This presentation provides an overview of IntelGenx Corp, an innovative drug delivery company. It discusses IntelGenx's focus on using oral thin film technology to improve drug delivery and its product pipeline, which includes films for migraines, erectile dysfunction, schizophrenia, and mild cognitive impairment. The presentation also provides financial results, noting revenue growth and net income, as well as IntelGenx's new manufacturing facility and strengthened management team.
August 19, 2021 from 1-2 pm
CORD’s LAST SUMMER webinar, Part 1 of our series on “How to Get Back to the PMPRB Original Mandate to prevent excessive drug pricing and support pharma R&D investment.” Learn why responding to the most recent (July 15th) proposed guideline changes is very important.
On August 19, 2021 from 1-2 pm, please JOIN:
Nutriband is a transdermal focused pharmaceutical company based in the United States with a goal to improve the safety, comfort and efficacy of existing drugs using transdermal technologies. The Company is developing a pharmaceutical pipeline to improve drug delivery technologies and capabilities for patients, physicians, and payers through transdermal delivery technologies. Nutriband’s lead product is its AVERSA® technology. AVERSA® abuse deterrent transdermal technology incorporates aversive agents to prevent the Abuse, DiVERsion, MiSuse and Accidental exposure of drugs with abuse potential, such as opioids. The Company’s first application for AVERSA® is an abuse deterrent fentanyl transdermal patch which it is developing to provide clinicians and patients a safe extended-release patch for chronic pain. The goal is to make opioid based pain treatments safe for all who need them. AVERSA technology has received patent protection in the European Union, Australia, Japan, Mexico, Russia with patent prosecution in the US and Canada. Nutriband has made sure to target all large applicable markets and its global patent protection has opened up many opportunities for the Company to make a big impact on the safety profile of drugs globally.
When: June 10, 2021
Only 5% of rare diseases have an approved drug therapy. Only 60% of orphan medicines approved by the US FDA or EU EMA are approved in Canada, and often many months or years later. Only 34% of approved orphan medicines are funded by Canadian public drug plans. Under the BEST of circumstances, only 10% of eligible patients get access to an approved medicine. And worldwide, only 1% of rare disease patients will receive an approved drug. Most without treatment are children. How can Canada’s Rare Disease Drug Strategy assure all eligible Canadian patients get access to the most appropriate medicine for their individual needs?
Two panels will be tasked to consider a “Canada Leading the Way” strategic pharmaceutic framework that (1) attracts early investment in R&D; (2) reduces and manages risk for early adoption of innovative therapies; and (3) leads to a sustained culture of collaboration and trust among all stakeholders, including regulators, industry, payers, and patients. In particular, what has Canada learned from addressing COVID, for example, in terms of screening, diagnosis, drug repurposing, vaccine procurement, timely intervention, and monitoring, that can apply directly to rare disease therapies?
Presented by Bill Dempster and Gerry Jeffcott of 360 Public Affairs.
The presentation covers the following topics:
- An overview of Canada’s health technology assessment (HTA) system, including the national and provincial processes, which evaluate individual medications or therapeutic classes to inform funding decisions by governments and private payers
- How these systems have evolved to date to include patients’ experiences
- Attendees will also explore, together, how the HTA system could be improved to become more patient-centered in order to better meet the needs, expectations and values of patients, looking at a number of key questions, including:
- How and at what stage should patients be involved in HTA processes?
- What are the criteria for successful involvement of patients in HTA processes?
- How should patients’ perspectives be evaluated and factored into the formulary recommendations and, ultimately, coverage decisions?
- What are some of the current obstacles/barriers for successful patient involvement and what are the strategies/approaches to address them?
Genetic Technologies Limited is a diversified molecular diagnostics
company developing tools for the prediction and assessment of cancer
risk to help physicians proactively manage patient health. The
Company’s lead products, ‘GeneType for Breast Cancer’ and
‘GeneType for Colorectal Cancer’, are clinically validated risk
assessment tests that are first in their class. The Company’s
development pipeline includes new tests for COVID-19, Type 2
diabetes, cardiovascular disease, prostate cancer, and melanoma.
Listed on the ASX in 2000 and NASDAQ in 2005, Genetic
Technologies has been a leader in the development and
commercialization of genetic risk assessment technology for 20 years.
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
The University General Hospital of Valencia presentation
FOR A BETTER SOCIETY
The University General Hospital of Valencia is a large Institution. Its foundational principles of public, accessible, quality health are part of our management model, orientated towards the welfare society.
Our sustainability as an institution, covering more than 500 years, is chiefly founded on How we relate to our professionals, our patients, our environment and to the people in order to achieve a Better Society.
SUMMARY
Whoever loses their memory loses their identity
The General University Hospital of Valencia Consortium
Corporate model
Clinical management: participation and efficiency model
University Hospital: Teaching and Research
Integrating the latest information technologies
Social dimension
Environmental dimension: Green Hospital
Programa del XXVI Simposium de Reumatología. Reumatología en Atención Primaria. Organizado por el Servicio de Reumatología y Metabolismo oseo del CHGUV
Más información en:
http://chguv.san.gva.es
August 19, 2021 from 1-2 pm
CORD’s LAST SUMMER webinar, Part 1 of our series on “How to Get Back to the PMPRB Original Mandate to prevent excessive drug pricing and support pharma R&D investment.” Learn why responding to the most recent (July 15th) proposed guideline changes is very important.
On August 19, 2021 from 1-2 pm, please JOIN:
Nutriband is a transdermal focused pharmaceutical company based in the United States with a goal to improve the safety, comfort and efficacy of existing drugs using transdermal technologies. The Company is developing a pharmaceutical pipeline to improve drug delivery technologies and capabilities for patients, physicians, and payers through transdermal delivery technologies. Nutriband’s lead product is its AVERSA® technology. AVERSA® abuse deterrent transdermal technology incorporates aversive agents to prevent the Abuse, DiVERsion, MiSuse and Accidental exposure of drugs with abuse potential, such as opioids. The Company’s first application for AVERSA® is an abuse deterrent fentanyl transdermal patch which it is developing to provide clinicians and patients a safe extended-release patch for chronic pain. The goal is to make opioid based pain treatments safe for all who need them. AVERSA technology has received patent protection in the European Union, Australia, Japan, Mexico, Russia with patent prosecution in the US and Canada. Nutriband has made sure to target all large applicable markets and its global patent protection has opened up many opportunities for the Company to make a big impact on the safety profile of drugs globally.
When: June 10, 2021
Only 5% of rare diseases have an approved drug therapy. Only 60% of orphan medicines approved by the US FDA or EU EMA are approved in Canada, and often many months or years later. Only 34% of approved orphan medicines are funded by Canadian public drug plans. Under the BEST of circumstances, only 10% of eligible patients get access to an approved medicine. And worldwide, only 1% of rare disease patients will receive an approved drug. Most without treatment are children. How can Canada’s Rare Disease Drug Strategy assure all eligible Canadian patients get access to the most appropriate medicine for their individual needs?
Two panels will be tasked to consider a “Canada Leading the Way” strategic pharmaceutic framework that (1) attracts early investment in R&D; (2) reduces and manages risk for early adoption of innovative therapies; and (3) leads to a sustained culture of collaboration and trust among all stakeholders, including regulators, industry, payers, and patients. In particular, what has Canada learned from addressing COVID, for example, in terms of screening, diagnosis, drug repurposing, vaccine procurement, timely intervention, and monitoring, that can apply directly to rare disease therapies?
Presented by Bill Dempster and Gerry Jeffcott of 360 Public Affairs.
The presentation covers the following topics:
- An overview of Canada’s health technology assessment (HTA) system, including the national and provincial processes, which evaluate individual medications or therapeutic classes to inform funding decisions by governments and private payers
- How these systems have evolved to date to include patients’ experiences
- Attendees will also explore, together, how the HTA system could be improved to become more patient-centered in order to better meet the needs, expectations and values of patients, looking at a number of key questions, including:
- How and at what stage should patients be involved in HTA processes?
- What are the criteria for successful involvement of patients in HTA processes?
- How should patients’ perspectives be evaluated and factored into the formulary recommendations and, ultimately, coverage decisions?
- What are some of the current obstacles/barriers for successful patient involvement and what are the strategies/approaches to address them?
Genetic Technologies Limited is a diversified molecular diagnostics
company developing tools for the prediction and assessment of cancer
risk to help physicians proactively manage patient health. The
Company’s lead products, ‘GeneType for Breast Cancer’ and
‘GeneType for Colorectal Cancer’, are clinically validated risk
assessment tests that are first in their class. The Company’s
development pipeline includes new tests for COVID-19, Type 2
diabetes, cardiovascular disease, prostate cancer, and melanoma.
Listed on the ASX in 2000 and NASDAQ in 2005, Genetic
Technologies has been a leader in the development and
commercialization of genetic risk assessment technology for 20 years.
PAREXEL Principal Consultant Angela McGillivary discusses commercial considerations, clinical development, regulatory requirements, submission and post approval strategies in emerging markets
Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The Company’s portfolio is comprised of drug candidates intended to transform existing treatment and prevention paradigms. Its lead Phase 3 antifungal candidate, rezafungin, will report Phase 3 data at the end of 2021. The potential peak sales opportunity for rezafungin in the US is ~$750M. In addition, the Company is developing Drug-Fc Conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak® platform.
The University General Hospital of Valencia presentation
FOR A BETTER SOCIETY
The University General Hospital of Valencia is a large Institution. Its foundational principles of public, accessible, quality health are part of our management model, orientated towards the welfare society.
Our sustainability as an institution, covering more than 500 years, is chiefly founded on How we relate to our professionals, our patients, our environment and to the people in order to achieve a Better Society.
SUMMARY
Whoever loses their memory loses their identity
The General University Hospital of Valencia Consortium
Corporate model
Clinical management: participation and efficiency model
University Hospital: Teaching and Research
Integrating the latest information technologies
Social dimension
Environmental dimension: Green Hospital
Programa del XXVI Simposium de Reumatología. Reumatología en Atención Primaria. Organizado por el Servicio de Reumatología y Metabolismo oseo del CHGUV
Más información en:
http://chguv.san.gva.es
Reportaje sobre la historia del Hospital General Universitario de Valencia, un centro con más de 500 años de trayectoria inninterrumpida por la salud de los ciudadanos.
IntelGenx, through its cutting edge formulation platforms, has developed a broad and diverse product portfolio, including products for the treatment of severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder, idiopathic pulmonary fibrosis, allergies and pain management.
Milestone Scientific Inc. (MLSS) is a leading
medical research and development company
that designs and patents innovative injection
technology. Milestone's computer controlled
systems make injections precise, efficient, and
virtually painless.
With 174 foreign patents and 19 US patents
issued Milestone Scientific is the leader in
modern injection technology.
Milestone Scientific Inc. (MLSS) is a leading
medical research and development company
that designs and patents innovative injection
technology. Milestone's computer controlled
systems make injections precise, efficient, and
virtually painless.With 174 foreign patents and 19 US patents
issued Milestone Scientific is the leader in
modern injection technology.
IntelGenx, through its cutting edge formulation platforms, has developed a broad and diverse product portfolio, including products for the treatment of severe depression, hypertension, erectile dysfunction, benign prostatic hyperplasia, migraine, insomnia, bipolar disorder, idiopathic pulmonary fibrosis, allergies and pain management.
2. 1
2
To the extent any statements made in this presentation contain information that is not historical, these statements are
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements
on our current expectations and projections about future events. Our actual results could differ materially from those
discussed in, or implied by, these forward-looking statements.
Forward-looking statements are identified by words such as "believe," "anticipate," "expect," "intend," "plan," "will,"
"may" and other similar expressions. In addition, any statements that refer to expectations, projections or other
characterizations of future events or circumstances are forward-looking statements. Forward-looking statements
include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and
Drug Administration and Canadian Therapeutic Products Directorate approvals, acceptance and demand for new
pharmaceutical products, the impact of competitive products and pricing, new product development and launch,
reliance on key strategic alliances, availability of raw materials and finished products, the regulatory environment, tax
rate assumptions, the outcome of legal proceedings, fluctuations in operating results and other risks detailed from
time to time in the Company's filings with the Securities and Exchange Commission and the Ontario Securities
Commission. IntelGenx undertakes no obligation to update or revise any forward-looking statement.
2
Forward Looking Statements
4. 3
2
4
Oral Thin Films
Oral Thin Films Provide
Significant Market Opportunities
for Improving Drug Delivery
• IntelGenx CEO co-developer of the
Listerine breath strips
• Oral films provide quicker action to relieve symptoms
• IntelGenx’s goal to become a leader in
pharmaceutical oral film development &
manufacturing
5. 4
5
Clearly Defined BD Strategy
We are focused on areas where oral films
are particularly well-suited:
Develop and commercialize products that provide tangible patient benefits
leveraging oral films, such as:
• Reduced side effects
• Improved bio-availability
• Response time versus existing drugs
• Lifecycle management
• Repurpose existing drugs for new indications using oral films
• “First-to-file” Generic drugs where high technology barriers to
entry exist in reproducing branded films
6. 6
Prioritization of Future Product Sourcing
Balancing Risks and Opportunities for an Optimized Portfolio
Overall
Risk
Time to MarketSlow Fast
Low
High
Drug Repurposing
Patient Benefits
Lifecycle Mgmt
FTF Generics
IntelGenx Future Focus
Deal Value
Low
Medium
High
7. 6
A Robust Product Pipeline to Address
Significant Market Opportunities
Indication
Partnering
Availability
Formulation
Development
Pilot
Study
Pivotal
Study
Filing Launch
Films Migraine – Rizaport TM -
Rizatriptan
Available
except Spain
Erectile Dysfunction -
Tadalafil
Available
Schizophrenia - Loxapine Available
Central Nervous System -
Montelukast
Available
Respiratory (Cough & Cold) In Discussion
Cardiovascular In Discussion
Opioid Dependence
Par
Pharmaceutical
Undisclosed Term Sheet
Pain Term Sheet
Central Nervous System Term Sheet
5 7
8. 7
8
• High dose version of Wellbutrin XL®
• Only approved, once-daily, bupropion HCl 450mg dose
in a single tablet
• Launched commercially October 2013 in partnership
with Edgemont Pharmaceuticals
• Sold US revenue to SWK Holdings for $6M
• Development cost $2.5M, total revenue $15M = 6-fold
ROI
• Non-dilutive source of funding, will be used to advance
film projects
Successful monetization of first
in-house development
9. 8
9
For Migraines
Leverages VersaFilm™ Technology
• European Mktg Approval – November 2015
• Co-development partnership with RedHill Biopharma
• Definitive agreement signed July 2016 with
Grupo Juste for Spain & additional territories
• Actively pursuing several opportunities to open new
markets - negotiations with future commercialization
partners ongoing
• Planned USA submission to FDA Q1/2017
• Expected USA launch Q3/2017
10. 9
For Erectile Dysfunction
• The first oral thin film using IntelGenx
proprietary drug delivery technology,
VersaFilm™, for ED
• Containing tadalafil (Cialis® - Eli Lilly),
a major molecule in the ED market
• Demonstrated bioequivalence to Cialis®
• Orally disintegrating films without need
for water provide unprecedented patient
convenience and a discrete dosing
alternative
• 505(b)(2) USA NDA submission in
Q1/2017
• Expected USA launch Q1/2018
10
11. 10
For Schizophrenia &
Bipolar 1 Disorder
11
• The first oral thin film using IntelGenx
proprietary drug delivery technology,
VersaFilm™, for Schizophrenia & Bipolar
1 disorder
• Fast-acting loxapine oral dosage – to
treat acute agitation with Schizophrenia &
Bipolar 1 disorder in non-institutionalized
patients
• Reduces risk of pulmonary problems
and potential risk of violence and injury to
patients and others
• Formulation optimization stage – results
expected Q2 2017
12. 11
For Mild Cognitive Impairment
12
• IntelGenx is repurposing Montelukast
for the treatment of MCI by leveraging
its VersaFilm™ technology
• The drug is known and approved for a
completely different indication (asthma)
• Strong preclinical experience
• Results from first phase 1 trial in humans
available
• Looking for a commercial partner
13. 12
2
13
Clinical Data
0.0
100.0
200.0
300.0
400.0
500.0
600.0
0.00 5.00 10.00 15.00 20.00 25.00 30.00
Montelukastconcentration(ng/mL)
Time (hrs)
Montelukast Avg Plasma Profile
Test buccal film 10mg
Ref tablet 10mg
• First clinical study successfully completed
• Significantly increased bioavailability after administration of VersaFilm product
compared to commercial tablet
• Drug crosses blood/brain barrier when given as film
• Phase II-a study (proof of concept) to commence Q1/2017
• First efficacy data in humans available Q4/2017
• Several Pharma companies have expressed strong interest
Before
MMSE 13:
moderate to severe
dementia
MMSE 22:
mild dementia
After 2 Months of
Montelukast
14. 13
14
Completion of Construction
of Manufacturing Facility
• 17,000 sq ft facility in Montreal -
construction completed in Q1 2016
• Facility to be fully operational by Q1 2017
• High capacity manufacturing and
packaging equipment
• Lower costs, controls quality
and de-risks investment
for new products
GROSS MARGINS of 40% PLUS
We have built a state-of-the-art
oral film development and manufacturing facility
15. 14
Strengthened Management Team
Over 20 Employees, including 7 with Ph.D.’s
Andre Godin, CPA, CA
Executive VP, CFO
• 25+ years biotech/pharma
industry experience
• Member of the Canadian
Chartered Professional
Accountants and the
Canadian Institute of
Chartered Accountants
Nadine Paiement, M. Sc.
VP, Research & Development
• Co-inventor of IntelGenx
Trilayer Technology
• 15 years experience in
product development and
technology transfer
Edward Miller, B. Comm
Director, Investor Relations
• 15 years experience in
investor relations
• 10 + years experience in
pharmaceutical / biotech
Horst G. Zerbe, Ph. D.
Chairman, President & CEO
• Co-Founder of Listerine
breath strips
• 30+ years drug delivery /
pharma experience
• Holds over 40 patents in drug
delivery and numerous
scientific publications
15
Dana Matzen, Ph.D.
VP, Business & Corporate
Development
• 15 years experience in
pharmaceutical product
licensing
• Prev. Director, BD at Paladin
• Completed 13 transaction,
7 new product launches
John Durham, B. Sc.
VP, Operations
• 20+ years experience in
pharmaceutical
manufacturing, quality
management, product
development
• Held executive positions with
several Canadian and US
companies
16. 15
16
What Makes IntelGenx the Best in Oral Films
1. History
• Dr. Zerbe a pioneer with over 30 plus years in oral films
2. Formulation Team
• Strong in applying biopharmaceutical aspects to formulation development
• Top quality scientists: highly creative, focused on problem solving & innovative approaches
• Experienced in developing films for oral (GI), sublingual & buccal absorption
3. Clearly Defined Corporate Strategy And Business Model
• Focus on drug repurposing, lifecycle management, patient benefits, and FTF
• Provider of comprehensive pharmaceutical services to industry partners
4. Competitive Manufacturing Capabilities
• First in Canada
• New state-of-the-art manufacturing facility
• Offer one-stop-shopping to our partners with lean operations keeping costs down
• Customized manufacturing equipment
21. 20
21
Solid Platform for Growth
Significant Market Potential
• New manufacturing facility will offer many competitive advantages
• Strengthened management team to accelerate execution of business plan
• Implemented product sourcing strategy to identify high-value product opportunities
• Building strategic partnerships with relevant partners in the pharmaceutical industry
Solid Platform for Growth