Clinical Data’s Billionaire Chairman a Major Player in Firm’s Newly FDA-Approved Antidepressant

1/25/11

Randal “RJ” Kirk is building another biotech winner. The billionaire Virginian, who is chairman of Newton, MA-based pharmaceutical company Clinical Data (NASDAQ:CLDA), has been a catalyst for the firm’s new FDA approval of an antidepressant.

Kirk, a major shareholder in Clinical Data for years and chairman since 2004, has advocated for the 39-year old firm’s transformation from a diagnostics and research company to a pharmaceutical developer, according to company CEO Drew Fromkin. This strategy paid off hugely yesterday as the company’s stock surged by more than 50 percent on news that its antidepressant, vilazodone, had garnered FDA approval on January 21.

Vilazodone’s approval is among of string of successes that Kirk, an attorney by training, and his business partners have had in biotech. He was previously founder and chairman of Radford, VA-based New River Pharmaceuticals, which was sold to the Ireland-based drug company Shire for $2.6 billion in 2007. New River developed a drug for attention deficit hyperactivity disorder (ADHD) that Shire markets as Vyvanse. Forbes reported that Kirk cleared $1.2 billion from Shires’s buyout of New River. He had also made millions on the 1998 sale of a Virginia drug distribution company he co-founded called General Injectables & Vaccines.

“His ownership and involvement are clearly material,” says Robert Hazlett, a biotech analyst for BMO Capital Markets, who gives Clinical Data’s stock an “outperform” rating. “He has a longstanding presence in healthcare broadly and drug development specifically.”

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  • Saumitra

    ” it did not outperform placebo in an earlier clinical trial. Yet Clinical Data’s chief medical officer, Carol Reed, later met with the FDA and learned how the drug could be advanced into late-stage clinical trials ”

    I wonder how Carol was able to bring Viibryd back from the dead. Would love to know what changes did FDA suggest – say primary end points / different biomarker / different I/E critera…