Skip to main content


Cornerstone Therapeutics Acquires Cardiokine

By Cardiokine, Press Release
Press Release.


January 04, 2012 07:30 ET

Cornerstone Therapeutics Acquires Cardiokine

CARY, NC–(Marketwire – Jan 4, 2012) – Cornerstone Therapeutics (NASDAQ: CRTX)

•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 (NASDAQ: CRTX), a specialty pharmaceutical company focused on acquiring, developing and commercializing proprietary products for the hospital and respiratory markets, today announced that it has acquired Cardiokine Inc., a specialty pharmaceutical company focused on developing hospital products for cardiovascular indications. The merger was effective Dec. 30, 2011.

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. (NASDAQ: CRTX), headquartered in Cary, N.C., is a specialty pharmaceutical company focused on acquiring, developing and commercializing products for the respiratory, hospital and related specialty markets. Key elements of the Company’s strategy are to focus on identifying therapeutic niches within respiratory, hospital and related specialty markets to leverage existing business and create new opportunities; promote the Company’s current products to high prescribing physicians through the Company’s respiratory sales force and to hospital-based healthcare professionals through the Company’s hospital sales force; license or acquire rights to existing patent- or trade secret-protected, branded products, which can be promoted through the same channels to generate on-going high-value earnings streams; advance the Company’s development projects and further build a robust pipeline; and generate revenues by marketing approved generic products through the Company’s wholly owned subsidiary, Aristos Pharmaceuticals, Inc. 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 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.

Biogen Idec and CardioKine partner to develop Lixivaptan, a novel Vasopressin Antagonist

By Cardiokine, Press Release
Press Release.


Lixivaptan to enter Phase III clinical trial in 2007 in heart failure patients.


Cambridge, MA and Philadelphia, PA (July 2, 2007) – Biogen Idec (NASDAQ: BIIB) and Cardiokine, Inc., a privately-held specialty pharmaceutical company focused on the development of drugs for the treatment of heart failure and related indications, today announced the signing of an agreement to jointly develop lixivaptan, an oral compound expected to enter a Phase III clinical trial this year for the potential treatment of hyponatremia in patients with congestive heart failure (CHF).

Lixivaptan is a selective V2 vasopressin receptor antagonist that, in clinical trials, has demonstrated promising activity in treating hyponatremia, an imbalance of sodium and water in the body. Lixivaptan works by causing water to be excreted from the kidney, without affecting sodium or other electrolytes. Particularly in heart failure patients, hyponatremia is associated with volume overload, a key symptom leading to hospitalization of these patients. In addition, hyponatremia is an important feature of other disorders including liver cirrhosis and syndrome of inappropriate antidiuretic hormone (SIADH), and can contribute to morbidity and negative outcomes.

“With this late-stage oral compound, we continue to leverage our global development and specialty market expertise to grow our business and broaden our therapeutic focus. An effective treatment for hyponatremia could be beneficial to patients with a variety of diseases, including heart failure,” said James C. Mullen, Biogen Idec’s President and Chief Executive Officer (CEO). “This program will expand our efforts in cardiovascular care and we look forward to working with Cardiokine to deliver this promising new product for patients.”

“We are extremely pleased to be partnering lixivaptan with Biogen Idec. We share an appreciation of the adverse health consequences associated with hyponatremia and have a common vision for lixivaptan. Biogen Idec’s proven development and commercialization capabilities in concert with Cardiokine’s development team will make this vision a reality,” said David Brand, President and CEO of Cardiokine.

Under terms of the agreement, Cardiokine will receive a $50 million upfront payment and up to $170 million in additional milestone payments for successful development and global commercialization of lixivaptan, as well as royalties on commercial sales. Biogen Idec will be responsible for the global commercialization of lixivaptan and Cardiokine will have an option for limited co-promotion in the United States (U.S.). The agreement is expected to become effective in the third quarter of 2007, and is subject to the satisfaction of certain closing conditions and customary approvals.


About lixivaptan
Lixivaptan is a highly potent, non-peptide, selective V2 vasopressin receptor antagonist. It antagonizes the action of vasopressin (also known as antidiuretic hormone, ADH) on the V2 receptors in the kidney-collecting duct, causing water to be excreted from the kidney, without affecting sodium or other electrolytes. Based on this mechanism of action, lixivaptan shows promise in the treatment of disease states associated with water retention and electrolyte imbalance.

About hyponatremia
Hyponatremia is the most common electrolyte disorder in clinical practice. It is estimated that the incidence of hyponatremia in hospitalized patients in the U.S. is greater than one million. Hyponatremia is recognized as an independent contributor to negative patient outcomes in many chronic diseases, most notably CHF, as well as cirrhosis and SIADH.

About Cardiokine
Cardiokine, headquartered in Philadelphia, is a privately held specialty pharmaceutical company focused on the development of pharmaceuticals for the treatment and prevention of heart failure and related cardiovascular and metabolic indications. Additional information about Cardiokine is available at

About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec’s significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis. For press releases and additional information about the company, please visit,

Biogen Idec Safe Harbor
This press release contains forward-looking statements regarding the agreement with Cardiokine and the development of lixivaptan. These statements are based on the companies’ current beliefs and expectations. Drug development involves a high degree of risk. Only a small number of research and development programs result in commercialization of a product. Factors which could cause actual results to differ materially from Biogen Idec’s current expectations include the risk that the company may not be able to demonstrate the safety and efficacy of lixivaptan at each stage of the clinical trial process; technical hurdles relating to the manufacture of lixivaptan may be encountered; the company may not be able to meet applicable regulatory standards or regulatory authorities may fail to approve lixivaptan; and the company may encounter other unexpected hurdles.

For more detailed information on the risks and uncertainties associated with Biogen Idec’s drug development activities, see the section entitled “Risk Factors” in Biogen Idec’s quarterly report on Form 10-Q for the fiscal quarter ended March 31, 2007 that was filed with the Securities and Exchange Commission, as well as other periodic and current reports of Biogen Idec filed with the Securities and Exchange Commission. Biogen Idec assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.