Sunovion Announces Results of Phase 3 Long-Term Safety Study Showing SUN-101/eFlow® (glycopyrrolate) Was Well-Tolerated in People with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease (COPD)

MARLBOROUGH, Mass.–(BUSINESS WIRE)–Sunovion
Pharmaceuticals Inc. (Sunovion) today announced positive results
from GOLDEN-5, a long-term safety study evaluating SUN-101
(glycopyrrolate), a nebulized, long-acting muscarinic antagonist (LAMA)
delivered via an innovative investigational nebulizer system
(SUN-101/eFlow^®).
The study results showed that SUN-101/eFlow^® was
well-tolerated as a twice-daily maintenance treatment for
bronchoconstriction in people with moderate-to-very severe chronic
obstructive pulmonary disease (COPD), with a similar overall incidence
of adverse events to standard of care treatment. Results also showed
that the incidence of major adverse cardiovascular events (MACE) was
similar to the approved active comparator.
“Sunovion has a longstanding history of advancing treatment options for
patients with COPD,” said Antony Loebel, M.D., Executive Vice President
and Chief Medical Officer at Sunovion. “The results from the GOLDEN-5
study further build on the strong safety and efficacy profile we have
seen in our previous Phase 3 studies, and we look forward to advancing
SUN-101/eFlow^® through the regulatory process as the first
nebulized LAMA for patient use.”
“As a physician, it is always gratifying when I can tell my patients
that there are new treatment options that may help them manage their
COPD,” said Nicola Hanania, M.D., Associate Professor, Baylor College of
Medicine. “If approved, SUN-101/eFlow^® could be a
breakthrough for COPD patients, allowing for delivery of glycopyrrolate
via a state-of-the-art device which combines the attributes of
nebulizers and hand-held devices.”
The innovative, proprietary eFlow^® nebulizer system,
developed by PARI Pharma GmbH, is a unique closed system delivery device
currently in development for the treatment of moderate-to-very severe
COPD. It is a portable, hand-held, electronic nebulizer system that uses
a vibrating, perforated membrane to generate an inhalable aerosol. The
eFlow^® nebulizer closed system is designed to deliver the
entire dose of medication in two to three minutes from a distinctive
proprietary drug vial inserted into the device. A standard jet nebulizer
typically takes up to 10 minutes. The investigational combined product,
consisting of SUN-101 and the eFlow^® nebulizer closed system,
has not been approved by the U.S. Food and Drug Administration (FDA) for
the treatment of COPD.
Sunovion will present data from the GOLDEN-5 study at an upcoming
medical meeting. Along with the recently reported Phase 3 efficacy
studies GOLDEN-3 and GOLDEN-4, the GOLDEN-5 long-term safety data will
support the SUN-101/eFlow^® New Drug Application (NDA),
anticipated for submission to the FDA during 2016.
About the GOLDEN-5 Clinical Trial
GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic
Nebulizer)-5 was a Phase 3, 48-week, randomized, open-label,
active-controlled, parallel-group, multicenter safety trial designed to
evaluate the long term safety and tolerability of SUN-101/eFlow^®
in adults with moderate-to-very severe COPD. The study enrolled 1,087
patients at 111 investigational sites in the United States and Europe.
The study evaluated 50 mcg of SUN-101/eFlow^® delivered
twice-daily and active comparator 18 mcg of Spiriva^®
(tiotropium bromide) delivered once-daily by the HandiHaler^®
device. The primary safety endpoints were: the number and percentage of
study participants with treatment-emergent adverse events (TEAE), the
number and percentage of study participants with treatment-emergent
serious adverse events (SAE) and the number and percentage of study
participants who discontinued the study due to TEAEs. The secondary
endpoints are the mean change from baseline over 48 weeks in trough
forced expiratory volume in one second (FEV₁) for all
subjects and number and percentage of subjects with MACE [NCT02276222].
The study was unique in that it included not only patients who were
taking effective background long acting bronchodilator therapy but also
patients with very severe disease and co-existing significant
cardiovascular illness. Approximately 10 percent of the population were
elderly (>75 years), 65 percent were classified as being high-risk
cardiovascular patients and more than 40 percent were taking long acting
bronchodilator therapy.
About SUN-101/eFlow^®
SUN-101 (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA)
bronchodilator delivered via the innovative, proprietary investigational
eFlow^® nebulizer closed system. 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^®
nebulizer closed system 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 COPD
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.¹ Approximately 15.7 million adults in the U.S. report
that they have been diagnosed with COPD.² It is estimated
that several million more adults have undiagnosed COPD.³ 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
constant 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
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 spirit of innovation is driven by the conviction
that scientific excellence paired with meaningful advocacy and relevant
education can improve lives. 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 acetate).
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, are
wholly-owned direct subsidiaries of Sunovion Pharmaceuticals Inc.
Additional information can be found on the Company’s web sites: www.sunovion.com,
www.sunovion.eu
and www.sunovion.ca.
Connect with Sunovion on Twitter @Sunovion
and LinkedIn.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is a top-ten listed pharmaceutical company in
Japan. 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.
BROVANA is a registered trademark of Sunovion Pharmaceuticals Inc.
LATUDA
is a registered trademark of Sumitomo Dainippon Pharma Co., Ltd.
APTIOM
is used under license from BIAL.
eFlow^® is a registered
trademark of PARI GmbH.
Spiriva^® is a registered
trademark of Boehringer Ingelheim Pharma GMBH & Co KG.
HandiHaler^®
is a registered trademark of Boehringer Ingelheim Pharma GMBH & Co KG.
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

References
¹ National Heart, Lung and Blood
Institute. What Is COPD? Available at https://www.nhlbi.nih.gov/health/health-topics/topics/copd/.
Accessed: March 2, 2016
² 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 https://www.cdc.gov/mmwr/
³
National Heart, Lung, and Blood Institute. “What is COPD?” Available at: https://www.nhlbi.nih.gov/health/educational/copd/what-is-copd/index.htm.
Accessed: March 2, 2016