2013 Apr 15 Annual Report 2012 - Phosphagenics

12
OPIOID PATCH PROGRAM
The opioid patch program has evolved since
the Company announced the success of its
Oxycodone patch prototype in June 2009.
This patch was taken to the clinic in February
2010 and achieved its end points of safety and
delivery into the bloodstream. In March 2011,
we partnered with 3M who helped develop a
patch to take to the clinic in early 2012. Again
this improved patch met primary endpoints of
safety and delivery but issues of crystallisation
meant that this had to be resolved prior to
any further steps towards commercialisation.
With the assistance of our new development
partner Labtec Phosphagenics was able to
resolve those issues and formulate a patch that
is ready to return to the clinic in early 2013.
In December 2012, Phosphagenics announced
the expansion of the opioid patch portfolio to
include other opioids with the first candidate being
chosen Oxymorphone. Oxymorphone is an opioid
of similar structure to Oxycodone but in the oral
form is around 3.5 times as potent. Oxymorphone
clinical trials began in February. The Oxymorphone
market is dominated by the Endo product Opana
which has about 2/3rds of the total market of in
excess of $600 million per annum (which grew
by around 17% last year).
Oxymorphone is a drug which when taken orally
has very low bioavailability. This and the fact it is
considerably more potent than Oxycodone and
Morphine made it an ideal choice for transdermal
delivery. All the known advantages of transdermal
delivery still apply, but with the benefit of being
able to cater for more severe pain indications than
Oxycodone and Morphine. It was an excellent
achievement that our research team was able
to take the oxymorphone patch from idea to
clinical trials in 6 months. This emphasises the
level of expertise that has been reached by them.
The Opioid Patch Program Remains the
Focus of our Pharmaceutical Developments
The opioid patch program is entering the clinic with
its two main opioid patches in 2013. The patches
are being designed to provide sustained delivery
of opioids over 72 hours. Pain has reached
epidemic proportions in the US with more people
affected by pain than diabetes, heart disease
and cancer combined. In 2009, 257 million
prescriptions for opioids were dispensed
in America.
Chronic pain which is persistent pain can be
very debilitating. A recent market research report
indicates that more than 1.5billion people globally
suffer from chronic pain with 100 million in the US.
Currently there are only two opioids delivered
transdermally. Fentanyl which is now generic
but was originally branded as Duragesic, and
Buprenorphen which is a synthetic opioid which
The company in early 2013 also announced the
expansion of the program to investigate the use
of oxycodone as a topical application (via a patch)
for more localised pain relief, following on from
some earlier pre clinical results. A non systemic
delivery of an opioid would be a unique product
with none of the issues that are caused by
delivery into the bloodstream.
PHOSPHAGENICS ANNUAL REPORT 2012