MannKind Resubmits New Drug Application to U.S. FDA for AFREZZA for the Treatment of Adults with Diabetes

  MannKind Resubmits New Drug Application to U.S. FDA for AFREZZA for the
  Treatment of Adults with Diabetes

Business Wire

VALENCIA, Calif. -- October 14, 2013

MannKind Corporation (Nasdaq: MNKD) today announced the resubmission on
October 13, 2013 of a new drug application (NDA) to the U.S. Food and Drug
Administration (FDA) seeking approval for the marketing and sale of AFREZZA^®
(insulin human [rDNA origin]) Inhalation Powder with an indication to improve
glycemic control in adults with type 1 or type 2 diabetes. The resubmission is
based on the entire data set from the extensive AFREZZA clinical development
program and particularly the positive results from two recent Phase 3 trials,
one in patients with type 1 diabetes (study 171) and one in patients with type
2 diabetes (study 175).

“We designed the recent studies with input and guidance from the FDA, and both
achieved their primary efficacy endpoints and safety objectives,” said Alfred
Mann, Chairman and Chief Executive Officer of MannKind Corporation. “I am very
proud of our team for completing an extensive submission on a very ambitious
schedule. We will continue to work with the FDA to bring AFREZZA to market for
the millions of diabetes patients in the United States who might benefit from
this novel product.”

About AFREZZA^®

AFREZZA^® (uh-FREZZ-uh) is a novel, ultra rapid-acting mealtime insulin
therapy developed by MannKind Corporation to improve glycemic control in adult
patients with type 1 or type 2 diabetes. It is a drug-device combination
product, consisting of AFREZZA Inhalation Powder delivered using a small,
discreet and easy-to-use inhaler. Administered at the start of a meal, AFREZZA
Inhalation Powder dissolves immediately upon inhalation to the deep lung and
delivers insulin quickly to the bloodstream. Peak insulin levels are achieved
within 12 to 15 minutes of administration, compared to 45-90 minutes for
injected rapid acting insulin analogs and 90-150 minutes for injected regular
human insulin.

About MannKind Corporation

MannKind Corporation (Nasdaq: MNKD) focuses on the discovery, development and
commercialization of therapeutic products for patients with diseases such as
diabetes. Its lead product candidate, AFREZZA^®, has completed Phase 3
clinical trials. MannKind maintains a website at www.mannkindcorp.com to which
MannKind regularly posts copies of its press releases as well as additional
information about MannKind. Interested persons can subscribe on the MannKind
website to e-mail alerts that are sent automatically when MannKind issues
press releases, files its reports with the Securities and Exchange Commission
or posts certain other information to the website.

Forward-Looking Statements

This press release contains forward-looking statements, including statements
related to the results of clinical studies and the potential use of AFREZZA to
improve glycemic control in diabetes patients, that involve risks and
uncertainties. 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 our current expectations. 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: the risk that the FDA may not accept the NDA for review,
the risk that the FDA may disagree with our interpretation of our Phase 3
study results, the risk that the FDA may not approve the NDA for AFREZZA, the
timing of regulatory review and decisions, our ability to manage our existing
cash resources or raise additional cash resources, stock price volatility 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, 2012 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
we undertake no obligation to revise or update any forward-looking statements
to reflect events or circumstances after the date of this press release.

Contact:

Company Contact:
MannKind Corporation
Matthew Pfeffer
Chief Financial Officer
661-775-5300
mpfeffer@mannkindcorp.com
or
Media Inquiries:
MCS Healthcare Public Relations
Laura De Zutter or Jeff Hoyak
800-477-9626
laurad@mcspr.com
jeffh@mcspr.com
 
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