MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) announced today that
it has entered into a collaboration agreement with JDRF (formerly
known as Juvenile Diabetes Research Foundation), the leading global
organization funding type 1 diabetes research. The
collaboration will combine JDRF’s significant scientific and human
resources with MannKind’s active participation in the field of
diabetes research and development in order to advance new
treatments and therapies in areas of strategic alignment that can
transform the lives of people with diabetes. A focus of the
collaboration will be on the use of Afrezza®, with its unique
insulin delivery method, in the pediatric population.
“We are excited to be working with JDRF and the
leading scientific experts, community physicians and people with
diabetes that are associated with this organization,” stated Dr.
Ray Urbanski, Chief Medical Officer of MannKind Corporation. “We
have already begun to evaluate Afrezza for use in the pediatric
population and we look forward to working with JDRF to advance our
mutual interests in advancing therapies for all patients with type
1 diabetes.”
“JDRF is pleased to partner with MannKind to
explore opportunities to help facilitate making Afrezza more
broadly available to the T1D community interested in benefiting
from this important therapeutic,” said Aaron Kowalski, PhD., JDRF
Chief Mission Officer, Vice President of Research. “MannKind is a
fantastic organization focused on addressing the needs of people
living with T1D and we look forward to collaborating and continuing
to drive research to improve the lives of people with type 1
diabetes.”
About MannKind Corporation
MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD)
focuses on the discovery, development and commercialization of
therapeutic products for patients with diseases such as
diabetes. MannKind maintains a website at
http://www.mannkindcorp.com to which MannKind regularly posts
copies of its press releases as well as additional information
about MannKind. 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 Securities and
Exchange Commission or posts certain other information to the
website.
INDICATION
Prescription Afrezza® (insulin human) Inhalation
Powder is a rapid-acting inhaled insulin used to treat adults with
diabetes for the control of high blood sugar.
LIMITATIONS OF USE
Do not use Afrezza as a substitute for
long-acting insulin; Afrezza must be used in combination with
long-acting insulin in patients with type 1 diabetes.
Do not use Afrezza to treat diabetic
ketoacidosis.
Afrezza is not recommended in patients who smoke
or who have recently stopped smoking.
IMPORTANT SAFETY INFORMATION FOR
AFREZZA
WARNING: RISK OF ACUTE BRONCHOSPASM IN
PATIENTS WITH CHRONIC LUNG DISEASE
- Acute bronchospasm has been observed in patients with asthma
and COPD using Afrezza.
- Afrezza is contraindicated in patients with chronic lung
disease such as asthma or COPD.
- Before initiating Afrezza, perform a detailed medical history,
physical examination, and spirometry (FEV1) to identify potential
lung disease in all patients.
Do not use Afrezza if you have problems with
your lungs, such as asthma or COPD. Do not use Afrezza during a low
blood sugar reaction (hypoglycemia). If you are allergic to any of
the ingredients in Afrezza, do not use Afrezza as this may cause a
significant and severe allergic reaction.
Before using Afrezza, your doctor will take a
medical history, and do a physical exam and a breathing test
(called spirometry) to determine if you have lung problems.
Patients with lung problems should not use Afrezza. If your doctor
finds you have lung problems, use of Afrezza may cause a severe
asthma-like breathing problem. Afrezza can reduce lung function, so
your doctor will also want to test your breathing 6 months after
starting Afrezza, and then each year after that, with more frequent
testing done if you have symptoms such as wheezing or coughing.
Tell your doctor if you currently have lung cancer or have had it
in the past, or if you have an increased risk of developing lung
cancer.
You must test your blood sugar levels while
using insulin, such as Afrezza. Do not make any changes to your
dose or type of insulin without talking to your healthcare
provider. Any change of insulin should be made carefully and only
under your doctor's care.
The most common side effect of insulin,
including Afrezza® (insulin human) Inhalation Powder, is low blood
sugar (hypoglycemia), which can be serious and life-threatening.
Some people may experience symptoms such as shaking, sweating, fast
heartbeat, and blurred vision. It may cause harm to your heart or
brain. It is important for you to understand how to manage the use
of Afrezza, and to understand how to lessen the risk of
hypoglycemia events.
Tell your doctor about other medicines you take,
especially ones commonly called TZDs (thiazolidinediones) and
supplements, because they can change the way insulin works. If you
have heart failure or other heart problems, it may get worse while
you take TZDs with Afrezza. Before starting Afrezza, it is
important to tell your doctor about all your medical conditions
including if you have a history of lung problems, if you are
pregnant or plan to become pregnant, or if you are breast-feeding
or planning to breast-feed.
In addition to low blood sugar (hypoglycemia),
other possible side effects associated with Afrezza include cough,
throat pain or irritation, headache, diarrhea, tiredness, and
nausea.
Please see full Prescribing Information for
Afrezza, including Boxed WARNING and www.afrezza.com.
About Afrezza®
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 4 unit, 8 unit and 12-unit cartridges. The
disposable inhaler can be used for up to 15 days, should be kept in
a clean, dry place with the mouthpiece cover on and may be wiped
with a clean, dry cloth if needed.
Forward-Looking Statements
This press release contains forward-looking
statements that involve risks and uncertainties, including
statements regarding MannKind’s ability to advance the use of
Afrezza. 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 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 these risks and
uncertainties, which include, without limitation, the ability to
generate significant product sales for MannKind, 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, 2015 and
subsequent periodic reports on Form 10-Q and current reports on
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 press release.
Company Contact:
Rose Alinaya
SVP, Finance
661-775-5300
ralinaya@mannkindcorp.com
MannKind (NASDAQ:MNKD)
Historical Stock Chart
From Apr 2024 to May 2024
MannKind (NASDAQ:MNKD)
Historical Stock Chart
From May 2023 to May 2024