– Agreement includes U.S. rights to Utibron™ Neohaler®,
Seebri™ Neohaler® and Arcapta®
– Expanded portfolio provides treatment options for people with all
stages of COPD –
MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion
Pharmaceuticals Inc. (Sunovion) today announced that it has entered
into an exclusive license agreement with Novartis for the U.S.
commercialization rights to three approved medicines, Utibron™ Neohaler®
(indacaterol and glycopyrrolate) inhalation powder (27.5 mcg/15.6 mcg),
Seebri™ Neohaler® (glycopyrrolate) inhalation powder (15.6
mcg) and Arcapta® Neohaler® (indacaterol)
inhalation powder (75 mcg), which are indicated for the long-term,
maintenance treatment of airflow obstruction in people with chronic
obstructive pulmonary disease (COPD). With this transaction, Sunovion
now has the broadest COPD portfolio in the U.S., providing handheld and
nebulized treatment options for people with all stages of COPD.
Under terms of the agreement, Sunovion has the exclusive rights to
market Utibron™ Neohaler®, Seebri™ Neohaler® and
Arcapta® Neohaler® in the U.S. Utibron™ Neohaler®
and Seebri™ Neohaler® were approved by the U.S. Food and Drug
Administration (FDA) in 2015, and Sunovion plans to bring them to market
in 2017. Arcapta® Neohaler® was approved in the
U.S. in 2011 and made available to people with COPD in 2012. Novartis
will continue to manufacture these three medicines under the terms of
the agreement. Novartis and its affiliates will continue to retain the
commercialization rights for Ultibro® Breezhaler®
(indacaterol/glycopyrronium), Seebri® Breezhaler®
(glycopyrronium) and Onbrez® Breezhaler®
(indacaterol) outside of the U.S.
“Sunovion has a long-standing commitment to advancing respiratory health
and to providing new treatment options for people with COPD,” said David
Frawley, Executive Vice President and Chief Commercial Officer,
Sunovion. “We are pleased to add Utibron™ Neohaler®, Seebri™
Neohaler® and Arcapta® Neohaler® to our
respiratory portfolio as these will complement our existing products and
allow us to provide a wide range of treatment options for people with
Sunovion’s COPD portfolio includes Brovana® (arformoterol
tartrate), an FDA approved twice-daily nebulized long-acting beta
agonist (LABA), and SUN-101/eFlow® (glycopyrrolate), an
investigational nebulized long-acting muscarinic antagonist (LAMA), for
which Sunovion submitted a New Drug Application (NDA) to the FDA in July
Utibron™ Neohaler®, Seebri™ Neohaler®, and Arcapta®
Neohaler® are delivered by the Neohaler®, a
handheld dry powder inhaler device.
About LAMAs and LABAs
Long-acting bronchodilators currently are the first-line standard of
care maintenance therapy for symptomatic patients with COPD.1
Within that class there are long-acting muscarinic antagonists (LAMAs)
and long-acting beta agonists (LABAs), both of which are widely used and
important therapeutic approaches. LAMA and LABA medicines dilate, or
open, the airways in the lungs to prevent symptoms such as wheezing,
cough, chest tightness and shortness of breath. Combining a LAMA and a
LABA may offer additive benefits, including increased efficacy, compared
with a LAMA or LABA alone. As a result, patients with increasing
severity are often treated with both a LAMA and LABA.
Chronic obstructive pulmonary disease, also known as COPD, includes
chronic bronchitis and emphysema, and is a progressive respiratory
disease that causes worsening obstruction to airflow in the lungs over
time.2 Approximately 15.7 million adults in the U.S. report
that they have been diagnosed with COPD.3 It is estimated
that several million more adults have undiagnosed COPD.4 COPD
is responsible for over 120,000 deaths per year, making it the third
leading cause of death in the U.S.3 COPD develops slowly and
the symptoms often worsen over time, potentially limiting the ability to
perform routine activities.1 Symptoms of COPD include
coughing, wheezing, shortness of breath, excess production of mucus in
the lungs, the inability to breathe deeply and the feeling of being
unable to breathe.3 The symptoms of COPD can be most severe
during the night and early morning.5 Morning symptoms can be
associated with limitation of activities during the day, impaired health
status and increased risk of exacerbation.6 Night-time
symptoms disturb sleep, reduce sleep quality and, in the long term, may
be associated with development or worsening of cardiovascular diseases,
cognition, depression and increased mortality.7
About Utibron™ Neohaler® (indacaterol and
glycopyrrolate) Inhalation Powder
Utibron™ Neohaler® (indacaterol and
glycopyrrolate) Inhalation Powder is a twice-daily combination
long-acting beta agonist and long-acting muscarinic antagonist
(LABA/LAMA) approved in the U.S. for the long-term maintenance treatment
of airflow obstruction in people with COPD, including chronic bronchitis
and/or emphysema. Phase 3 clinical trials demonstrated that Utibron™
Neohaler® offers the additive benefits of the LABA
indacaterol and the LAMA glycopyrrolate compared to each component
alone. Utibron™ Neohaler® also showed
clinically meaningful improvements in health-related quality of life and
reduced use of rescue medication compared to placebo in the trials.
Health status was assessed using the St. George’s Respiratory
Questionnaire (SGRQ)8 total score, which is a composite of
symptoms, activities and impact on daily living.
The most common adverse reactions (≥1% and more common than placebo)
reported in two 12-week clinical trials with Utibron™ Neohaler®
(and placebo) were: nasopharyngitis, 4.1% (1.8%); hypertension, 2.0%
(1.4%); back pain, 1.8% (0.6%); oropharyngeal pain, 1.6% (1.2%).
For additional information, please see Utibron™ Neohaler® Full
Prescribing Information including Box Warning and Medication
Guide at http://utibron.sunovion.com.
About Seebri™ Neohaler® (glycopyrrolate)
Seebri™ Neohaler® (glycopyrrolate) Inhalation Powder is a
twice-daily long-acting muscarinic antagonist (LAMA) approved in the
U.S. for the long-term maintenance treatment of airflow obstruction in
people with COPD, including chronic bronchitis and/or emphysema. Seebri™
Neohaler® is delivered by a dry powder inhaler (DPI), and its
active ingredient, glycopyrrolate, has a well-documented safety and
efficacy profile. In clinical trials, Seebri™ Neohaler®
showed clinically meaningful improvements in health-related quality of
life and reduced use of rescue medication compared to placebo. Health
status was assessed using the St. George’s Respiratory Questionnaire
(SGRQ) total score, which is a composite of symptoms, activities and
impact on daily living.
The most common adverse reactions (≥1% and more common than placebo)
reported in two 12-week clinical trials with Seebri™ Neohaler®
(and placebo) were: upper respiratory tract infection, 3.4% (2.3%);
nasopharyngitis, 2.1% (1.9%); urinary tract infection, 1.4% (1.3%);
sinusitis, 1.4% (0.7%); oropharyngeal pain, 1.8% (1.2%).
Please see full Prescribing Information for Seebri™ Neohaler®
About Arcapta® Neohaler®
(indacaterol) Inhalation Powder
Arcapta® Neohaler® (indacaterol) Inhalation Powder
is a once-daily long-acting beta agonist (LABA) approved for the
long-term, maintenance bronchodilator treatment of airflow obstruction
in patients with COPD, and has been available in the U.S. since 2012.
The product provides proven efficacy with once daily dosing and 24-hour
Health-related quality of life was measured using the St. George’s
Respiratory Questionnaire (SGRQ) in the confirmatory COPD clinical
trials. SGRQ is a disease-specific patient reported instrument which
measures symptoms, activities, and its impact on daily life. At week 12,
pooled data from these trials demonstrated an improvement over placebo
in SGRQ total score of -3.8 with a 95% confidence interval (CI) of
(-5.3, -2.3) for the ARCAPTA NEOHALER 75 mcg dose.
Most common adverse reactions (>2% and more common than placebo)
associated with Arcapta Neohaler® 75 mcg use in the three month pivotal
studies were cough (6.5%), oropharyngeal pain (2.2%), nasopharyngitis
(5.3%), headache (5.1%) and nausea (2.4%).
For additional information, please see Arcapta® Neohaler®
Full Prescribing Information including Box Warning and Medication
Guide at http://arcapta.sunovion.com.
About Brovana ® (arformoterol tartrate)
Brovana® (arformoterol tartrate) Inhalation Solution is
indicated for the long-term, twice-daily (morning and evening)
maintenance treatment of bronchoconstriction in patients with chronic
obstructive pulmonary disease (COPD), including chronic bronchitis and
emphysema. BROVANA is for use by nebulization only.
Important Safety Information for BROVANA
WARNING: ASTHMA-RELATED DEATH
agonists (LABA) increase the risk of asthma-related death. Data from a
large placebo-controlled US study that compared the safety of another
long-acting beta2-adrenergic agonist
(salmeterol) or placebo added to usual asthma therapy showed an increase
in asthma-related deaths in patients receiving salmeterol. This finding
with salmeterol is considered a class effect of LABA, including
arformoterol, the active ingredient in BROVANA (see WARNINGS). The
safety and efficacy of BROVANA in patients with asthma have not been
established. All LABA, including BROVANA, are contraindicated in
patients with asthma without use of a long-term asthma control
medication (see CONTRAINDICATIONS).
BROVANA is not indicated for the treatment of acute episodes of
bronchospasm, i.e., rescue therapy, and does not replace fast-acting
rescue inhalers. BROVANA should not be initiated in patients with
acutely deteriorating COPD, which may be a life-threatening condition.
BROVANA should not be used in conjunction with other inhaled,
long-acting beta2-agonists. BROVANA should not be used with
other medications containing long-acting beta2-agonists.
Patients who have been taking inhaled short-acting beta2-agonists
on a regular basis should be instructed to discontinue their regular use
and to use them only for symptomatic relief for acute respiratory
All LABAs, including BROVANA, are contraindicated in patients with
asthma without use of a long-term asthma control medication.
As with other inhaled beta2-agonists, BROVANA can produce
paradoxical bronchospasm that may be life-threatening. If paradoxical
bronchospasm occurs, BROVANA should be discontinued immediately and
alternative therapy instituted.
BROVANA, like other beta2-agonists, can produce a clinically
significant cardiovascular effect in some patients as measured by
increases in pulse rate, blood pressure, and/or symptoms.
BROVANA should be used with caution in patients with cardiovascular
disorders, especially coronary insufficiency, cardiac arrhythmias, and
hypertension; in patients with convulsive disorders or thyrotoxicosis;
and in patients who are unusually responsive to sympathomimetic amines.
BROVANA, as with other beta2-agonists, should be administered
with extreme caution to patients being treated with monoamine oxidase
inhibitors, tricyclic antidepressants, or drugs known to prolong the
corrected QT interval (QTc) because the action of adrenergic agonists on
the cardiovascular system may be potentiated by these agents.
Overall efficacy of BROVANA was maintained throughout the 12-week trial
duration. Some tolerance to the bronchodilator effect of BROVANA was
observed after 6 weeks of dosing (at the end of the dosing interval),
although the trough forced expiratory volume in 1 second (FEV1)
improvement remained statistically significant. This was not accompanied
by other clinical manifestations of tolerance.
The five most common adverse events reported with frequency ≥2% in
patients taking BROVANA, and occurring more frequently than in patients
taking placebo, were pain (8% vs 5%), chest pain (7% vs 6%), back pain
(6% vs 2%), diarrhea (6% vs 4%), and sinusitis (5% vs 4%).For more
information, please see the full Prescribing Information and Medication
Guide for BROVANA.
For additional information, please see the full Prescribing Information
and Medication Guide for BROVANA (arformoterol tartrate) Inhalation
You are encouraged to report negative side effects of prescription drugs
to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA)
bronchodilator delivered via the innovative, proprietary investigational
eFlow® closed system nebulizer. SUN-101/eFlow® is
currently in development as a nebulized treatment for patients with
moderate-to-very severe chronic obstructive pulmonary disease (COPD).
The investigational combined product, consisting of SUN-101 and the eFlow®
closed system nebulizer which has been optimized for SUN-101 delivery,
has not been approved by the U.S. Food and Drug Administration (FDA) for
the treatment of COPD.
About Sunovion Pharmaceuticals Inc. (Sunovion)
Sunovion is a global biopharmaceutical company focused on the innovative
application of science and medicine to help people with serious medical
conditions. Sunovion’s vision is to lead the way to a healthier world.
The Company’s spirit of innovation is driven by the conviction that
scientific excellence paired with meaningful advocacy and relevant
education can improve lives. With patients at the center of everything
it does, the Company has charted new paths to life-transforming
treatments that reflect ongoing investments in research and development
and an unwavering commitment to support people with psychiatric,
neurological and respiratory conditions. Sunovion’s track record of
discovery, development and commercialization of important therapies has
included Brovana® (arformoterol tartrate), Latuda®
(lurasidone HCI), and most recently Aptiom® (eslicarbazepine
Headquartered in Marlborough, Mass. Sunovion is an indirect, wholly
owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion
Pharmaceuticals Europe Ltd., based in London, England, and Sunovion
Pharmaceuticals Canada Inc., based in Mississauga, Ontario, and Sunovion
CNS Development Canada ULC, based in Toronto, Ontario are wholly-owned
direct subsidiaries of Sunovion Pharmaceuticals Inc. Additional
information can be found on the Company’s web sites: www.sunovion.com,
Connect with Sunovion on Twitter,
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical
companies in Japan operating globally in major pharmaceutical markets,
including Japan, the United States, China and the European Union.
Sumitomo Dainippon Pharma aims to create innovative pharmaceutical
products in the Psychiatry & Neurology area and the Oncology area, which
have been designated as the focus therapeutic areas. Sumitomo Dainippon
Pharma is based on the merger in 2005 between Dainippon Pharmaceutical
Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo
Dainippon Pharma has about 7,000 employees worldwide. Additional
information about Sumitomo Dainippon Pharma is available through its
corporate website at www.ds-pharma.com.
UTIBRON is a trademark of Novartis AG
SEEBRI is a trademark of
ARCAPTA is a registered trademark of Novartis AG
is a registered trademark of Novartis AG
ULTIBRO is a registered
trademark of Novartis AG
ONBREZ is a registered trademark of
BREEZHALER is a registered trademark of Novartis AG
is a registered trademark of Sunovion Pharmaceuticals Inc.
is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
is used under license from BIAL.
eFlow® is a registered
trademark of PARI GmbH.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon
Pharma Co., Ltd.
© 2016 Sunovion Pharmaceuticals Inc.
For a copy of this release, visit Sunovion’s web site at www.sunovion.com
1 GOLD Guidelines 2016. http://www.goldcopd.org/guidelines-global-strategy-for-diagnosis-management.html.
Accessed: April 20, 2016
2 National Heart, Lung and
Blood Institute. What Is COPD? Available at http://www.nhlbi.nih.gov/health/health-topics/topics/copd/.
Accessed: March 2, 2016
3 MMWR: Morbidity and Mortality
Weekly Report. Employment and Activity Limitations Among Adults with
Chronic Obstructive Pulmonary Disease — United States, 2013. March 27,
2015; 64(11). Available at http://www.cdc.gov/mmwr/
National Heart, Lung, and Blood Institute. “What is COPD?” Available at: http://www.nhlbi.nih.gov/health/educational/copd/what-is-copd/index.htm.
Accessed: March 2, 2016
5 Partridge MR, Karlsson N,
Small IR. Patient insight into the impact of chronic obstructive
pulmonary disease in the morning: an internet survey. Curr Med Res Opin.
6 Roche N, Small M, Broomfield S,
Higgins V, Pollard R. Real world COPD: association of morning symptoms
with clinical and patient reported outcomes. COPD. 2013;10:679–86.
Agusti A, Hedner J, Marin JM, Barbé F, Cazzola M, Rennard S. Night-time
symptoms: a forgotten dimension of COPD. Eur Respir Rev. 2011;20:183–94.
Utibron™ Neohaler® (indacaterol and glycopyrrolate) inhalation powder.
East Hanover, NJ: Novartis Pharmaceuticals Corporation, October 2015.
Sunovion Pharmaceuticals Inc.
Patrick Gaffey, 508-357-7740
Director, Corporate Communications