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

VALENCIA, Calif.--(BUSINESS WIRE)--
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.”

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.

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.

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.

Company Contact:MannKind CorporationMatthew PfefferChief
Financial Officer661-775-5300mpfeffer@mannkindcorp.comorMedia
Inquiries:MCS Healthcare Public RelationsLaura De Zutter or
Jeff Hoyak800-477-9626laurad@mcspr.comjeffh@mcspr.com

Source: MannKind Corporation