Sunovion Presents New Clinical Safety Data From the Pediatric Development Program for ZETONNA® (ciclesonide) Nasal Aerosol at

  Sunovion Presents New Clinical Safety Data From the Pediatric Development
  Program for ZETONNA® (ciclesonide) Nasal Aerosol at ACAAI Annual Meeting

Business Wire

MARLBOROUGH, Mass. -- November 12, 2012

Sunovion Pharmaceuticals Inc. (Sunovion) today announced that clinical study
data for ZETONNA^®  (ciclesonide) Nasal Aerosol were presented during a
scientific poster session at the annual meeting of the American College of
Allergy, Asthma & Immunology (ACAAI) in Anaheim, California. Among the data
presented were results of a safety study that evaluated the effect of ZETONNA
compared with placebo on the hypothalamic pituitary adrenal (HPA) axis in
pediatric patients 6 to 11 years old with perennial allergic rhinitis (PAR)
(Poster #336), as well as results from a Phase III pivotal seasonal allergic
rhinitis (SAR) trial that assessed the 24-hour efficacy of ZETONNA in patients
12 years of age and older (Poster #335). Additionally, one poster presented
results from a scintigraphy study utilizing a radiolabelled solution of
ciclesonide nasal aerosol, which provided information on nasal cavity
retention as measured by radioactivity after two minutes (Poster #339).

“These initial HPA axis safety data from our pediatric development program
showed that in PAR patients age 6 to 11, once-daily ZETONNA resulted in no
apparent suppression of cortisol secretion, a measure of systemic safety;
further, once-daily ZETONNA was associated with an improvement in reflective
total nasal symptom scores (rTNSS),” said Alistair Wheeler, M.D., Vice
President, Clinical Development and Medical Affairs at Sunovion
Pharmaceuticals Inc. “This first step in our pediatric program underscores our
commitment to providing allergic rhinitis treatment options to patients of a
variety of ages, and we look forward to sharing additional data when they are

Pediatric Study Findings Presented by Sunovion at ACAAI:

  *An Evaluation of the Effect of Ciclesonide Hydrofluoroalkane Nasal Aerosol
    on Hypothalamic Pituitary Adrenal Axis in Pediatric Patients with
    Perennial Allergic Rhinitis (Poster #336)

    The HPA axis trial was designed as a randomized, placebo-controlled,
    double-blind clinical study that enrolled 89 patients 6 to11 years of age
    with a ≥ 1 year history of PAR. Patients were given ZETONNA [CIC-HFA 74
    mcg (37 mcg/actuation/nostril)] (N=47), or vehicle placebo (N=42)
    once-daily in the morning for six weeks. The study evaluated the effect of
    ZETONNA on the HPA axis as assessed by serum cortisol levels (a surrogate
    marker of HPA axis function). Changes from regular serum cortisol
    concentration were measured over 24 hours following the treatment. In
    addition, efficacy was evaluated by assessing changes in nasal symptom
    scores (changes in reflective total nasal symptom scores, or rTNSS) from
    baseline to end of treatment.

    Results demonstrated that once-daily treatment with ZETONNA did not result
    in any apparent suppression of cortisol secretion; additionally, treatment
    with ZETONNA demonstrated improvements in nasal allergy PAR symptoms
    (difference of -0.7 in rTNSS from baseline versus placebo), and adverse
    events were similar to placebo in this study. The most frequently reported
    adverse events for the placebo and ZETONNA groups, respectively were:
    headache (2.4% vs. 6.4%) and oropharyngeal pain (9.4% vs. 0%), and
    specific nasal AEs that were reported included epistaxis (4.8% vs. 2.1%).

Additional Data Presented by Sunovion at ACAAI:

  *Analysis of Improvement in Nasal and Ocular Symptoms in the Morning
    Following Once-Daily (morning) Treatment with Ciclesonide Nasal Aerosol in
    Patients with Seasonal Allergic Rhinitis (Poster #335)

    In a randomized, double-blind, Phase III study, patients with a ≥2 year
    history of SAR were given ZETONNA [CIC-HFA 74 mcg (37
    mcg/actuation/nostril)] (N=237), CIC-HFA 148 mcg (74
    mcg/actuation/nostril) (N=237), or placebo (N=235) once-daily AM for two
    weeks. Patient-reported diaries were used to record change from baseline
    in morning reflective and instantaneous total nasal symptom score (AM
    rTNSS, AM iTNSS) and reflective and instantaneous total ocular symptom
    score (AM rTOSS, AM iTOSS), averaged over the two week treatment period.
    The AM rTNSS and AM rTOSS were recorded over the previous 12 hours, and AM
    iTNSS and AM iTOSS were recorded over the previous 10 minutes.

    The study showed significant improvements in morning reflective and
    instantaneous nasal and ocular symptoms of seasonal allergic rhinitis
    (SAR) in patients treated once-daily with ZETONNA or a 148 mcg dose of
    CIC-HFA over two weeks compared to placebo, demonstrating the once-daily
    efficacy of ZETONNA.

  *A Scintigraphy Study Evaluating the Nasal and Pulmonary Deposition of a
    Radiolabeled Solution of Ciclesonide Hydrofluoroalkane Nasal Aerosol and a
    Radiolabeled Suspension of Ciclesonide Aqueous Nasal Spray in Healthy
    Subjects (Poster #339)

    In a Phase I, open-label, two-period, non-randomized scintigraphy study,
    healthy volunteer patients (N=10) 18-65 years of age received a single
    dose of a radiolabeled solution of CIC-HFA 148 mcg via a metered dose
    inhaler, a washout period of ≥72 hours, followed by a single dose of a
    radiolabeled suspension of CIC-AQ (aqueous) 200 mcg via an aqueous nasal
    pump spray. The amount of the radioactivity from the radiolabelled CIC-HFA
    and radiolabelled CIC-AQ remaining in the nasal cavity and lungs were
    measured to determine the nasal and pulmonary deposition.

    At approximately two minutes post-administration, 98.36 percent of the
    radioactivity from the radiolabeled solution of CIC-HFA and 76.38 percent
    of radiolabeled suspension of CIC-AQ was retained in the nasal cavity. A
    small amount of radiolabeled CIC-HFA (1.42 percent) and radiolabeled
    CIC-AQ (0.55 percent) was measured in the lungs.

ZETONNA Nasal Aerosol 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 (74 mcg), one spray per nostril (37 mcg) dosing that
utilizes a hydrofluoroalkane (HFA) propellant to dispense the medication.

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 prescriptions 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 2 to 6 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 two 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 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, 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 central nervous system (CNS) 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

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 CNS field, which has been designated as the key therapeutic area and will
also focus in on other specialty disease categories with significant unmet
medical needs, which are designated as frontier 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

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
Nycomed.GmbH , used under license.

  For a copy of this release, visit Sunovion’s web site at


Sunovion Pharmaceuticals Inc.
Patricia Moriarty, 508-787-4279
Sr. Director, Corporate Communications
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