First potential new active cough treatment in over 50 years
MAGNOLIA, Texas & LONDON--(BUSINESS WIRE)-- Pernix™ Therapeutics Holdings, Inc. (NYSE Amex: PTX), a specialty pharmaceutical company primarily focused on the pediatric market, and SEEK, a leading UK privately-owned drug-discovery group, 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 commercialization 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 (BC1036) in the United States.
Manfred Scheske, Chief Executive Officer of the SEEK/Pernix joint venture, commented: “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 JP 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.
About Pernix Therapeutics
Pernix Therapeutics Holdings, Inc. is a specialty pharmaceutical company primarily focused on large and underserved opportunities in pediatric and other niche markets. The company manages a balanced portfolio of branded and generic products and low-risk product candidates. The company’s commercially-proven branded products include its family of prescription treatments for cough and cold (Brovex®, Aldex®, Pediatex®); CEDAX® (ceftibuten), an antibiotic for middle ear infections; ReZyst® (lactobacillus and bifidobacterium), a probiotic chewable tablet and QuinZyme® (ubiquinone 58b), a cardiovascular supplement. Pernix also seeks to expand its portfolio of branded products through collaborations such as the agreement with ParaPro, LLC to exclusively co-promote Natroba™ (spinosad) Topical Suspension, 0.9%, an FDA-approved topical treatment for head lice. The company promotes its branded products through an established U.S. sales force. Through its wholly-owned subsidiary, Macoven Pharmaceuticals, Pernix markets 11 generic products, including five authorized generic equivalents of the Company’s brands. Founded in 1999, the Company is based in The Woodlands, TX.
Additional information about Pernix is available on the Company’s website located at www.pernixtx.com.
Pernix™ is a registered trademark of Pernix Therapeutics, LLC. Natroba™ is a trademark of its owner, ParaPRO, LLC.
Cautionary Notice Regarding Forward-Looking Statements
The Company wishes to caution readers not to place undue reliance on any forward-looking statements, which speak only as of the date made. No assurances can be given regarding the future performance of the Company. The Company wishes to advise readers that factors could affect the Company’s financial performance and could cause the Company’s actual results for future periods to differ materially from any opinions or statements expressed with respect to future periods in any current statements.
The Company does not undertake, and specifically declines any obligation, to publicly release the result of any revisions which may be made to any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
Pernix Therapeutics Holdings, Inc.
Joseph T. Schepers
Director, Investor Relations
832-934-1825 ext. 2007
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