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Intra-Cellular Therapies received FDA approval for Calypta, to treat patients with Schizophrenia.

There are already drugs on the market for this, but they apparently have several undesirable side effects such as weight gain, hair loss, and nausea.

Allergan’s (AGN) Vraylar revenue was $236 million last quarter, up 70%. In March they got FDA approval to treat bipolar disorder, something ITCI is working on for Calypta as well, and currently in Phase 3.

Johnson & Johnson’s (JNJ) Invega Sustenna is a $3.4 billion drug.

H. Lundbeck A/S and Otsuka Pharmaceutical’s Rexulti. is doing roughly $300 million a year, and growing mid 20s percentage.

So the opportunity is there for blockbuster status for Calypta, and with a current $1.5 billion market cap, and today's stock offering of $300 million, we're talking about $1.9 billion market cap for a potential blockbuster owner over time.

The key then is adaption to Calypta, mainly due to reduced side effects.

Here are the side effects of Invega:

Here are the side effects of Calypta in the trials:

Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of CAPLYTA has been evaluated in 1724 adult patients with schizophrenia exposed to one or more doses. Of these patients, 811 participated in short-term (4- to 6-week), placebo-controlled trials with doses ranging from 14 to 84 mg/day. A total of 329 CAPLYTA-exposed patients had at least 6 months of exposure and 108 had at least 1 year of exposure to the 42-mg dose of CAPLYTA.

There was no single adverse reaction leading to discontinuation that occurred at a rate of >2% in CAPLYTA-treated patients.

The most common adverse reactions (incidence of at least 5% of patients exposed to CAPLYTA and greater than twice the rate of placebo) are somnolence/sedation and dry mouth.

So basically sedation and dry mouth. However in Intra Cellular's literature, they list all the common side effects with all of the other Schizophrenia drugs. Are they going to clarify the actual side effects with just sedation and dry mouth when promoting Calypta or are they going to have to put all these other side effects that are found in other drugs as well, effectively taking away their one advantage and just making them appear to be an also-ran?

With Invega sales of $3.4 billion, and the quick uptake of Vraylar, the opportunity seems there. I have read we won't know true growth rates or adaption for Calypta for a few quarters after they sell initial stocking packages.
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