Company Update (NASDAQ:IPCI): IntelliPharmaCeutics Intl Inc (USA) Announces Par Pharmaceutical’s Launch of Additional Strengths of Generic Focalin XR Capsules


IntelliPharmaCeutics Intl Inc (USA) (NASDAQ: IPCI) announced that its United States (“U.S.”) marketing partner, Par Pharmaceutical (“Par”), has launched the 25 and 35 mg strengths of its generic Focalin XR  (dexmethylphenidate hydrochloride extended-release) capsules in the U.S.

The U.S. Food and Drug Administration (“FDA”) has granted final approval to Par’s abbreviated new drug application (“ANDA”) for its generic Focalin XR capsules in the 5, 10, 15, 20, 25, 30, 35 and 40 mg strengths. The Company is unable to state or estimate an actual launch date of any remaining strengths, but currently intends to provide an update once it is advised by Par of the launch of any additional strengths of its generic Focalin XR.

As the first filer of an ANDA for generic Focalin XR in the 25 and 35 mg strengths, Par will have 180 days of U.S. generic marketing exclusivity for those strengths.  Under a licensing and commercialization agreement between the Company and Par, the Company receives quarterly profit-share payments on Par’s U.S. sales of generic Focalin XR.

Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, “We are thrilled to begin the New Year with news of Par’s launch, with 180 days of U.S. generic market exclusivity, of the 25 and 35 mg strengths of its generic Focalin XR. The launch of these additional strengths builds on the 15 and 30 mg strengths currently marketed by Par, and should significantly improve our revenues in 2017.”

Focalin XR, a drug used in the treatment of attention deficit hyperactivity disorder, is marketed by Novartis Pharmaceuticals Corporation. According to Symphony Health Solutions, sales for the 12 months ended November 2016 of Focalin XR in the 25 and 35 mg strengths, respectively, in the U.S. were approximately $66 million and $14 million (TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer’s published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price).

There can be no assurance as to whether any of the recently-approved strengths of generic Focalin XR will be successfully commercialized. (Original Source)

Shares of Intellipharmaceutics International closed yesterday at $2.86, down $0.05 or -1.72%. IPCI has a 1-year high of $3.35 and a 1-year low of $1.41. The stock’s 50-day moving average is $2.86 and its 200-day moving average is $2.26.

On the ratings front, Intellipharmaceutics International has been the subject of a number of recent research reports. In a report issued on November 25, Maxim Group analyst Jason Kolbert reiterated a Buy rating on IPCI, with a price target of $6, which implies an upside of 110% from current levels. Separately, on October 17, Aegis Capital Corp.’s Difei Yang 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, Jason Kolbert and Difei Yang have a yearly average loss of -15.3% and a return of 3.0% respectively. Kolbert has a success rate of 29% and is ranked #4281 out of 4348 analysts, while Yang has a success rate of 43% and is ranked #1235.

Intellipharmaceutics International, Inc. is a pharmaceutical company, which engages in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. Its patented Hypermatrix technology is a multidimensional controlled-release drug delivery platform that can be applied to the development of existing and new pharmaceuticals in the areas of neurology, cardiovascular, gastrointestinal tract, diabetes and pain.