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WE MAKE APPROVED DRUGS BETTER
TSX-V: IGX OTCQX: IGXT
Leader in Pharmaceutical Films
Your Specialist in Contract Development & Manufacturing
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.
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
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.
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
To partner with us, please contact our business development department:
+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