Skyepharma PLC – Trading Update And Capital Markets Meeting
LONDON, UK, 26 November, 2015 - Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug development company, today publishes an update ahead of its Capital Markets meeting being held today. This comprises a trading update, the latest status of SKP-2075, the disclosure of SKP-2076 as a triple ICS (inhaled corticosteroid) / LABA (long-acting beta agonist) / LAMA (long-acting muscarinic antagonist) combination and further development of the oral business.
Trading update
Overall trading to date has continued to perform in line with the Board’s expectations for the full year. In addition, the Group has benefited from higher cash receipts and as a result, year-end cash is expected to be ahead of the Board’s previous expectations.
flutiform®
flutiform®, the combination of the fast-acting LABA formoterol, and the most widely prescribed ICS fluticasone, has now been approved in 38 countries and launched in 30. In addition, applications for marketing authorisations are currently under review in a further 15 countries.
In Europe, good progress continues to be made on the development of a breath-actuated version of flutiform®. If approved and launched, Skyepharma would be eligible for revenues on this product from royalties, milestones and filled-canister supply in the same manner as for sales of flutiform®. In addition, progress is being made with the COPD (chronic obstructive pulmonary disease) clinical study, following completion in May of the recruitment of over 1,700 patients. Mundipharma has now met with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to agree on what is required for the resubmission of its application for a European paediatric indication of flutiform® for asthma and is considering the timing of this.
In Asia-Pacific, including China, Mundipharma has completed recruitment for a clinical trial of flutiform® for COPD involving more than 900 patients treated over a 12-week period. Preparations are also being made for a clinical trial in China for asthma which will commence once the Chinese Food and Drug Administration (CFDA) has approved the investigational new drug application.
In Japan, Kyorin reported gross sales of flutiform® of Yen 3.0 billion (£16.0 million1) in the six months ended 30 September 2015, compared with Yen 0.9 billion (£5.2 million1) in the comparable prior year period and Yen 3.6 billion (£20.3 million1) for the full year ended 31 March 2015.
In Latin America, the Group’s partner, Sanofi, has obtained approval in Colombia for flutiform®, which is already approved in Argentina. Further filings are in preparation. Skyepharma and Sanofi are in discussions with a third party to commercialise flutiform® in Latin America.
Development pipeline
The Group continues to make encouraging progress in implementing its strategy to develop inhalation products with developments for the new products, SKP-2075 and SKP-2076. These products are aimed at the global market for the treatment of asthma and/or COPD currently worth approximately U.S.$29 billion per annum2.
SKP-2075
Skyepharma commenced work on the first product candidate (SKP-2075) for COPD using the novel inhaled therapy platform acquired from Pulmagen in 2014. SKP-2075 is being developed as a single capsule dry powder inhaler, comprising fluticasone propionate and a low dose of theophylline. Good progress has been made in formulating the product and with commencement of non-clinical studies for the treatment of COPD/smoking asthma. The Board believes that the treatment of COPD/smoking asthma is a clinically important medical need and SKP-2075 has the potential to be one of the first products developed for this patient group. A Phase II efficacy and safety clinical trial is planned to commence in 2016 and expected to be concluded during 2017. It is being designed to produce statistically significant results with a view to partnering SKP-2075 for further development and commercialisation. The Board has decided to extend the scope of the clinical programme by generating dose-ranging data at the same time to offer the potential for a relatively quick development for Europe which the Board believes adds considerable value to the project. The cost of the additional investment in developing SKP-2075 is expected to be circa £2 million per annum for each of 2016 and 2017 and is expected to be offset by further revenues from flutiform® supply with the additional capacity planned to come on stream during 2016.
SKP-2076
Skyepharma commenced feasibility work on a new inhaled product candidate, SKP-2076, early in 2015. SKP-2076 is a triple ICS/LABA/LAMA combination product incorporating known chemical entities aimed at the potential market for asthma patients who are not adequately controlled on current combination ICS/LABA therapies. Encouraging progress is being made with the initial formulation for SKP-2076, which is expected to move into GMP pilot scale manufacturing in 2016. In light of the positive experience with flutiform®, the Board believes that SKP-2076 could add significant value to Skyepharma’s respiratory franchise and has the potential for relatively quick development for Europe. Skyepharma is already engaged in partnering discussions to licence and fund the further development of this product after the initial formulation stage.
Oral developments
As previously announced, the Group is developing Soctec™, a concept for a novel, proprietary gastro-retentive drug delivery platform technology comprising a buoyant self-orienting capsule. It is targeted at gastro-retention and aims to retain the drug delivery device in the upper gastro-intestinal (“GI”) tract for as long as possible with the active ingredient being released for delivery for local action or absorption in the stomach or the upper GI tract. After an encouraging proof of concept study, progress is being made with further development to optimise the Soctec™ technology and plan for potential scale up. This technology is being marketed to potential partners.
A second technology is also under development for gastro-retention, aimed at higher payload requirements, and is currently in the final prototyping stage. Materials are being manufactured in preparation for a clinical proof of concept trial to be conducted in H1 2016.
The Group's licence partner for its SKP-1041 sleep maintenance product, Somnus Therapeutics, Inc. (“Somnus”), has been unable to secure further development funding despite a successful Phase II dose-ranging study. Somnus is, therefore, in the process of transferring all rights, materials and data back to Skyepharma. The Group has no current plans to develop SKP-1041. The only impact on the Group will be the earlier release of the remaining U.S.$0.3 million (£0.2 million) of deferred income, from the U.S.$5 million milestones paid by Somnus to date, as revenues in 2015.
Hikma Pharmaceuticals PLC (“Hikma”) and Skyepharma have established a collaboration to develop complex oral generic products and a first development project is being carried out.
Peter Grant, Chief Executive Officer of Skyepharma, commented:
"We remain on track to deliver substantial growth in revenues in 2015, with continued contributions from flutiform, Pacira’s EXPAREL and the GSK Ellipta-range products. This strong performance underpins our ability to invest in building the pipeline for additional future growth as well as meeting anticipated future demand for flutiform.
“Today we have announced our plans to build on the success of flutiform by developing SKP-2076, a new ICS/LABA/LAMA triple combination product for the treatment of asthma. We believe SKP-2076 has the potential for relatively quick progress through clinical trials in Europe, putting Skyepharma in a position to benefit from the anticipated new market for fixed-combination triple therapies for asthma. SKP-2075 also has the potential for relatively quick development in Europe with our plan to generate dose-ranging data as part of our Phase II programme. With SKP-2075 in COPD/smoking asthma and SKP-2076 in asthma, additional potential indications and markets for flutiform and novel oral delivery technologies in development, we have a promising pipeline which we believe can deliver significant additional long-term growth.”
Capital Markets meeting
A Capital Markets meeting is being held this morning at the offices of FTI Consulting in London. Skyepharma management team members and two external speakers will make a series of presentations to provide a detailed review of Skyepharma’s development pipeline as well as an update on the progress of the Group’s key growth drivers and strategy. Further details of today’s event are listed at the end of this press release and the Skyepharma presentations will be available on Skyepharma’s website before the end of today.
-Ends-
For further information, please contact:
Skyepharma PLC
Peter Grant, Chief Executive Officer
Andrew Derodra, Chief Financial Officer
+44 207 881 0524
Jonathan Birt, Investor and Media Relations
+44 786 036 1746
FTI Consulting
Julia Phillips/Rob Winder/Natalie Garland-Collins
+44 203 727 1000
N+1 Singer
Shaun Dobson/Jen Boorer +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 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 1 Using exchange rates for the relevant period.
2 Company analysis based on: i) Chronic obstructive pulmonary disease. Forecast. Datamonitor, DMKC0047510, Publication Date: 03/10/2014
ii) Asthma. Forecast, DMKC0082148, Publication Date: 18/06/2014 iii) Extrapolation of main market sales to global sales numbers with a factor of 25%
Trading update
Overall trading to date has continued to perform in line with the Board’s expectations for the full year. In addition, the Group has benefited from higher cash receipts and as a result, year-end cash is expected to be ahead of the Board’s previous expectations.
flutiform®
flutiform®, the combination of the fast-acting LABA formoterol, and the most widely prescribed ICS fluticasone, has now been approved in 38 countries and launched in 30. In addition, applications for marketing authorisations are currently under review in a further 15 countries.
In Europe, good progress continues to be made on the development of a breath-actuated version of flutiform®. If approved and launched, Skyepharma would be eligible for revenues on this product from royalties, milestones and filled-canister supply in the same manner as for sales of flutiform®. In addition, progress is being made with the COPD (chronic obstructive pulmonary disease) clinical study, following completion in May of the recruitment of over 1,700 patients. Mundipharma has now met with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to agree on what is required for the resubmission of its application for a European paediatric indication of flutiform® for asthma and is considering the timing of this.
In Asia-Pacific, including China, Mundipharma has completed recruitment for a clinical trial of flutiform® for COPD involving more than 900 patients treated over a 12-week period. Preparations are also being made for a clinical trial in China for asthma which will commence once the Chinese Food and Drug Administration (CFDA) has approved the investigational new drug application.
In Japan, Kyorin reported gross sales of flutiform® of Yen 3.0 billion (£16.0 million1) in the six months ended 30 September 2015, compared with Yen 0.9 billion (£5.2 million1) in the comparable prior year period and Yen 3.6 billion (£20.3 million1) for the full year ended 31 March 2015.
In Latin America, the Group’s partner, Sanofi, has obtained approval in Colombia for flutiform®, which is already approved in Argentina. Further filings are in preparation. Skyepharma and Sanofi are in discussions with a third party to commercialise flutiform® in Latin America.
Development pipeline
The Group continues to make encouraging progress in implementing its strategy to develop inhalation products with developments for the new products, SKP-2075 and SKP-2076. These products are aimed at the global market for the treatment of asthma and/or COPD currently worth approximately U.S.$29 billion per annum2.
SKP-2075
Skyepharma commenced work on the first product candidate (SKP-2075) for COPD using the novel inhaled therapy platform acquired from Pulmagen in 2014. SKP-2075 is being developed as a single capsule dry powder inhaler, comprising fluticasone propionate and a low dose of theophylline. Good progress has been made in formulating the product and with commencement of non-clinical studies for the treatment of COPD/smoking asthma. The Board believes that the treatment of COPD/smoking asthma is a clinically important medical need and SKP-2075 has the potential to be one of the first products developed for this patient group. A Phase II efficacy and safety clinical trial is planned to commence in 2016 and expected to be concluded during 2017. It is being designed to produce statistically significant results with a view to partnering SKP-2075 for further development and commercialisation. The Board has decided to extend the scope of the clinical programme by generating dose-ranging data at the same time to offer the potential for a relatively quick development for Europe which the Board believes adds considerable value to the project. The cost of the additional investment in developing SKP-2075 is expected to be circa £2 million per annum for each of 2016 and 2017 and is expected to be offset by further revenues from flutiform® supply with the additional capacity planned to come on stream during 2016.
SKP-2076
Skyepharma commenced feasibility work on a new inhaled product candidate, SKP-2076, early in 2015. SKP-2076 is a triple ICS/LABA/LAMA combination product incorporating known chemical entities aimed at the potential market for asthma patients who are not adequately controlled on current combination ICS/LABA therapies. Encouraging progress is being made with the initial formulation for SKP-2076, which is expected to move into GMP pilot scale manufacturing in 2016. In light of the positive experience with flutiform®, the Board believes that SKP-2076 could add significant value to Skyepharma’s respiratory franchise and has the potential for relatively quick development for Europe. Skyepharma is already engaged in partnering discussions to licence and fund the further development of this product after the initial formulation stage.
Oral developments
As previously announced, the Group is developing Soctec™, a concept for a novel, proprietary gastro-retentive drug delivery platform technology comprising a buoyant self-orienting capsule. It is targeted at gastro-retention and aims to retain the drug delivery device in the upper gastro-intestinal (“GI”) tract for as long as possible with the active ingredient being released for delivery for local action or absorption in the stomach or the upper GI tract. After an encouraging proof of concept study, progress is being made with further development to optimise the Soctec™ technology and plan for potential scale up. This technology is being marketed to potential partners.
A second technology is also under development for gastro-retention, aimed at higher payload requirements, and is currently in the final prototyping stage. Materials are being manufactured in preparation for a clinical proof of concept trial to be conducted in H1 2016.
The Group's licence partner for its SKP-1041 sleep maintenance product, Somnus Therapeutics, Inc. (“Somnus”), has been unable to secure further development funding despite a successful Phase II dose-ranging study. Somnus is, therefore, in the process of transferring all rights, materials and data back to Skyepharma. The Group has no current plans to develop SKP-1041. The only impact on the Group will be the earlier release of the remaining U.S.$0.3 million (£0.2 million) of deferred income, from the U.S.$5 million milestones paid by Somnus to date, as revenues in 2015.
Hikma Pharmaceuticals PLC (“Hikma”) and Skyepharma have established a collaboration to develop complex oral generic products and a first development project is being carried out.
Peter Grant, Chief Executive Officer of Skyepharma, commented:
"We remain on track to deliver substantial growth in revenues in 2015, with continued contributions from flutiform, Pacira’s EXPAREL and the GSK Ellipta-range products. This strong performance underpins our ability to invest in building the pipeline for additional future growth as well as meeting anticipated future demand for flutiform.
“Today we have announced our plans to build on the success of flutiform by developing SKP-2076, a new ICS/LABA/LAMA triple combination product for the treatment of asthma. We believe SKP-2076 has the potential for relatively quick progress through clinical trials in Europe, putting Skyepharma in a position to benefit from the anticipated new market for fixed-combination triple therapies for asthma. SKP-2075 also has the potential for relatively quick development in Europe with our plan to generate dose-ranging data as part of our Phase II programme. With SKP-2075 in COPD/smoking asthma and SKP-2076 in asthma, additional potential indications and markets for flutiform and novel oral delivery technologies in development, we have a promising pipeline which we believe can deliver significant additional long-term growth.”
Capital Markets meeting
A Capital Markets meeting is being held this morning at the offices of FTI Consulting in London. Skyepharma management team members and two external speakers will make a series of presentations to provide a detailed review of Skyepharma’s development pipeline as well as an update on the progress of the Group’s key growth drivers and strategy. Further details of today’s event are listed at the end of this press release and the Skyepharma presentations will be available on Skyepharma’s website before the end of today.
-Ends-
For further information, please contact:
Skyepharma PLC
Peter Grant, Chief Executive Officer
Andrew Derodra, Chief Financial Officer
+44 207 881 0524
Jonathan Birt, Investor and Media Relations
+44 786 036 1746
FTI Consulting
Julia Phillips/Rob Winder/Natalie Garland-Collins
+44 203 727 1000
N+1 Singer
Shaun Dobson/Jen Boorer +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 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 1 Using exchange rates for the relevant period.
2 Company analysis based on: i) Chronic obstructive pulmonary disease. Forecast. Datamonitor, DMKC0047510, Publication Date: 03/10/2014
ii) Asthma. Forecast, DMKC0082148, Publication Date: 18/06/2014 iii) Extrapolation of main market sales to global sales numbers with a factor of 25%