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

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 Codeine, a drug used in most common cough treatments, is in the process of being withdrawn from use by under 18's in the OTC market in the UK.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, [email protected]

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