutical Research and Development LLC, of New Brunswick, N.J., in the U.S. and Janssen-Cilag International NV, of Beerse, Belgium, in Europe. Both applications will be subject to a standard review. Ceftobiprole is an anti-MRSA, broad-spectrum, cephalosporin antibiotic designed to inhibit penicillin-resistant targets in many Gram-positive cocci, resulting in potent bactericidal activity toward MRSA and penicillin-resistant Streptococcus pneumoniae.

• Cardium Therapeutics Inc., of San Diego, received fast track designation from the FDA for its lead product candidate, the myocardial ischemia therapy Generx (alferminogene tadenovec, Ad5FGF-4). Generx is a DNA-based growth factor designed to increase angiogenesis and blood flow in the heart. It currently is being studied in a 300-patient, randomized, placebo-controlled, double-blind Phase III trial.

• Crucell NV, of Leiden, the Netherlands, has created two business units, for vaccines and proteins. Björn Sjöstrand was named to head the vaccines unit. He was CEO of SBL Vaccines, which was acquired by Crucell in November 2006. Arthur Lahr will head the protein unit. He was Crucell's chief strategy officer and executive vice president of sales and business development.

• Genomic Health Inc., of Redwood City, Calif., said the Blue Cross and Blue Shield Association Medical Advisory Panel has concluded that use of Genomic Health's Oncotype DX breast cancer assay to inform decision making about adjuvant chemotherapy meets the association's criteria for women with estrogen receptor-positive, node-negative, tamoxifen-treated breast cancer.

• Invitrogen Corp., of Carlsbad, Calif., has signed an exclusive agreement with Biocon Ltd., of Bangalore, India, to market pharmaceutical-grade insulin to the global cell culture market. Insulin is a widely used growth factor to delay apoptosis in mammalian cell culture which leads to increased productivity. Terms were not disclosed.

• KeyGene NV, of Wageningen, the Netherlands, has established a joint lab for plant molecular breeding with the Shanghai Institutes for Biological Sciences (SIBS). The lab will operate within the Institute for Plant Physiology and Ecology of SIBS, a branch of the Chinese Academy of Sciences in Shanghai.

• Living Cell Technologies Ltd., of Melbourne, Australia, has established a Level 1 American Depositary Receipt Program (ADR) sponsored by the Bank of New York. The company's ADRs will trade under the ticker symbol LVCLY and was effective July 17, and each ADR will represent 10 ordinary LCT shares. The ADR program facilitates the purchase of LCT stock in the over-the-counter pink sheet market by U.S. investors, who already hold more than 10 percent of its shares.

• Novozymes A/S, of Franklin, N.C., has strengthened its role in India by signing a definitive agreement to buy the enzyme activities of Biocon Ltd., of Bangalore, India, for $115 million. The purchase price includes $102 million, of which $97 million will be paid up front, and $5 million when business targets have been met. In addition, $13 million for committed service fees and lease payments will be paid over a period of up to 10 years. The purchase price corresponds to around four times fiscal year 2006/2007 realized sales. Biocon's board of directors has unanimously recommended the sale and shareholders representing about 60 percent of the total shares have committed to vote for the transaction. Novozymes does not currently hold any stake in Biocon. Biocon's enzymes business includes industrial enzymes, food additives and process aids. It also has a stake in the global enzymes market for the juice and wine industries. The transaction is expected to be completed around October 2007.

• Salix Pharmaceuticals Ltd., of Raleigh, NC, submitted a new drug application to the FDA seeking approval of a 1,100-mg tablet formulation of balsalazide disodium, the active ingredient in the company's marketed ulcerative colitis drug Colazal. Colazal currently is available in 750-mg capsules. Salix garnered positive data in a Phase III trial of the 1,100-mg tablet formulation last month.

• Solagran Ltd., of Sydney, Australia, has been notified by the Russian Ministry of Heath that the pharmaceutical registration of both Bioeffective and the associated medicine Ropren has been finalized. Ropren is a natural hepatoprotector, which will be used to treat chronic liver disease, including hepatitis and cirrhosis. The company said it next will pursue approval in the European Union.

• TechnoVax Inc., of Tarrytown, N.Y., presented data on its 1918 VLP vaccine based on its virus-like particle technology, at the American Society for Virology meeting in Corvallis, Ore. Preclinical results on the 1918 VLP vaccine, which is designed to protect against the highly virulent 1918 pandemic influenza virus, showed protection against a surrogate virus in animals. Also, TechnoVax presented data on its bivalent VLP vaccine technology, which is designed to protect against two antigenically distinct influenza viruses.

• Theratechnologies Inc., of Montreal, has entered into an agreement with Sakai Chemical Industry Co. Ltd., of Tokyo, to regain exclusive rights for its lead compound, TH9507, in Japan. The rights were returned to Theratechnologies without financial compensation. Theratechnologies has licensed its TH9507 in 2002 for hip fracture, with options for immune response, sleep and chronic obstructive pulmonary disorder indications. However, since then Theratechnologies has focused its TH9507 clinical efforts on lipodystrophy, a disease related to HIV. Recently, Sakai has made the strategic decision not to exercise any of its options and has agreed to return the rights for Japan, and all options for all indications, back to Theratechnologies.

• Tibotec Pharmaceuticals Ltd., a Cork, Ireland-based unit of Johnson & Johnson, submitted a new drug application with the FDA, seeking approval of TMC125 (etravirine) for treating HIV. The non-nucleoside reverse transcriptase inhibitor was studied in two Phase III trials in combination with other antiretroviral agents. Tibotec said TMC125 is the first NNRTI to show antiviral activity in patients with documented NNRTI resistance. The product has been granted fast-track designation from the FDA. Regulatory submissions for TMC125 in other countries are expected in the coming months.

• Uluru Inc., of Addison, Texas, has signed a feasibility agreement with an unnamed veterinary company to evaluate the delivery of drugs to companion animals using its patented mucoadhesive erodible film technology. The initial feasibility study is focused on the delivery of a proprietary active in dogs to achieve bioequivalence to an orally administered product. Under the terms of the agreement, the partner will assume the costs of feasibility testing. Preliminary studies conducted to date have indicated a high acceptance level of this dosage form in dogs.