SOURCE: Cornerstone Therapeutics

Cornerstone Therapeutics

July 02, 2012 08:03 ET

FDA Approves Cornerstone Therapeutics' ANDA for Generic Tussionex® Pennkinetic® Product

CARY, NC--(Marketwire - Jul 2, 2012) - Cornerstone Therapeutics Inc. (NASDAQ: CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products for the hospital, and related specialty markets, today announced that the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for a generic Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product. The antitussive/antihistamine combination product is a generic equivalent for the product currently sold under the Tussionex® Pennkinetic® brand name. The product is indicated for the relief of cough and upper respiratory symptoms associated with allergy or a cold in adults and children six years of age and older.

CRTX 067 was developed through a collaboration including Cornerstone, Coating Place, Inc. and Neos Therapeutics, LP, a subsidiary of Neos Therapeutics, Inc. Cornerstone will market the product through its wholly-owned generics subsidiary, Aristos Pharmaceuticals, Inc. Coating Place manufactures and supplies the active pharmaceutical ingredients (APIs), including a patent-protected version of hydrocodone polistirex. Neos developed the CRTX 067 drug product formulation using its proprietary formulation technology, Dynamic Time Release Suspension® (DTRS®), and Neos will be the exclusive manufacturer of the approved drug product.

"We are pleased with the FDA's decision to approve our generic antitussive/antihistamine product," said Craig A. Collard, Cornerstone's Chief Executive Officer. "Given the recent industry challenges and changes related to prescription cough and cold medications, this product affords patients an approved generic drug product alternative as well as providing Cornerstone the opportunity for growth."

Collard added, "While Cornerstone recently completed its strategic shift away from primary care, one of our main goals through Aristos is to continue to seek out and introduce opportunistic generic products. The addition of a generic Tussionex to Aristos' product portfolio is yet another successful execution of this plan."

Cornerstone will begin manufacturing its generic antitussive/antihistamine product immediately. Despite competition from other generics, Cornerstone believes that there is a strong market opportunity given the demand that exists within this market. Antitussives are some of the most commonly prescribed medications during cough and cold season. Total prescriptions for Tussionex and related generics were 2.59 million in 2011 according to IMS Health, a third-party provider of prescription data. This represents a 2% increase in prescription volume as compared to 2010. Cornerstone management believes its distribution expertise will allow Cornerstone to effectively gain market share for its generic product.

Important Safety Information
Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is contraindicated in children younger than 6 years of age due to the potential occurrence of respiratory depression that can lead to death, and in patients with a recognized allergy or sensitivity to hydrocodone or chlorpheniramine. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension inhibits the cough reflex and may be associated with dose-related respiratory depression or irregular and periodic breathing. In the post-operative setting and in patients affected by pulmonary disease or depressed ventilatory function, caution should be used when Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is administered. In case of head injury, other intracranial lesions, or a prior increase in intracranial pressure, narcotic-associated respiratory depression and increase in cerebrospinal fluid pressure may be significantly enhanced. Moreover, narcotics are associated with adverse reactions which may mask the clinical course of patients with head injuries. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension is a Schedule III narcotic. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension should be prescribed and used with caution due to the fact that repeated administration of narcotics is associated with psychic and physical dependence and tolerance. The administration of narcotics may mask the diagnosis of acute abdominal conditions and their clinical course. Obstructive bowel disease may result from the chronic use of narcotics, particularly in patients with intestinal motility disorders. In patients with narrow-angle glaucoma, asthma, or prostatic hypertrophy, caution is needed when prescribing this drug. Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension should be used with caution in elderly or debilitated patients and those with severe hepatic or renal dysfunction, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.

About Cornerstone Therapeutics
Cornerstone Therapeutics Inc. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital, niche respiratory and related specialty markets. Key elements of the Company's strategy are to focus its commercial and internal development efforts in the hospital and related specialty product sector within the U.S. pharmaceutical marketplace; continue to seek out opportunities to acquire companies and marketed and/or registration-stage products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. For more information, visit

About Neos Therapeutics, Inc.
Neos Therapeutics, Inc. is a specialty pharmaceutical company focused on the development, manufacture and sale of FDA approved drug products which utilize the Company's proprietary delivery technologies. Neos' drug products are being developed using the Dynamic Time Release Suspension® (DTRS®) and Rapidly Disintegrating Ionic Masking™ (RDIM™) technologies, that deliver controlled-release (CR) small molecule APIs in either liquid or orally disintegrating tablet (ODT) dosage forms. By utilizing APIs that are FDA-approved and known to be safe and effective, Neos can reduce development and regulatory risk and efficiently advance targeted proprietary Rx products through the FDA's 505(b)(2) New Drug Application (NDA) approval process. For more information, visit

About Coating Place, Inc.
Coating Place is an established niche pharmaceutical company specializing in Wurster fluid bed technology focused on drug delivery system development and contract manufacturing. It provides its customers with modified & extended release bulk active products through innovative development, unique manufacturing capabilities and integrated quality philosophy. Coating Place's extended-release drug-resin API's were developed using its patented DRC Technology combined with its trade secret linear scale-able Wurster manufacturing process. For more information, visit

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein, other than statements of historical fact, including our strategy and our future operations and opportunities, including our plans regarding the manner and timing for the manufacture, launch and sale of our Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including our ability to satisfy FDA and other regulatory requirements, our ability to develop and maintain the necessary sales, marketing, supply chain, distribution and manufacturing capabilities to commercialize our products, and our ability to successfully commercialize our generic products, including our Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release suspension product, in a market that has existing generic products, and the other factors described in Item 1A (Risk Factors) of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the SEC) on March 6, 2012. In addition, the statements in this press release reflect our expectations and beliefs as of the date of this release, and these statements should not be relied upon as representing our views as of any other date and do not reflect the potential impact of any acquisitions, mergers, dispositions, business development transactions, joint ventures or investments that we may make or enter into. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise, except as required by law.

Tussionex® and Pennkinetic® are registered trademarks of the UCB Group of companies.

Dynamic Time Release Suspension® and DTRS® are registered trademarks of Neos Therapeutics, LP, and Rapidly Disintegrating Ionic Masking™ and RDIM™ are trademarks of Neos Therapeutics, Inc.