• Cambridge Antibody Technology plc, of Cambridge, UK, formed a drug discovery collaboration with MSM Protein Technologies Inc., of Boston, to develop antibody-based drugs targeting multi-spanning membrane proteins. In the two-year research agreement, MSM will use its technology and drug discovery techniques to display multi-spanning membrane proteins to select antibodies from CAT libraries against a number of CAT-nominated targets and MSM-nominated targets. In return, CAT will pay MSM to conduct that discovery work on CAT's behalf. Both companies will have obligations to pay milestones and royalties to one another.

• Critical Therapeutics Inc., of Lexington, Mass., said the FDA accepted for filing the company's new drug application for the twice-daily, controlled-release formulation of zileuton. The company is seeking approval of zileuton CR in the prevention and chronic treatment of asthma in adults and children 12 years or older. The PDUFA date is May 31, 2007, and pending regulatory approval, the company expects to launch the zileuton CR in the second half of 2007. An immediate-release formulation of zileuton, a 5-lipoxygenase inhibitor, is already on the market in the U.S.

• Diffusion Pharmaceuticals LLC, of Charlottesville, Va., completed a private financing round of $1.5 million, with proceeds expected to support its overall growth and the advancement of its lead compound, trans-sodium crocetinate (TSC), into Phase I trial in early 2007. The company completed all animal toxicology studies required by the FDA for filing an investigational new drug application for TSC.

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., said its Latin American marketing partner, Stiefel Laboratories Inc., of Coral Gables, Fla., received Brazilian regulatory approval for the Levulan Kerastick product. Additional launches are expected to follow in a number of other Latin American countries, subject to regulatory approvals. DUSA's Levulan photodynamic therapy technology platform is approved for treating pre-cancerous actinic keratoses and is being developed for acne and photodamage.

• Genta Inc., of Berkeley Heights, N.J., said Genasense (oblimersen), received orphan drug designation from the Therapeutic Goods Administration, the regulatory authority in Australia, for use of the compound in patients with Stage IV malignant melanoma. In the U.S., an approval decision is expected by the end of the month on the antisense chemotherapy sensitizer for use in chronic lymphocytic leukemia.

• Insmed Inc., of Richmond, Va., said it has sued Brisbane, Calif.-based Tercica Inc. for allegedly making false and misleading statements in the advertising and promotion of Increlex, Tercica's drug for short stature. Insmed is seeking an injunction barring Tercica from making what it believes are misleading statements regarding the convenience and cost of its product vs. Insmed's short stature drug IPlex, as well as an order compelling Tercica to issue corrections and award profits, damages and attorney's fees and costs to Insmed. This suit is a counterclaim that's part of Insmed's response to false advertising claims Tercica brought against Insmed in June. Portions of those claims were dismissed earlier this month, and the matter is scheduled for trial in March.

• Jennerex Biotherapeutics Inc., of San Francisco, agreed to out-license South Korean rights to JX-594 to Green Cross Corp., of Seoul. The oncolytic vaccinia virus' initial indication is liver cancer, with plans for melanoma. Terms of the deal call for Green Cross to fund all development, regulatory, manufacturing and commercialization activities in that territory for JX-594 and pay Jennerex a royalty on commercial sales there. Jennerex is responsible for the product's clinical supply, though Green Cross can opt to manufacture it for the South Korean market.

• Lentigen Corp., of Baltimore, said it obtained Small Business Innovation Research Phase I funding from the National Institutes of Health to evaluate the concept of using lentiviral-engineered T cells that express chimeric receptors and signaling modules to improve the efficacy of cancer immunotherapies directed against the tumor-associated antigen, mesothelin. The goal will be to demonstrate that human T cells can be modified using a lentiviral delivery system for a potential approach to existing therapies, which have limited effectiveness against tumors expressing mesothelin.

• NicOx SA, of Sophia Antipolis, France, received scientific advice on its proposed Phase III plan for naproxcinod (HCT 3012) from the Committee for Medicinal Products for Human Use of the European Medicines Agency. The CMP said it agrees with NicOx's pre-approval safety database proposal for naproxcinod as a therapy for osteoarthritis, and the database does not include a long-term cardiovascular safety study.

• Valentis Inc., of Burlingame, Calif., entered an asset sale agreement for San Diego-based Inovio Biomedical Corp. to acquire certain non-core technology rights and intellectual property, including GeneSwitch gene regulation technology, certain PINC polymers (synthetic gene delivery system including poly-glu excluding non-nucleic acid delivery methods), certain cationic lipids and certain expression technologies. The total price of the transaction was $860,000, of which a portion was offset by an outstanding debt Valentis owed to Inovio from a 2001 license agreement. Earlier this month, Valentis signed a merger agreement with Burlingame, Calif.-based Urigen NA. (See BioWorld Today, Oct. 10, 2006.)

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