Skyepharma PLC Interim Management Statement (8287T)

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RNS Number : 8287T

Skyepharma PLC

09 October 2014

SKYEPHARMA PLC - INTERIM MANAGEMENT STATEMENT

LONDON, UK, 9 October, 2014 - Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug delivery company, today publishes its Interim Management Statement for the period 1 July 2014 to 8 October 2014 and provides an update on key events since the 2014 interim results announced on 21 August 2014. Skyepharma is hosting a Capital Markets meeting in London today and further details are provided below and on the Skyepharma website.

Trading

Overall trading to date has continued to perform in line with the Board's expectations. As anticipated, revenue during the period has benefited from increased flutiform(R) supply sales, higher royalties from flutiform(R) and the new GSK inhalation products and a share of higher EXPAREL(R) net sales.

Update on flutiform(R)

flutiform(R) , the combination of the fast acting LABA (Long-Acting Beta Agonist), formoterol, and the most widely prescribed ICS (Inhaled Corticosteroid), fluticasone, has now been approved in 31 countries and launched in 25, including recent launches in Austria and Singapore.

Mundipharma International Corporation Limited ("Mundipharma"), the Group's licensee for flutiform(R) in most of the world outside the Americas and Japan, continues to make progress to broaden the product's range of approved indications. Mundipharma has confirmed that recruitment is on track with the European chronic obstructive pulmonary disease (COPD) study involving 1,530 patients. In September, the results of Mundipharma's pivotal phase III study for flutiform(R) in paediatric asthma showed that the primary endpoints had been met (p<0.001) and a European regulatory filing is in preparation. Mundipharma has started recruiting for a COPD trial in the Asia Pacific region and is also preparing to carry out clinical trials for asthma in China and hopes to launch the product there within the next five years.

Mundipharma's co-marketing partner, Zambon Italia srl, is preparing for the launch of the product in Italy later this year under the Abriff(R) brand. Additionally, Mundipharma continues to plan for the potential launch in Spain before the end of the year, which would trigger a further milestone payment of EUR2.0 million (GBP1.6 million at current rates).

In Japan, Kyorin Pharmaceutical Co, Ltd. ("Kyorin") is planning a December 2014 launch of the 120-puff version of flutiform(R) following the successful market introduction of the 56-puff version in November 2013. In Latin America, flutiform(R) received its first approval in the region in Argentina in April; a new drug application is under review in Colombia and further applications are being prepared. Skyepharma and Sanofi, the Group's licensee in the region, are continuing to review the impact of ongoing weakness of local currencies.

Acquisition of inhaled therapy platform and development of SKP-2075

Skyepharma has commenced development of the first product candidate (SKP-2075) for COPD using the novel inhaled therapy platform acquired from Pulmagen Therapeutics (Synergy) Limited ("Pulmagen") as announced on 13 August 2014. The Group intends to conduct a phase II efficacy and safety trial sized to produce statistically significant results with a view to partnering SKP-2075 for further development and commercialisation. By way of consideration, Pulmagen will receive certain launch milestones and a share of Skyepharma's potential future revenues from the successful exploitation of the acquired rights.

Licences to GlaxoSmithKline ("GSK")

GSK has made further progress in the period with its new inhalation products which use the Group's technology. Anoro(R) Ellipta(R) had its first launches in Europe in July (Germany and the UK) and in Japan in September, and marketing authorisation was granted in Australia in July, all for the once-daily treatment of COPD.

EXPAREL(R)

On September 25, 2014 Pacira Pharmaceuticals, Inc. ("Pacira") announced receipt of a warning letter from the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) referencing certain promotional materials on EXPAREL(R) . In response, Pacira management have stated that they believe that the current labelling supports the claims being challenged by the FDA.

Contract development work

Following successful early stage formulation and process development for the lead compound being developed by RespiVert (Janssen Biotech, Inc), the project is now being transitioned to a third party. The Group's skilled resource freed up by this transfer will be deployed into pipeline-building projects including SKP-2075.

Novel concept for a gastro-retentive drug delivery platform

The Group continues to work on a number of concepts for novel oral drug delivery platform technologies innovated internally. A preliminary study in healthy volunteers has been carried out on the first such concept, Soctec(TM), and initial data is supportive of the concept and for further development. Soctec(TM) is a concept for a novel, proprietary gastro-retentive drug delivery platform technology, comprising a buoyant self-orienting capsule. The aim is to support controlled release of a drug in the stomach for an extended period of time to take advantage of the optimal upper gastrointestinal tract absorption window. Once the detailed results of the preliminary study have been fully analysed, Skyepharma expects to carry out further work to optimise the technology and produce additional proof of concept data.

Cash and debt

As expected, on 30 September the Group received the U.S.$8 million (GBP4.9 million at current rates) milestone already recognised in the H1 2014 interim results, in respect of EXPAREL(R) sales.

As previously announced, on 3 October 2014 Skyepharma repaid the entire outstanding Euro principal of the CRC Finance facility of EUR12.7 million (GBP10.0 million at the time) at a cost of GBP10.5 million including accrued interest and a make-whole amount of 5.2%. This early settlement saves GBP1.8 million of finance costs (net of the make-whole amount) which would otherwise have arisen based on prevailing interest rates through to the normal maturity of December 2016. Following this repayment, the CRC Finance facility consists of a U.S. Dollar principal of U.S.$16.3 million (GBP10.0 million at current rates), with an overall interest rate currently at 10.2%. The Board will continue to review opportunities for retiring expensive debt early whilst retaining sufficient capacity to invest in the development portfolio and support growth of existing marketed products.

Strengthening of Business Development capabilities

In line with its stated strategy, the Group continues to strengthen its business development capabilities. Christian Pangratz joined Skyepharma as Executive Vice President, Business Development and Alliance Management, with effect from 1 October 2014. Christian was previously Vice President, Corporate Development, at Vectura GmbH, and Chief Business Officer at Activaero.

Capital Markets meeting

Skyepharma is today hosting a Capital Markets meeting at the offices of FTI Consulting in London. Skyepharma management team members and two third-party speakers will make a series of presentations to provide greater insight into the Company's current operations and market drivers.

The presenters and topics for today's event are listed in the notes to editors section of this press release and the Skyepharma presentations will shortly be available on Skyepharma's website.

Peter Grant, Chief Executive Officer of Skyepharma, commented:

"We remain confident in the potential for strong growth from the eight new products approved or launched since March 2012, with positive sales momentum continuing since the interim results were announced in August.

"We are focused on delivering the next phase of growth through strategic investment in new products and technologies. In our inhalation business, work has begun on the development of SKP-2075, the lead product in our new anti-inflammatory therapy platform for the treatment of COPD. In our oral business, we are encouraged by the progress we are making in the development of Soctec(TM), our novel gastro-retentive drug delivery platform.

"The Group remains well-placed to leverage its rejuvenated revenue-generating product base and build a strong platform for future growth."

-Ends-

For further information please contact:

 
 Skyepharma PLC 
 Peter Grant, Chief Executive Officer 
  Andrew Derodra, Chief Financial Officer             [phone] 
 Jonathan Birt, Investor and Media Relations           [phone] 
 FTI Consulting 
 Julia Phillips/Rob Winder/Natalie Garland-Collins    [phone] 
 
 
 N+1 Singer 
 Shaun Dobson/Gillian Martin    [phone] 
 

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 16 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

Skyepharma's presentations for the Capital Markets meeting will shortly be available in the investor relations section of the Company's website at:

www.skyepharma.com/Investors/Presentations_and_webcasts

   --      Introduction: Peter Grant, Chief Executive Officer, Skyepharma PLC 
   --      Investing for future growth: Andrew Derodra, Chief Financial Officer, Skyepharma PLC 

-- Skyepharma's Oral business: Dr. Guy Vergnault, Vice President, Oral Drug Delivery Solutions, Skyepharma PLC

-- Skyepharma's Inhalation business: Dr. Geraldine Venthoye, Executive Vice President, Pharmaceutical Development; Dr. Kirsten Kaiser, Executive Vice President, Medicinal & Regulatory Development, Skyepharma PLC

-- flutiform(R) - the clinical and patient experience: Dr. Andrew Menzies-Gow, consultant in respiratory medicine at Royal Brompton and Harefield NHS Trust

   --      flutiform(R) in Japan: Mr. Masahiro Yamashita, President, Kyorin Holdings Inc.* 

*Presentation not on website

This information is provided by RNS

The company news service from the London Stock Exchange

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