Forest to acquire Clinical Data ( developer of Viibryd); enhanced staffing

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Clinical Data hires reps for Viibryd launch

January 26, 2011| By  Staton

Now that Clinical Data has an FDA approval in hand, it's gearing 

up to grab a piece of the $12 billion antidepressant market. The

 company is hiring sales reps and rolling out a marketing

 campaign to support its new drug Viibryd, hailed as the first SSRI

 without troublesome sexual side effects. Viibryd will face some

 entrenched competition, including branded drugs such as

 Cymbalta and Lexapro, as well as a slew of generics.

As Medical Marketing & Media reports, Clinical Data started early

 this year with a print campaign designed to prepare the ground

 for a launch. Advertorials pointed out side effects of existing

 antidepressants and suggested that patients might need another,

 better-tolerated alternative. Meanwhile, a New York ad agency is

 working on branding, and others are preparing to target payers

 and physicians.

Clinical Data CEO Drew Fromkin told MM & M that he's aiming to

 have 150 reps ready to go for a second-quarter launch. They'll

 target psychiatrists first, then aim to expand into primary care.

 Marketing materials will focus on Viibryd's differences from

 existing meds. The drug will be touted as the " first and only "

 antidepressant to combine an SSRI and a serotonin 1a receptor

 partial agonist in one molecule, Fromkin said.

Of course, Viibryd's side-effect profile will see the spotlight, too.

  " We have a very safe drug here, and the adverse events are

 very different than you see in other [depression] drugs, " Fromkin 

said. And although the CEO didn't mention it specifically, you can

 bet that marketing will get around to talking about the data on

 sexual side effects, which didn't crop up in Viibryd patients more

 often than they did in those taking placebo.

Late-breaking news: Forest to acquire Clinical Data

Feb 23, 2011By:  From staff reports

Forest Laboratories $1.2 billion acquisition of Clinical Data, the developer of Viibryd (vilazodone HCl) for the treatment of adults with major depressive disorder (MDD), is expected to allow Forest to leverage its existing presence in the antidepressant category.

Viibryd, the first-and-only selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist, was approved January 21. The acquisition is expected to be complete in the second quarter.

With Celexa (citalopram hydrobromide) and Lexapro (escitalopram oxalate), Forest is said to have a proven track record of successfully commercializing novel anti-depressants. Lexapro is set to lose patent protection in early 2012. Forest also makes Namenda (memantine HCl) for Alzheimer’s, which is expected to lose protection by 2015.

According to a Clinical Data press release, the market for the treatment of MDD is more than 200 million prescriptions annually and increasing. Viibryd is expected to retain market exclusivity until March 2020 including full patent term extension of its composition of matter patent and anticipated pediatric exclusivity.

“Viibryd offers a unique dual mechanism of activity that may prove advantageous in patients not responding to current standards of care,” said Calabrese, RPh, MHP, Clinical Editor of Formulary, Drug Topics' sister publication.

“Depression is a debilitating disease that affects the daily lives of millions of patients. We believe that we are uniquely positioned to bring Viibryd to market in light of our long and successful experience of clinical development and expertise in the antidepressant market,” said , chairman, CEO, and president of Forest. “This transaction is consistent with our strategy to acquire new products that will help offset the loss of revenues due to patent expiries. Viibryd will be the second new product that we expect to launch this year in addition to Teflaro [ceftaroline fosamil].”

www.viibryd.com/