MannKind Completes Phase 3 Clinical Study of AFREZZA in Patients with Type 2 Diabetes
VALENCIA, Calif.--(BUSINESS WIRE)--Jun. 17, 2013--
MannKind Corporation (Nasdaq: MNKD) today announced that all
follow-up visits have been completed for the patients enrolled in Study
175, a Phase 3 clinical study of AFREZZA® (insulin human
[rDNA origin]) inhalation powder, an investigational, ultra rapid-acting
mealtime insulin therapy, administered using MannKind’s next-generation
inhaler. MannKind expects to release data from this study later this
summer.
Study 175 assessed AFREZZA using the next-generation inhaler in patients
with type 2 diabetes whose disease is inadequately controlled on
metformin with or without a second or third oral medication. After a
run-in period during which the subjects remained on their oral
medication, 353 patients were randomized to additional treatment with
AFREZZA or to Technosphere® inhalation powder (placebo). The study also
had a titration period, followed by a 12-week evaluation period to
assess HbA1c levels.
About AFREZZA®
AFREZZA® is a novel, ultra rapid acting mealtime insulin therapy being
developed by MannKind Corporation for the treatment of adult patients
with type 1 or type 2 diabetes for the control of hyperglycemia. It is a
drug-device combination product, consisting of AFREZZA Inhalation
Powder, pre-metered into single-use cartridges, and a light, discreet
and easy-to-use inhaler. Administered at the start of a meal, AFREZZA
dissolves immediately upon inhalation and delivers insulin quickly to
the blood stream. Peak insulin levels are achieved within 12 to 14
minutes of administration, mimicking the release of meal-time insulin
observed in healthy individuals. To date, the AFREZZA clinical program
has involved 61 different clinical studies and over 5,600 adult patients.
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
in late stage clinical investigation for the treatment of adults with
type 1 or type 2 diabetes for the control of hyperglycemia. MannKind
maintains a website at www.mannkindcorp.com
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Forward-Looking Statements
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risks and uncertainties. Words such as "believes", "anticipates",
"plans", "expects", "intend", "will", "goal", "potential" and similar
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forward-looking statements are based upon the Company's current
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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 or
completing and analyzing the results of clinical studies, MannKind’s
ability to manage its 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
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and MannKind undertakes no obligation to revise or update any
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Source: MannKind Corporation
MannKind Corporation
Matthew Pfeffer
Chief Financial Officer
661
775-5300
mpfeffer@mannkindcorp.com