Cardiokine

Cardiokine, Inc. operated as a specialty pharmaceutical company with a strategic focus on developing treatments for cardiovascular diseases. Founded in 2003 by James Mervis and headquartered in Philadelphia, the company centered its efforts on addressing significant unmet needs within the cardio-renal and metabolic disease markets.

The company's formation was catalyzed by the in-licensing of its lead compound, lixivaptan, from Wyeth Pharmaceuticals in 2004. Lixivaptan is an orally active, selective vasopressin V2 receptor antagonist. Its mechanism of action involves blocking the vasopressin hormone, which causes the kidneys to retain water, thereby helping patients eliminate excess fluids while sparing electrolytes. The primary therapeutic target for lixivaptan was hyponatremia, a condition of low sodium concentration in the blood, particularly in patients with congestive heart failure, which affects millions in the U.S. annually.

Cardiokine successfully navigated the clinical development process for lixivaptan, advancing it through multiple Phase II and III trials. The company secured significant venture capital to fund these extensive research and development activities, raising a total of $87 million over two rounds. A Series A round in April 2004 brought in $37 million, followed by a $50 million Series B round in May 2006, with participation from investors such as Aisling Capital, Healthcare Ventures, and F-Prime Capital. In 2007, Cardiokine entered into a partnership with Biogen Idec to jointly develop and globally commercialize lixivaptan.

A pivotal moment in the company's history occurred on December 30, 2011, when it was acquired by Cornerstone Therapeutics Inc. (now Chiesi USA). The acquisition provided Cornerstone with the worldwide rights to lixivaptan. Following the acquisition, a New Drug Application (NDA) for lixivaptan was filed with the U.S. Food and Drug Administration (FDA) on December 29, 2011. However, in September 2012, an FDA advisory committee voted against the approval of lixivaptan for treating hyponatremia in patients with heart failure, citing that the drug's modest benefits did not outweigh its risks.

Keywords: Cardiokine, lixivaptan, specialty pharmaceutical, cardiovascular diseases, cardio-renal, hyponatremia, congestive heart failure, vasopressin V2 receptor antagonist, clinical trials, Cornerstone Therapeutics, Biogen Idec, Wyeth Pharmaceuticals, James Mervis, drug development, venture capital, pharmaceutical acquisition, NDA filing, FDA advisory committee