Forest Labs Snaps Up Clinical Data

Clinical Data (Nasdaq: CLDA  ) chief executive Drew Fromkin wasn't blowing smoke last month when he told analysts that his firm was in talks about a potential change in control. About a month after gaining FDA approval for its anti-depression drug, the Newton, MA-based company said today that it has agreed to be acquired by the New York pharmaceutical company Forest Laboratories (NYSE: FRX  ) for an initial sum of $1.2 billion.

Forest Labs agreed to shell out $30 per share or $1.2 billion in upfront cash -- a 6.6 percent premium above the average stock price of Clinical Data since it announced its FDA approval on January 24 -- to buy Clinical Data as well as up to $6 per share more to stockholders if Clinical Data's drug vilazodone (Viibryd) reaches certain sales goals over the next seven years. The boards of each company have already approved the deal, which is expected to close in the second quarter of 2011, according to Clinical Data. This deal is the latest proof that drug developers with FDA-approved treatments remain hot buyout targets in a pharma industry that is starved for new products to replace brand-name drugs that losing patent protection, and are falling prey to generic competition.

Indeed, this deal comes as major players in the $12 billion U.S. antidepressant market, such as Eli Lilly (NYSE: LLY  ) , Pfizer (NYSE: PFE  ) , and, yes, Forest Labs, face competition from generics over the next few years. Clinical Data's antidepressant, however, has patent protections that might help maintain its market exclusivity through 2020 and potentially longer, according to the company. Forest Labs now plans a U.S. launch of the drug in the second half of 2011, building on its previous experience of marketing the antidepressants citalopram (Celexa) and escitalopram (Lexapro). The key composition of matter patent on escitalopram is due to expire in March 2012, meaning that Forest will soon need another anti-depressant to keep its sales force busy.

Vilazodone is somewhat unusual among the well-known class of antidepressents known as selective serotonin reuptake inhibitors (SSRIs). The drug, which proved safe and effective in two eight-week clinical trials, not only acts as an SSRI but is also said to target the 5HT1A receptor, which is the target of the anti-anxiety pill buspirone. Clinical Data hasn't made any claims about whether the dual mechanism offers additional benefits for people with depression, but it might help differentiate the drug among many other SSRIs in the marketplace. Forest Labs is presumably betting that vilazodone will become an important new treatment option for patients.

At a personal level, check off the pending sale of Clinical Data as another big payday for the company's chairman, Randal "RJ" Kirk. Last month I wrote how the health care entrepreneur from Virginia, who controlled 52.5 percent of Clinical Data's stock as of September 30, has amassed a fortune through the sale of his previous companies such as Radford, VA-based New River Pharmaceuticals (sold to Shire for $2.6 billion in 2007) and General Injectables & Vaccines in 1998. Kirk also recruited Fromkin, who he met in the 1996 while Fromkin was an executive at Medco Health, to the company in 2005.

Fromkin was initially brought in as a consultant when Clinical Data was pursuing its acquisition of New Haven, CT-based Genaissance Pharmaceuticals, which the firm bought in 2005, the CEO told me last month. The Genaissance buyout brought Clinical Data the rights to vilazodone, which was originally developed by Germany-based Merck KGaA and shelved midway through its development. Yet Clinical Data medical chief Carol Reed and her team met with the FDA and developed a dosing regimen for vilazodone that proved successful in the late-stage clinical trials that helped pave the way to the FDA's approval of the treatment on January 21.

In addition to Kirk, Clinical Data's other noteworthy investors, have included the holding company for Fidelity Investments, OrbiMed Advisors, and Times Square Capital Management, Fromkin has said. Of course, Kirk appears to be the biggest financial winner in the company's sale to Forest Labs.

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Ryan McBride is Xconomy's correspondent. You can reach him at rmcbride@xconomy.com, or follow him on Twitter at http://twitter.com/Ryan_McBride.

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