Sunovion Presents New Analyses that Continue to Support ZETONNA® (ciclesonide) Nasal Aerosol’s Efficacy in SAR and PAR

  Sunovion Presents New Analyses that Continue to Support ZETONNA®
  (ciclesonide) Nasal Aerosol’s Efficacy in SAR and PAR

Post-Hoc Analyses Based on the Pooled Studies Support Efficacy in SAR and PAR
                                   Patients

Business Wire

MARLBOROUGH, Mass. -- February 25, 2013

Sunovion Pharmaceuticals Inc. (Sunovion) today announced results of two
post-hoc analyses for ZETONNA^® (ciclesonide) Nasal Aerosol, which were
presented during a scientific poster session at the annual meeting of the
American Academy of Allergy, Asthma & Immunology (AAAAI) in San Antonio,
Texas. One poster included results from a pooled analysis of total and
individual nasal symptoms stratified by baseline severity following treatment
with ZETONNA 74 mcg once-daily (one spray per nostril) or placebo in patients
12 to 65 years of age with seasonal allergic rhinitis (SAR) (Poster #668). An
additional poster presented results from a post-hoc responder analysis in
patients 12 to 65 years of age with SAR or perennial allergic rhinitis (PAR).
Patients following treatment with ZETONNA 74 mcg once-daily (one spray per
nostril) demonstrated higher percentages of responses defined as at least 20%,
30% or 50% in symptom improvement from baseline compared with placebo patients
(Poster #667).

“These post-hoc analyses provide further support for ZETONNA’s efficacy in
treating symptoms associated with SAR and PAR in patients 12 years and older,”
said Alistair Wheeler, M.D., Vice President, Clinical Development and Medical
Affairs at Sunovion Pharmaceuticals Inc.“Our findings showed there was
significant improvement in patients with different degrees of baseline symptom
severity in our studies."

ZETONNA is approved by the U.S. Food and Drug Administration (FDA) for the
treatment of symptoms associated with SAR and PAR in adolescents and adults 12
years of age and older. It is the only approved dry nasal aerosol with once
daily, one spray per nostril (37 mcg) dosing that utilizes a hydrofluoroalkane
(HFA) propellant to dispense the medication.

Poster Presentations by Sunovion at AAAAI:

  *A Post-hoc Analysis of Improvement in Individual Nasal Symptoms by Their
    Baseline Severity Following Treatment with Ciclesonide Hydrofluoroalkane
    Nasal Aerosol in Patients with Seasonal Allergic Rhinitis (Poster #668)

In two randomized, double-blind, placebo-controlled Phase III SAR studies that
enrolled 918 patients 12 to 65 years of age with a ≥2 year history of SAR,
patients were given ZETONNA 74 mcg [CIC-HFA (37 mcg/actuation nostril)] or
placebo, once daily for two weeks. The pooled analysis evaluated change from
baseline in patient-reported total and individual reflective nasal symptoms of
runny nose, itchy nose, sneezing and congestion by baseline severity.

This analysis showed that the treatment with ZETONNA resulted in greater
improvement compared with placebo in all individual reflective nasal symptoms
of SAR. The adjusted mean treatment differences (95% confidence intervals)
were 0.31 (0.20, 0.43), 0.27 (0.17, 0.38), 0.21 (0.10, 0.32), and 0.21 (0.12,
0.31) in sneezing, runny nose, itching, and congestion, respectively for
subjects with severe reflective total nasal symptom scores (rTNSS) at
baseline.

  *A Post-hoc Responder Analysis of Improvement in Symptoms Following
    Treatment with Ciclesonide Hydrofluoroalkane Nasal Aerosol in Patients
    with Seasonal and Perennial Allergic Rhinitis (Poster #667)

In a post-hoc responder analysis, improvement in nasal and ocular symptoms in
patients with SAR and nasal symptoms in patients with PAR following treatment
with ZETONNA were evaluated. Data for this analysis was collected from
randomized, double-blind, placebo controlled Phase III SAR (pooled from two
studies) and PAR (one study) studies. The study participants consisted of
patients 12 to 65 years of age with SAR (N=918) or PAR (N=605) who received
ZETONNA 74 mcg (one actuation/nostril, 37 mcg/actuation) or placebo for two
weeks (SAR) or 26 weeks (PAR). The responder analysis was performed by
evaluating the percent change from baseline in reflective nasal (rTNSS) and
ocular (rTOSS, SAR only) symptom scores.

The analysis of the three studies showed that treatment with ZETONNA resulted
in greater improvement in nasal and ocular symptoms of SAR and nasal symptoms
of PAR. For nasal symptoms, a higher percentage of SAR patients reported ≥20%
improvement from baseline (40.8% ZETONNA vs. 21% placebo), ≥30% improvement
from baseline (30.2% ZETONNA vs. 11.9% placebo), and ≥50% improvement from
baseline (11.2% ZETONNA vs. 3.8% placebo) in rTNSS with ZETONNA compared with
placebo averaged over the 2-week treatment period. A higher percentage of PAR
patients during the treatment of 26 weeks also reported ≥20% improvement from
baseline (61.6% ZETONNA vs. 52.6% placebo), ≥30% improvement from baseline
(50.2% ZETONNA vs. 37.2% placebo), and ≥50% improvement from baseline (25.9%
ZETONNA vs. 13.5% placebo) in rTNSS with ZETONNA compared with placebo. For
ocular symptoms, higher percentages of ≥20% improvement from baseline (39.3%
ZETONNA vs. 26.7% placebo), ≥30% improvement from baseline (27.9% ZETONNA vs.
14.8% placebo), and ≥50% improvement from baseline (12.7% ZETONNA vs. 5.5%
placebo) in rTOSS were reported after treatment with ZETONNA 74 mcg compared
with placebo averaged over the 2-week treatment period.

About ZETONNA^® (ciclesonide) Nasal Aerosol

ZETONNA^® (ciclesonide) Nasal Aerosol is a corticosteroid indicated for the
treatment of symptoms associated with seasonal allergic rhinitis (SAR) and
perennial allergic rhinitis (PAR) in adults and adolescents 12 years of age
and older. ZETONNA is not approved for any use in pediatric patients below the
age of 12. ZETONNA’s delivery system and once-daily formulation utilizes a 50
mcL volume per spray and provides 24-hour relief. ZETONNA uses an
environmentally-friendly hydrofluoroalkane (HFA) propellant and features a
built-in dose indicator so patients can track when their ZETONNA should be
refilled.

In three Phase III clinical studies that enrolled a total of 2,488 patients,
ZETONNA demonstrated statistically and clinically significant improvements in
quality of life measures, nasal symptoms and ocular symptoms of SAR, and the
nasal symptoms associated with PAR. The most common adverse reactions in these
short-term two to six week studies (≥2% incidence and greater than placebo)
included nasal discomfort, headache and epistaxis.

Important Safety Information for ZETONNA^®

Do not spray ZETONNA Nasal Aerosol in your eyes or directly onto your nasal
septum (the wall inside your nose between your 2 nostrils).

ZETONNA Nasal Aerosol may cause serious side effects, including:

  *nose bleeds and nasal ulcers. Call your healthcare provider right away if
    you start to have more nose bleeds or nasal ulcers.
  *hole in the cartilage in the nose (nasal septal perforation). Stop using
    ZETONNA Nasal Aerosol and call your doctor right away if you have symptoms
    of a nasal perforation. Symptoms of nasal perforation may include:
    crusting in the nose, nosebleeds, runny nose, and a whistling sound when
    you breathe.
  *thrush (Candida), a fungal infection in your nose, mouth, or throat. Tell
    your healthcare provider if you have any redness or white colored patches
    in your mouth or throat.
  *slow wound healing. You should not use ZETONNA Nasal Aerosol until your
    nose has healed, if you have a sore in your nose, if you have had surgery
    in your nose, or if your nose has been injured.
  *eye problems such as glaucoma and cataracts. If you have a history of
    glaucoma or cataracts or have a family history of eye problems, you should
    have regular eye exams while you use ZETONNA Nasal Aerosol.
  *immune system problems that may increase your risk of infections. You are
    more likely to get infections if you take medicines that may weaken your
    body’s ability to fight infections. Avoid contact with people who have
    contagious diseases such as chicken pox or measles while you use ZETONNA
    Nasal Aerosol. Symptoms of an infection may include: fever, pain, aches,
    chills, feeling tired, nausea, and vomiting.
  *adrenal insufficiency. Adrenal insufficiency is a condition in which the
    adrenal glands do not make enough steroid hormones. Call your healthcare
    provider right away if you experience the following symptoms of adrenal
    insufficiency: tiredness, weakness, dizziness, nausea, and vomiting.
  *slowed or delayed growth in children. A child’s growth should be checked
    regularly while using ZETONNA Nasal Aerosol.
  *allergic reactions. Call your healthcare provider right away if you
    experience swelling of the lips, tongue, or throat.

The most common side effects with ZETONNA Nasal Aerosol include nasal
discomfort, headache and nose bleeds.

Tell your doctor if you have any side effect that bothers you or that does not
go away.

These are not all the possible side effects of ZETONNA Nasal Aerosol.

For more information, please visit www.ZETONNA.com or call 1-888-394-7377, and
refer to the accompanying Full Prescribing Information.

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.

About Ciclesonide

ZETONNA^® (ciclesonide) Nasal Aerosol is the third ciclesonide formulation
marketed by Sunovion, with the others being ALVESCO^® (ciclesonide) Inhalation
Aerosol in an HFA formulation for the maintenance treatment of asthma in
adults and adolescents ages 12 and older, and OMNARIS^® (ciclesonide) Nasal
Spray for the treatment of nasal symptoms of seasonal allergic rhinitis in
adults and children age 6 and older and perennial allergic rhinitis in adults
and children age 12 years of age and older.

In 2008, Nycomed granted Sunovion the exclusive development, marketing and
commercialization rights for ciclesonide in the United States. Nycomed was
acquired by Takeda Pharmaceutical Company Limited in September 2011.

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a leading pharmaceutical company dedicated to discovering,
developing and commercializing therapeutic products that advance the science
of medicine in the Psychiatry & Neurology and Respiratory disease areas and
improve the lives of patients and their families. Sunovion’s drug development
program, together with its corporate development and licensing efforts, has
yielded a portfolio of pharmaceutical products including LATUDA^® (lurasidone
HCl) tablets, LUNESTA^® (eszopiclone) tablets, XOPENEX^® (levalbuterol HCI)
inhalation solution, XOPENEX HFA^® (levalbuterol tartrate) inhalation aerosol,
BROVANA^® (arformoterol tartrate) inhalation solution, OMNARIS^® (ciclesonide)
nasal spray, ZETONNA^® (ciclesonide) nasal aerosol and ALVESCO^® (ciclesonide)
inhalation aerosol.

Sunovion, an indirect, wholly-owned subsidiary of Dainippon Sumitomo Pharma
Co., Ltd., is headquartered in Marlborough, Mass. More information about
Sunovion Pharmaceuticals Inc. is available at www.sunovion.com.

About Dainippon Sumitomo Pharma Co., Ltd. (DSP)

DSP is a multi-billion dollar, top-ten listed pharmaceutical company in Japan
with a diverse portfolio of pharmaceutical, animal health and food and
specialty products. DSP aims to produce innovative pharmaceutical products in
the Psychiatry & Neurology field, which has been designated as one of the two
key therapeutic areas. DSP is based on the merger in 2005 between Dainippon
Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, DSP
has more than 7,000 employees worldwide. Additional information about DSP is
available through its corporate website at www.ds-pharma.com.

LATUDA ^ is a registered trademark of Dainippon Sumitomo Pharma Co., Ltd.
LUNESTA, XOPENEX, XOPENEX HFA, and BROVANA are registered trademarks of
Sunovion Pharmaceuticals Inc. OMNARIS and ALVESCO are registered trademarks of
Takeda GmbH, used under license.

  For a copy of this release, visit Sunovion’s web site at www.sunovion.com

Contact:

Sunovion Pharmaceuticals Inc.
Patricia Moriarty, 508-787-4279
Sr. Director, Corporate Communications
patricia.moriarty@sunovion.com
 
Press spacebar to pause and continue. Press esc to stop.