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Clinical Data to Submit Vilazodone NDA without PGx Marker; Reports 11 Percent Revenue Growth in Q3

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By Turna Ray

Clinical Data
is planning to submit a new drug application to the US Food and Drug Administration for its investigational depression drug vilazodone in the current quarter. However, due to unfavorable Phase III results on a response biomarker, the company will not be submitting its NDA with a pharmacogenomic companion test as previously hoped.

Although the PGx marker that would have predicted best-responders for vilazodone was not validated, the drug met its overall efficacy/safety endpoints in late-stage trials with statistical significance in major depressive disorder. The drug, both a selective serotonin reuptake inhibitor and a 5-HT1a partial agonist, combines two mechanisms that are commonly used in first- and second-line treatments for mood disorders and depression.

As such, "we are obviously very pleased with the results and the potential blockbuster opportunity in vilazodone, and look forward to submitting our NDA this quarter," a spokesperson for the company told Pharmacogenomics Reporter this week.

Originally discovered by Merck, vilazodone moved under a license agreement to GlaxoSmithKline in 2001 after Merck abandoned Phase II trials due to poor efficacy. GSK gave up on the drug in April 2003, and Merck decided to go through Genaissance in another attempt to get it to market. In 2005, Clinical Data got its hands on vilazodone through its acquisition of Gennaissance.

Clinical Data has said previously that it would continue to evaluate other biomarker candidates. "While our lead biomarker of response to vilazodone did not replicate in this trial, it is one in a series of candidate biomarkers that we will continue to evaluate," Carol Reed, chief medical officer of Clinical Data, said in a statement last June.

Clinical Data made the announcement about its forthcoming vilazodone NDA submission while reporting its financials for the three months ended Dec. 31, 2009, the third quarter of its 2010 fiscal year. The company reported an 11 percent revenue increase for the quarter, driven by sales from its PGxHealth division.

The Newton, Mass.-based drug and pharmacogenomic test developer netted total third-quarter revenues of $3.1 million, compared to $2.8 million for the third quarter of 2008. Sales of its Familion tests from its PGxHealth division were a key driver of that growth with revenues of $719,000 — a 25 percent increase year over year, Clinical Data said.

"Revenue has risen as a result of continued expansion of sales and marketing activities in fiscal 2009, the introduction of new and expanded tests and increased coverage policies from third-party payors," the company said in a statement. According to Clinical Data, third-party payor coverage for its Familion tests stands at approximately 280 million lives in the US. Additionally, in December PGxHealth became an approved Medicare provider and a Medicaid provider in most states.

Also during the third quarter, Clinical Data launched another genetic test, the Familion DCM Test for dilated cardiomyopathy. DCM is an inherited heart disease which is the leading cause of heart transplants and a possible cause of sudden cardiac death. The launch marked the third genetic test launched by PGxHealth.

The company posted a net loss of $16 million compared to a net loss of $23.7 million during the same period the previous year.

Clinical Data also lowered its R&D expenses by 36 percent to $9.7 million from $15.1 million year over year. The firm's SG&A spending fell 11 percent to $6.2 million from $7 million. Clinical Data said in a statement that it expects its sales and marketing expenses to continue at a comparable rate over the next several quarters as it increases its sales activity for the Familion tests.

"We strengthened our financial resources in support of these programs and broadened our investor base through our successful public offering completed in November," Drew Fromkin, Clinical Data CEO, said in a statement.

Cash and cash equivalents at December 31, were $70.2 million, including net proceeds of $44.2 million raised from a public offering of 2,750,000 shares of common stock at a price of $17.25 per share completed in November.

"We will also continue to pursue collaborative opportunities to advance our growing pipeline and supplement our financial resources," Fromkin said.

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