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Cornerstone Therapeutics Inc. Announces FDA Advisory Committee to Review Lixivaptan for Treatment of Hyponatremia


7/25/2012 9:14:22 AM

CARY, NC--(Marketwire - July 25, 2012) -

Cornerstone Therapeutics Inc. (NASDAQ: CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products for the hospital, niche respiratory and related specialty markets, announced today the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) of the U.S. Food and Drug Administration (FDA) has scheduled a review of the New Drug Application (NDA) for lixivaptan (CRTX 080) for the proposed indication of the treatment of symptomatic hypervolemic and euvolemic hyponatremia associated with heart failure and syndrome of inappropriate antidiuretic hormone (SIADH), respectively. The meeting is scheduled for September 13, 2012.

"Hyponatremia is a very common and complex condition, and we are committed to bringing lixivaptan to the market," said Craig A. Collard, Cornerstone's Chief Executive Officer. "Our team looks forward to discussing the data supporting the potential efficacy benefit and safety profile of lixivaptan with the committee and the FDA."

In March, Cornerstone announced the FDA's acceptance of the Company's NDA for lixivaptan. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 29, 2012. The Company continues to work closely with the FDA during NDA review. Cornerstone acquired lixivaptan through its 2011 acquisition of Cardiokine Biopharma, which became a wholly owned subsidiary of Cornerstone.

Hyponatremia affects up to six million people in the U.S. with direct medical costs estimated to range between $1.6 and $3.6 billion annually. Lixivaptan is a highly potent, non-peptide, oral capsule that works by reducing the action of a hormone (vasopressin) that blocks fluid excretion. Lixivaptan acts specifically on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.

The FDA will publish materials and details pertaining to the meeting at http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm.

About Hyponatremia
Hyponatremia is a metabolic condition that occurs when there is not enough sodium (salt) in the blood. It is the most common electrolyte disorder among hospitalized patients affecting up to six million people in the U.S. and is often diagnosed in patients with heart failure. In the U.S. alone, there are five million heart failure patients, and each year one-fourth of them develop hyponatremia. Other causes of hyponatremia include burns, diuretic medications, kidney disease, liver cirrhosis and syndrome of inappropriate antidiuretic hormone (SIADH).

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 www.crtx.com.

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 statements regarding the progress and timing of our product development programs and related trials, our strategy and our future operations and opportunities, 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 the results of preclinical studies and clinical trials with respect to our products under development, our ability to satisfy FDA and other regulatory requirements, our ability to enter into strategic licensing, product acquisition, collaboration or co-promotion transactions on favorable terms, if at all, 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.



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