SkyePharma PLC : Anoro Receives Positive Opinion from CHMP

ANORO® RECEIVES POSITIVE OPINION FROM CHMP IN EUROPE

LONDON, UK, 21 February, 2014 - Skyepharma PLC (LSE SKP),the expert oral and inhalation drug delivery company, today announces that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for umeclidinium/vilanterol (UMEC/VI) as a once-daily maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). UMEC/VI would be marketed by GSK under the proposed brand name Anoro®.

Anoro® is a combination of two bronchodilator molecules: umeclidinium bromide and vilanterol, administered using the Ellipta® inhaler. Anoro® incorporates one of Skyepharma's dry powder inhalation formulation technologies licensed to GSK. 

Alongside the positive opinion on Anoro®, the CHMP has also issued a positive opinion for UMEC monotherapy, which also incorporates the same Skyepharma technology. The UMEC monotherapy would be marketed under the proposed brand name Incruse.

The technology has also been incorporated in Breo® Ellipta® , which was approved in the U.S. in May 2013 for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD and launched at the end of October.  Breo® Ellipta® is also 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 and the UMEC monotherapy involve, in total, three chemical entities, with a total potential income to Skyepharma of up to £9 million a year.

A positive opinion from the CHMP is one of the last steps before the European Commission grants marketing authorisation. GSK has said it anticipates a final decision by the European Commission in the second quarter of 2014.

In December 2013, Anoro® Ellipta® was approved for use in appropriate patients with COPD by the U.S. Food and Drug Administration and Health Canada. In April 2013, a regulatory submission for UMEC/VI was filed in Japan and is currently under review.

Peter Grant, Chief Executive Officer of Skyepharma, commented:

"One of Skyepharma's proprietary dry powder inhalation formulation technologies is incorporated in GSK's new respiratory combination products, Breo and Anoro, with the potential to generate up to £9 million in royalties each year for the Group. The positive opinion from the CHMP brings Anoro nearer to potential approval and launch in Europe, which would further support Skyepharma's flow of royalties from innovative new products in leading markets."

The brand names Anoro®, Breo®, Relvar® and Ellipta® are trademarks of the GSK group of companies. 

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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, visitwww.skyepharma.com