MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD), a
fully integrated biopharmaceutical company focusing on the
discovery and development of therapeutic products for patients with
diseases such as diabetes, announced today the launch of a new
Titration Pack containing 60 – 4 unit cartridges, 60 – 8 unit
cartridges and 60 – 12 unit cartridges of Afrezza (insulin human)
Inhalation Powder.
This new package is intended to simplify
physician prescribing of Afrezza and allow patients greater dose
flexibility in managing their diabetes, while potentially reducing
the cost burden of multiple copays.
Michael Castagna, Chief Commercial Officer of
MannKind Corporation, stated, “We are excited to see our new
Titration Packs entering the supply chain this week. This new
titration box along with our new sample program will enable higher
dose mealtime insulin patients to dose Afrezza appropriately and
manage their disease in as few inhalations as possible.”
The new titration package compliments a similar
Titration Pack with 90 – 4 unit and 90 – 8 unit cartridges that
launched in July 2016 and now makes up almost 25% of weekly
Afrezza units dispensed.
Additionally, the Company is transitioning its
sales force from a contract sales organization to an expanded team
fully staffed by MannKind employees. The new team is expected
to be trained and in the field over the next two weeks. The
expanded sales force will be able to reach approximately 75% of the
total Rapid Acting Insulin Market. The Company is also changing its
diabetes nurse educator model, going from a small dedicated team to
a much larger nurse team operating on a per diem basis. These
efforts are expected to enhance the education and training of
patients initiating Afrezza therapy, thereby increasing compliance
and persistence.
“The new package, along with our new sales force
expansion and nurse educator model, will enable us to make a
stronger impact in how we market Afrezza without dramatically
increasing our cost structure. Additionally, our Commercial
organization has several direct-to-consumer and digital media
initiatives deploying in the next few months that will further
expand our promotional efforts,” said Matthew Pfeffer, Chief
Executive Officer.
INDICATIONPrescription
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 USEDo 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 breastfeeding or
planning to breastfeed.
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
CORPORATIONMannKind 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 STATEMENTSThis
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 ability to
generate significant product sales for MannKind, 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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