25 Jun 2015 07:00
Interim Results Pre-close Trading Update
LONDON, UK, 25 June 2015 - Skyepharma PLC (LSE: SKP), the expert oral and inhalation drug development company, today publishes a pre-close trading update ahead of the announcement due in late August 2015 of its interim results for the six months ending 30 June 2015.
Current trading
The Group continues to trade in line with the Board's expectations for the full financial year. flutiform® royalty and product supply revenues benefit from increasing demand and there has been growth of royalties from the new GSK Ellipta®-range products and from Solaraze® in the U.S. as reported in the AGM trading update on 12 May. Based on current consensus of analysts covering Pacira, the Board continues to anticipate that the U.S.$8.0 million (£5.2 million) EXPAREL® sales milestone payable to Skyepharma if annual net sales (on a cash received basis) exceed U.S.$250 million should be achieved in 2015.
Following recent launches in Malaysia, the Philippines, Kuwait and the UAE, flutiform® is now available in 30 countries for the treatment of asthma in adults and adolescents aged 12 and above. It has also been approved in a further six countries and applications for marketing authorisations are under review in a further 14 countries.
In May, the Group's development and marketing partner, Mundipharma, completed recruitment for its European clinical study of flutiform® for Chronic Obstructive Pulmonary Disease (COPD). This study is a 52 week multi-centre, randomised, double-blind, active-controlled, parallel-group study and has successfully recruited over 1,700 patients.
On 28 May, Pacira announced that it had completed the End-of-Review process with the U.S. Food and Drug Administration (FDA) regarding its supplemental New Drug Application (sNDA) for the use of EXPAREL® for administration as a nerve block to provide postsurgical analgesia. Pacira plans to conduct additional Phase III studies for upper extremity and lower extremity nerve blocks that together would cover the majority of nerve blocks performed today in the U.S. Pacira anticipates working with the FDA to finalise the design of the Phase III trials and expects to initiate the studies by the end of 2015.
Peter Grant, Chief Executive Officer of Skyepharma, commented:
"Skyepharma has had a good first half of the year and we remain confident of the outlook for the full financial year. Sales of flutiform, a key value driver of the business, continue to grow and the product has been launced in four additional countries. The Group has benefitted from increased royalties from GSK's new inhalation products, which use technology licenced from Skyepharma, from sales of Solaraze in the U.S and from its 3 percent. share of increased sales of EXPAREL. The combination of further launches and product approvals continues to build momentum for the future and we look forward to this progressing thoughout 2015."
- Ends -
For further information please contact:
Skyepharma PLC | |
Peter Grant, Chief Executive Officer Andrew Derodra, Chief Financial Officer | +44 (0)20 7881 0524 |
Jonathan Birt, Investor and Media Relations
| +44 (0)7860 361746 |
N+1 Singer | |
Shaun Dobson/Jen Boorer | +44 (0)20 7496 3000 |
FTI Consulting | |
Julia Phillips/Rob Winder/Natalie Garland-Collins | +44 (0)20 3727 1000 |
About Skyepharma PLC
Skyepharma combines proven scientific expertise with validated proprietary technologies to develop innovative oral and inhalation pharmaceutical products. The Group's licenses cover 16 approved inhalation, oral, topical and injectable products, which generate milestones, recurring royalties, and in some cases, product supply revenues. The Group also earns milestones and contract development revenues from new product developments. Products developed by Skyepharma are marketed by some of the world's most respected pharmaceutical companies. For more information, visit www.skyepharma.com