• Amgen Inc., of Thousand Oaks, Calif., said the European Committee for Medicinal Products for Human Use issued a positive opinion to approve marketing authorization for Kepivance (palifermin) in the European Union. The opinion recommends clearing palifermin to decrease the incidence, duration and severity of oral mucositis in patients with hematologic (blood) cancers undergoing myeloablative therapy associated with a high incidence of severe oral mucositis, and requiring autologus bone marrow transplant. Kepivance was approved in the U.S. late last year. (See BioWorld Today, Dec. 17, 2004.)

• Discovery Laboratories Inc., of Warrington, Pa., submitted its response to the FDA's approvable letter for Surfaxin (lucinactant) for respiratory distress syndrome in premature infants. The company said it believes the response provides the information necessary for the FDA to complete its review of the new drug application within six months. The agency issued the approvable letter in February, asking the company to address certain labeling, chemistry and manufacturing issues. (See BioWorld Today, Feb. 15, 2005.)

• Pharmacopeia Inc., of Princeton, N.J., agreed to sell about 2.5 million shares of newly issued common stock at $3.43 per share to certain institutional investors for aggregate proceeds of about $8.5 million, before placement fees and other offering expenses. The offering price of $3.43 was determined by applying a 15 percent discount to the 5-day trailing average closing price of $4.04 as of market close on July 26. Jefferies & Co. acted as financial adviser and sole placement agent. Pharmacopeia's stock (NASDAQ:PCOP) closed Friday at $4.07, down 5 cents.

• Resverlogix Corp., of Calgary, Alberta, established a wholly owned subsidiary, RVX Therapeutics Inc., to hold its non-core assets, such as TGF-Beta Shield, that will be used separately from its Nexvas technology for cardiovascular applications. An independent third-party has been hired to provide appropriate valuation for this transfer.

• Schering AG, of Berlin, and Novartis Pharma AG, of Basel, Switzerland, said an interim review by an Independent Safety Monitoring Board of the CONFIRM 2 trial with PTK/ZK in cancer showed that the trial had a low probability of demonstrating an improvement in overall survival at final analysis. The companies said investigators will be informed of the board's findings to allow for discussion as to whether treatment should continue. The Phase III CONFIRM 2 trial was designed to evaluate the potential overall survival benefit of once daily oral treatment with PTK/ZK in combination with chemotherapy (FOLFOX-4 regimen) as second-line therapy in patients with metastatic colorectal cancer.

• Senomyx Inc., of La Jolla, Calif., agreed to a two-year extension of the collaborative research phase under its ongoing partnership with Kraft Foods Global Inc. During the extension, Senomyx will continue working with Kraft on the discovery and development of flavor modifiers. Kraft will pay Senomyx incremental funding of more than $2.7 million over the two-year-period, and Senomyx would be entitled to royalties.

• TargeGen Inc., of San Diego, selected as the lead drug for clinical development TG 100801, a topically administered multi-target kinase inhibitor, which will be tested for major eye diseases including macular degeneration, diabetic macular edema and diabetic retinopathy. Preclinical studies have shown in multiple species that the compound delivered in eye drop form is able to penetrate the eye and achieve potentially effective therapeutic levels in the choroid and retinal region of the eye.

No Comments