MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) has
assumed responsibility for the worldwide development and
commercialization of Afrezza® (insulin human) Inhalation Powder
from Sanofi, effective today, in a transition that ensures patients
will not experience any interruption in their treatment. Under
terms of the transfer agreement, Sanofi will continue to distribute
Afrezza from its existing inventory until MannKind begins to
distribute Afrezza during the third quarter.
“Today’s return of control of Afrezza is a
landmark day for MannKind,” said Matthew Pfeffer, Chief Executive
Officer of MannKind. “We are thrilled to begin the process of
making Afrezza the successful mealtime treatment for people with
diabetes that we always believed it would be. In the coming weeks,
we will roll out more information about our commercial team for
Afrezza, the resources that we are designing for patients and
physicians, and our plans for the future.”
Afrezza (uh-FREZZ-uh), approved in 2014 by the
U.S. Food and Drug Administration, is a rapid-acting inhaled
insulin therapy indicated to improve glycemic control in adult
patients with diabetes. Taken at the start of a meal using a
specially designed inhaler, Afrezza dissolves rapidly upon
inhalation to the deep lung and delivers insulin quickly to the
bloodstream. Peak insulin levels are achieved within 12 to 15
minutes of use and help to control post-meal blood sugar spikes
that affect HbA1C levels. Afrezza should not be used by
patients who have problems with their lungs (such as asthma or
COPD) and is not recommended in patients who smoke or who have
recently stopped smoking.
“The continued availability of Afrezza is
welcome news for patients and their physicians who seek effective
treatment options for type 1 and type 2 diabetes,” said Steven
Edelman, M.D., Professor of Medicine, University of California, San
Diego and founder and director of Taking Control of Your Diabetes
(tcoyd.org). “Afrezza truly addresses an unmet need in diabetes
care. Having even a few less injections a week is a benefit
for many of my patients.”
Afrezza is not a substitute for long-acting
insulin but must be used in combination with long-acting insulin in
patients with type 1 diabetes.
MannKind will work with the diabetes community
to ensure that Afrezza remains available for the many patients who
are passionate about its benefits. “I am thrilled to work with
MannKind to ensure current and new patients know about the
continued availability of Afrezza,” said Laura Kronen, author of
“Too Sweet: The Not-So-Serious Side to Diabetes”, diabetes
life coach and an early adopter of Afrezza. “To the diabetes
community, Afrezza represents advancement in insulin delivery and a
novel way to manage their disease.”
MannKind has established an Afrezza Customer
Service Center. Customers with questions or comments about
Afrezza can call (877) 323-8505. Certain Afrezza patient
support programs (including co-pay assistance cards) will continue
and new programs will be introduced in the second quarter,
replacing legacy programs.
The company also plans to present four abstracts
at the American Diabetes Association (ADA) scientific meeting in
June, including the results of two completed post-marketing
studies. Two additional late-breaking abstracts have also
been submitted to the ADA and, if accepted, will be
presented.
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.
About MannKind Corporation
MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD)
focuses on the discovery and development of therapeutic products
for patients with diseases such as diabetes. MannKind
maintains a website at 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.
Forward-Looking Statements
This press release contains forward-looking
statements that involve risks and uncertainties, including
statements regarding MannKind’s ability to directly commercialize
Afrezza and the commercial potential 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 successful transition with Sanofi
for the return of Afrezza, 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
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