FDA Requests Additional Data on PULMINIQ(TM) (Cyclosporine, USP) Inhalation Solution; Agency Action Letter States that PULMINIQ is ''Approvable'' But Additional Study is Required.EMERYVILLE, Calif. -- Chiron Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CHIR CHIR Chiricahua National Monument (US National Park Service) ) today announced that the company has received an action letter from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) stating that the company's New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for PULMINIQ(TM) (cyclosporine cyclosporine /cy·clo·spor·ine/ (-spor´en) a cyclic peptide from an extract of soil fungi that selectively inhibits T cell function; used as an immunosuppressant to prevent rejection in organ transplant recipients and to treat severe , USP USP - unique sales point ) inhalation solution is "approvable" but that an additional pre-approval study is required to confirm the efficacy of the drug. In the NDA for PULMINIQ, Chiron is seeking an indication to increase survival and prevent chronic rejection in patients receiving allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik) 1. having cell types that are antigenically distinct. 2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically lung transplants, in combination with standard immunosuppressive therapy. Chiron is evaluating possible next steps for PULMINIQ. "Chiron in-licensed PULMINIQ knowing the significant regulatory challenges associated with a single-center trial with a small patient population. We took on these challenges because we believe strongly in the data for PULMINIQ," said Craig Wheeler, president, Chiron BioPharmaceuticals. "We will carefully review our options before making any decisions regarding the product." About Chiron Chiron delivers innovative and valuable products to protect human health by advancing pioneering science across the landscape of biotechnology. The company works to deliver on the limitless promise of science and make a positive difference in people's lives. For more information about Chiron, please visit www.chiron.com. This news release contains forward-looking statements, including statements regarding regulatory review and approval, that involve risks and uncertainties and are subject to change. Forward-looking statements often address our expected future performance and often contain words such as "expects," "anticipates," "intends," "plans," "believes," "seeks" or "will." A discussion of the company's operations and financial condition, including factors that may affect its business and future prospects that could cause actual results and developments to differ materially from those expressed or implied by forward-looking statements, is contained in documents the company has filed with the SEC, including the Form 10-K for the year ended December 31, 2004, and the Form 10-Q for the quarter ended March 31, 2005, and will be contained in all subsequent periodic filings made with the SEC. These documents identify important factors that could cause the company's actual performance to differ from current expectations, including, among others, the outcome of clinical trials, regulatory review and approvals, manufacturing capabilities, intellectual property protections and defenses, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , stock-price and interest-rate volatility, marketing effectiveness, additional adverse developments resulting from the suspension of Chiron's UK license to manufacture FLUVIRIN(R) influenza virus vaccine influenza virus vaccine n. A vaccine containing influenza virus, usually several strains of the virus, prepared in chick embryos and used to immunize against influenza. from October 5, 2004, through March 2, 2005, the announcement of such suspension and the litigation and investigations relating to those matters. In addition, the company may engage in business opportunities, the successful completion of which is subject to certain risks, including approval by Novartis AG, regulatory approvals, and the integration of operations. Chiron does not undertake an obligation to update the forward-looking information the company is giving today. Note: FLUVIRIN and PULMINIQ are trademarks of Chiron Corporation. |
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