MannKind Updates Status of NDA Submission for AFRESA
February 26 2009 - 7:12PM
PR Newswire (US)
VALENCIA, Calif., Feb. 26 /PRNewswire-FirstCall/ -- MannKind
Corporation (NASDAQ:MNKD) today provided an update on the status of
its new drug application ("NDA") for AFRESA(R), an ultra
rapid-acting insulin that has completed Phase 3 clinical trials. As
previously announced, our internal goal was to submit the NDA to
the Food and Drug Administration ("FDA") by the end of February.
Based on editorial decisions made during the final stages of
preparing the dossier, we have decided to extend the submission
date by approximately three weeks. The document is fully drafted.
However, we decided during our final review that it would be
preferable to remove several tens of thousands of pages of back-up
data from the submission and instead make this material available
to the FDA upon request. This change will significantly reduce the
size of the NDA and should make the NDA more reviewer-friendly.
"Although I am mindful of our goal to submit the NDA as quickly as
possible, it is more important to me that we provide the FDA with a
high-quality submission that can be efficiently reviewed," said Dr.
Peter Richardson, MannKind's Corporate Vice President and Chief
Scientific Officer. "I am not willing to rush the final
hyper-linking and quality-checking activities, especially when
these efforts could potentially facilitate the FDA's review of our
new drug application for AFRESA." About AFRESA(R) 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 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,
MannKind's ability to enter into any collaborations or strategic
partnerships, MannKind's ability to raise additional financing 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:
Matthew Pfeffer, Chief Financial Officer of MannKind Corporation,
+1-661-775-5300, Web Site: http://www.mannkindcorp.com/
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