MannKind Reports Successful Completion of Device Bioequivalence Trial
January 13 2009 - 04:30PM
PR Newswire (US)
VALENCIA, Calif., Jan. 13 /PRNewswire-FirstCall/ -- MannKind
Corporation (NASDAQ:MNKD) today announced successful completion of
its trial to demonstrate equivalence of its commercial inhaler to
the version of the device that was used in clinical trials to
deliver AFRESA(TM), MannKind's ultra rapid acting insulin that
recently completed Phase 3 clinical trials. Study 138 -
Bioequivalence of Clinical and Commercial Scale Inhalers Study 138
compared the bioequivalence of MannKind's inhalation device, which
underwent some design changes after the initiation of Phase 3
clinical trials in order to make the device more rugged and less
costly to manufacture. Clinical trial subjects were administered
AFRESA Inhalation Powder from the same bulk lot, according to a
randomized two-way crossover protocol, consistent with the standard
requirements of bioequivalence testing. As previously announced,
this study was requested by FDA at AFRESA's pre-NDA meeting held in
July 2008. Dr. Peter Richardson, MannKind's Chief Scientific
Officer, commented, "We were confident from bench testing that the
improvements we made with the device had preserved all critical
air-flow parameters, but we recognized at our pre-NDA meeting the
FDA's desire to validate this fact with in-vivo data. We
collaborated with the agency in the design of the study and now
have an extensive body of in vitro and in vivo evidence to
demonstrate equivalence of the two device versions against a range
of measures. Together with the recent announcement that we met the
primary end-points of our pivotal Phase 3 program, we now have a
clear path to submission of the AFRESA NDA. With study 138
complete, there are no longer any outstanding elements of the NDA
and we expect to have the complete NDA submitted to FDA within the
next few weeks." About AFRESA AFRESA is an ultra rapid acting
insulin product that has completed Phase 3 trials. The
pharmacokinetic profile of AFRESA sets it apart from all other
insulin products. The large surface area of the lung provides
unique access to the circulatory system. The pH-sensitive AFRESA
particles immediately dissolve upon contact with the lung surface,
releasing insulin monomers that rapidly enter the bloodstream. It
achieves peak insulin levels within 12-14 minutes of
administration, effectively mimicking the release of meal-time
insulin observed in healthy individuals, but which is absent from
patients with diabetes. About MannKind Corporation MannKind
Corporation (NASDAQ:MNKD) focuses on the discovery, development and
commercialization of therapeutic products for patients with
diseases such as diabetes and cancer. Its pipeline includes AFRESA,
which has completed Phase 3 clinical trials, and MKC253, which is
currently in Phase 1 clinical trials. Both of these investigational
products are being evaluated for their safety and efficacy in the
treatment of diabetes. MannKind maintains a website at
http://www.mannkindcorp.com/ to which MannKind regularly posts
copies of its press release as well as additional information about
MannKind. Interested persons can subscribe on the MannKind website
to email alerts that are sent automatically when MannKind issues
press releases, files its reports with the SEC or posts certain
other information to the website. Forward-Looking Statements This
press release contains forward-looking statements, including
statements related to the plans and timing for the submission of a
new drug application. Words such as "believes", "anticipates",
"plans", "expects", "intend", "will", "goal", "potential" and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon
MannKind's current expectations and involve risks and
uncertainties. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, which
include, without limitation, risks related to the progress, timing
and results of clinical trials, difficulties or delays in seeking
or obtaining regulatory approval and other risks detailed in
MannKind's filings with the Securities and Exchange Commission,
including the Annual Report on Form 10-K for the year ended
December 31, 2007 and periodic reports on Form 10-Q and Form 8-K.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date of this
press release. All forward-looking statements are qualified in
their entirety by this cautionary statement, and MannKind
undertakes no obligation to revise or update any forward-looking
statements to reflect events or circumstances after the date of
this news release. DATASOURCE: MannKind Corporation CONTACT: Peter
Richardson, Chief Scientific Officer of MannKind Corporation,
+1-201-983-5064, Web Site: http://www.mannkindcorp.com/
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