Intellipharmaceutics International Inc. (IPCI)

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A Game Changer: On May 21, FDA gave guidance to IPCI that the Rexista NDA could be filed without a Phase 3 trial, if they could demonstrate bioequivalence to Oxycontin. By IPCI only having to do a bioequivalence trial for Rexista Oxycodone XR compared to Purdue’s Oxycontin, the company will now run a smaller trial of only 24-40 patients. IPCI can file for FDA approval within 6 to 12 months. On May 26, FDA granted Rexista Oxycodone XR fast track designation. With a “fast track designation” for Rexista Oxycodone XR, it is possible the NDA could be reviewed in 6 months or less and the drug could be launched at the end of 2016/H1 2017 (we’ve modeled in a mid 2017 to H2 2017 launch which is now very conservative).

ACTION – Maintaining Speculative BUY Rating

We are maintaining our US$12 target price and SPECULATIVE BUY rating. Investors should focus on Rexista Oxycodone XR targeting a US$2.3 billion market. As well, at least four ANDA (generic) approvals are expected and long overdue for IPCI, the timing of these approvals is uncertain due to its large ANDA review backlog at the FDA.



Courtesy: Mackie Research