Hospitals

Cornerstone Therapeutics acquires Cardiokine; NDA filed prior to deal

Respiratory treatments company Cornerstone Therapeutics (NASDAQ:CRTX) is broadening its offerings with the acquisition of cardiovascular drug company Cardiokine Biopharma. Cary, North Carolina-based Cornerstone’s acquisition of Cardiokine, located in Philadelphia, was completed on Dec. 30, a day after Cardiokine filed a New Drug Application (NDA) for its lead drug candidate, lixivaptan. Lixivaptan has completed phase 3 […]

Respiratory treatments company Cornerstone Therapeutics (NASDAQ:CRTX) is broadening its offerings with the acquisition of cardiovascular drug company Cardiokine Biopharma.

Cary, North Carolina-based Cornerstone’s acquisition of Cardiokine, located in Philadelphia, was completed on Dec. 30, a day after Cardiokine filed a New Drug Application (NDA) for its lead drug candidate, lixivaptan.

Lixivaptan has completed phase 3 clinical trials for the treatment of hyponatremia, a condition in which the sodium levels of the blood are abnormally low. The condition is commonly diagnosed in patients with heart failure. Cardiokine cites estimates that the United States has 5 million heart failure patients annually, which results in more than 1 million hospitalizations and 550,000 cases of hyponatremia.

Financial terms of the acquisition were not disclosed. But Cornerstone has been explicit in its goals to build its portfolio by acquiring products. Last June, Craig A. Collard, CEO and chairman of its board of directors, said that Cornerstone had $86 million in cash on hand and no debt. He told analysts the company was actively seeking acquisitions. In lixivaptan, Cornerstone acquires a compound that has completed phase 3 clinical trials and if approved, would be used in a hospital setting. That’s key because Cornerstone has been making an effort to find other products to sell alongside Curosurf, the company’s top-selling drug that is also a hospital-based product. Cornerstone would be able to pitch another hospital-based product without having to expand its sales force.

Curosurf, which treats respiratory distress in infants, generated $9.3 million in third-quarter 2011 sales, up 16 percent compared over the same period in 2010. In 2011 through the third quarter, Curosurf generated $25.4 million, up 7 percent compared to the first nine months of 2010. Collard said more acquisitions are coming.

“We are very excited about adding a hospital product to complement Curosurf, our neonatal lung surfactant,” Collard said in a statement. “This is the first of several deals we hope to complete as we continue to execute the strategic plan that we initiated in 2011.”

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

And although Collard did not state this explicitly, those deals will probably be acquisitions of more hospital-based products.

Cardiokine was founded in Philadelphia in 2004 and lead compound lixivaptan was licensed from Wyeth later that year. The company has raised more than $87 million in outside investment. Dr. Cesare Orlandi, former Cardiokine chief medical officer, will continue to work on lixivaptan as a consultant to Cornerstone.

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