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Clinical Data Accelerates Vilazodone Theranostic Into Phase III, Plans NDA in 08; Launch in 09?


Genaissance appears to be paying dividends for Clinical Data.

Clinical Data, which closed its acquisition of Genaissance last October [see 10/13/2005 PGx Reporter], last week said it has accelerated the development of vilazodone, a failed but otherwise safe antidepressant Genaissance had been trying to resuscitate by pairing it to a companion diagnostic.

Clinical Data cut short a Phase II study Genaissance launched last year and now plans to start enrolling patients in a Phase III trial over the next few days, according to Carol Reed, Clinical Data's chief medical officer.

The company said it plans to file a new drug application based on these data in 2008, and, depending on US regulators, could launch the theranostic one year later.

The accelerated start of the Phase III trial represents an important milestone in the development of companion diagnostic/therapeutic products, which comprise a pillar of pharmacogenomics-based drug discovery and development. The combination of vilazodone and its companion diagnostic, which aims to identify patients most likely to respond to the drug, is one of the earliest theranostics to reach Phase III.

Developing vilazodone in-house could be a challenge for Clinical Data because the company, whose expertise has been in diagnostics, has never developed a drug and brought it to market on its own. "This would be a new undertaking."

It is also noteworthy because vilazodone, if approved, could encourage other drug makers to use pharmacogenomics technologies to revive ineffective but otherwise safe candidates.

Kevin Rakin, who had been CEO of Genaissance before it was acquired by Clinical Data, last year said he expected vilazodone to reach the market by 2010. Reed said the company's abrupt move to Phase III "should accelerate that timeline." She said it is "possible" that vilazodone could reach the market in 2009.

Rakin had also said last year that by the second half of 2006, Genaissance hoped to have a marketing and development partner for the drug. This week, Reed said Clinical Data is "in the process of formulating … plans" to partner vilazodone development with a bigger drug maker or another kind of ally. "But it's not necessarily the only pathway open to us," she said, stressing that Clinical Data could decide to develop the drug in-house.

But this option could be a challenge for Clinical Data because the company, whose expertise has been in the diagnostics arena, has never developed a drug and brought it to market on its own. "This would be a new undertaking," Reed told Pharmacogenomics Reporter this week. She declined to comment whether Merck, which initially asked Genaissance to revive the drug, or GlaxoSmithKline, which also failed at one time to develop vilazodone on its own, would partner with Clinical Data.

In a statement last week, Clinical Data said it "anticipates" having initial results from the Phase III study available by mid-2007. "The successful outcome of this trial would serve as one of two pivotal trials required" for an NDA, which the company said it "hopes" to file with the US Food and Drug Administration "as early as year end 2008."

As part of that study, Clinical Data will attempt to identify biomarkers linked to vilazodone response, and "plan[s] to use these biomarkers to develop a test to screen for patients who are likely to benefit from the drug."

This is where Clinical Data hopes vilazodone will penetrate a market dense with similar drugs [see accompanying table]. Vilazodone is a selective serotonin reuptake inhibitor, a class of antidepressants used to treat depression, anxiety disorders, and some personality disorders. As a class, the drugs generated around $13 billion in total revenue last year, according to industry figures. Yet their efficacy rates are spotty, and all carry adverse events that could be severe or even lethal.

Potential Vilazodone Rivals
Generic Brand
Citalopram Celexa, Cipramil, Emocal, Sepram
Escitalopram oxalate Lexapro, Cipralex
Fluoxetine Prozac, Fontex, Seromex, Seronil, Sarafem
Fluvoxamine maleate Luvox, Faverin
Paroxetine Paxil, Seroxat, Aropax, Deroxat
Sertraline Zoloft, Lustral

"There are so many SSRIs, the market itself is very, very fragmented," Reed said, adding that no drug currently owns more than 30 percent of market share. She said vilazodone will "differentiate" itself because of its companion diagnostic.

Reed said Clinical Data plans to enroll 400 patients in the Phase III trial, and expects to randomize the first individual in early February. The study will be double-blinded and placebo-controlled, she added.

Reed said Clinical Data has chosen a "small number of sites" in the United States to perform the study, though she declined to identify them. She said they comprise a mix of academic and "investigative research" centers that have expertise in depression.

Originally discovered by Merck, vilazodone moved under a license agreement to GlaxoSmithKline in 2001 after Merck abandoned Phase II trials due to poor efficacy. Glaxo gave up on the drug in April 2003, and Merck decided to go through Genaissance in another attempt to get it to market.

— Kirell Lakhman ([email protected])

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