Forest to acquire Clinical Data

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-HT_1A 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 David 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 Howard Solomon, 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].”

Solomon added that the company is hoping to obtain FDA approval later this quarter for Daxas (roflumilast), for the treatment of COPD, and plans to submit NDAs for aclidinium and linaclotide in the second half of this year and for 2 additional products in calendar 2012.

In addition, the transaction brings to Forest Stedivaze (apadenoson), a potent agonist of the adenosine A2A receptor subtype with improved selectivity for this receptor over other subtypes (A1 and A2B). Stedivaze is a coronary vasodilator in phase 3 development as a pharmacologic stress agent for radionuclide myocardial perfusion imaging.