SEEK and Pernix(TM) Therapeutics Appoint J.P.Morgan to Auction Theobromine (BC1036) Asset

March 24, 2011

LONDON and MAGNOLIA, Texas, March 24, 2011 /PRNewswire/ –

– First Potential New Active Cough Treatment in Over 50 Years

SEEK, a leading UK privately-owned drug-discovery group and Pernix(TM)
Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical
company primarily focused on the pediatric market, today announced that they
have engaged J.P.Morgan to auction the theobromine assets of the joint
venture. The auction will be for the global commercialisation rights
(excluding Korea) of theobromine. The decision to conduct an auction is based
on the interest shown within the pharmaceutical industry for theobromine
(BC1036), an antitussive drug candidate in late-stage development that
addresses the significant need for a non-opioid, non-codeine treatment for
persistent cough.

In South Korea, theobromine (BC1036) has already shown efficacy and
non-inferiority versus codeine in a phase III study, and marketing
authorization was granted to Ahngook, a South Korean company.

Pivotal phase III trials for theobromine (BC1036) are scheduled to begin
in the European market in the second half of 2011, and a regulatory filing is
expected in 2012. SEEK and Pernix are also in on-going discussions with the
US Food and Drug Administration (FDA) to determine the clinical trial program
and regulatory requirements for theobromine in the United States.

Manfred Scheske, Chief Executive Officer of the SEEK/Pernix joint
venture, comments: “We believe theobromine (BC1036) is a late-stage, low-risk
asset and will be the first new treatment for cough in over 50 years. Given
the prevalence of the condition and the need for a non-opioid, non-codeine
cough product, theobromine will be an important new treatment option for
physicians and patients. I believe that theobromine has substantial potential
at the primary-care level as a prescription medicine and it may also become
one of the most significant global OTC switch opportunities for a long time.”

Cooper Collins, Chief Executive Officer of Pernix, said: “We are pleased
to work with J.P. Morgan during the auction, which will ensure that we
maximize the value of theobromine (BC1036), an important asset for our joint
venture and shareholders.”

About theobromine

Theobromine is an alkaloid that is naturally present in dark chocolate
and is an existing human metabolite of caffeine. It has been shown to inhibit
the inappropriate firing of the vagus nerve, which is a key feature of
persistent cough. This peripheral mechanism of action differentiates
theobromine from codeine and other centrally acting agents.

About persistent cough

Persistent cough is a very common condition, afflicting over 800 million
people worldwide, with an estimated 12% of the general population (7.5
million in the UK), having the symptom on a daily or weekly basis. Persistent
cough, defined as a cough that persists for more than two weeks, has numerous
causes but falls into two broad categories; that causing an asthma-like
syndrome of the airways and oesophageal reflux. Failure to treat cough can
lead to enormous consequences in terms of loss of employment, healthcare
utilisation and a psychosocial morbidity.

About SEEK

Founded in 2004, SEEK (previously known as PepTcell) is a privately-owned
drug discovery group, 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 and autoimmune diseases,
transplantation tolerance induction, respiratory diseases, cancer and


Source: newswire

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