2. 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.
2
3. 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.
3
4. 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.
4
5. Pharmaceutical Industry Profile
Intellipharmaceutics Focus
ANDA NDA 505 (b)(2) NDA 505 (b)(1)
GENERICS DRUGS DRUGS
Identical Drug Copies Novel Proprietary Modifications Novel Patented Drugs
of Approved Drugs
development
Estimated
timeline
2-4 years 3-4 years 10-12 years
5
6. 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™ IntelliOsmotic™
IntelliPaste™ IntelliPellets™ IntelliGITransporter™
IntelliFoam™ IntelliShuttle™
6
7. HypermatrixTM Technology
Capabilities Key Advantages
Controlled release
Extended release Shorter development timelines
Pulsatile release Cost effective development
Chrono mimicry Once-a-day dosing
Quick disintegrating release Chrono therapeutic dosing
Site specific delivery Suitable for hydrophilic/hydrophobic,
Prevention of dose dumping potent, and high dose compounds
Abuse resistance
Alcohol resistance
Enhanced bioavailability
Capabilities have been repeatedly
substantiated in vitro and in vivo
7
8. Disclosed Product Candidates
U.S. Pilot Clinical /
Product Brand Indication Formulation Scale-up FDA review
Sales** Studies BE Studies
dexmethyl-
Focalin XR® $596M ADHD
phenidate Partnered with Par Pharmaceutical (NYSE:PRX)
venlafaxine
Effexor XR® $2.5B* Depression
HCI
pantoprazole
Protonix® $1.8B* GERD
sodium
metformin Glucophage®
$431M* Diabetes
HCl XR
Schizophrenia,
quetiapine bipolar disorder,
Seroquel XR® $1.1B major depressive
fumarate disorder
Lamictal®
lamotrigine $217M Epilepsy
XR™
carvedilol
Coreg CR® $314M CHF
phosphate
oxycodone CR Oxycontin $2.9B Pain
*includes sales of generics
** Wolters Kluwer Health data for the 12 months ending Dec 2011
8
9. 1st ANDA: Generic Focalin XR®
Overview & Highlights
Examples of US Economic Potential (1)
Indicated for ADHD
Partnered with Par Pharmaceutical (NYSE:PRX) Brand Sales
ANDA filed with FDA for 5, 10, 15, 20, 30mg strengths
Paragraph IV certification; patent litigation settled with $596M(3)
Novartis, Elan, Celgene for 5, 10, 15, 20mg strengths
Potential launch Q4 2012 for first four strengths Discount
(~90% of brand sales)
70% 50%
Par Pharmaceutical (NYSE:PRX) Partnership
Market Penetration
License & Commercialization Agreement
(Nov. 2005 / expanded Aug. 2011 to include additional strengths) 10% 20%
IPCI pays development costs / Par responsible for others (2)
Potential Revenue
10 year profit-sharing agreement from commercial launch
to PAR/IPCI partnership
of product
Par is a top 10 U.S. Pharma company with an approximate $18M $60M
$1 billion market cap
(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
10. 2nd ANDA: Generic Effexor XR®
Overview & Highlights
Examples of US Economic Potential (1)
Indicated for major depressive disorders
Brand and Generic Sales
Available for partnering
ANDA accepted by the FDA as of Jan. 2010 for all $2.5B(2)
strengths of the approved brand product
Paragraph IV certification; litigation settled Discount
Potential launch upon FDA approval
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. 10
11. 3rd ANDA: Generic Protonix®
Overview & Highlights
Examples of US Economic Potential (1)
Indicated for conditions associated with GERD
(i.e.. ulcers) Brand and Generic Sales
Available for partnering
$1.8B(2)
ANDA accepted by the FDA as of June 2010 for all
strengths of the approved brand product Discount
Paragraph IV certification; no litigation
Potential launch upon FDA approval 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. 11
12. 4th ANDA: Generic Glucophage® XR
Overview & Highlights
Examples of US Economic Potential (1)
Indicated for the management of type 2 diabetes
Available for partnering Brand and Generic Sales
ANDA accepted by the FDA as of Aug 2010 for two
$421M(2)
strengths of the approved brand product
Paragraph IV certification; no litigation Discount(3)
Potential launch upon FDA approval
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
12
13. 5th ANDA: Generic Seroquel XR®
Overview & Highlights
Examples of US Economic Potential (1)
Indicated for the treatment of schizophrenia, bipolar
disorder, and major depressive disorder Brand Sales
Available for partnering
$1.1B(2)
ANDA accepted by the FDA as of Feb 2011 for four
strengths of the approved brand product Discount
Paragraph IV certification; litigation initiated
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. 13
14. 6th ANDA: Generic Lamictal® XR™
Overview & Highlights
Examples of US Economic Potential (1)
Indicated for the treatment of epilepsy (anticonvulsant) Brand Sales
Available for partnering
ANDA accepted by the FDA as of Sep 2011 for four $217M(2)
strengths of the approved brand product
Paragraph I certification; no litigation 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.
14
15. 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
15
16. Oxycodone and its Abuse
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
16
17. Growing Interest in Abuse Resistance
DURECT, PAIN THERAPEUTICS, KING, and PFIZER CASE STUDY
Dec 2002 Pain completes a deal with
$9M +6%-11.5% Durect to develop and
commercialize selected long-
of sales acting oral opioid products – incl.
(also includes reimbursment of R&D efforts; abuse resistant Remoxy.
% dependant on volume of sales)
Nov 2005
$400M +15/20% King Pharma completes a deal
with Pain for Remoxy and other
of sales 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)
March 2011
Pfizer completes
$3.6B acquisition of King.
17
18. 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
Designed to resist the release of the entire dose
when chewed or consumed with alcohol
Rexista technology platform applicable to additional
opioid drug candidates (i.e., oxymorphone,
hydrocodone, and morphine)
The FDA’s move to restrict the prescribing of extended-
release opioid analgesics should benefit tamper-resistant
formulations such as IPCI’s Rexista™
18
19. 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)
RESULTS
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
19
20. RexistaTM Oxycodone XR
Overview & Highlights
Clinical stage Examples of US Economic Potential (1)
Phase 1 proof-of-concept study completed
Primary manufacturing equipment has been delivered Controlled-release Oxycodone Sales
and qualified
$2.9B(2)
Manufacturing scale-up of clinical batches for use in
Phase 1 & 2 studies in progress 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. 20
21. State-of-the-Art Facility
TORONTO, ONTARIO
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
In-house manufacturing of clinical
batches saves valuable time
and protects proprietary technologies
21
22. 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
22