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Cornerstone Therapeutics Inc. Receives FDA Acceptance for CRTX 080 NDA for Treatment of Hyponatremia


3/13/2012 8:31:05 AM

CARY, NC--(Marketwire - March 13, 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 that the U.S. Food and Drug Administration (FDA) accepted a New Drug Application (NDA) for CRTX 080, Cornerstone's product candidate for the treatment of hyponatremia. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 29, 2012.

"This event marks another critical milestone in the focused execution of our strategic plan," said Craig A. Collard, Cornerstone's Chief Executive Officer. "CRTX 080 is an important addition to our hospital product portfolio. The hyponatremia market increased 86% in 2011, and we look forward to launching CRTX 080 into this rapidly expanding market."

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. CRTX 080 is a highly potent, non-peptide, oral capsule that works by reducing the action of a hormone (vasopressin) that blocks fluid excretion. CRTX 080 acts specifically on the vasopressin-2 receptor in the kidneys, causing water to be excreted while sparing sodium without affecting other electrolytes.

"We are pleased that CRTX 080 has passed this critical threshold in the drug development cycle," said Alan Roberts, Cornerstone's Vice President, Scientific Affairs. "The FDA's acceptance of our NDA brings Cornerstone one step closer to being able to provide an effective, well-studied treatment option for this complex condition that affects millions of patients."

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 secretion (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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