TSX-V: IGX OTCQX: IGXT Leader in Pharmaceutical Films Your Specialist in Contract Development & Manufacturing WE MAKE APPROVED DRUGS BETTER
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. 1
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. Our Core Values Honesty & Openness Customer Orientation Teamwork & Collaboration Innovation & Creativity Accountability Respect WE MAKE APPROVED DRUGS BETTER 2
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 3 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)
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 Regulatory & Quality Dossiers in Multiple Territories (E.U., U.S.) Compliant with ICH, GMP & ISO Manufacturing State-of-the-Art Equipment Full Scale Manufacturing High Speed Cost Effective WE MAKE APPROVED DRUGS BETTER 4
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. 5
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. WE MAKE APPROVED DRUGS BETTER 6
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: 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. 7
WE PROVIDE COMPREHENSIVE R&D SERVICES TO DESIGN CUSTOMIZED PRODUCTS Stability Assessment Talent Management Patent Search Formulation Feasibility Assessment Innovative Process Taste Masking Intellectual Property R&D Team Analytical Permeation Studies Materials Sourcing Specification Validation Clinical Study Regulatory PK Analysis Timeline and Budget Process Scale-up Project Monitoring 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. Predevelopment Patent search Feasibilty Study Analytical methods Formulation Optimization including taste masking Scale-up Batch records Testing Clinical trial Monitoring Commercial Manufacturing under GMP WE MAKE APPROVED DRUGS BETTER 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. 8
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 9 > Pilot > Clinical
MANUFACTURING & PACKAGING Cutting-edge manufacturing equipment: 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. 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. WE MAKE APPROVED DRUGS BETTER Our teams of experts are committed to go above and beyond to satisfy the needs of our customers. 10
WE MAKE APPROVED DRUGS BETTER To partner with us, please contact our business development department: bdcontact@intelgenx.com +1 514 331 7440 Ext 220 IntelGenx Corp. 6420 Abrams, Saint-Laurent, Quebec, Canada H4S 1Y2 +1 514 331 7440 www.intelgenx.com