Drug Delivery Platforms that Enhance Compliance and Efficacy

Intellipharmaceutics technologies are a multidimensional controlled-release drug delivery platform that we believe can be applied to the efficient development of a wide range of existing and new pharmaceuticals.

About

Operating in the Specialty Pharmaceutical Market

At Intellipharmaceutics, we are engaged in the research, development and commercialization of controlled-release and targeted pharmaceutical products, both novel and generic, with a particular emphasis in the opioid abuse deterrence space.

Our proprietary Hypermatrix™ technologies are central to the development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. This technology allows for the intelligent and efficient design of drugs through the precise control of a number of key variables. This allows us to respond to varying drug attributes and patient requirements, producing a desired controlled-release effect in a time and cost-effective manner. We believe that the flexibility of these technologies allows us to develop complex drug delivery solutions within an industry-competitive timeframe.

How controlled-release differs from immediate-release drugs

Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug.

U.S. Opioid Deaths – An Epidemic

We are building upon the need to provide more efficacious abuse deterrent technology to help curb the rise of opioid dependence, abuse and deaths. Our nPODDDS™ technology platform is designed to provide for certain unique drug delivery features in a product, while our PODRAS™ delivery technology platform is designed to prevent overdose when more pills than prescribed are swallowed intact.

By the numbers:

24.6M

Americans who live with substance dependence or abuse

1.9M

Americans who live with prescription opioid abuse or dependence

46

Overdoses deaths/day

33,091

Deaths in 2015 from prescription opioids

14%

Increased rates of opioid overdose deaths from 2014 to 2015

$50B

Direct annual healthcare cost of opioid abuse

Sources

*Source: American Society of Addiction Medicine – 2015 Facts & Figures

*Source: Center for Disease Control (CDC) – Increases in Drug & Opioid Deaths – December 16, 2016

Strategic Focus

The principal focus of our development activities previously targeted difficult-to-develop controlled-release generic drugs which follow an ANDA regulatory path. Our current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. We have increased our research and development ("R&D") emphasis towards specialty new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both Oxycodone hydrochloride ER and Regabatin™.

Our unique Hypermatrix, nPODDDS™ and PODRAS™ technologies allow us to provide life-cycle management or new chemical entity delivery system solutions for virtually any small molecule.

Learn More About our Strategic Focus

Pipeline

Product Brand US Sales Indication Clinical/BE Studies FDA Filed FDA Approved
NDA
Oxycodone hydrochloride ER OxyContin® $1.94B* Pain
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
FDA Approved Phase not started
Regabatin™ Lyrica® $4.57B* Neuropathic Pain
Clinical/BE Studies Phase in progress
FDA Filed Phase not started
FDA Approved Phase not started
ANDA
Dexmethylphenidate Focalin XR® $802M* ADHD
Clinical/BE Studies Phase complete
FDA Filed Phase complete
Partnered with PAR
FDA Approved Phase in progress
Metformin Glucophage® XR $528M* Diabetes
Clinical/BE Studies Phase complete
FDA Filed Phase complete
Available for Partnering
FDA Approved Phase in progress
Venlafaxine Effexor XR® $693M* Depression
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
FDA Approved Phase not started
Pantoprazole Prototonix® $337M* GERD
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
FDA Approved Phase not started
Quetiapine Seroquel XR® $557M* Schizophrenia
Clinical/BE Studies Phase complete
FDA Filed Phase complete
Partnered with Mallinckrodt
FDA Approved Phase in progress
Lamotrigine Lamictal®XR™ $531M* Epilepsy
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
Partnered with Mallinckrodt
FDA Approved Phase not started
Levetiracetam Keppra XR® $134M* Epilepsy
Clinical/BE Studies Phase complete
FDA Filed Phase complete
Available for Partnering
FDA Approved Phase in progress
Desvenlafaxine Pristiq® $582M* Depression
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
Partnered with Mallinckrodt
FDA Approved Phase not started
Ranolazine Ranexa® $926M* Chronic Angina
Clinical/BE Studies Phase complete
FDA Filed Phase in progress
FDA Approved Phase not started
Carvedilol Coreg CR® $214M* Heart failure, Hypertension
Clinical/BE Studies Phase in progress
FDA Filed Phase not started
FDA Approved Phase not started

Source: Represents sales for all strengths, unless otherwise noted, for the 12 months ended August 2017 in the US., including sales of generics in 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. Source: Symphony Health Solutions Corporation. The information attributed to Symphony Health Solutions Corporation herein is provided as is, and Symphony makes no representation and/or warranty of any kind, including but not limited to, the accuracy and/or completeness of such information.

State-of-the-Art, FDA-Acceptable Facility

The demand for our technological know-how continues to promote the relocation and expansion of our premises. Our facilities consist of approximately 65,000 square feet with some of the most sophisticated pharmaceutical equipment employed in the industry. Our facilities allow us to conduct intensive R&D projects and create, test and manufacture products for the market. These in-house resources not only allow us to focus on a wide range of projects, but also to maximize efficiency ensuring rapid progress through the various stages of drug development - from formulation to regulatory submission. Our manufacturing facility has been granted FDA acceptable status following completion of a cGMP and pre-approval inspection. Health Canada has also approved our GLP QC labs and cGMP manufacturing plant.

Dr. Amina Odidi
Dr. Isa Odidi

A History of Leveraging Proven Drug Delivery Capabilities

Our company’s history is rooted in complex generics with controlled-release novel delivery systems. The predecessor to Intellipharmaceutics International was founded by Drs. Isa and Amina Odidi in 1998. The achievements of our founders include the development of numerous FDA approved and commercially successful controlled release drugs for others.

Since our founding, we have expanded our premises twice and have amassed an array of core assets, including seven proprietary drug delivery technologies, over 70 issued and pending patents, and a growing pipeline of ANDA and NDA product candidates.

Backed by a Strong Leadership Team

Our management and scientific teams have a history of successfully developing and bringing prescription controlled-release drugs to market.