MannKind Submits NDA for AFRESA for Treatment of Diabetes
March 16 2009 - 2:14PM
PR Newswire (US)
VALENCIA, Calif., March 16 /PRNewswire-FirstCall/ -- MannKind
Corporation (NASDAQ:MNKD) today announced that it has submitted a
New Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) requesting approval of AFRESA(R) (insulin monomer human [rDNA
origin]) Inhalation Powder and the AFRESA(R) Inhaler for the
treatment of adults with type 1 or type 2 diabetes mellitus for the
control of hyperglycemia. There are 23.6 million people in the
United States, or 8% of the population, who have diabetes. Diabetes
currently affects 246 million people worldwide and is expected to
affect 380 million by 2025. Each year, a further 7 million people
develop diabetes and 3.8 million people succumb to the disease.
AFRESA is an ultra rapid-acting insulin. It is a drug-device
combination product, consisting of AFRESA Inhalation Powder
pre-metered into single unit dose cartridges and the AFRESA Inhaler
as the delivery device for oral inhalation. However, the feature
that distinguishes AFRESA from all other insulin products is not
the route of administration - it is the pharmacokinetic profile.
The large surface area of the lung provides unique access to the
circulatory system. The pH-sensitive AFRESA particles immediately
dissolve upon contact with the lung surface, releasing insulin
monomers that rapidly enter the bloodstream. AFRESA achieves peak
insulin levels within 12-14 minutes of administration, effectively
mimicking the release of meal-time insulin observed in healthy
individuals, but which is absent or impaired in patients with
diabetes. The NDA submission is based on an extensive clinical
program, involving 44 completed studies and five ongoing studies at
the time of submission. The clinical program included over 5,300
patients. More than 2,450 subjects with type 1 or type 2 diabetes
were randomly assigned to treatment with AFRESA in the pooled
controlled Phase 2/3 clinical studies. In addition, the clinical
pharmacology program included more than 450 subjects exposed to
AFRESA in single-dose studies. The extent of exposure meets the
current guidance from the FDA regarding the development of
therapies for the treatment of diabetes. "We are delighted to have
reached this important milestone," said Alfred Mann, Chairman and
Chief Executive Officer of MannKind Corporation. "This NDA
submission is the culmination of years of clinical research that
has supported our long-held belief that AFRESA will be a
first-in-class ultra rapid-acting insulin with the potential to
change the way diabetes is treated." 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 diabetes
pipeline includes AFRESA(R), an ultra rapid-acting prandial insulin
and MKC253, an inhaled formulation of human GLP-1. MannKind also
has two cancer immunotherapeutic products in clinical development.
MannKind maintains a website at http://www.mannkindcorp.com/ to
which the company regularly posts copies of its press releases as
well as additional information. 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 SEC
or posts certain other information to the website. Forward-Looking
Statements This press release contains forward-looking statements,
including statements related to the positioning and potential
indication for the company's lead product. 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 MannKind's current expectations and
involve risks and uncertainties. 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, risks and
uncertainties related to the parties' abilities to obtain the
necessary third-party consents and to otherwise complete the
transactions contemplated in their agreements 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, 2008 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 news release. DATASOURCE: MannKind Corporation CONTACT:
Matthew Pfeffer, Chief Financial Officer of MannKind Corporation,
+1-661-775-5300, Web Site: http://www.mannkindcorp.com/
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