Pernix Therapeutics Holdings Inc., an integrated specialty pharmaceutical company focused primarily on the pediatric market, today announced its new joint venture with SEEK, a leading UK private drug discovery group.
The companies have licensed or assigned all of their relative intellectual property to the joint venture to undertake the late-stage development and registration of BC1036, a first-in-class drug designed to address the serious need for a safer and more effective, non-opioid treatment for persistent cough.
According to today’s announcement, persistent cough is a very common condition, though the cough market has seen little to no innovation over the past 20 years despite the side-effects associated with current treatments.
“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 Alyn Morice, head of the Hull Cough Clinic, stated in the press release.
After a consultation with European regulatory authority, Pernix and SEEK will conduct a single pivotal phase III trial of BC1036, which is expected to begin in the first half of 2011. The new venture is also in discussions with the U.S. Food and Drug Administration and said they expect to confirm the regulatory program early next year.
Pernix said that based on the successful launch of BC1036 in 2009 as AnyCough™ in Korea, BC1036 has the potential to be on the market in Europe and the U.S. within two years from trial commencement.
“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,” Cooper Collins, president and CEO of Pernix stated. “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. 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.”
For more information visit www.pernixtx.com