West Coast Editor

Personalized medicine-focused Clinical Data Inc.'s third sale of in vitro diagnostics (IVD) assets, gaining about $4.5 million right away from France-based Elitech Group and $15 million when the deal finishes, puts the firm in even better position to leverage assets that include a Phase III-positive compound for depression.

"I think we're feeling very comfortable about the next 12 to 24 months, easily," said Caesar Belbel, chief legal officer for the Newton, Mass.-based firm. As of June 30, Clinical Data had about $16 million in cash and cash equivalents.

Shares of the company (NASDAQ:CLDA) closed Friday at $27.31, down 35 cents.

"Anyone can see we're trading at an all-time high," Belbel said. "The stock price has appreciated very handsomely. We could go back out and raise more money, if that's what our board decided to do."

Elitech, of Puteaux, France, is buying Vital Scientific B.V., of Dieren, the Netherlands, to complement its own portfolio of IVD tests, so Clinical Data can devote more resources to pharmacogenomics tests and targeted therapeutics - both of which are coming together in vilazodone, the depression compound that yielded positive early Phase III results last month. (See BioWorld Today, Sept. 5, 2007.)

Vilazodone uniquely puts together in a single drug the effects of a selective serotonin reuptake inhibitor, like New York-based Pfizer Inc.'s Zoloft (sertraline) and a 5HT1A partial agonist, and Clinical Data is working on a test that would determine whether a patient is likely to respond.

Vilazodone in other hands failed earlier trials, and has yet to be compared in a head-to-head trial with a marketed drug.

The 410-patient study hit the primary endpoint of mean change from baseline in the Montgomery-Asberg Depression Rating Scale score compared to placebo (p=.001), and met a key secondary endpoint of the study, mean change from baseline on the Hamilton Depression Rating Scale (p=.022), with a safety profile similar to marketed SSRIs.

Clinical Data got rights to vilazodone through the $56 million, all-stock merger in 2005 with New Haven, Conn.-based Genaissance Pharmaceuticals Inc., which less than a year earlier had licensed the compound from Merck KGaA, of Darmstadt, Germany. (See BioWorld Today, Sept. 24, 2004, and June 22, 2005.)

Last year, Clinical Data spun off the vilazodone push into a firm called Precigen Therapeutics Inc., two months after starting the pivotal study in adult patients diagnosed with major depressive disorder. At least one long-term safety study and another pivotal study are likely before a new drug application is submitted. (See BioWorld Today, March 31, 2006, and May 16, 2006.)

Elitech offers clinical, microbiology, immunology and electrophoresis products, sold through distributors and its subsidiaries in the U.S. and several European countries.

In November, Clinical Data sold its Australian unit, Vital Diagnostics Pty., for net proceeds of $1 million, and in June, the firm sold its U.S. branch, Clinical Data Sales and Service Inc., netting about $7 million.

Yet to be divested is a small firm in Italy that sells a desktop erythrocyte sedimentation rate test, Belbel said.

"We'll look at opportunities if they should arise," he said, noting that the subsidiary is "profitable and very well managed as a stand-alone enterprise," and Clinical Data hopes to sell the unit "sooner rather than later."

The company has a Cogenics division, too, which sells molecular and pharmacogenomics services. In 2005, Clinical Data bought Icoria Inc., of Research Triangle Park, N.C., and followed that with the acquisition of Genome Express, of Grenoble, France. Late last month, Clinical Data bought privately held Epidauros Biotechnologie AG, of Bernried, Germany, in a cash deal valued at $11.84 million.

Epidauros "really brought a lot to the table for us," including intellectual property and a fee-for-service component, Belbel said.