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

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

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 available.”

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 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 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 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 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 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 Nycomed.GmbH , used under license.

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