IntelliPharmaCeutics International Inc. (NASDAQ: IPCI) is watching its shares jump on Monday after the company announced that it received a tentative approval from the U.S. Food and Drug Administration. Specifically, the tentative approval was for the company’s abbreviated new drug application (ANDA) for quetiapine fumarate extended-release tablets in varying doses.
The tentatively-approved product is a generic equivalent for the corresponding strengths of the branded product Seroquel XR sold in the U.S. by AstraZeneca.
For some quick background, Seroquel XR, and the drug active quetiapine fumarate, are indicated for use in the treatment of schizophrenia and bipolar disorder.
According to the settlement between IntelliPharmaCeutics and AstraZeneca from July 2012, the company is permitted to launch its generic version of Seroquel XR in certain varying doses on November 1, 2016.
There are currently no generics of Seroquel XR available in the U.S. market as the product is still under Astra Zeneca’s patent protection until November 1, 2017.
Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, commented:
We are thrilled the FDA has granted tentative approval of our generic version of Seroquel XR®, which should further demonstrate our core drug development competency in controlled-release delivery technologies. As Seroquel XR® has yet to come off patent protection, we believe the tentative approval represents a substantial commercial opportunity for the Company.
Excluding Monday’s move, the stock has outperformed the broad markets rising about 18% year to date. Over the past 52-weeks the stock is up nearly 29%.
Shares were last trading up nearly 18% at $2.80, with a consensus analyst price target of $6.67 and a 52-week trading range of $1.41 to $3.19.