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WE MAKE APPROVED DRUGS BETTER TSX-V: IGX OTCQX: IGXT Leader in Pharmaceutical Films Your Specialist in Contract Development & Manufacturing

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Page 1: Leader in Pharmaceutical Filmss2.q4cdn.com/790425727/files/doc_downloads/2017/... · formulation of a leading treatment for migraine. […] IntelGenx possesses a deep knowledge in

WE MAKE APPROVED DRUGS BETTER

TSX-V: IGX OTCQX: IGXT

Leader in Pharmaceutical Films

Your Specialist in Contract Development & Manufacturing

Page 2: Leader in Pharmaceutical Filmss2.q4cdn.com/790425727/files/doc_downloads/2017/... · formulation of a leading treatment for migraine. […] IntelGenx possesses a deep knowledge in

Our Mission

We make approved drugs better,

with next generation pharmaceutical

products that address unmet

medical needs and offer significant

benefits to patients and physicians.

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CORPORATE OVERVIEW

IntelGenx is a leading oral drug delivery company focused on the

development and manufacturing of innovative pharmaceutical films

and transdermal products based on its proprietary VersaFilm™

technology platform.

• Established in 2003.

• 25 years+ experience in oral films.

• Offices & manufacturing facilities based in Montreal, Canada.

• Listed on the TSX-V and OTC-QX.

WE MAKE APPROVED DRUGS BETTER

Accountability Respect

Customer Orientation

Teamwork & Collaboration

Honesty & Openness

Our Core Values

Innovation & Creativity

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WE HAVE ESTABLISHED STRATEGIC PARTNERSHIPS VALIDATING OUR ATTENTION TO CUSTOMER SERVICE

“We are extremely satisfied to announce the planned arrival of this new

formulation of a leading treatment for migraine. […] IntelGenx possesses

a deep knowledge in the pharmaceutical industry including strong

leadership in innovative formulations that improve the compliance and

the administration pattern of gold standard drugs.”

President of Grupo Juste (July 2016)

Juste’s Pharma Unit is now part of Exeltis Spain, a company of Chemo Group

“We are pleased to announce the signing of the definitive agreement

with IntelGenx and look forward to working very hard with them to bring

this much-needed product to patients suffering from cancer pain.”

CEO of Tetra Bio-Pharma (April 2017)

“Par is very pleased to expand its commercial relationship with

IntelGenx. With their innovative technology and talented development

team, IntelGenx represents an ideal partner for Par.”

CEO of Par Pharmaceutical Companies, Inc. (January 2014)

Par is a company of Endo International plc

“Partnering on four complex products with IntelGenx clearly validates

IntelGenx’ advanced oral delivery platform. We look forward to continuing to

grow our relationship with IntelGenx in 2017 and leveraging both companies’

talent to develop additional products with high barriers to entry.”

President and GM of Xiromed USA, Chemo Group (December 2016)

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OUR ADVANTAGE

We offer a full range of services in the development and

manufacturing of oral films and transdermal products while

expanding our own product pipeline.

• R&D: Our team of highly qualified researchers is extremely

versatile, creative and efficient in developing innovative products

protected by strong intellectual property.

• Intellectual Property: The VersaFilm™ technology platform

and products are protected by several issued patents and

pending applications.

• Regulatory&Quality: Our knowledgeable regulatory team

monitors project development closely in order to ensure

GMP compliance and a smooth transition from R&D to regulatory

approval and commercial manufacturing.

• Manufacturing: IntelGenx’ highly skilled team demonstrates

technological expertise in scale-up, technology transfer and

manufacturing of pharmaceutical thin films.

R&D

Formulation

Feasibilty Study

Analytical Method Development

Clinical Monitoring

Intellectual Property

Patented Products & Technologies

Patent Filings

FTO Opinions

Manufacturing

State-of-the-Art Equipment

Full Scale Manufacturing

High Speed

Cost Effective

Regulatory & Quality

Dossiers in Multiple Territories

(E.U., U.S.)

Compliant with ICH, GMP & ISO

WE MAKE APPROVED DRUGS BETTER

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The IntelGenx Advantage

Our focus, expertise, creativity

and responsiveness in oral film

development enable us to offer

our partners a full range of

services that deliver high quality

and cost effective products.

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WE HAVE A PROVEN TRACK RECORD

Rizaport™ is a proprietary oral thin film

formulation of rizatriptan for the treatment

of acute migraines which has been granted a

European marketing authorization.

• Rizaport™ represents an attractive therapeutic alternative

for migraine patients.

• The thin film disintegrates rapidly without the need for water,

has a pleasant taste, and its pocket size makes it ideal for

migraine sufferers to carry-on-the-go.

• Patients can also take their medication without exacerbating

nausea, one of the most important attributes when selecting

a product to treat migraine headaches.

IntelGenx successfully developed a generic

formulation of buprenorphine and naloxone

sublingual film indicated for the maintenance

treatment of opioid dependence.

• An Abbreviated New Drug Application (ANDA) was filed

at the U.S. FDA by our U.S. based co-development and

commercialization partner Par Pharmaceutical.

• The submission was accepted for review at the U.S. FDA.

• The reference listed drug is Suboxone®

(buprenorphine and naloxone) sublingual film.

6WE MAKE APPROVED DRUGS BETTER

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WE OFFER FULL SERVICE CAPABILITY TO FOSTER THE GROWTH OF OUR PARTNERS

• Our state-of-the-art facilities are equipped with the most

modern equipment to deliver high-quality, cost-effective products,

while accommodating client requirements at each stage of

product development.

• IntelGenx’ manufacturing plant, established to support the

VersaFilm™ technology platform, provides lab-scale to pilot

and commercial-scale production, offering full service capabilities

to our clients:

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R&D LAB-SCALE

Together with our formulation

specialists, our R&D

development laboratories are

fitted with high-tech equipment

and tools for the formulation

and development of innovative

thin film pharmaceuticals.

SCALE-UP & TECHNOLOGY TRANSFER

Our film experts manage

IntelGenx’ modern and

customized equipment to

allow for a proportional

parametric transfer from

small to large scale production,

facilitating manufacturing

development processes.

COMMERCIAL MANUFACTURING

Our team’s unique experience

with large scale production

of thin films, including high

viscosity blends, suspensions

and monolayer or multilayer

film products, provides

significant advantages to

our customers.

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8WE MAKE APPROVED DRUGS BETTER

WE PROVIDE COMPREHENSIVE R&D SERVICES TO DESIGN CUSTOMIZED PRODUCTS

• IntelGenx follows a structured approach for each film project.

Our expert team supports you from pre-development activities

up to the commercial manufacturing of the product.

• Together we establish the goals of each project and define

milestone targets during the development process.

• A joint R&D steering committee will meet and discuss the project

on a regular basis to allow for full budget transparency and

progress on set development timelines.

• If you are looking for a reliable partner to develop your product,

please contact our Business Development group today

for a customized quote.

Stability Assessment

Talent Management

Patent Search

FormulationFeasibility

Assessment

Innovative Process

Intellectual Property

AnalyticalMaterials Sourcing

Taste Masking Permeation

Studies

Specification

ValidationClinical Study Regulatory

PK Analysis

Timeline and Budget Process

Scale-up

Project Monitoring

R&D Team

Pre- development

Patent search

Feasibilty Study

Analytical methods

Formulation Optimization including taste masking

Scale-up

Batch records

Testing

Clinical trial

Monitoring

Commercial Manufacturing under GMP

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SCALE-UP, PROCESS DEVELOPMENT & TECHNOLOGY TRANSFER

• IntelGenx’ highly skilled team provides technological

expertise in scale-up, process development and technology

transfer of pharmaceutical films.

• Our unique experience at all scales of production of pharmaceutical

films, including suspensions, solubilizations, monolayer or

multilayer film products to name a few, constitutes significant

advantages for our customers.

• Our films experts ensure optimal process development to

allow customers’ product specifications to be successfully

achieved in downstream manufacturing operations.

• Our equipment has been carefully designed to provide a

proportional parametric transfer from small to large scale

production, allowing great efficiency in our operating processes.

• We can operate from small to large scale with blending volumes

ranging from 1 to 100 kilograms.

• We are devoted to respond to our clients’ needs and match

our manufacturing processes and equipment to their product

and volume specifications.

• Our team will be pleased to assist you with the

batch production for:

> Stability > Validation

> Lab-scale > Commercial

> Scale-up > Tech-transfer

> Pilot > Clinical

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MANUFACTURING & PACKAGING

Cutting-edge manufacturing equipment:

• Solvent compatible blending tanks to produce both aqueous

and solvent-based coating mass.

• Coating lines with variable coating techniques and widths

to match product requirements.

• Versatile slitting units to optimize yields.

• Capability to manufacture more than 20,000 film units

per hour to supply global markets.

High-speed packaging:

• Die-cut films of desired shape and size.

• Unit dose packaging of films into pouches.

• Serialization with Unique Product Identifier.

• Capability to supply bulk or secondary packed films.

• High volume capacity with up to 55,000 film units

packaged per hour.

• Our equipment and procedures have been designed to comply

with all regulatory standards. Our GMP facility is dedicated to

the development and manufacturing of pharmaceutical films.

We are licensed to handle narcotics and controlled substances.

• We assess all critical process parameters during the development

process of your product using Design of Experiments (DOE)

methodology to:

> Accelerate processes,

> Increase cost effectiveness,

> Mitigate risks.

• Our teams of experts are committed to go above and beyond

to satisfy the needs of our customers.

IntelGenx is equipped with

state-of-the-art operating

lines offering great flexibility

to design customized-film

products with volumes

ranging from R&D test

quantities to millions of

commercial film units.

WE MAKE APPROVED DRUGS BETTER

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To partner with us, please contact our business development department:

[email protected]

+1 514 331 7440 Ext 220

WE MAKE APPROVED DRUGS BETTER

IntelGenx Corp. 6420 Abrams, Saint-Laurent, Quebec, Canada H4S 1Y2

+1 514 331 7440

www.IntelGenx.com