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February 2012
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Intellipharmaceutics Corporate Presentation, February 2012

May 08, 2015

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Intellipharmaceutics Corporate Presentation, February 2012. Includes a products update.
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Page 1: Intellipharmaceutics Corporate Presentation, February 2012

February 2012

Page 2: Intellipharmaceutics Corporate Presentation, February 2012

Forward-looking Statements Certain statements in this presentation, as well as certain oral statements made by management during the presentation, constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and/or “forward-looking information” under the Ontario Securities Act. These statements include, without limitation, statements regarding the Company’s plans and milestones; status of developments, funding or expenditures; partnering activities; regulatory submissions; strategies; future operations, financial positions, sales, revenues costs, and market penetration. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue”, “intends”, “could”, or the negative of such terms or other comparable terminology. You should not place undue reliance on these statements, which are subject to a multitude of risks and uncertainties that could cause actual results, future circumstances or events to differ materially from those stated in or implied by such statements. These risks and uncertainties include, but are not limited to, securing and maintaining corporate alliances, the need for additional capital and the effect of capital market conditions and other factors, including the current status of our programs; capital availability; the potential dilutive effects of any financing; the timing, costs and uncertainties of our R & D and regulatory efforts to commercialize our present and future products; and estimates regarding capital requirements and future revenues. Additional risks and uncertainties relating to the Company can be found in the “Risk Factors” sections of our annual information form dated February 28, 2011 and Form 20-F for the year ended November 30, 2010, and in our other public filings. We disclaim any intention or obligation, except as required by law, to update or revise such statements, whether as a result of new information, future events or otherwise. The projections and/or illustrative examples, as the case may be, are included solely to provide certain overview information concerning the variable financial results of drug commercialization in this industry sector when certain assumptions are used, and how those results could impact the potential future operating results of the Company. No assurance can be made that such results will be achieved. The Company may conduct the business in a manner different from that set forth in the assumptions, as changing circumstances may require. Actual results of operations are likely to vary from the projections and the variations may be material and adverse. The projections should not be regarded as a representation or prediction that the Company will achieve or is likely to achieve any particular results. Without limiting the generality of the foregoing, no assurance can be given as to whether or when the Company will receive regulatory approval for any of the Company’s drug formulations.

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Page 3: Intellipharmaceutics Corporate Presentation, February 2012

Overview

Specialty Pharmaceuticals Company (NASDAQ: IPCI; TSX: I)

Six ANDAs under review by the FDA for generics of: • Focalin XR®, Effexor XR®, Protonix®, Glucophage® XR ,

Seroquel XR®, Lamictal® XR™ (represents approximately $6.6B of branded and generic sales)

Rexista™ Technology – abuse resistant drug delivery platform • Rexista Oxycodone XR

- Phase I proof-of-concept study complete • Potential application to other opioid drug candidates

Controlled-Release (CR) Focus: high-value products / alt. delivery systems • $15B+ of CR medicines off patent in the near term (1)

• Technical barriers can result in fewer competitors and higher margins

Strategic alliance with Par Pharmaceutical (NYSE: PRX) for generic Focalin XR

Broad range of drug delivery solutions • 30+ patents issued and pending (1) Source: Emerging Opportunities in Controlled-Release Generic Drugs; Episcom 2009.

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Page 4: Intellipharmaceutics Corporate Presentation, February 2012

Experienced Management Team

Dr. Isa Odidi, MBA - Chairman & CEO, Co-Chief Scientific Officer Over 30 years of industry experience Held senior positions at Biovail Corp. (now merged with Valeant (NYSE & TSX: VRX)) Proven success in developing several approved CR drugs

Dr. Amina Odidi - President & COO, Co-Chief Scientific Officer Over 30 years of industry experience Extensive experience developing and applying proprietary technologies to the development of CR drugs Proven success in developing several approved CR drugs

John Allport, B.A.Sc., M.A., LL.B. - Vice President, Legal Affairs and Licensing Over 20 years of experience in the field of IP law; served with Sim Lowman Ashton & McKay LLP of Toronto working for and against many Fortune 500 companies

Dr. Patrick N. Yat - Vice President, Pharmaceutical Analysis and Chemistry

Over 15 years of industry experience serving with Health Canada, Patheon, Inc., and Biovail Corp.

Shameze Rampertab, CA, MBA, BSc. - CFO & Vice President, Finance and Administration Over 15 years of public company and industry experience Served as the Director, Finance and Secretary-Treasurer for then-public Drug Royalty Corp.; served as biotech analyst at several investment banking firms including Canaccord Capital; was a Partner, Healthcare Investment Banking at LOM

Ira Baeringer, MBA, B.A.-Vice President, Business Development

20 years of experience in pharmaceutical licensing, development, supply, acquisitions, divestitures, and alliance management.

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Page 5: Intellipharmaceutics Corporate Presentation, February 2012

Pharmaceutical Industry Profile

NDA 505 (b)(1) DRUGS

ANDA GENERICS

NDA 505 (b)(2) DRUGS

Identical Drug Copies Novel Patented Drugs Novel Proprietary Modifications of Approved Drugs

2-4 years 3-4 years 10-12 years

Estim

ated

de

velo

pmen

t tim

elin

e

Intellipharmaceutics Focus

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Page 6: Intellipharmaceutics Corporate Presentation, February 2012

HypermatrixTM Technology

Drug matrix technology defined as multi-dimensional in nature

Group of technologies based on Hypermatrix™ concept

Broad range of release profiles taking into account • Physical and chemical characteristics of a drug • Therapeutic use • Optimal site for release of API in GIT

Used alone or in combination to optimize development and performance

IntelliMatrix™

IntelliPaste™

IntelliFoam™

IntelliPellets™

IntelliOsmotic™

IntelliShuttle™

IntelliGITransporter™

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Page 7: Intellipharmaceutics Corporate Presentation, February 2012

HypermatrixTM Technology

Capabilities

Controlled release Extended release Pulsatile release Chrono mimicry Quick disintegrating release Site specific delivery Prevention of dose dumping Abuse resistance Alcohol resistance Enhanced bioavailability

Key Advantages

Shorter development timelines Cost effective development Once-a-day dosing Chrono therapeutic dosing Suitable for hydrophilic/hydrophobic,

potent, and high dose compounds

Capabilities have been repeatedly substantiated in vitro and in vivo

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Page 8: Intellipharmaceutics Corporate Presentation, February 2012

Disclosed Product Candidates

dexmethyl-phenidate

Focalin XR® $596M ADHD

venlafaxine HCI

Effexor XR® $2.5B* Depression

pantoprazole sodium

Protonix® $1.8B* GERD

metformin HCl

Glucophage® XR

$431M* Diabetes

quetiapine fumarate

Seroquel XR® $1.1B Schizophrenia,

bipolar disorder, major depressive

disorder

lamotrigine Lamictal®

XR™ $217M Epilepsy

carvedilol phosphate

Coreg CR® $314M CHF

Product Brand U.S. Sales**

Indication Formulation Pilot

Studies Scale-up

Clinical / BE Studies

FDA review

oxycodone CR

Oxycontin

$2.9B Pain

Partnered with Par Pharmaceutical (NYSE:PRX)

*includes sales of generics ** Wolters Kluwer Health data for the 12 months ending Dec 2011

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Page 9: Intellipharmaceutics Corporate Presentation, February 2012

1st ANDA: Generic Focalin XR®

Indicated for ADHD Partnered with Par Pharmaceutical (NYSE:PRX) ANDA filed with FDA for 5, 10, 15, 20, 30mg strengths Paragraph IV certification; patent litigation settled with

Novartis, Elan, Celgene for 5, 10, 15, 20mg strengths Potential launch Q4 2012 for first four strengths

(~90% of brand sales)

Overview & Highlights

License & Commercialization Agreement (Nov. 2005 / expanded Aug. 2011 to include additional strengths)

IPCI pays development costs / Par responsible for others (2)

10 year profit-sharing agreement from commercial launch

of product

Par is a top 10 U.S. Pharma company with an approximate

$1 billion market cap

Par Pharmaceutical (NYSE:PRX) Partnership

(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, based on available information concerning third party brand product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Company forecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for Par and IPCI (if any) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2) Other costs include bioequivalence, API, scale up / scalability and commercialization costs. (3) Wolters Kluwer Health data for the 12 months ending Dec 2011. 9

Examples of US Economic Potential (1)

Brand Sales

$596M(3)

Discount

70% 50%

Market Penetration

10% 20%

Potential Revenue to PAR/IPCI partnership

$18M $60M

Page 10: Intellipharmaceutics Corporate Presentation, February 2012

2nd ANDA: Generic Effexor XR®

Indicated for major depressive disorders

Available for partnering

ANDA accepted by the FDA as of Jan. 2010 for all

strengths of the approved brand product

Paragraph IV certification; litigation settled

Potential launch upon FDA approval

Overview & Highlights

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Examples of US Economic Potential (1)

Brand and Generic Sales

$2.5B(2)

Discount

90% 80%

Market Penetration

2% 5%

Potential Revenue to IPCI and partner

$5M $25M

(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, based on available information concerning third party brand and generic product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Company forecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for a potential partner and IPCI (if any) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2) Wolters Kluwer Health data for the 12 months ending Dec 2011.

Page 11: Intellipharmaceutics Corporate Presentation, February 2012

3rd ANDA: Generic Protonix®

Indicated for conditions associated with GERD

(i.e.. ulcers)

Available for partnering

ANDA accepted by the FDA as of June 2010 for all

strengths of the approved brand product

Paragraph IV certification; no litigation

Potential launch upon FDA approval

Overview & Highlights

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Examples of US Economic Potential (1)

Brand and Generic Sales

$1.8B(2)

Discount

85% 75%

Market Penetration

2% 5%

Potential Revenue to IPCI and partner

$5M $23M

(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, based on available information concerning third party brand and generic product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Company forecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for a potential partner and IPCI (if any) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2) Wolters Kluwer Health data for the 12 months ending Dec 2011.

Page 12: Intellipharmaceutics Corporate Presentation, February 2012

4th ANDA: Generic Glucophage® XR

Overview & Highlights

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Examples of US Economic Potential (1)

Brand and Generic Sales

$421M(2)

Discount(3)

0% 0%

Market Penetration

1% 5%

Potential Revenue to IPCI and partner

$4M $20M

(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, based on available information concerning third party brand and generic product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Company forecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for a potential partner and IPCI (if any) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2) Wolters Kluwer Health data for the 12 months ending Dec 2011. (3) Discount not applied as product sales are almost all generic sales

Indicated for the management of type 2 diabetes

Available for partnering

ANDA accepted by the FDA as of Aug 2010 for two

strengths of the approved brand product

Paragraph IV certification; no litigation

Potential launch upon FDA approval

Page 13: Intellipharmaceutics Corporate Presentation, February 2012

5th ANDA: Generic Seroquel XR®

Indicated for the treatment of schizophrenia, bipolar

disorder, and major depressive disorder

Available for partnering

ANDA accepted by the FDA as of Feb 2011 for four

strengths of the approved brand product

Paragraph IV certification; litigation initiated

Overview & Highlights

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Examples of US Economic Potential (1)

Brand Sales

$1.1B(2)

Discount

85% 75%

Market Penetration

5% 20%

Potential Revenue to IPCI and partner

$8M $55M

(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, based on available information concerning third party brand product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Company forecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for a potential partner and IPCI (if any) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2) Wolters Kluwer Health data for the 12 months ending Dec 2011.

Page 14: Intellipharmaceutics Corporate Presentation, February 2012

6th ANDA: Generic Lamictal® XR™

Indicated for the treatment of epilepsy (anticonvulsant)

Available for partnering

ANDA accepted by the FDA as of Sep 2011 for four

strengths of the approved brand product

Paragraph I certification; no litigation

Overview & Highlights

14

Examples of US Economic Potential (1)

Brand Sales

$217M(2)

Discount

70% 50%

Market Penetration

10% 20%

Potential Revenue to IPCI and partner

$6M $21M

(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, based on available information concerning third party brand product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Company forecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for a potential partner and IPCI (if any) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2) Wolters Kluwer Health data for the 12 months ending Dec 2011.

Page 15: Intellipharmaceutics Corporate Presentation, February 2012

IPCI’s RexistaTM Technology Platform TAMPER-DETERRENT ALCOHOL-RESISTANT

CONTROLLED-RELEASE TECHNOLOGY

Provides deterrence against intentional (drug abuse) and unintentional dose dumping

dose dumping is the rapid release of active ingredient

from a controlled-release drug into the blood stream that can result in increased toxicities, side effects, and a loss of efficacy - usually results if a

tablet is crushed and consumed or taken with alcohol

Utilizes a paste in a capsule - a novel dosage form designed specifically to prevent dose dumping

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Page 16: Intellipharmaceutics Corporate Presentation, February 2012

www.oxycontinabuse.com

Oxycodone abuse continues to increase; current products remain easy to abuse - easy to circumvent extended release mechanism - crush / chew and ingest; crush and snort; extract and inject

On April 19, 2011 the FDA announced the requirement of an Opioids Risk Evaluation and Mitigation Strategy (REMS) as part of a broader action plan to address the national prescription drug abuse epidemic in the US

Oxycodone and its Abuse

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Page 17: Intellipharmaceutics Corporate Presentation, February 2012

Growing Interest in Abuse Resistance DURECT, PAIN THERAPEUTICS, KING, and PFIZER CASE STUDY

Nov 2005

March 2011

$400M +15/20% of sales

King Pharma completes a deal with Pain for Remoxy and other

abuse resistant opioids. ($150 million upfront, $150 million milestone payments, $100 million in R&D expenses; 15% royalty on first billion of sales, 20% thereafter)

$3.6B Pfizer completes

acquisition of King.

Dec 2002 Pain completes a deal with Durect to develop and

commercialize selected long-acting oral opioid products – incl.

abuse resistant Remoxy.

$9M +6%-11.5% of sales

(also includes reimbursment of R&D efforts; % dependant on volume of sales)

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Page 18: Intellipharmaceutics Corporate Presentation, February 2012

RexistaTM Oxycodone XR NDA 505(b)(2) REGULATORY PATHWAY

Controlled-release oxycodone in a novel dosage form (paste in a capsule) designed to deter abuse from

- Snorting or inhalation - IV injection

Rexista technology platform applicable to additional opioid drug candidates (i.e., oxymorphone, hydrocodone, and morphine)

Designed to resist the release of the entire dose when chewed or consumed with alcohol

The FDA’s move to restrict the prescribing of extended-release opioid analgesics should benefit tamper-resistant

formulations such as IPCI’s Rexista™

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Page 19: Intellipharmaceutics Corporate Presentation, February 2012

RexistaTM Oxycodone XR PILOT PROOF-OF-CONCEPT CLINICAL TRIAL

Randomized 12 subject cross-over study

Comparing:

• single dose of RexistaTM oxycodone CR (40 mg capsule, once-daily) with

• two doses of OxyContin® (20mg, twice-daily)

Rexista oxycodone demonstrated sustained release pharmacokinetic activity

→ blood plasma concentrations maintained at clinically significant levels over a 24 hour period

The bioavailability of a single dose of RexistaTM oxycodone was comparable to that of two doses of Oxycontin® dosed at 12 hour intervals

RESULTS

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Page 20: Intellipharmaceutics Corporate Presentation, February 2012

Clinical stage

Phase 1 proof-of-concept study completed

Primary manufacturing equipment has been delivered

and qualified

Manufacturing scale-up of clinical batches for use in

Phase 1 & 2 studies in progress

Overview & Highlights

RexistaTM Oxycodone XR

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Examples of US Economic Potential (1)

Controlled-release Oxycodone Sales

$2.9B(2)

Market Penetration

10% 30%

Potential Revenue to IPCI and partner

$290M $870M

(1) The figures in this chart are provided to illustrate a sample of the potential variability of the economics in the generics marketplace as it applies to the proposed markets for our product candidates, based on available information concerning third party brand and generic product sales , and the indicated assumptions regarding discounts and market penetration. The figures do not represent any Company forecasts or projections. The actual figures will be highly dependent on a number of variables, including the number of competitors in the market. Sample revenue figures are for potential partner and IPCI (if any) combined, and are before production and sales costs. No assurance can be given regarding the attainability of the illustrative amounts or the reliability of the assumptions on which they are based. (2) Wolters Kluwer Health data for the 12 months ending Dec 2011.

Page 21: Intellipharmaceutics Corporate Presentation, February 2012

State-of-the-Art Facility

Granted FDA acceptable status following completion

of cGMP and pre-approval inspection

GLP QC labs and cGMP manufacturing plant

Capacity of ~500m oral solid dosage / year

All stages of development controlled in-house • Methods development • Formulation development • Manufacture of clinical batches • Regulatory filings

TORONTO, ONTARIO

In-house manufacturing of clinical batches saves valuable time

and protects proprietary technologies

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Page 22: Intellipharmaceutics Corporate Presentation, February 2012

Milestones

Obtain FDA approval of our generic version of Focalin XR®

File two additional ANDAs with the FDA

Establish additional development/marketing alliances

Schedule a pre-IND meeting with FDA to discuss Rexista™ oxycodone clinical development plan

Complete manufacturing of clinical batches of Rexista™ oxycodone

Initiate Phase I studies using clinical batches of Rexista™oxycodone

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Page 23: Intellipharmaceutics Corporate Presentation, February 2012

Selected Financial Data

Shares outstanding (Q4/11.30.11 ) 15.9M

Fully-diluted shares outstanding (Q4/11.30.11 ) 23.8M

Market capitalization (01.31.12) $49M

% Owned by insiders 38%

Cash (Q4/11.30.11 ) $4.8M

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