CARY, NC--(Marketwire - Jan 4, 2012) - Cornerstone Therapeutics (
- Cornerstone acquires worldwide rights to investigational therapy for hyponatremia
- Hyponatremia is one of the most common metabolic conditions affecting up to 6 million people in the U.S. with direct medical costs estimated to range between $1.6 and $3.6 billion annually
- New Drug Application for lixivaptan filed Dec. 29, 2011; FDA approval expected in Q1 2013
- Expected launch of the product in the U.S. hospital market in 2013
Cornerstone Therapeutics (
Under the terms of the agreement, Cornerstone will acquire all outstanding shares of Cardiokine which is located in Philadelphia. Cardiokine recently completed a series of phase III clinical trials for its lead compound, lixivaptan for treatment of hyponatremia, and filed a New Drug Application (NDA) with the FDA on Dec. 29, 2011. Lixivaptan is an orally active, selective vasopressin 2 receptor antagonist and has the potential to address a large unmet medical need as current treatment options have significant limitations that have impeded adoption by many hospitals.
"We are very excited about adding a hospital product to complement Curosurf, our neonatal lung surfactant. This is the first of several deals we hope to complete as we continue to execute the strategic plan that we initiated in 2011," said Craig A. Collard, Cornerstone's Chief Executive Officer. "The hyponatremia market is expected to grow significantly in the coming years and currently has limited treatment alternatives. The acquisition of Cardiokine allows Cornerstone to expand our pipeline into a new area of treatment and creates the potential to use our hospital specialty expertise to help meet the needs of patients with hyponatremia."
Mr. Collard continued, "Consistent with our stated strategic intent, we expect this transaction to be accretive within the first full year following launch. Additionally, we will continue the ex-U.S. licensing discussions initiated by Cardiokine, which present the opportunity for incremental revenue."
"The clinical trials of lixivaptan were conducted in addition to current standard care in patients with hyponatremia associated with heart failure and the syndrome of inappropriate hormone secretion (SIADH), and comprise the largest placebo-controlled dataset to date in these populations," said Cesare Orlandi, MD, former Cardiokine Chief Medical Officer, who will continue his work on lixivaptan as a consultant to Cornerstone.
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 hormone secretion (SIADH).
About Cornerstone Therapeutics
Cornerstone Therapeutics Inc. (
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 3, 2011 and in our subsequent filings with the SEC. 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.