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RNS Number : 4753A
Skyepharma PLC
07 June 2016
Skyepharma signs exclusive agreement to access Lucideon's abuse
deterrent drug delivery technology
First product to be developed for the growing U.S.$11bn U.S.
opioid market
LONDON, UK, 7 June, 2016 - Skyepharma PLC (LSE: SKP), the expert
oral and inhalation drug development company, announces that its
oral business has signed an exclusive feasibility, development and
licence agreement with Lucideon Limited, part of Lucideon Group Ltd
("Lucideon"), the international materials development and
commercialisation organisation, giving Skyepharma access to
Lucideon's iCRT-deter abuse deterrent controlled release
technology.
Skyepharma initially intends to use the technology to develop an
abuse deterrent formulation of a major opioid for the U.S. market
which according to GBI Research is set to grow from $11 billion in
2014 to $17.7 billion by 2021(1) . The companies will collaborate
over the coming months to assess the feasibility of using the
technology in this novel way. Skyepharma will fund this development
work, in line with current R&D spend plans. Lucideon will
provide specialist expertise with its technology and Skyepharma's
oral business will formulate the product and complete an abuse
deterrence challenge study. If the feasibility stage is successful,
Skyepharma's oral business plans to develop the product as a
generic for the U.S. market.
There is growing awareness of the issue of opioid abuse by
public health, governmental and regulatory bodies. The U.S. Centers
for Disease Control and Prevention (CDC) now considers prescription
drug abuse in the U.S. an epidemic(2) . Additionally, the U.S. Food
and Drug Administration (FDA)(3) , has called for a far-reaching
action plan to reassess the agency's approach to opioid medication.
The plan will focus on policies aimed at reversing the epidemic,
while still providing patients in pain access to effective relief
and will expand access to, and encourage the development of, abuse
deterrent formulations of opioid products. As a result, the market
for abuse deterrent technologies is expected to grow strongly and
there is likely to be demand for more advanced technologies which
deter multiple methods of abuse.
Lucideon's iCRT-deter proprietary oral drug delivery platform
technology is designed to enable drug products to retain their
controlled-release properties regardless of tampering methods such
as chewing, crushing and heating.
Skyepharma's oral business has proven expertise in developing
controlled-release oral pharmaceutical products and has the
capabilities, in its Lyon Facility, to formulate product and
manufacture clinical trial supplies.
Lucideon is eligible for appropriate milestone payments as the
development progresses as well as a single digit share of
Skyepharma's royalty revenues from in-market sales of the product.
Assuming a successful development, the investment by Skyepharma is
expected to be c. GBP4 million over four years, which is within
Skyepharma's existing guidance for overall investment in research
and development.
Peter Grant, Chief Executive Officer of Skyepharma,
commented:
"The agreement with Lucideon is an exciting development for
Skyepharma's oral business. It combines leading and innovative
technology from Lucideon with Skyepharma's proven oral
pharmaceutical development capabilities to address a major need in
a very large and growing market. If the feasibility study is
successful, this could provide additional development and clinical
trial supply work for the Lyon Facility where the manufacturing
business is due to return to Skyepharma on expiry of the lease to
Aenova on 30 June 2016. The route to market is also highly
innovative - the generic (ANDA) route to filing provides a
relatively rapid potential for approval, whilst opening up further
opportunities should regulators seek to require greater abuse
deterrence in marketed opioids."
Tony Kinsella, Chief Executive of Lucideon, said:
"The partnership with Skyepharma's oral business demonstrates
how Lucideon's technologies reach into multiple industries and we
are delighted to be collaborating with a company with a strong
track record in successful partnerships. We are pleased that our
technology will be combined with Skyepharma's pharmaceutical
development expertise to extend our reach further into the
healthcare sector. We hope to have further opportunities to
collaborate with Skyepharma using our iCRT family of technologies.
This contract demonstrates the strength of our growing platform
technology portfolio, particularly, but not exclusively, in
healthcare markets."
-Ends-
1. GBI Research report, August 2015: Opioids Overview to 2021:
An Assessment of Pain Management and Dependence
2. L. Paulozzi, et al., T: Cdc Grand Rounds: Prescription Drug
Overdoses - A U.S. Epidemic MMWR 61(01); 10-13. (2012)
3. FDA press release 4 February 2016
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
About Lucideon
Lucideon is a leading international provider of materials
development, commercialisation, testing and assurance. The company
improves the competitive advantage and profitability of its clients
by providing them with the expertise and innovative thinking that
they need to optimise their materials, products and processes.
Through its offices and laboratories in the UK, US and the Far
East, Lucideon services high-technology sectors including
healthcare, ceramics, aerospace and energy. For more information,
visit www.lucideon.com
About Lucideon's iCRT-deter technology
iCRT-deter is Lucideon's proprietary oral drug delivery platform
technology that provides abuse deterrent controlled release
properties. The technology incorporates active molecules within the
porous matrix and is designed to enable drug products to retain
their controlled-release properties during tampering methods such
as chewing, crushing and heating.
Key abuse deterrent features include:
-- Extremely hard structure that is very difficult to crush.
-- Particulate technology that allows individual particles to
retain their properties even if crushed.
-- Extremely high melting point to deter injection.
-- Low solubility and large particle sizes unsuitable for injection through suspension.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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June 07, 2016 09:56 ET (13:56 GMT)
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