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."
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.
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 diabetes/obesity.