MannKind Presents New Scientific Data at 54th Annual Meeting of the European Association for the Study of Diabetes
October 03 2018 - 9:00AM
Presentation 55 Total and severe
hypoglycemia is reduced with use of inhaled Technosphere® Insulin
(TI) relative to insulin aspart in type 1 diabetes
MannKind Corporation (Nasdaq:MNKD), announced that it presented new
scientific data in an oral and poster presentation at the 54th
Annual Meeting of the European Association for the Study of
Diabetes (EASD) in Berlin, Germany. The oral presentation
(presentation 55) and poster presentation (poster 1046; PS 097)
both took place Tuesday, October 2, 2018. MannKind’s STAT study
results were also presented at the conference in two poster
presentations (Poster 813; PS 068 and Poster 677; PS 051).
Oral Presentation Highlights |
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Title: |
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Total
and Severe Hypoglycemia is Reduced with Use of Inhaled Technosphere
Insulin (TI) Relative to Insulin Aspart in Type 1
Diabetes |
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Presenter: |
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David Kendall,
MD, Chief Medical Officer, MannKind Corporation |
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Description: |
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A post-hoc
regression analysis of a representative subset of the AFFINITY 1
(24-week treat-to-target in type 1 diabetics) evaluated overall and
severe hypoglycemic event rates in patients with Afrezza relative
to subcutaneous insulin. |
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Highlights: |
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• Individuals on
Afrezza experienced significantly lower rates of hypoglycemia vs
insulin aspart |
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· Overall
rates of hypoglycemia with Afrezza were 26% lower across all levels
of HbA1c |
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• Differences in the average achieved HbA1c do not account for
the observed differences in hypoglycemia rate |
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• Afrezza
allows for greater HbA1c reduction with lower rates of
hypoglycemia |
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· HbA1c
could be reduced from 8.0% to approximately 6.8% and meet treatment
goal with no increase in hypoglycemia rate; |
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· Patients already at 6.8% HbA1c would be expected to
experience 4 fewer hypoglycemia events per month. |
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Conclusion: |
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The ultra-rapid
time action profile of Afrezza provides tight glycemic control
without increasing the risk of hypoglycemia. Switching to Afrezza
as mealtime insulin therapy may also benefit the patients already
at HbA1c goal by reducing the frequency of hypoglycemic
events. |
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Poster Presentation Highlights |
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Title: |
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Diabetes
Duration, BMI, and HbA1c Have Greater Effects on Pulmonary Function
(PF) Than Inhaled Technosphere® Insulin |
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Presenter: |
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Frank Pompilio,
PharmD, VP, Medical Affairs, MannKind Corporation |
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Description: |
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Data from a
pulmonary function study of patients with type 1 and type 2
diabetes was utilized to evaluate the effects of diabetes duration,
body mass index, and HbA1c on baseline PF and changes in PF during
24 months of treatment when compared in patients receiving Afrezza
and usual care. |
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Highlights: |
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• The
magnitude of Afrezza’s effect on FEV1 was comparable to those
normally associated with diabetes-related factors such as high body
mass index (BMI), elevated HbA1c and long-standing diabetes |
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• None of
these effects were clinically significant |
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• Afrezza-related decreases in FEV1 were small,
non-progressive and reversible after two years of treatment |
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Conclusion: |
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Diabetes-related
factors are associated with reductions in pulmonary function that
exceed the reversible changes seen with inhaled insulin treatment.
The effects of Afrezza on pulmonary function are not clinically
significant, do not increase with time, and have been demonstrated
to resolve if treatment with Afrezza is stopped. |
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“These two presentations represent just two of
the numerous disclosures we hope to publish in the coming months,”
said David Kendall, M.D., Chief Medical Officer of MannKind
Corporation. “These two studies are critical to helping build
awareness of the potential clinical impact and longer term safety
of Afrezza. These and other recently published data significantly
advance our understanding of the treatment opportunity that Afrezza
therapy may offer. MannKind’s medical, regulatory and safety teams
are committed to ensuring that this information is made available
to both individuals living with diabetes and the medical community
alike, and we are pleased that we were able to share this data more
broadly at EASD.”
About Afrezza®Available by prescription,
Afrezza® (insulin human) Inhalation Powder is a rapid-acting
inhaled insulin indicated to improve glycemic control in adult
patients with diabetes mellitus. Afrezza consists of a dry powder
formulation of human insulin delivered from a small and portable
inhaler. Administered at the beginning of a meal, Afrezza dissolves
rapidly upon inhalation to the lung and passes quickly into the
bloodstream (in less than one minute). This rapid absorption allows
Afrezza to begin reducing blood sugar levels within about 12
minutes of administration.
Afrezza is available in 4-unit, 8-unit and
12-unit single-dose cartridges of insulin powder that can be used,
as prescribed by a health care professional, in combination with
other diabetes medications to achieve target blood sugar levels.
For Afrezza doses exceeding 12 units, patients may use a
combination of existing cartridge strengths. For more information
on Afrezza, please visit www.afrezza.com.
About MannKind
CorporationMannKind Corporation (NASDAQ:MNKD) focuses
on the development and commercialization of inhaled therapeutic
products for patients with diseases such as diabetes and pulmonary
arterial hypertension. MannKind is currently
commercializing Afrezza® (insulin human) Inhalation Powder, the
Company's first FDA-approved product and the only inhaled
rapid-acting mealtime insulin in the United States, where it
is available by prescription from pharmacies
nationwide. MannKind is headquartered in Westlake
Village, California, and has a state-of-the art manufacturing
facility in Danbury, Connecticut. The Company also employs
field sales and medical representatives across the U.S. For further
information, visit www.mannkindcorp.com.
Forward-Looking StatementsThis
press release contains forward-looking statements that involve
risks and uncertainties. Words such as "believes," "anticipates,"
"plans," "expects," "intends," "will," "goal," "potential" and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based
upon MannKind'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 various risks and
uncertainties detailed in MannKind's filings with
the SEC, including its annual report on Form 10-K for the year
ended December 31, 2017. 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.
Company Contact: Rose Alinaya SVP, Investor
Relations 818-661-5000 ir@mannkindcorp.com
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