(This is an extract from the lecture delivered by Shyamsunder Panchavati on 2nd September 2010 at Hyderabad)
Human being lives in whirlpool of Industries. All the industries revolve around the living beings specially the human beings. One industry or profession that keeps the human being fit enough to wither the whirlpool and keeps the industry going is the Medical Profession. Hence the Medical Profession occupies the high pedestal in this world.
View the abstract at
http://capacitybuildingdevelopment.blogspot.com/2010/09/pharmaceutical-industry-overview_06.html
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(This is an extract from the lecture delivered by Shyamsunder Panchavati on 2nd September 2010 at Hyderabad)
Human being lives in whirlpool of Industries. All the industries revolve around the living beings specially the human beings. One industry or profession that keeps the human being fit enough to wither the whirlpool and keeps the industry going is the Medical Profession. Hence the Medical Profession occupies the high pedestal in this world.
View the abstract at
http://capacitybuildingdevelopment.blogspot.com/2010/09/pharmaceutical-industry-overview_06.html
Market Exclusivity Under the Waxman-Hatch ActMichael Swit
March 19, 2007 presentation to the San Diego County Bar Association IP Section, with a focus on:
•Orphan Drug Exclusivity (Seven Years)
•Five-Year Exclusivity
•Three-Year Exclusivity
•Pediatric Exclusivity (Six Months)
•180-Day Exclusivity
Presentation at the Center for Professional Advancement (CFPA) Course on Generic Drug Approval, August 2013. New Brunswick, NJ., with a focus on the key basic provisions of the 1984 Hatch-Waxman Act
Yuvraj Regmi on Hatch-Waxman Act and Amendments and CFRYUVRAJ REGMI
VERY USEFUL PPT FOR UNDERSTANDING HACTH WAXMAN ACT AND CODE OF FEDERAL REGULATION.
THIS PPT HAS BEEN PREPARED FROM VARIOUS SOURCES AVAILABLE ON INTERNET.
Hatch- waxman act (The drug price competition and patent term restoration act...Mohit Kumar
The Drug Price Competition and Patent Term Restoration Act , informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.
Pharmaceutical globalization: Where are drugs invented?thinkBiotech
Maintaining control of pharmaceutical drug innovation is key for national security, public health, and economic development. We know that much of late-stage development has gone overseas, but the question remains: Where are drugs invented? Using the DrugPatentWatch.com database I demonstrate a model to track pharmaceutical globalization using patents, and reveal the locations of pharmaceutical innovation.
Frost & Sullivan - Initiation of Coverage - Oramed Pharmaceuticals Daniel Grunstein
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Keynote by Michael Berman, Former President at Boston Scientific and Healthcare IT entrepreneur and innvestor, about US digital healthcare investment trends and opportunities for the mHealth Israel meetup community
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2. Forward-Looking Statements
THIS PRESENTATION (TOGETHER WITH ANY AMENDMENTS OR SUPPLEMENTS), THE ACCOMPANYING
MATERIALS, ANY FINANCIAL MODELS AND THE APPENDICES (WHICH ARE AVAILABLE FROM THE COMPANY ON
REQUEST), CONTAIN CERTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO THE
COMPANY THAT ARE BASED ON OUR BELIEFS, ASSUMPTIONS AND INFORMATION AVAILABLE TO US AS OF THE
DATE OF THIS PRESENTATION.
STATEMENTS THAT ARE NOT HISTORICAL FACTS, INCLUDING STATEMENTS ABOUT THE COMPANY’S BELIEFS,
DESIGNS, ANTICIPATION, AIMS, GOALS, EXPECTATIONS AND POTENTIAL RESULTS ARE FORWARD-LOOKING
STATEMENTS.
IN ADDITION, IN THIS PRESENTATION, THE WORDS “WILL,” “MAY,” “BELIEVE,” “ANTICIPATE,” “INTEND,”
“ESTIMATE,” “EXPECT,” “PROJECT,” “PLAN,” “SHOULD,” “COULD,” AND SIMILAR EXPRESSIONS, AND THEIR
VARIATIONS AND NEGATIVES, AS THEY RELATE TO THE COMPANY OR THE POSSIBLE PERFORMANCE OF THE
COMPANY, ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. SUCH STATEMENTS REFLECT OUR
VIEW WITH RESPECT TO FUTURE EVENTS AS OF THE DATE OF THIS PRESENTATION AND ARE SUBJECT TO
CERTAIN RISKS, UNCERTAINTIES AND ASSUMPTIONS, INCLUDING THE RISK FACTORS DESCRIBED IN THIS
PRESENTATION AND ANY ACCOMPYING MEMORANDUMS.
2Please visit www.alitair.com for more information
3. Alitair Corporate Overview
Products & technologies compete in existing markets valued at over $35 billion
Supported by strong intellectual property with a long period of exclusivity
Two focus areas are ion-exchange resin formulations and respiratory disease
Ion-exchange resins: Overdose Reduction Technology and Rx Cough
Respiratory: Bronchiectasis (received FDA Orphan Drug designation in 20141)
Proven, experienced management team – committed to executing the business plan
and effectively increasing the valuation of Alitair
Monetize the portfolio over the next 18-30 months
$5.3 million previously invested has driven the portfolio forward to this next
valuation inflection point … clear path forward over the next 18-30 months
31 Source: Alitair Press Release January 7, 2014
4. Required Investment
Seeking $30 million … to move Alitair assets forward over the next 18-30 months to the
next major clinical development milestones and position the assets for monetization
ODRTM Proof of Concept completed -- ready for out-licensing to biopharma companies with
opioid, benzodiazepine and anti-anxiolytic products / portfolios
Three (3) patent protected prescription cough products ready for FDA submission via the
505(B)(2) pathway1 – ready for asset sale or out-licensing deal
Completed Phase II study for ALT-092; ready for Phase III – ready for asset sale, co-
development deal, or out-licensing deal
Targeted Founder’s Round and Private Placement: Net $5 million (2Q-3Q 2017)
Post Private Placement Round, Alitair Valuation ~$30 million
(~15 million shares @ $2.00 per share)
Next Step -- $25-30 million in additional funding and IPO Filing
41 Requires PK / bioequivalence studies only
2 IND open, FDA accepted Phase II Study design
5. Why Invest in Alitair?
Balanced approach: 3 late-state clinical development programs utilizing a mix of
proven ion-exchange resin formulations and late-stage, well characterized molecules
1. Technology to reduce the overdose risks associated with use and misuse of
prescription drugs which lead to over 15,000 deaths in 20151
2. Introduction of three oral, twice-a-day (BID) tablets for cough, the leading
specific reason patients seek a doctor visit in the US2
3. Development of the first potential FDA approved treatment for bronchiectasis
which affects 160,000 patients who face ~2x the risk of death (vs. a matched
population)
5
1
2
3
1 Source: CDC WONDER Database, 2016
2 CDC National Ambulatory Medical Care Survey, 2013
6. Why Invest in Alitair?
Products enter into large pre-established markets
$3 billion Rx Cough market
$3 billion Bronchiectasis market
$30-$35 billion in annual revenues in opioid,
benzodiazepine and anti-anxiolytics – upfront
payments, milestone payment and royalty
opportunities
Product development can leverage well defined
pathways to FDA approval – 505(b)(2) and Orphan
Drug guidelines … higher chances of success, less
costly, faster time to approvals
Late-stage, well characterized molecules
6
5 patents issued in 2012-2015
Additional IP possibilities being
explored
7. Why Invest in Alitair?
Experienced and Proven Executive Team
Core Adams Respiratory Team that
developed the Mucinex brand leading to a
$2.3 billion acquisition
General Management and Functional
Experience Across Pharma
Building talented teams
New Product Development
Clinical Trial Management
Business Development
Revenue growth & P/L Management
Board Membership Experience at PhRMA
and BIO
Broad industry insights and issues
management
James Hoyes | Chief Executive Officer1
(formerly President & Head of US Operations at EMD Serono2)
William Howard, PhD, MBA | President and Founder1
(formerly SVP, New Products/Business Development, Adams
Respiratory Therapeutics)
Helmut H. Albrecht, MD, MS, FFPM | Chief Scientific Officer
(formerly Head of R&D, Adams Respiratory Therapeutics)
Frank Koos | SVP Business Development
(formerly VP, Sales, Adams Respiratory Therapeutics)
Russ Somma, PhD | SVP R&D
(formerly R&D, Novartis)
Bob Casale| Member, Board of Directors1
(formerly COO, Adams Respiratory Therapeutics)
7
1 Indicates Board Membership
2 Head Operating Unit of Merck Serono
8. Alitair Portfolio of Technologies and Products to Address Urgent
Unmet Medical Needs
Overdose Reduction (ODRTM): Patent protected technology addressing the
growing opioid overdose crisis facing the US
183,000 lives lost to prescription drug overdose from 1999-
2015; overdose deaths in 2015 quadrupled vs. 1999!
Over 1,000 ER treatments per day for misusing prescription
opioids as directed resulting in a $2-3 billion healthcare cost
burden
8
1
1st Priority
In 2015, there were 52,400 drug overdose deaths; 33,000 involved an
opioid. Of these, over 15,000 deaths involved a prescription opioid. !
9. Alitair Overdose Reduction (ODRTM) Technology
A Potential Game-Changer within the Opioid Overdose Crisis
This slide illustrates the principle of overdose
reduction -- the same formulation releases a
progressively lower amount of drug at higher
doses
ODR™ technology cannot be
circumvented by crushing the capsules
or tablets and smoking or snorting the
active ingredients
ODR™ uses approved excipients and
well established manufacturing
technology
ODR™ is a life saving technology!
9
1st Priority
10. Alitair Portfolio of Technologies and Products to Address Urgent
Unmet Medical Needs
Chronic cough is one of the leading reasons patients seek a doctor visit – 26 million
visits per year
Clear need for a twice-a-day, oral, tablet formulation
88% of physicians are ‘likely to prescribe‘ due to the differentiated profile
Prescription market long dominated by narcotic formulations; however, the recent high growth
segment is non-narcotic benzonatate Alitair has both product types: codeine and
hydrocodone, each combined with pseudoephedrine, and benzonatate
Clear development pathway utilizing the FDA 505(b)(2) guideline which requires
pharmacokinetic (PK) testing only to confirm bioequivalence
Patent protected ion-exchange resin formulation
4 issued patents including a composition of matter patent on benzonatate
Market potential approaching $3 billion
10
2
Fastest FDA Approvals
11. Source: IMS - Rx’s in millions Dec 2015
Benzonatate Tablet Opportunity
Strong Growth with Little Promotion --
Prescribing More than Tripled over the Last
10 Years
Compelling Reasons to Prescribe
BID tablets formulation reduces safety
risks with current GelCap formulations
Nothing new in the cough market for
many years
Very few branded competitors – highly
fragmented market
Non-narcotic segment experiencing
fastest rate of growth
11
Fastest FDA Approvals
12. Alitair Portfolio of Technologies and Products to Address Urgent
Unmet Medical Needs
The 160,000 patients suffering from bronchiectasis have no FDA approved
treatments and face a death rate twice the normal population
ALT-09 has received Orphan Drug designation from the FDA for bronchiectasis patients with
and without Cystic Fibrosis; 130,000 and 30,000 patients respectively
Treatment costs for bronchiectasis are high and uncontrolled symptoms lead to costly
hospitalizations and chest physiotherapy
Orphan Drug status provides 7 years of market exclusivity, improved approval rates and
financial benefits related to tax credits, FDA filing fee waiver, etc.
ALT-09 is a well known and well characterized small molecule approved in European
markets for COPD
ALT-09 has received the green light from the FDA to initiate a Phase II study at 2 dosages for
treatment of bronchiectasis
Market potential of at least $3 billion
12
3
Highest Peak
Sales Potential
13. ALT-09 as a Potential Treatment for Bronchiectasis
ALT-09 Appears to be a Multi-Factorial Drug
Improves mucus clearance within the
airways
Inhibits bacterial growth, synergistic with
antibiotics
Exhibits both anti-oxidant and anti-
inflammatory properties
ALT-09 Showed Consistent Effects in Bronchiectasis
Patients in Several Small Studies Related to FEV1
Changes from Baseline – Larger Studies are
Warranted Based on these Findings
13
14. Alitair 18-30 Month Milestones
News Flow and Monetization Opportunities
Phase III Start
(PK Study Only)
Phase III Completion
NDA Submission via 505(b)(2)
Pathway
Overdose Reduction
(ODR) Technology
Narcotic Cough Products
(Codeine w/ Pseudo and
Hydrocodone w/ Pseudo)
Non-Narcotic Cough
Product (Benzonatate)
Orphan Drug Candidate
(ALT-09) - Erdosteine
14
Phase II Start
(Single Dose Study – PK
Only)
Phase II
Completion
Phase III Start
(Multiple Dose Study –
PK Only)
Phase III
Completion
NDA Submission via
505(b)(2) Pathway
Successful IND / Start of Proof of
Concept Study in Humans
Successful POC Study1 Data Package Ready
for Out-licensing
Test Unique Formulation Additional Patents Pending
Start Phase II Complete Phase II
1 Include confirmation that FDA Abuse Deterrence Guidelines are met.
2 Confirm Lupin formulation work, single dose PK data and reopen IND.
ConfirmPriorPKData2
andComplete
FormulationWork
15. Key Take-Away Messages
Unique opportunity to invest -- Seeking $25-$30 million in
new funding
Late stage, well characterized suite of products and
technologies that can compete effectively in large multi-billion
dollar markets in the near term
All supported by a strong patent portfolio – 5 patents issued;
other patents pending
Proven management team – committed to the business plan
execution
Following successful financing, will provide a series of
meaningful milestones over the next 18-30 months
15Please visit www.alitair.com for more information
[1]
ODRTM
[2]
Cough
Portfolio
[3]
Orphan
Drug
17. Legal Disclaimer
FOR DISCUSSION PURPOSES ONLY – NOT FOR USE IN PROMOTIONAL ACTIVITIES
This presentation is a draft for discussion purposes only.
This presentation contains information with respect to future products and/or indications that are not presently approved by the FDA and
thus can not be promoted by Alitair. Off-label promotion is against company policy. Information about non-approved prescription products is
to be used only for legitimate business planning purposes (e.g., investments/ fund-raising, discussions of ongoing or potential clinical
development plans, considerations of promotional strategies if and when new indications are approved, production planning, and for
budgeting and forecasting revenues). All revenue assumptions or projections assume strict compliance with the company policy prohibiting
any promotion of off-label uses of Alitair products.
This document may also contain forecasts and market assessments regarding Alitair products that have been prepared for confidential
business analysis and planning purposes and may consider various business scenarios; be aware that none of these analysis may hold true as
the markets and regulatory policy evolves over time. Product forecasts and the assumptions used do not reflect or constitute a legal analysis
or a legal assessment as to which scenario(s) is/are more likely. They reflect a clinical development, regulatory and/or commercial position
based on currently available information. They do not represent a final agreed course of action and any inference to that effect is not
intended and is hereby expressly disclaimed.
Note: Please direct any questions on this document to James Hoyes, CEO, Alitair Pharmaceuticals, Inc.
19. Alitair Portfolio of Technologies and Products to Address Urgent
Unmet Medical Needs
Overdose Reduction (ODRTM): Patent protected technology addressing the
growing opioid overdose crisis facing the US
ODRTM is based on a proprietary ion-exchange resin that can be out-licensed to
many potential companies with products in the opioid, benzodiazepine and anti-
anxiety therapeutic areas – represent a $30-35 billion market opportunity
ODRTM technology uniquely addresses both overdose reduction and abuse
deterrence aspects of the opioid crisis
Patent issued in December 2015
19
1st Priority
20. Market Potential for Alitair ODRTM Technology
Licensing Opportunity for ODRTM – Mix of upfront payments, milestone payments and
ongoing royalties
366 million prescriptions in narcotic (including opioid), benzodiazepine and anti-anxiety
classes valued at $35 billion
Opioid products – 1st priority
Also benzodiazepines & anti-anxiety classes
Wide range of target companies
Variety of life cycle management options
Branded and generics
20
1st Priority
21. US Cough/Cold Market Totals 37.1 Million Prescriptions, Up
1.5% Since 2010
21
Fastest FDA Approvals
22. Bronchiectasis Causes Permanent Damage
There are both young and elderly
bronchiectasis patients, and all
Cystic Fibrosis patients suffer from
bronchiectasis
Bronchiectasis causes devastating lung
damage: repetitive lung infections lead
to excessive scar tissue and degraded
lung function, and it can cause death
Bronchiectasis patients
have double the death rate of the
general population
22
Highest Peak
Sales Potential
23. ALT-09 Market Research and
Pricing Study Completed by Medical Marketing Economics
Medical Marketing Economics is one of the premier pricing and
reimbursement consulting company in the USA
Interviewed pulmonologists who treat bronchiectasis patients
Use in 80% of bronchiectasis patients
Pricing estimated at $25-30K per year
FDA stated indication will be for both CF and non-CF bronchiectasis : about
160,000 patients total
Market potential of $3.4 billion
23
Highest Peak
Sales Potential
24. Clear Regulatory Pathways
Overdose Reduction Technology (ODRTM)
Proof of concept in humans required prior to out-licensing
Utilize patent protected ion-exchange resin formulation
Cough Portfolio
505(B)(2) approval pathway … no additional safety and efficacy studies required
Utilize patent protected ion-exchange resin formulations
PK “steady-state” and “fed/fast” studies (bioequivalence) needed for 2 narcotic combinations
PK “single dose”, “steady-state”, and “fed/fast” studies (bioequivalence) needed for the non-
narcotic (benzonatate)
ALT-09
Orphan Drug Status Granted
Phase II study design approved by FDA (two dosing arms, placebo)
24
25. ALT-09 End of Phase 1 Meeting Completed at FDA
Ready to start a Phase 2 Study, an open IND at FDA
Extensive human efficacy data in COPD
Excellent safety profile
Three published studies on use in bronchiectasis
FDA alignment on our proposed Phase 2 study
FDA gave us the green light for the study at all planned dose levels, 600mg and 900mg per
day
Ready to start Phase 2 clinical study in bronchiectasis
25
26. Quantitative Market Research: Likelihood to Prescribe at 88%
The physicians’ likelihood to prescribe is a key measure of the overall breadth of physician
interest, in that it indicates the adoption of Benzonatate into the physicians’ portfolios of
treatment tools
Physician responses were compared to the TNSfyi database of physician responses for new
drugs or new indications for acute conditions.
Physician responses are above average for a Benzonatate formulation
42% of Physicians definitely would prescribe
46% of Physicians probably would prescribe
26
Editor's Notes
At one hour,
10 mg release 43.4% or 4.34 mg
4 x 10 mg releases 20.1%, or 8.04 mg (vs. expected 17.36 mg; 4 x 4.34 mg)
8 x 10 mg releases 13.5%, or 10.8 mg (vs. expected 34.88 mg; 8 x 4.34 mg)