MannKind Provides Regulatory Update

VALENCIA, Calif.--(BUSINESS WIRE)-- MannKind Corporation (Nasdaq: MNKD) today announced that it was informed by the U.S. Food & Drug Administration (FDA) that due to a potential government shutdown the FDA has decided to cancel an End-of-Review meeting with MannKind that was to be held on April 15, 2011. The FDA stated that when it is able to do so it will reschedule the meeting to the next possible date. MannKind will provide a further update about its planned interactions with the FDA at its first quarter analyst call on April 25, 2011.

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 lead product candidate, AFREZZA®, is in late stage clinical investigation for the treatment of adults with type 1 or type 2 diabetes for the control of hyperglycemia. MannKind is also evaluating an investigational cancer immunotherapy product, MKC1106-MT, in a phase 2 clinical trial. MannKind maintains a website at http://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 future interactions with the FDA, 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 seeking or obtaining regulatory approval 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, 2010 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.



CONTACT:

MannKind Corporation
Matthew Pfeffer
Chief Financial Officer
661-775-5300
[email protected]

KEYWORDS:   United States  North America  California

INDUSTRY KEYWORDS:   Health  Biotechnology  Clinical Trials  Oncology  Pharmaceutical  Research  Diabetes  FDA  Science  General Health

MEDIA:

Logo
 Logo

Suggested Articles

Data from a 10,000-patient trial showed that people with osteoarthritis taking Novartis' Ilaris had 40% to 47% lower rates of joint replacements.

Immunic's lead asset beat placebo at reducing damage to myelin, which protects nerve fibers, in patients with relapsing multiple sclerosis.

The appointment sees Kobayashi switch from developing Dermira’s anti-IL-13 drug to advancing Aslan’s would-be rival.