FDA Requests Additional Data on PULMINIQ(TM) (Cyclosporine, USP) Inhalation Solution; Agency Action Letter States that PULMINIQ
July 15 2005 - 8:00AM
Business Wire
Chiron Corporation (NASDAQ:CHIR) today announced that the company
has received an action letter from the U.S. Food and Drug
Administration (FDA) stating that the company's New Drug
Application (NDA) for PULMINIQ(TM) (cyclosporine, USP) 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 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, 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 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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