Tuesday, October 2, 2012

Takeda and Lundbeck Submit NDA for Vortioxetine for treatment of MDD - A $400million opportunity

Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) jointly announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational agent vortioxetine (Lu AA21004) for the treatment of major depressive disorder (MDD) in adult patients.

Vortioxetine is under investigation as an antidepressant with multimodal activity that is thought to work through a combination of two complementary mechanisms of actions: receptor activity modulation and reuptake inhibition. In vitro studies indicate that vortioxetine is a 5-HT3 and 5-HT7 receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the serotonin transporter (SERT).

The NDA includes data from six short-term placebo controlled studies, including one dedicated study in the elderly, which have been conducted in regions throughout the world and support statistically significant efficacy of vortioxetine in a dose range of 5 to 20 mg per day. Efficacy of vortioxetine was also demonstrated in a long-term relapse-prevention study in MDD. The vortioxetine global clinical development program included more than 7,500 individuals exposed to the drug.

Market Potential for Vortioxetine
In volume terms (numbers of prescriptions), antidepressants are the biggest segment in the US
market with more than 20m prescriptions filled every month. Nearly 10% of all prescriptions filled in the US are antidepressants. This means that even with a very small volume share, sales can be significant.Depression is a highly generecised market.
As far as Vortioxetine is concerned, it lacks differentiation from existing agents and may have very limited potential,. Marketing efforts would primarily determine the sales potential. With Effexor already off patent and Cymbalta going off patent in 2014, the going is likely to be difficult for Vortioxetine.  Viibryd an anti depressant which was launched by Forest a year back has been able to garner a 0.5% market share as of now, which translates into an annual sales of $200million.
Assuming  a 2% market share for Vortioxetine, the drug can reach peak sales of $400million.