Big competitors don't scare Drew Fromkin. The CEO of Clinical Data (Nasdaq: CLDA) says that the small Newton, MA-based drug developer is willing to take on industry giants in the multibillion-dollar U.S. market for antidepressants.

The company sent in its application for approval of its experimental antidepressant, vilazodone, to the FDA in late March. It's too early to tell whether the agency will approve the company's application to start selling the drug in the U.S., but if Clinical Data can pass FDA scrutiny, it could have its first drug on the market by early 2011, Fromkin says.

Clinical Data is open to forming partnerships with larger drug companies to potentially co-market vilazodone, but the scrappy firm is preparing to market the product on its own in the U.S. if need be, Fromkin says. The go-it-alone strategy would pit Clinical Data, which has about 160 employees, against pharmaceutical behemoths such as Indianapolis-based Eli Lilly (NYSE: LLY), London-based GlaxoSmithKline (NYSE: GSK), and New York-based Pfizer (NYSE: PFE).

Fromkin, however, doesn't think that Clinical Data would have to match the marketing might of large players in the $12 billion U.S. market for antidepressants.

With a lean sales force of about 150 people, the CEO says, the company could focus on specialty physicians such as psychiatrists who prescribe most of the antidepressants in the country. In fact, he adds, 13 percent of U.S. doctors who prescribe the drugs order about 70 percent of the prescriptions for antidepressants, meaning his firm wouldn't have to call on the bigger pool of general practitioners and primary care doctors who write prescriptions to target those who order the most scripts. Also, he's expecting some major companies in the market to reduce their sales efforts for drugs that no longer have patent protections, leaving them open to competition from generic drugs that cost less.

"The market will very rapidly need much less promotion, being that many of these other products [that are off or nearly off patent] are not being promoted," says Fromkin, a 22-year veteran of the medical products industry, who initially joined Clinical Data as chief marketing officer in 2005.

Fromkin also believes that psychiatrists and other physicians who prescribe antidepressants would welcome the novel characteristics of vilazodone. The anti-depression pill, which has succeeded in two Phase III trials, seeks to combine the features of a common antidepressant and an anti-anxiety drug. The drug's antidepressant feature is supposed to stem from its ability to act as a selective serotonin reuptake inhibitor -- not unlike paroxetine (Paxil). The other part of the molecule is designed to work as as a so-called 5-HT1A agonist to treat anxiety, like buspirone. Both mechanisms improve levels of the mood-stabilizing neurotransmitter called serotonin, while the latter mechanism is also linked to preventing sexual dysfunction, a common side effect of antidepressants, as well as curbing anxiety, Fromkin says.

A U.S. approval of vilazodone would reward Clinical Data's strategy of acquiring molecules with solid commercial prospects from other biotech companies. Clinical Data gained rights to the drug through its 2005 acquisition of New Haven, CT-based Genaissance Pharmaceuticals, which had licensed the molecule from Germany's Merck KGaA. German Merck had ended development of the drug after it had trouble performing better than placebo in a mid-stage trial, Fromkin says. Clinical Data, however, has altered the dosing regimen from the one Merck used, a key reason for its success in late-stage clinical trials. (Clinical Data was also developing a genetic test that would help doctors prescribe vilazodone for appropriate patients, but development of the test was dropped because it lacked effectiveness, according to Fromkin.)

Rescuing molecules from drug-development limbo, as the case was with vilazodone, has been a bonanza for other companies such as Lexington, MA-based Cubist Pharmaceuticals (Nasdaq: CBST). Cubist raked in more than half of billion dollars last year from sales of the antibiotic drug daptomycin (Cubicin), which the company licensed from Eli Lilly in the early 1990s for an initial fee of about $1 million as well as future royalties. While Clinical Data isn't typically included among the list of high-fliers in the Massachusetts biotech scene, the success of vilazodone could quickly elevate its status.

The success of vilazodone in clinical trials has already provided a big boost to Clinical Data's stock price over the past year. The stock began to rebound in early 2009 after a slump in share prices. The stock closed yesterday at $17.24 per share, in the upper half of its $9-$22 price range over the past 52 weeks. In previous years, the company has relied heavily on funding from its chairman, Randal Kirk, who owned 62.5 percent of the firm's common stock as of September 2009, according to a regulatory filing. Yet the company has also found backing from institutional sources such as Fidelity and Vanguard funds. At the end of 2009, Clinical Data's $70.2 million in capital reserves were enough to support its operations through 2010, the company has said.

Vilazodone's reception with the FDA will have a huge impact on Clinical Data's future, but the company isn't banking on just one drug. The firm is in a late-stage clinical trial of a molecule called stedivaze for use in cardiac imaging exams, and it has other drug in early stages of development.

The FDA typically tells companies whether they will perform a detailed review of a new drug application within 60 days of submission, Fromkin says. It's been nearly 50 days since Clinical Data said it submitted its application for vilazodone, so we should find out soon whether the application is going to move ahead to the next phase of the regulatory process.

http:/g.fool.com/img/Article/partners/Xconomy200x40.gif

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.

Pfizer is a Motley Fool Inside Value recommendation. The Fool owns shares of GlaxoSmithKline and has a disclosure policy.