FDA accepts filing of New Drug Application for Nycomed's ciclesonide HFA nasal aerosol

Mon Jun 6, 2011 4:00am EDT

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Nycomed / FDA accepts filing of New Drug Application for Nycomed's ciclesonide HFA nasal aerosol . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement.

  • Pressurized metered dose nasal formulation for allergic rhinitis 
  • If approved, will strengthen the ciclesonide franchise in the United States, licensed by Nycomed to Sunovion 


Nycomed's licensing partner Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) submitted for ciclesonide nasal aerosol in a hydrofluoroalkane (HFA) formulation.  The proposed dosing for ciclesonide HFA nasal aerosol is 74 mcg once-daily (37 mcg per spray; one-spray per nostril) and the proposed indication is for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR) and Perennial Allergic Rhinitis (PAR), in adults and adolescents age 12 and older.  Nycomed granted Sunovion exclusive development, marketing and commercialization rights for ciclesonide in the United States.


The delivery system for ciclesonide HFA nasal aerosol is a pressurized metered-dose, nasal aerosol formulation designed to dispense a small volume (50 mcL) of the fine, dry mist of ciclesonide to a patient's nose.  


"We are pleased with the FDA's acceptance of the NDA filing for ciclesonide HFA nasal aerosol," said Anders Ullman, Executive Vice President R&D at Nycomed. "With Sunovion we have a strong partner in the United States, committed to developing ciclesonide to offer a new therapeutic option for the millions of individuals suffering with seasonal and perennial allergies."


"Ciclesonide HFA nasal aerosol has the potential to be a valuable new treatment option for patients who suffer from seasonal and perennial allergies," said Michael Blaiss, M.D., Clinical Professor of Pediatrics and Medicine at The University of Tennessee Health Sciences Center. "If approved at the proposed dose, this new product could offer symptom relief with a low volume nasal spray."  


The FDA has communicated that the application will be subject to a standard review.  Acceptance of the NDA filing does not represent final evaluation of the adequacy of the data submitted in the NDA.


The NDA for ciclesonide HFA nasal aerosol reflects data from several clinical trials. The efficacy of ciclesonide HFA nasal aerosol was evaluated in three randomized, double-blind, parallel-group, multi-center, placebo-controlled clinical trials with primary efficacy endpoints evaluated over 2 to 6 weeks' duration conducted in the US in adolescents and adults with allergic rhinitis.  The three trials included a total of 2,488 subjects.  Of these, 761 received the 74 mcg once daily dose.  The primary endpoint within the pivotal trials was the difference from placebo in the change from baseline of the average morning and evening reflective total nasal symptom scores (rTNSS).  Additional efficacy endpoints assessed included reflective total ocular symptom scores (rTOSS) and quality of life measured via the use of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).  


The safety data are based on five clinical trials evaluating doses of ciclesonide HFA nasal aerosol up to 282 mcg.  One trial did not evaluate the 74 mcg dose.  Four of the clinical trials were two to six weeks in duration and one trial was 26 weeks in duration.  Data from the first six weeks of the 26 week trial were pooled with the short term data from the other four studies.  Short-term data of two to six weeks duration in the four short term trials was evaluated, including 884 patients with SAR or PAR who were administered the 74 mcg dose.


About Ciclesonide
Ciclesonide is Nycomed's patented corticosteroid with a novel principle of action. It is a prodrug that is activated by intracellular esterases following oral or nasal inhalation.


Ciclesonide HFA nasal aerosol is the third ciclesonide formulation studied by Sunovion, with the others being ALVESCO® (ciclesonide) Inhalation Aerosol in a 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 seasonal allergic rhinitis in adults and children age 6 and older and perennial allergic rhinitis in adults and children age 12 and older.


In 2008, Nycomed granted Sunovion the exclusive development, marketing and commercialization rights for ciclesonide in the United States.


About Allergic Rhinitis
Allergic rhinitis, commonly referred to as hay fever, is a collection of symptoms, predominantly in the nose and eyes, to allergens such as dust, dander and pollen. It is the most common allergic disease in the U.S., affecting an estimated 50 million people(1), approximately between 10-30% of adults and as many as 40% of children.  The sensitized immune system produces antibodies to these allergens, which cause chemicals called histamines to be released into the bloodstream, causing itching, swelling of affected tissues, mucus production, hives, rashes and other symptoms. Symptoms vary in severity from person to person.(2)


Allergic rhinitis is the fifth leading chronic disease among all ages, resulting in nearly 4 million missed or lost workdays each year and costing more than $700 million in total lost productivity.(3) Each year, nearly 17 million physician office visits are attributed to allergic rhinitis, with seasonal allergic rhinitis (SAR) accounting for more than half of all allergy visits.(1)


SAR, which is also often referred to as hay fever, is caused by an allergy to the pollen of trees, grasses, weeds or mold spores. Depending on the allergen, the section of the country and the pollination periods, SAR may occur in the spring, summer or fall and may last until the first frost.


Some people have symptoms of rhinitis no matter what the season. This is referred to as perennial allergic rhinitis, and it can be caused by allergens such as animal dander, indoor mold, dust mites and cockroaches.(4)


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® brand lurasidone HCl, LUNESTA® brand eszopiclone, XOPENEX® brand levalbuterol HCI Inhalation Solution, XOPENEX HFA® brand levalbuterol tartrate inhalation aerosol, BROVANA® brand arformoterol tartrate inhalation solution, OMNARIS® brand ciclesonide nasal spray and ALVESCO® brand ciclesonide inhalation aerosol in a HFA formulation.


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 Nycomed
Nycomed is a privately owned global pharmaceutical company with a diversified portfolio focused on branded medicines in gastroenterology, respiratory and inflammatory diseases, pain, osteoporosis and tissue management. A range of OTC products completes the portfolio.


Its R&D is structured around collaborations. In-licensing and expanding in emerging markets are cornerstones of the company's growth strategy.
Nycomed employs 12,500 associates worldwide, and its products are sold in more than 100 countries. It has strong platforms in Europe and in fast-growing markets such as Russia/CIS, Latin America, Asia and the Middle East. In the US and Japan its products are available through best in class partners.


Headquartered in Zurich, Switzerland, the company generated total sales of € 3.2 billion in 2010 and an adjusted EBITDA of € 851 million.
For more information visit www.nycomed.com



For further information
Media:
General phone: +41 44 555 15 10
Tobias Cottmann, phone: +41 44 555 15 01


Investors:
Christian B. Seidelin, phone: +41 44 555 11 04



(1) CDC Fast Facts A-Z," Vital Health Statistics, 2003


(2) Medline Plus, a service of the U.S. National Library of Medicine and the National Institutes of Health. [Internet]. Available from http://www.nlm.nih.gov/medlineplus/ency/imagepages/19319.htm. Accessed: February 25, 2011.


(3) Chronic Conditions: A Challenge for the 21st Century. National Academy on an Aging Society, 2000.


(4) American Academy of Allergy, Asthma and Immunology (AAAAI). [Internet]. Available from http://www.aaaai.org/patients/gallery/rhinitissinusitis.asp. Accessed: February 25, 2011.


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.

 

This press release has been issued by Nycomed International Management GmbH,
Thurgauerstrasse 130, CH-8152 Glattpark-Opfikon, Zurich, Switzerland.





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Thurgauerstrasse 130 Glattpark-Opfikon Switzerland





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