- Glucose Lowering Effect Compares Favorably to Conventional Insulin
Injections -
- When Added to Oral Therapy, Patients Achieve Glucose Control With Fewer
Excursions -
VALENCIA, Calif., June 14 /PRNewswire-FirstCall/ -- MannKind Corporation
(Nasdaq: MNKD), focused on discovering, developing and commercializing
treatments for diabetes and cancer, announced today additional findings from
two separate studies of inhaled Technosphere(R) Insulin (TI), MannKind's lead
product for the treatment of diabetes, during two oral presentations at the
American Diabetes Association's 65th Scientific Sessions in San Diego,
California.
"Our study indicated that Technosphere(R) Insulin can be used in
conjunction with an oral diabetes medication with less risk that the
combination could cause an excursion from glucose control, such as
hypoglycemia, commonly associated with regular subcutaneous insulin. A second
study demonstrated the reliability of absorption and effect of Technosphere(R)
Insulin," stated Hakan Edstrom, President and Chief Operating Officer of
MannKind Corporation. "We expect that many patients will prefer to receive
insulin by inhalation, rather than by subcutaneous injection."
1. Presentation No. 357-OR: "A Randomized, Double-blind, Placebo
Controlled Study of the Efficacy and Safety of Inhaled Technosphere(R)
Insulin in Patients with Type 2 Diabetes (T2DM)."
This was a randomized, double-blind, placebo controlled study of the
efficacy and safety of inhaled Technosphere(R) Insulin in patients
with type 2 diabetes. The study confirmed that the postprandial
glucose control was significantly improved when TI was added to oral
therapy. A mean reduction in total glucose excursions of about 50%
was seen, together with a reduction of maximum postprandial glucose
increase of about 30 mg/dl. Postprandial excursions are part of the
glucose burden in diabetes, but there is increasing evidence that
these excursions are an independent risk factor as well. The
reduction in postprandial glucose excursions was reflected in a
significant reduction in HbA1c, which is a measure of the average
amount of blood sugar over the last two to three months.
2. Presentation No. 358-OR: "The Variability and Time-Action Profile of
Inhaled Technosphere(R)/Insulin Compares Favorably to that of
Subcutaneous Human Regular Insulin."
It is important for patients with diabetes to have tight glucose
control prior to, during and following a meal so as to avoid serious
complications of diabetes like blindness and irreversible damage to
the kidneys and nerves. This study found that the variability of
insulin absorption and glucose lowering effect of repeated inhalations
of TI compares favorably to regular subcutaneous insulin during the
first three hours of dosing.
About MannKind Corporation
MannKind (Nasdaq: MNKD) focuses on the discovery, development and
commercialization of therapeutic products for diseases such as diabetes and
cancer. The Company is currently in Phase 3 clinical trials of its lead
product, the Technosphere(R) Insulin System, in Europe to study its potential
for the treatment of diabetes. MannKind plans to begin the first U.S. Phase 3
long-term safety study of Technosphere(R) Insulin in type 1 and type 2
patients this year. This System consists of a proprietary dry powder
Technosphere(R) formulation of insulin that is inhaled into the deep lung
using the Company's MedTone(R) inhaler. MannKind believes that the
performance characteristics, unique kinetics, convenience and ease of use of
the Technosphere(R) Insulin System may have the potential to change the way
diabetes is treated. For more information on MannKind Corporation and its
technology, visit www.mannkindcorp.com.
Forward-Looking Statements
This press release contains forward-looking statements, including
statements related to MannKind's clinical trials and product candidates, 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, risks related to the
progress, timing and results of clinical trials, intellectual property
matters, difficulties or delays in seeking or obtaining regulatory approval,
manufacturing the Company's lead product candidate, competition from other
pharmaceutical or biotechnology companies, the Company's ability to enter into
any collaborations or strategic partnerships or obtain additional financing to
support the Company's operations, the Company's ability to meet milestones and
other risks detailed in MannKind's filings with the SEC, including the Annual
Report on 10-K for the year ended December 31, 2004 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.
SOURCE MannKind Corporation
06/14/2005
CONTACT: Hakan Edstrom, President and Chief Operating Officer of
MannKind Corporation, +1-661-775-5360, hedstrom@mannkindcorp.com
Web site: http://www.mannkindcorp.com
