PARIS and VALENCIA, Calif., Feb.
3, 2015 /PRNewswire/ -- Sanofi and MannKind Corporation
announced today that Afrezza® (insulin human) Inhalation
Powder, the only inhaled insulin, is now available by prescription
in U.S. retail pharmacies nationwide. Afrezza is approved by the
U.S. Food and Drug Administration to control high blood sugar in
adults with type 1 and type 2 diabetes.
Experience the interactive Multimedia News Release here:
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"Many people living with diabetes are not able to control
their blood sugar on their current medications and may benefit from
using insulin. Now they have another option to administer insulin
that is not an injection," said Dr. Janet McGill, M.D., Professor of Medicine at
Washington University School of
Medicine in St. Louis and Afrezza
clinical trial investigator. "This delivery option may
help change the dialogue between health care professionals and
people living with diabetes about initiating or intensifying
insulin therapy."
Afrezza is a drug-device combination product that consists of a
dry formulation of human insulin delivered from a small and
portable inhaler to help patients achieve blood sugar control.
Afrezza is rapidly absorbed and has a short duration of action. It
is administered at the beginning of a meal.
Afrezza can help control high blood sugar as part of a diabetes
management plan that may include diet, exercise and other diabetes
medications. Afrezza should not be used in patients with chronic
lung disease such as asthma or COPD. Afrezza cannot be used to
treat diabetic ketoacidosis. Afrezza is not recommended in patients
who smoke or who have recently stopped smoking.
"Afrezza is an important addition to Sanofi's growing
diabetes portfolio of integrated, personalized offerings, and it is
one that highlights our dedication to bringing innovative therapies
to people with this disease," said Pierre Chancel, Senior Vice
President Diabetes Division, Sanofi. "There is a recognized need
for an insulin that doesn't require an injection, and our
organization is committed to making this new treatment option
available to patients."
"We are extremely proud to see the many years of work that
went into developing Afrezza culminate in the day when it is now
available to help people manage their diabetes," stated
Alfred Mann, Executive Chairman,
MannKind Corporation.
About Afrezza
Afrezza is a rapid-acting, inhaled
insulin used to control high blood sugar in adults with type 1 and
type 2 diabetes. The product consists of a dry 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 delivers insulin quickly to the
bloodstream. Peak insulin levels are achieved within 12–15 minutes
of administration. Afrezza is available in 4-unit and 8-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 8 units, patients may use a combination of
4 unit and 8 unit cartridges. Other sizes of cartridges are being
considered. 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.
Sanofi and MannKind have entered into a worldwide exclusive
licensing agreement to develop and commercialize Afrezza. Under the
collaboration agreement, Sanofi is responsible for global
commercial, regulatory and development activities.
INDICATION
Prescription Afrezza is a rapid-acting inhaled insulin used to
treat adults with type 1 and type 2 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.
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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, 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 at
www.Afrezza.com.
About Sanofi Diabetes
Sanofi strives to help people
manage the complex challenge of diabetes by delivering innovative,
integrated and personalized solutions. Driven by valuable insights
that come from listening to and engaging with people living with
diabetes, the Company is forming partnerships to offer diagnostics,
therapies, services, and devices including blood glucose monitoring
systems. Sanofi markets injectable, oral and inhaled medications
for people with type 1 or type 2 diabetes.
About Sanofi
Sanofi, a global healthcare leader,
discovers, develops and distributes therapeutic solutions focused
on patients' needs. Sanofi has core strengths in the field of
healthcare with seven growth platforms: diabetes solutions, human
vaccines, innovative drugs, consumer healthcare, emerging markets,
animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
About MannKind Corporation
MannKind Corporation
(NASDAQ: MNKD) focuses on the discovery, development and
commercialization 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 as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
results, events, operations, services, product development and
potential, and statements regarding future performance.
Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates",
"plans" and similar expressions. Although Sanofi's and MannKind's
management teams believe that the expectations reflected in such
forward-looking statements are reasonable, investors are cautioned
that forward-looking information and statements are subject to
various risks and uncertainties, many of which are difficult to
predict and generally beyond the control of Sanofi and MannKind,
that could cause actual results and developments to differ
materially from those expressed in, or implied or projected by, the
forward-looking information and statements. These risks and
uncertainties include among other things, the uncertainties
inherent in research and development, future clinical data and
analysis, including post marketing, decisions by regulatory
authorities, such as the FDA or the EMA, regarding whether and when
to approve any drug, device or biological application that may be
filed for any such product candidates as well as their decisions
regarding labeling and other matters that could affect the
availability or commercial potential of such product candidates,
the absence of guarantee that the product candidates if approved
will be commercially successful, the future approval and commercial
success of therapeutic alternatives, the Group's ability to benefit
from external growth opportunities, trends in exchange rates and
prevailing interest rates, the impact of cost containment policies
and subsequent changes thereto, the average number of shares
outstanding as well as those discussed or identified in the public
filings with the SEC and the AMF made by Sanofi and MannKind,
including those listed under "Risk Factors" and "Cautionary
Statement Regarding Forward-Looking Statements" in Sanofi's annual
report on Form 20-F for the year ended December 31, 2013, and those risks and
uncertainties listed in MannKind's annual report on Form 10-K for
the year ended December 31, 2013, and
listed or described in subsequent reports filed by MannKind with
the Securities and Exchange Commission. Other than as required by
applicable law, neither Sanofi nor MannKind undertake any
obligation to update or revise any forward-looking information or
statements.
Disclosure: After being involved in clinical trials of Afrezza,
Dr. Janet McGill served as a
consultant for MannKind Corporation and Sanofi in 2014. She is
currently a consultant for Sanofi.
Afrezza® is a registered trademark of MannKind
Corporation.
Patented: See
http://www.mannkindcorp.com/our-technology-patent-notices.htm
Manufactured by:
MannKind Corporation
Danbury, CT 06810
Distributed by:
Sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
A SANOFI COMPANY
Contacts :
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Sanofi Media
Relations
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Sanofi Investor
Relations
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MannKind Investor
Relations
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Jack
Cox
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Sebastien
Martel
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Matthew
Pfeffer
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Tel.: + 33 (0) 1 53
77 46 46
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Tel.: + 33 (0) 1 53
77 45 45
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+1-661-775-5300
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jack.cox@sanofi.com
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ir@sanofi.com
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mpfeffer@mannkindcorp.com
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Sanofi US Diabetes
Communications
Susan
Brooks
+1 908 981
6566
susan.brooks@sanofi.com
|
Sanofi Global
Diabetes Communications
Phil
McNamara
+1 908 981
5497
philip.mcnamara@sanofi.com
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SOURCE Sanofi and MannKind Corporation