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Skyepharma PLC (SKYEF) Capital Markets Meeting And Update On flutiform® Sales



12/4/2013 9:47:18 AM

LONDON, UK, 4 December, 2013 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug delivery company, is today hosting a Capital Markets meeting in London. Skyepharma management and third party speakers will make a series of presentations to provide greater insight into the Company’s current operations and market drivers.

Today’s meeting follows a successful Capital Markets Day held at the Company's Research & Development centre in Muttenz, Switzerland, at the end of September and will provide an opportunity to learn more about Skyepharma’s proven capabilities in oral drug delivery and inhalation drug development. The event will also review the Company’s global partnerships, progress on existing products, including flutiform®, and future partnering and drug development opportunities.

Speakers at today’s meeting at the offices of FTI Consulting include Peter Grant, Chief Executive Officer of Skyepharma; Geraldine Venthoye, Vice President, Pharmaceutical Development, Skyepharma; Georg Toufar, Chief Marketing Officer and Board Director of Mundipharma International; and Professor David Price, Professor of Primary Care Respiratory Medicine, University of Aberdeen. The presentations for today’s event are listed in the notes to editors section of this press release and will be available on Skyepharma’s website.

Developments since the publication of the Interim Management Statement on 10 October 2013 that will be covered in today’s meeting include the following:

- Mundipharma management has stated that uptake and sales of flutiform® continue to be in line with their expectations. According to Mundipharma, in-market sales* of flutiform® from launch (which commenced in September 2012) to the end of September 2013 totalled approximately €12 million* (approximately £10 million at current rates). When compared with the most recent launch of a new non-generic combination brand in the ICS/LABA market segment, flutiform® continues to track in-market value of total sales for the same period post launch across those countries where available. Mundipharma has achieved a “share of voice”† in this segment similar to that of the category leaders, and market research shows that flutiform® messages and key data are being well received. (*Source: IMS Health, IMS MIDAS. Sept MAT 2013. †Note: “Share of voice” represents the proportion of discussions recalled by prescribers based on independent surveys).

- GSK and Theravance announced on 18 November that RELVAR® ELLIPTA® (fluticasone furoate/vilanterol) has been approved in 31 countries in Europe for the treatment of asthma and COPD. The medicine was made available in the United States on 30 October under the brand name BREO® ELLIPTA® for the treatment of COPD. BREO® ELLIPTA® is not indicated for the relief of acute bronchospasm or for the treatment of asthma. RELVAR® ELLIPTA® received approval in September 2013 for the treatment of bronchial asthma in Japan. BREO® ELLIPTA® and RELVAR® ELLIPTA® incorporate one of the Group's proprietary dry powder formulation technologies for inhalation products which is licensed to GSK. 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. The FDA target date (PDUFA) for ANORO® ELLIPTA® (umeclidinium/vilanterol), which is subject to the same technology licence, is 18 December 2013.

- As previously announced, the Skyepharma Group entered into an agreement with its United States licensee, Fougera Pharmaceuticals Inc. (“Fougera”), such that, if a generic version of Solaraze® is launched by Tolmar, Inc. (“Tolmar”) in the United States, the royalty rate payable on sales of Solaraze® by Fougera will increase from a low teens to a high teens percentage of net sales and certain milestones will be payable. A generic product has recently been launched by Tolmar in the United States, and the royalty rate will increase accordingly and a milestone is due to Skyepharma. The increased royalty rate applies to sales by Fougera of its own authorised generic which has also recently been launched.

- On 31 October 2013, Pacira Pharmaceuticals, Inc. (“Pacira”) reported that sales of EXPAREL® in the third quarter ended 30 September, 2013, totalled $20.0 million, up from $15.2 million in the second quarter. Pacira continued its steady expansion of EXPAREL® sales, reporting 297 total new accounts in the third quarter, an average of 23 new customers per week. As of September 30, 2013, 1,732 total accounts had ordered EXPAREL® since launch, with 165 accounts each ordering more than $100,000. The customer base has continued to grow along with acceptance and use of EXPAREL® in hospitals that adopted the product early in the launch. The Group is entitled to three per cent of net sales of EXPAREL® in the United States (based on cash received by Pacira), and a similar share of net sales if approved and launched in Japan, the UK, France, Germany, Italy and Spain.

For further information please contact:

Skyepharma PLC

Peter Grant, Chief Executive Officer +44 207 881 0524

Andrew Derodra, Chief Financial Officer

FTI Consulting

Julia Phillips/Stephanie Cuthbert/Natalie Garland-Collins +44 207 269 7121

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 is eligible for revenues from 14 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

Capital Markets meeting presentations

The presentations for the Skyepharma Capital Markets meeting can be accessed on the investor relations section of the Company’s website at:

www.skyepharma.com/Investors/Presentations_and_webcasts

- Introduction: Peter Grant, Chief Executive Officer

- Skyepharma’s inhalation business: Dr Geraldine Venthoye, Vice President, Pharmaceutical Development, Skyepharma

- flutiform® - growing momentum in Europe: Georg Toufar, Chief Marketing Officer and Board Director, Mundipharma International

- flutiform® - the clinical and patient perspective: Professor David Price, Professor of Primary Care Respiratory Medicine, University of Aberdeen.

- Skyepharma’s oral business: Peter Grant

- Strategy: Peter Grant and Geraldine Venthoye


Read at BioSpace.com


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