IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, today announced that the United States Food and Drug Administration (“FDA”) has reinstated a previously-imposed (and then subsequently rescinded) requirement that the Company’s tentatively-approved strengths of its generic Focalin XR®(dexmethylphenidate hydrochloride extended-release) capsules (the “Product”) will have to meet new conditions for bioequivalence prior to receiving final approval. The strengths affected are 5 mg, 10 mg, 20 mg and 40 mg. The already-approved 15 mg and 30 mg strengths of its generic Focalin XR®capsules now in the market are not affected. The new bioequivalence requirements also do not apply to any of the Company’s other drug product candidate applications for commercial approval now pending with the FDA.

To briefly summarize the relevant correspondence from the FDA on this matter:

  • In November 2013, the FDA granted the Company tentative approvals for the 5 mg, 10 mg, 20 mg, and 40 mg strengths of its generic Focalin XR®.
  • In June 2015, the FDA required that the Company demonstrate bioequivalence with Focalin XR® for the 40 mg strength, under new bioequivalence criteria, as a basis for the approval of each of the affected strengths.
  • In July 2015, the FDA rescinded its June 2015 requirement that the Company demonstrate bioequivalence with Focalin XR® for the 40 mg strength, under new bioequivalence criteria, as a basis for the approval of each of the affected strengths.
  • The FDA has now reinstated the requirement that the Company demonstrate bioequivalence with Focalin XR® for the 40 mg strength, under new bioequivalence criteria, as a basis for the approval of each of the affected strengths. More specifically, in reverting to the requirement for a demonstration of bio-equivalence under new criteria, the FDA stated “Upon review, we have concluded that our rescission was issued in error.”

“We are, of course, disappointed by this unexpected action by the FDA. We remain committed in our efforts to achieve final approval for each of the affected strengths,” stated Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics.

The Company intends to consider and pursue appropriate courses of action towards achieving final approval for each of the affected strengths. There can be no assurance that the new conditions can be successfully met, or that the affected strengths of the Product will be granted final FDA approval or sold commercially. (Original Source)

Shares of Intellipharmaceutics closed yesterday at $3.25 . IPCI has a 1-year high of $3.92 and a 1-year low of $1.94. The stock’s 50-day moving average is $3.29 and its 200-day moving average is $2.88.

On the ratings front, Intellipharmaceutics has been the subject of a number of recent research reports. In a report issued on July 14, Brean Murray Carret analyst Jonathan Aschoff reiterated a Buy rating on IPCI, with a price target of $8, which implies an upside of 146.2% from current levels. Separately, on July 13, Maxim Group’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $8.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Jonathan Aschoff and Jason Kolbert have a total average return of 12.5% and -6.4% respectively. Aschoff has a success rate of 53.6% and is ranked #181 out of 3724 analysts, while Kolbert has a success rate of 33.3% and is ranked #3681.

IntelliPharmaCeutics International Inc is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs.