MISSISSAUGA, Ontario,
Oct. 11 /PRNewswire-FirstCall/ --
Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX)
announced today that Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA)
has received a Complete Response Letter (CRL) from the U.S. Food
and Drug Administration (FDA) regarding Alexza's New Drug
Application (NDA) for AZ-004 (Staccato® loxapine) submitted as
Adusuve™ Staccato® (loxapine) inhalation aerosol, 5 mg and 10 mg.
Valeant's subsidiary, Biovail Laboratories International SRL
(BLS), entered into a collaboration and license agreement with
Alexza Pharmaceuticals, Inc. in February
2010 for the U.S. and Canadian rights to commercialize
AZ-004. AZ-004 is being developed for the rapid treatment of
agitation in patients with schizophrenia or bipolar disorder.
A CRL is issued by the FDA's Center of Drug Evaluation and
Research indicating that the NDA review cycle is complete and that
the application is not ready for approval. In the CRL
received by Alexza, the FDA stated that their primary clinical
safety concern was related to data from three Phase I pulmonary
safety studies with AZ-004. This concern was based on
observed, dose-related post-dose decreases in forced expiratory
volume in one second, or FEV1, a standard measure of lung function,
in healthy subjects, and in subjects with chronic obstructive
pulmonary disease (COPD) and asthma. Alexza intends to meet
with the FDA in the near future to discuss steps necessary to
address this FDA concern. Alexza has previously reported that
there were no serious or severe respiratory adverse events in these
trials or reported in the two Phase III clinical trials of AZ-004.
All respiratory symptoms that developed after treatment in
Phase I subjects with COPD and asthma were either self-limiting or
readily managed with an inhaled bronchodilator.
The CRL also raised issues relating to the suitability of the
stability studies undertaken by Alexza and certain other items
relating to the FDA's recently completed pre-approval manufacturing
inspection. Because AZ-004 incorporates a novel delivery
system, the CRL also included input from FDA's Center for Devices
and Radiological Health (CDRH). CDRH requested a human
factors study and related analysis to validate that the product can
be used effectively in the proposed clinical setting. CDRH
also requested further bench testing of the product under an
additional "worst-case" manufacturing scenario.
About Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a
multinational specialty pharmaceutical company that develops,
manufactures and markets a broad range of pharmaceutical products
primarily in the areas of neurology, dermatology and branded
generics. More information about Valeant Pharmaceuticals
International, Inc. can be found at www.valeant.com.
Caution Regarding Forward-Looking Information
To the extent any statements made in this document contain
information that is not historical, these statements are
forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended, and may be
forward-looking information as defined under applicable Canadian
securities legislation (collectively, "forward-looking
statements").
These forward-looking statements relate to, among other things,
future interactions with FDA with respect to AZ-004.
Forward-looking statements can generally be identified by the
use of words such as "believe", "anticipate", "expect", "estimate",
"intend", "continue", "plan", "project", "will", "may", "should",
"could", "would", "target", "potential" and other similar
expressions. In addition, any statements that refer to
expectations, projections or other characterizations of future
events or circumstances are forward-looking statements.
Actual results may differ materially from those expressed or
implied in such statements. Important factors that could
cause actual results to differ materially from these expectations
include, among other things, future actions by Alexza or BLS with
respect to AZ-004, the FDA's review of the approvability of or
other action with respect to AZ-004, and the risk factors as
detailed from time to time in Valeant's reports filed with the
Securities and Exchange Commission ("SEC") and the Canadian
Securities Administrators ("CSA").
Valeant does not undertake any obligation to update or revise
any forward-looking statement, except as may be required by
law.
Contact
Information:
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Contact for Valeant
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Laurie W. Little
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949-461-6002
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laurie.little@valeant.com
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SOURCE Valeant Pharmaceuticals International, Inc.
Copyright . 11 PR Newswire