Update on Forest Labs' Cariprazine - Analyst Blog

Pipeline updates are highly awaited events in the pharma/biotech sector as they play an important role for investors in deciding whether or not to invest in a particular company. These updates provide information on experimental drugs and at times give an insight into the commercial potential of the candidate once it is successfully developed and commercialized.

Late last week, Forest Laboratories, Inc. FRX and partner, Gedeon Richter plc, announced positive results from a phase IIb study (n=819) on cariprazine. The study was conducted to evaluate the efficacy, safety and tolerability of the candidate for the treatment of adults (between 18 and 65 years of age) suffering from major depressive disorder MDD who have responded inadequately to antidepressant therapy ADT.

Of the three treatment groups in the study, the cariprazine (2–4.5 mg/day) and ADT combination showed a statistically significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score compared to placebo at 8 weeks. The other two treatment groups were the combinations of cariprazine (1-2 mg/day) and ADT, and placebo and ADT.

The positive results from the study are encouraging. Forest Labs mentioned in its press release that around 16 million adults in the U.S. are affected annually by MDD. Moreover, the World Health Organization believes that depression will become the second leading cause of disability by 2020.

We note that the MDD market currently has big players like Eli Lilly and Company LLY. Moreover, companies like Alkermes ALKS are also trying to enter the market – Alkermes has a phase III candidate, ALKS 5461, in its pipeline.

Forest Labs is also evaluating cariprazine for the treatment of adults suffering from schizophrenia and bipolar mania. However, in November last year, the company had received a complete response letter in the U.S. for this indication.

Meanwhile, Forest Labs was in the news last month when Actavis, Inc. ACT announced its intention to acquire the former for a cash and equity transaction valued at about $25 billion. The deal is expected to close in mid-2014.

Forest Labs carries a Zacks Rank #3 (Hold). A better ranked stock  includes Alkermes carrying a Zacks Rank #1 (Strong Buy).