Maxim Affirms Intellipharmaceutics (IPCI) at 'Buy' Following Q3 Results; Says Rexista NDA is Next Big Event
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Maxim reaffirms Intellipharmaceutics International (Nasdaq: IPCI) at Buy with a price target of $6 following Q3 results issued Thursday night.
Jason Kolbert noted the following on Friday:
- Licensing agreement. Intellipharmaceutics recently announced a commercial supply agreement with Mallinckrodt ($3M upfront) for an exclusive license to market, sell and distribute in the U.S. the following extended release (XR) drug product candidates for which Intellipharmaceutics has filed ANDAs: Seroquel XR (ANDA Tentatively Approved by FDA); Pristiq (ANDA Under FDA Review); and Lamictal (ANDA Under FDA Review).
- Tentative FDA approval. The company recently 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 Seroquel XR, on November 1, 2016, (subject to FDA final approval of the Company's ANDA for those strengths)."
- Conclusion. We await the next major event for ICPI - NDA filing and acceptance (60 days) for Rexista, followed by the PDUFA (6 months from acceptance) date, setting the stage for a partnership opportunity.
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