Novel triple ICS/LABA/LAMA combination builds on success of flutiform®
LONDON, UK, 23 December, 2015 - Skyepharma PLC (LSE SKP), the expert oral and inhalation drug development company, today announces that the Group has entered into a feasibility and option agreement with Mundipharma Laboratories GmbH, which is expected to lead to the Mundipharma network of independent associated companies (“Mundipharma”) being the global development and commercialisation partner for SKP-2076, Skyepharma’s novel triple ICS/LABA/LAMA1 fixed dose combination product in a pressurised Metered Dose Inhaler (pMDI).
In light of the positive experience with flutiform®, which is marketed by Mundipharma in Europe and many other markets and by Kyorin in Japan, the Board believes that SKP-2076 could add significant value to Skyepharma’s respiratory franchise and has the potential for relatively rapid development in Europe.
Under the agreement, Skyepharma is responsible for certain feasibility work which is planned to be completed in Q2 2016. Mundipharma has the option, exercisable until shortly after completion of the feasibility work, to complete the development of, and commercialise, SKP-2076 under exclusive global development and licence agreements which the parties have agreed to use good faith and reasonable efforts to negotiate based on heads of terms already established. Skyepharma would provide chemistry, manufacturing and control (CMC) services to Mundipharma to support this development, which would be funded by Mundipharma.
Skyepharma generated the concept of SKP-2076 internally and commenced feasibility work in early 2015. Encouraging progress is being made on the initial formulation for SKP-2076, which is expected to be ready to move into GMP pilot-scale manufacturing in 2016.
A non-refundable option fee of several hundred thousand Euros is receivable shortly by Skyepharma in respect of the feasibility and option agreement. The milestones and royalty terms are expected to include substantial initial, development, launch and sales milestones as well as royalties on product sales, once the development and licence agreements are finalised.
Peter Grant, Chief Executive Officer of Skyepharma, commented:
“This new partnership further expands our excellent relationship with Mundipharma based on our successful collaboration on flutiform, which is growing well in multiple markets. The ICS/LABA/LAMA triple combination is a natural extension of the flutiform franchise and we believe it has the potential to provide an important additional treatment option for doctors and patients. SKP-2076 is a great example of innovation at Skyepharma, leveraging our expertise and strong relationships with partners to generate benefits for patients and value for shareholders.”
-Ends-
[1] ICS – Inhaled corticosteroid LABA – Long-acting beta agonist LAMA – Long-acting muscarinic agonist
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/Gillian Martin/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
About Mundipharma
The Mundipharma independent associated companies have become leaders in pain management, and are building a growing presence in the oncology, rheumatoid arthritis and respiratory markets. Through innovation and acquisition, the Mundipharma mission is to deliver cutting-edge treatment solutions that meet the pressing needs of healthcare professionals and patients. For more information: www.mundipharma.com.
