Two-Year Study to Focus on Pulmonary Safety in Patients With
Type 1 and Type 2 Diabetes
VALENCIA, Calif., June 29 /PRNewswire-FirstCall/ -- MannKind Corporation
(Nasdaq: MNKD), focused on discovering, developing and commercializing
treatments for diabetes and cancer, today announced that it has initiated
patient enrollment in its pivotal phase 3 safety trial of inhaled
Technosphere(R) Insulin (TI) in the United States. The open-label,
randomized, prospective study will evaluate the pulmonary safety of TI in
patients with type 1 and type 2 diabetes. This is the second phase 3 clinical
trial of inhaled Technosphere(R) Insulin following the commencement of
MannKind's initial phase 3 efficacy study in Europe in late 2004.
"Our pharmacokinetic studies have shown that Technosphere Insulin is
rapidly absorbed into the bloodstream, mimicking the first phase insulin
release that has been lost in all patients with diabetes. This approximation
of the first phase release significantly improves glucose control without
increasing the risk of hypoglycemia. Earlier this month MannKind presented
data at the American Diabetes Association Scientific Sessions from a recently
completed phase 2b study, showing significant reductions in HbA1c levels over
a three-month period with no increase in the risk of hypoglycemia. We hope to
obtain further confirmation of these findings in our phase 3 studies, moving
this important new treatment for diabetes closer to commercialization," said
Hakan Edstrom, President and Chief Operating Officer of MannKind Corporation.
In addition to the initiation of the pivotal phase 3 safety trial, the
Company is in the process of scaling up its manufacturing facilities in
anticipation of regulatory filings and commercialization. With the current
clinical package, the Company's data demonstrates that Technosphere Insulin is
stable for at least 18 months under refrigerated conditions and for at least
two months at room temperature, which is equivalent to or surpasses
commercially available insulin products.
About Technosphere Insulin
The MannKind inhaled insulin delivery system consists of a proprietary dry
powder Technosphere(R) formulation of insulin that is inhaled into the deep
lung using MannKind Corporation's proprietary MedTone(R) inhaler, which
utilizes single-use, disposable, plastic cartridges containing Technosphere(R)
Insulin powder. The inhaler is light, easy to use, and fits in the palm of
the patient's hand, which is believed to facilitate patient compliance. The
Company believes that the combination of Technosphere(R) Insulin's unique
performance characteristics including the rapid transfer of the insulin into
the blood and the significantly higher bioavailability, along with the
convenience and ease of use of the MedTone(R) inhaler, may have the potential
to change the way diabetes is treated. In particular, the Technosphere(R)
Insulin System may be the only product under development that produces a
profile of insulin levels in the bloodstream that approximates the natural
first-phase insulin release spike normally seen in healthy individuals
following the beginning of a meal.
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 the US and Europe to study its
potential for the treatment of diabetes. 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 Form 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.
Company Contact:
Hakan Edstrom
President and Chief Operating Officer
661-775-5360
hedstrom@mannkindcorp.com
SOURCE MannKind Corporation
06/29/2005
CONTACT: Hakan Edstrom, President and Chief Operating Officer of
MannKind Corporation, +1-661-775-5360, hedstrom@mannkindcorp.com
Web site: http://www.mannkindcorp.com
