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

By Seek, PRNE
Sunday, December 19, 2010

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

LONDON, December 20, 2010 - 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

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common cough treatments, is in the process of being withdrawn from use by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

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

For further information about SEEK please visit

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


1. Department of Cardiovascular and Respiratory Studies,
University of Hull, Castle Hill Hospital, Cottingham, East Yorkshire, 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

SEEK, Gregory Stoloff, Chief Executive Officer Tel: +44(0)20-7153-6570, Dr Stuart Robinson, Head of Medical Affairs Tel: +44(0)7789-487042, M: Communications, Nick Francis Tel: +44(0)20-7920-2320, Amber Bielecka Tel: +44(0)20-7920-2352

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