RELVAR ELLIPTA Receives Approval in Japan

RELVAR™ ELLIPTA™ Receives Regulatory Approval in Japan

Skyepharma eligible for royalties of up to £6 million per annum

LONDON, UK, 20 September, 2013 - Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug delivery company, announces that the regulatory committee (Bunka-Kai) of the Japanese Ministry of Health, Labour and Welfare ("MHLW") has approved RELVAR™ ELLIPTA™ (FF/VI) for the treatment of bronchial asthma (in cases where concurrent use of inhaled corticosteroid and long-acting inhaled beta2 agonist is required). RELVAR™ ELLIPTA™ is not indicated for the treatment of Chronic Obstructive Pulmonary Disease ("COPD") in Japan. RELVAR™ ELLIPTA™ is a combination product submitted by GlaxoSmithKline ("GSK") for the long-term, once-daily maintenance treatment of bronchial asthma.

RELVAR™ ELLIPTA™ combines the inhaled corticosteroid ("ICS") fluticasone furoate with the long-acting beta agonist ("LABA") vilanterol and incorporates one of the Group's proprietary dry powder formulation technologies for inhalation products licensed to GSK. This medicine has also been approved for the treatment of COPD in the United States, under the name BREO™ ELLIPTA™, where launch activities are expected to begin in Q3/Q4. BREO™ ELLIPTA™ is not indicated for the relief of acute bronchospasm or for the treatment of asthma in the United States. 

Skyepharma is entitled to a low single digit royalty on net sales of products using the licensed technology, capped at a maximum amount of £3.0 million per annum for each chemical entity for the life of the relevant patents. RELVAR™ ELLIPTA™ contains two chemical entities. RELVAR™ ELLIPTA™ was filed for approval in Europe in June 2012.

The technology has also been incorporated in another investigational combination product, with a proposed brand name of ANORO™ ELLIPTA™ (umeclidinium bromide/vilanterol) that contains two chemical entities, one of which is common to both RELVAR™ ELLIPTA™ and ANORO™ ELLIPTA™. NDAs (new drug applications) for ANORO™ ELLIPTA™ have been filed for approval across the world, including the United States, Europe and Japan. On 10 September 2013, an FDA Advisory Committee of the Pulmonary-Allergy Drugs Division recommended approval of ANORO™ ELLIPTA™ in the United States for the treatment of COPD and the Prescription Drug User Fee Act ("PDUFA") target date is 18 December 2013. The investigational medicine was filed for approval in Europe and Japan in January and April 2013 respectively. This medicine is not approved or licensed anywhere in the world.

Peter Grant, Chief Executive Officer of Skyepharma, commented:

"The approval of RELVAR ELLIPTA in Japan, the world's second largest pharmaceutical market, is yet another validation of Skyepharma's proprietary dry powder formulation technology for inhalation products. Today, we also announced the approval of flutiform for bronchial asthma treatment in Japan, further endorsing Skyepharma's ability to develop innovative and effective respiratory products. We look forward to the launch of both RELVAR ELLIPTA and flutiform in this market and to continuing to strengthen our platform for future growth."

RELVAR™, BREO™, ANORO™ and ELLIPTA™ are trademarks of the GlaxoSmithKline group of companies. The use of the brand name ANORO™ is not approved by any regulatory authorities.

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About Skyepharma

Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products. The Group receives revenues from 14 marketed products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses. The products developed by the Group are marketed throughout the world by big pharma as well as speciality pharmaceutical companies. For more information, visit www.Skyepharma.com.