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GlaxoSmithKline (GSK)'s BREO™ ELLIPTA™ Receives Regulatory Approval in U.S.


5/13/2013 12:17:37 PM

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LONDON, UK, 13 May, 2013 – Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug delivery company, announces that the United States Food and Drug Administration (“FDA”) has approved the New Drug Application (“NDA”) for BREO™ ELLIPTA™, a combination product submitted by GlaxoSmithKline (“GSK”), for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (“COPD”), including chronic bronchitis and/or emphysema. It is also approved for the reduction of COPD exacerbations in patients with a history of exacerbations. BREO™ ELLIPTA™ is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

BREO™ ELLIPTA™ (fluticasone furoate/vilanterol 100/25 mcg) incorporates one of the Group’s proprietary dry powder formulation technologies for inhalation products licensed to GSK. GSK has stated that it anticipates that BREO™ ELLIPTA™ will be available in the United States during the third quarter of 2013. This medicine is not approved or licensed in the European Union or anywhere outside of the U.S.

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. BREO™ ELLIPTA™ contains two chemical entities. The same combination product, with the proposed name of RELVAR™ ELLIPTA™ was filed for approval in Europe and Japan in June and September 2012 respectively.

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 BREO™ ELLIPTA™ and ANORO™ ELLIPTA™. NDAs for ANORO™ ELLIPTA™ have been filed for approval in the United States, Europe and Japan. The Prescription Drug User Fee Act (“PDUFA”) target date of the application for ANORO™ ELLIPTA™ (for COPD) by the FDA in the United States is 18 December 2013. The product was also 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 BREO™ ELLIPTA™ provides further validation of Skyepharma’s proprietary dry powder formulation technology for inhalation products. The Group’s technology has been incorporated in two potentially significant combination products, involving three chemical entities and could generate up to £9 million per annum in royalties. This, combined with previous product approvals and launches, and the encouraging progress with flutiform®, creates a strong platform for future growth. Skyepharma is positioned as an attractive and experienced drug delivery specialist for future partnering opportunities.”

The proposed brand names of ANORO™, BREO™, RELVAR™ and ELLIPTA™ are trademarks of the GSK group of companies.

For further information please contact:

Skyepharma PLC

Peter Grant, Chief Executive Officer +44 207 881 0524

FTI Consulting

Julia Phillips/Susan Stuart/Natalie Garland-Collins +44 207 831 3113

N+1 Singer

Shaun Dobson/Jennifer Wyllie +44 207 496 3000

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 13 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



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