Skyepharma, an expert oral and inhalation drug delivery company, has launched flutiform in Japan following agreement on pricing reimbursement. Flutiform is being marketed in Japan by Skyepharma's licensing partner, Kyorin Pharmaceutical Co, Ltd. as "flutiform 50 Aerosol" (56 inhalations) and "flutiform 125 Aerosol" (56 inhalations) for the treatment of patients aged 16 years and over with bronchial asthma. A milestone of several million US dollars was received from Kyorin following regulatory approval in September 2013 and Skyepharma is entitled to high-mid single digit royalties on net sales.

Flutiform is the first product on the Japanese market to combine the fast acting LABA (Long-Acting Beta Agonist) formoterol and the ICS (Inhaled Corticosteroid), fluticasone.  It has already been approved in 21 countries in Europe and in Australia, Hong Kong, Israel and South Korea.  The development for Japan involved close collaboration between Kyorin and Skyepharma, including the development of the 56 inhalations versions of flutiform.

Kyorin estimates that the market in Japan for asthma and Chronic Obstructive Pulmonary Disease (COPD) is currently worth US$ 2.4 to $2.8 billion, with asthma accounting for more than half of the total.  Kyorin also estimates that there are some 3.3 to 3.5 million adult asthma patients in Japan.

Kyorin is responsible for the development, marketing and distribution of flutiform in Japan, the world's second- largest pharmaceutical market.  Kyorin is a major player in the Japanese asthma market.  With its co-marketing partner MSD, Kyorin promotes the country's biggest-selling asthma product, Merck & Co's blockbuster montelukast, which is sold in Japan under the trade name Kipres (Singulair by MSD). Sales of Kipres totalled Yen 39.6 billion (c. US$ 400 million) in the year ended March 31, 2013.  Kyorin also sells Mucodyne (carbocisteine), a mucoregulant extensively prescribed for acute and chronic respiratory diseases with annual sales of Yen 19.1 billion (c. US$ 190 million). Through its distribution of Kipres and Mucodyne, Kyorin has built a large and experienced sales force of approximately 750 representatives that have well-established connections with respiratory specialists and prescribing physicians across Japan.

In line with standard practice, National Health Insurance (NHI) pricing reimbursement is only available for the 56 inhalations versions of the product for the first 12 months after launch. The 120 inhalations versions of flutiform,which are already approved for marketing, will therefore be launched in 12 months' time.  Agreed NHI pricing for the 56 inhalations versions of flutiform are comparable with equivalent combination inhaled asthma products.

Kyorin is targeting sales (measured at NHI prices) of flutiform during its fiscal year ending March 31, 2014 following launch of approximately Yen 1 billion (c. US$ 10 million).

Peter Grant, Chief Executive Officer of Skyepharma, commented: "The launch of flutiform by Kyorin brings a new inhaled treatment option to people suffering from asthma in Japan. Kyorin has already established a strong and highly successful position in the Japanese respiratory market and has built excellent relationships with key opinion leaders and clinicians in the field.  We are proud of our close and long-term partnership with Kyorin and look forward to flutiform'ssuccess in this important market."

Mitsutomo Miyashita, President of Kyorin Pharmaceutical Co., Ltd. ("Kyorin") (head office: Chiyoda-ku, Tokyo), commented: "Kyorin is delighted to launch flutiform, enabling us to provide a new treatment option to bronchial asthma patients. By enhancing our respiratory product portfolio with this new combination, Kyorin will continue to contribute to the improved treatment and quality of life of more asthma patientsin Japan.”

"Kyorin is pursuing its Franchise Customer (FC) strategy, which focuses sales and marketing activities on its priority fields of respiratory medicine, otolaryngology and urology. By concentrating on flutiform's early penetration of the market, Kyorin will strive to further reinforce its operational base in Japan."

Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products.

The Kyorin Group in Japan focuses on respiratory medicine, otolaryngology, and urology.