FDA Advisory Committee Recommends Approval of AFREZZA(R), MannKind Corporation's Investigational Drug to Treat Diabetes

FDA Advisory Committee Recommends Approval of AFREZZA(R), MannKind
Corporation's Investigational Drug to Treat Diabetes

VALENCIA, Calif., April 1, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation
(Nasdaq:MNKD) today announced that the Endocrinologic and Metabolic Drugs
Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 13 to
1 to recommend that AFREZZA^® (insulin human [rDNA origin]) Inhalation Powder
be granted marketing approval by the FDA to improve glycemic control in adults
with type 1 diabetes and voted 14 to 0 to recommend that AFREZZA be granted
marketing approval by the FDA to improve glycemic control in adults with type
2 diabetes. If approved, AFREZZA would be the first ultra rapid-acting
mealtime insulin therapy available in the United States.

"We are pleased with the Advisory Committee's approval recommendation in
support of AFREZZA, and we appreciate the thoroughness of their review," said
Alfred Mann, Chairman and Chief Executive Officer of MannKind Corporation. "We
look forward to working with the FDA as they complete their evaluation of
AFREZZA. Diabetes is a major health problem in the United States, and we are
committed to bring AFREZZA to the many patients who might benefit from this
novel product."

The FDA is not bound by the Advisory Committee's recommendation but will
consider its guidance in reviewing the New Drug Application (NDA) that was
submitted for AFREZZA. The Prescription Drug User Fee Act (PDUFA) date for the
FDA to complete its review of AFREZZA is April 15, 2014.

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^®, is under review by the FDA.
MannKind regularly posts copies of its press releases as well as additional
information about MannKind on its website www.mannkindcorp.com. Interested
persons can subscribe on the 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 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 the Company's 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, difficulties or delays in obtaining regulatory
feedback 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, 2013 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 press
release.

CONTACTS: Investors:
          Matthew J. Pfeffer
          Chief Financial Officer
          MannKind Corporation
          mpfeffer@mannkindcorp.com
          (661) 775-5300

          Media:
          Laura de Zutter
          MCS Healthcare Public Relations
          laurad@mcspr.com
          (908) 234-9900

          Jeff Hoyak
          MCS Healthcare Public Relations
          jeffh@mcspr.com
          (908) 884-6753

MannKind Corporation Logo
 
Press spacebar to pause and continue. Press esc to stop.