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Joint Venture Formed to Fund Development and Registration of a Codeine-free Treatment for Persistent Cough

December 20, 2010

LONDON, December 20, 2010 /PRNewswire/ –

– Theobromine Based Drug Close to Commercialisation, Has Potential to
Address the Serious Need for a Safer, Opioid Free Treatment for Persistent
Cough

SEEK, a leading UK privately-owned drug-discovery group,is pleased to
announce the establishment of a new joint venture entity with Pernix
Therapeutics Holdings, Inc. (NYSE Amex: PTX) (“Pernix”), an integrated
specialty pharmaceutical company focused primarily on the United States
pediatric market. The joint venture will undertake the late-stage development
and registration of BC1036, a first-in-class antitussive drug, to address the
serious need for an effective, safe, non-opioid treatment for persistent
cough. Both parties will also contribute all of their theobromine
intellectual property by way of licence or assignment into the joint venture.

Following consultation with a European regulatory authority, the new
venture will conduct a single pivotal Phase III trial of BC1036, which is
expected to begin in the first half of 2011. This truncated regulatory path
is due to the significant historical safety data available for theobromine
and the beneficial effect seen in human use to date. The new venture is also
in discussions with the US regulatory authorities and expects to be able to
confirm the regulatory programme in the US early next year.

Theobromine is a well-known, safe product that is found in previous use
medicines and can also be found in significant quantities in cocoa-based
products including chocolate, and as a metabolite of caffeine. Theobromine
has been shown to inhibit the inappropriate firing of the vagus nerve which
is a key feature of persistent cough(2). This peripheral mechanism of action
differentiates theobromine from codeine and other centrally acting agents,
and leads to its lower central nervous system side effect.

Persistent cough is a very common condition, affecting an estimated
10-12.5%(1) of people globally. Persistent cough is defined by a cough that
persists for more than two weeks and may arise mainly from cough predominant
asthma, oesophageal reflux and rhinitis. The cough market has seen little to
no innovation over the past twenty years despite the severe side-effects
associated with current treatments. Codeine, a drug used in most common cough
treatments, is in the process of being withdrawn from use by under 18′s in
the OTC market in the UK.

As a result of the successful launch of BC1036 in 2009 as AnyCough(TM) in
Korea and the resulting substantial data package, BC1036 has the potential to
be on the market within two years from trial commencement, subject to
receiving marketing authorisation. The new venture is collaborating closely
with leading experts in the UK Professor Morice, Head of Hull Cough Clinic,
and Professor Ian Pavord, University Hospitals Leicester.

Professor AlynMorice, Head of the Hull Cough Clinic, commented:
“Thousands of people across the UK suffer from persistent cough and, due to
the drawbacks of current opioid drugs such as codeine, we are in desperate
need of a non-opioid treatment with a drastically improved side effect
profile for patients.”

Professor Ian Pavord, Department of Respiratory Medicine and Thoracic
Surgery, GlenfieldHospital, Leicester, commented: “Persistent cough is a
highly debilitating condition that severely impacts the lives of sufferers
and their family and friends. Currently available treatment options are
limited and often associated with negative side effects. The existing human
data on BC1036 is very exciting and I look forward to being in a position to
offer an effective and safe drug to our patients.”

Manfred Scheske, who has recently joined SEEK as CEO of Consumer Health,
will provide leadership and direction to the development of BC1036. Scheske
was formerly President of Consumer Healthcare Europe at GlaxoSmithKline
(“GSK”), where he enjoyed a highly successful 25-year career with GSK in
Europe, North America and at a global level within GSK’s Consumer Healthcare
Leadership Team.

Commenting on this announcement, Manfred Scheske, CEO of Consumer Health
at SEEK, said: “I am very excited that we have funding for the late-stage
development of BC1036, which has the potential to dramatically impact the
treatment of persistent cough and could greatly benefit the quality of life
of persistent cough sufferers. Utilising my extensive US and European
experience from GSK, I am very much looking forward to taking this programme
forward towards commercialisation and to announcing the commencement of our
regulatory programme in the US and Europe next year.”

Cooper Collins, President and CEO of Pernix, said: “This partnership is
an exciting step forward in the growth of our company and provides an
opportunity to increase our share of the approximately $3 billion global
market for prescription and OTC cough suppressants while strengthening our
existing portfolio of branded products for upper respiratory ailments in
pediatrics. By partnering with SEEK, we are able to advance this novel
codeine-free natural cough suppressant in a more cost-effective and lower
risk regulatory path, which is consistent with our strategy for identifying
potential new products. Given the lack of new treatments for persistent cough
over the last two decades, we believe that our non-opiate antitussive
medicine offers an innovative alternative treatment for persistent cough
sufferers and look forward to working with SEEK to advance the development of
BC1036 through commercialization in Europe and the U.S.”

About SEEK

Founded in 2004, SEEK – previously known as PepTcell – is privately-owned
and funded, with headquarters in London, UK. Using a pioneering scientific
and commercially-driven approach, SEEK aims to create breakthrough medicines
which address major diseases in order to radically improve human health.
SEEK’s strategy is to take promising molecules through the challenging stages
of discovery to late-stage human proof-of-principle and then to seek partners
to take the molecules through the final stages of development and ultimately
commercialisation. SEEK’s current product-development areas are vaccines,
inflammation/autoimmune diseases, transplantation tolerance induction,
respiratory diseases, cancer and diabetes/obesity.

For further information about SEEK please visit http://www.seekacure.com.

About Pernix Therapeutics

Pernix Therapeutics Holdings, Inc. is an integrated specialty
pharmaceutical company primarily focused on serving the needs of the
pediatric marketplace. Commercially-proven branded product families include
CEDAX(R), Brovex(R), Aldex(R), Pediatex(R), ReZyst(R), QuinZyme(R) and
Z-Cof(R). The Company was originally founded in 1999 and is based in the
Houston, TX metropolitan area. Additional information about Pernix is
available on the Company’s website located at http://www.pernixtx.com.

References:

1. Department of Cardiovascular and Respiratory Studies, University of
Hull, Castle Hill Hospital, Cottingham, East Yorkshire, UK,
a.h.morice@hull.ac.uk

2. Barnes, etal. “Theobromine inhibits sensory nerve activation and
cough” The FASEB Journal express article 10.1096/fj.04-1990fje. Published
online November 17, 2004

SOURCE SEEK


Source: newswire



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