Nektar Reports on Pfizer and Sanofi-Aventis Statement on Status of Exubera
Posted on: Friday, 28 October 2005, 12:01 CDT
Nektar Therapeutics (Nasdaq:NKTR) reported today that Pfizer and sanofi-aventis, a member of the sanofi-aventis Group, said today that the U.S. Food and Drug Administration has notified the companies that it is extending its original review period for Exubera(R) (insulin (rDNA origin) powder for oral inhalation) by three months to review additional technical chemistry data submitted by the companies.
In September, an FDA Advisory Committee recommended approval of Exubera for the treatment of adults with type 1 and type 2 diabetes. FDA is not obligated to follow the Advisory Committee's recommendation, but usually does so. Pfizer and sanofi-aventis continue to work closely with the FDA so that this important medicine can be made available for patients.
About Nektar
Nektar Therapeutics enables high-value, differentiated therapeutics with its industry-leading drug delivery technologies, expertise and manufacturing capabilities. The world's top biotechnology and pharmaceutical companies are developing new and better therapeutics using Nektar's advanced technologies and know-how. Nektar also develops its own products by applying its drug delivery technologies and its expertise to existing medicines to enhance performance, such as improving efficacy, safety and compliance.
The information contained in this release is as of 28 October 2005. Nektar assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about a product candidate which is under review by the United States Food and Drug Administration and the European Medicines Evaluation Agency that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, whether and when such regulatory authorities will approve the product candidate, their decisions regarding labeling and other matters that could affect its commercial potential as well as competitive developments.
This release contains forward-looking statements that reflect management's current views as to Nektar's business strategy, product and technology development plans and funding collaborative arrangements, clinical trials, developments in connection with the regulatory approval process for Exubera. These forward-looking statements involve uncertainties and other risks that are detailed in Nektar's reports and other filings with the SEC, including its Annual Report on Form 10-K, as amended, for the year ended December 2004 and its Quarterly Report on 10-Q for the quarter ended June 30, 2005. Actual results could differ materially from these forward-looking statements.
Source: Business Wire
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