Maxim Group Reiterates Buy, $6 PT on IntelliPharmaCeutics (IPCI) as FDA Greenlights Generic Seroquel XR
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Maxim Group analyst Jason Kolbert reiterated a Buy rating and $6 price target on IntelliPharmaCeutics International (NASDAQ: IPCI) after announced on Friday that the company received tentative approval from the FDA for generic Seroquel XR (quetiapine fumarate extended-release tablets) in the 50, 150, 200, 300, and 400mg strengths.
- Intellipharmaceutics announced on Friday that the company received tentative approval from the FDA for generic Seroquel XR (quetiapine fumarate extended-release tablets) in the 50, 150, 200, 300, and 400mg strengths. As the company stated in its press release: "Pursuant to a settlement agreement between IPCI and AstraZeneca dated July 30, 2012, IPCI will launch its generic versions of the 50, 150, 200, 300, and 400mg strengths of generic Seroquel XR, on November 1, 2016, (subject to FDA final approval of the Company's ANDA for those strengths)."
- Such final FDA approval is subject to a 180-day exclusivity period relating to a prior filer or filers of a generic equivalent of the branded product. Two companies may have first-to-file status. There are currently no generics of Seroquel XR available in the U.S. market, as the product is still under AstraZeneca's patent protection until November 1, 2017.
- Conclusion. It's good news to hear of a tentative FDA approval, but given the fact that this may be the third generic in the marketplace, and that may not be for some time, the news is only a moderate positive for the company.
- What's the next major event for IPCI? The company plans to soon file the NDA for Rexista. That will kick off a 60-day period for the FDA to accept the NDA. Once accepted, we expect a six-month review time (six months PDUFA date). Pain Therapeutics' recent stumble could be positive for IPCI. IPCI's NDA filing and acceptance are coming next, followed by the PDUFA date, setting the stage for a partnership deal.
Shares of IntelliPharmaCeutics International closed at $2.38 yesterday.
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