ANORO ELLIPTA RECEIVES REGULATORY APPROVAL IN US

ANORO™ ELLIPTA™ RECEIVES REGULATORY APPROVAL IN U.S.

Skyepharma eligible for royalties of up to £9 million per annum following approval of ANORO™ ELLIPTA™

LONDON, UK, 19 December, 2013 - Skyepharma PLC (LSE SKP),the expert oral and inhalation drug delivery company, today announces that the U.S. Food and Drug Administration ("FDA") has approved the New Drug Application ("NDA") submitted by GlaxoSmithKline ("GSK") for ANORO™ELLIPTA™(umeclidinium / vilanterol) as a combination anticholinergic/long-acting beta2-adrenergic agonist indicated 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. ANORO™ELLIPTA™is not indicated for the relief of acute bronchospasm or for the treatment of asthma.

ANORO™ELLIPTA™is a combination of two bronchodilator molecules: umeclidinium bromide and vilanterol, administered using the ELLIPTATM inhaler. 

ANOROTM ELLIPTATM incorporates one of Skyepharma's dry powder inhalation formulation technologies licensed to GSK. 

The technology has also been incorporated in BREO® ELLIPTA®, which was approved in the U.S. in May for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD and launched at the end of October. This product has been approved under the brand name RELVAR® ELLIPTA® in Japan for the treatment of asthma and in Europe for the treatment of both asthma and COPD.

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 million per annum for each chemical entity for the life of the relevant patents. The two GSK combination products involve three chemical entities, with a total potential income to Skyepharma of up to £9 million a year.

GSK has stated that it anticipates that launch activities in the U.S. will commence during the first quarter of 2014 for ANORO™ELLIPTA™. The product has also been filed in Europe and Japan for the treatment of COPD.

Peter Grant, Chief Executive Officer of Skyepharma, commented:

"Skyepharma's flow of royalties continues to benefit from the approval and launch of highly promising and innovative new products in major markets. With the approval of both ANORO ELLIPTAand BREO ELLIPTA in the U.S., one of Skyepharma's proprietary dry powder inhalation formulation technologies is now incorporated in two respiratory combination products and could generate up to £9 million each year for the Group. In addition, the non-opioid analgesic EXPAREL has continued to grow strongly since its launch by Pacira in the U.S. and has the potential to deliver significant revenues for Skyepharma in the coming years. Recurring revenues from these and other new products, combined with encouraging progress with flutiform, means that the Group is well-placed for future growth."

The brand names ANORO™, BREO®, RELVAR® and ELLIPTA™, are trademarks of the GSK group of companies. ANORO™ELLIPTA™is not currently approved anywhere other than the United States.

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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 is eligible for revenues from 15 approved 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