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Hydrocodone Cough Suppressant Product Candidates — CBP 067 and CBP 069
Overview and Development Status
CBP 067 and CBP 069 are extended-release antihistamine and antitussive, or cough suppressant, combination product candidates currently in development. Cornerstone expects that both of these product candidates will require only pharmacokinetic studies for approval. Pharmacokinetic studies are designed to establish the kinetic profile of the test product and compare this profile to the profile of already approved products. Cornerstone plans to submit applications for marketing approval for these product candidates in 2009 and, if approved, commercially launch the product candidates in 2010. If approved, these product candidates will compete directly in the hydrocodone cough suppressant market.
Market Opportunity and Current Treatment Options
Cough can adversely affect quality of life, leading patients to seek medical attention. Health care providers have a variety of treatment options. Non-productive cough is commonly treated with antitussive and antitussive combinations that do not contain an expectorant, such as guaifenesin. Antitussive combination products that treat non-productive coughs typically combine an antitussive, including hydrocodone, codeine or dextromethorphan, with antihistamines, including chlorpheniramine or brompheniramine, or decongestants, including pseudoephedrine or phenylephrine. Dextromethorphan is available in both over-the-counter and prescription formulations. Hydrocodone, a centrally acting opioid antitussive, has been shown to be as effective as codeine but without gastrointestinal side effects.
According to Wolters Kluwer Health, in 2007, there were over 26 million prescriptions generated for oral antitussive and antitussive combinations without an expectorant. Of these, nearly 4.8 million were for Phenergan with codeine, which is available as a generic, and almost 3 million for UCB Pharma’s Tussionex® (hydrocodone polistirex and chlorpheniramine polistirex), which is only available as a brand.
On September 28, 2007, the FDA announced its intention to take enforcement action against companies marketing unapproved prescription drug products containing the narcotic hydrocodone. The action did not affect hydrocodone formulations that have FDA approval. Only eight cough suppressants containing hydrocodone were approved by the FDA as of August 31, 2008. Any company marketing unapproved hydrocodone drug products was required to cease manufacturing such products on or before December 31, 2007, and cease further shipment in interstate commerce on or before March 31, 2008, although pharmacies could continue to sell their remaining inventory.
According to Wolters Kluwer Health, U.S. sales of prescription hydrocodone cough suppressants were $300 million in 2007, with over 9.75 million prescriptions written. Approximately 55% of those prescriptions were for products not approved by the FDA.
In addition, 66% of the sales and 30% of the prescriptions written in 2007 for hydrocodone cough suppressants were generated by Tussionex, an approved extended-release hydrocodone and antihistamine combination. With limited availability of approved hydrocodone products, Tussionex prescriptions have increased dramatically in 2008. According to Wolters Kluwer Health, in April 2008, the month after the FDA enforcement action went into effect, Tussionex prescriptions grew 34% and sales grew 46% as compared to April 2007. Despite being approved by the FDA in 1987, Tussionex does not face any generic competition and has no patent protection.
Benefits of CBP 067 and CBP 069
Most antitussive and antitussive combination products that are currently marketed are in an immediate-release formulation, meaning they must be dosed every four to six hours, which can be inconvenient. For example, patients may not be able to sleep through the night because their antitussive is not effective for more than four hours. Cornerstone believes that CBP 067 and CBP 069 could improve patients’ quality of life by providing more convenient twice-daily, longer lasting dosing.
Proprietary Rights
Cornerstone has licensed the rights to market CBP 067 and CBP 069 utilizing the Dynamic Variable Release technology and the Dynamic Time Release Suspension™ technology of Neos and the drug resin complex technology of Coating Place, Inc., or Coating Place. Cornerstone expects that these licensed technologies will allow Cornerstone to formulate CBP 067 and CBP 069 with one or more active pharmaceutical ingredients that require immediate activation followed by a sustained timed release of the remaining active pharmaceutical ingredients over a 12-hour period. Neos’s Dynamic Variable Release technology is covered under a pending U.S. patent application that if issued would expire in 2024. Neos’s Dynamic Time Release Suspension technology is covered under a pending U.S. patent application that if issued would expire in 2025. Coating Place’s drug resin complex technology is covered under a pending U.S. patent application that if issued would expire in 2025.
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