Full Press Release Details
Chief Financial Officer
Laura De Zutter or Jeff Hoyak
MCS Healthcare Public Relations
MannKind Resubmits New Drug
Application to U.S. FDA for AFREZZA
for the Treatment of Adults with Diabetes
VALENCIA, California (Business Wire) 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).
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
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.