The document provides an overview of TARIS's market research on bladder cancer and overactive bladder syndrome (OAB). Key points include:
1) Bladder cancer represents a large underserved market opportunity with increasing development activity in recent years. The market research validated the potential for TARIS's sustained drug delivery approach to transform bladder cancer treatment.
2) The research estimated the peak US market opportunity for successful bladder cancer treatment to be over $1 billion based on incidence rates and treatment costs.
3) Research also found the economic burden of OAB to be high, around $36.5 billion annually in the US. TARIS's non-invasive treatment approach could address unmet needs and target
Global regenerative medicines market (technology, application and geography) ...Allied Market Research
Regenerative medicines have the unique ability to repair, replace and regenerate tissues and organs, affected due to some injury, disease or due to natural aging process.
February 18, 2016
The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.
This panel discussion brought together experts from legal practice, industry, and academia to discuss each of these issues and to recommend ways in which the agency and industry can move forward.
For more information, visit the website: http://petrieflom.law.harvard.edu/events/details/viability-of-fda-biosimilar-pathway.
Global regenerative medicines market (technology, application and geography) ...Allied Market Research
Regenerative medicines have the unique ability to repair, replace and regenerate tissues and organs, affected due to some injury, disease or due to natural aging process.
February 18, 2016
The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.
This panel discussion brought together experts from legal practice, industry, and academia to discuss each of these issues and to recommend ways in which the agency and industry can move forward.
For more information, visit the website: http://petrieflom.law.harvard.edu/events/details/viability-of-fda-biosimilar-pathway.
Is European market access becoming an incubator for rare disease development?...KateBenson18
FIECON's white paper 'Is European market access becoming an incubator for rare disease development?' explores the hypothesis that successful commercialisation in Europe is the biggest commercial opportunity for orphan drug manufacturers right now.
Strand featured in CIO Review: Pharma and Life Science Special edition - July 2014
Strand Genomics Inc recognised by CIO Review as one among 20 most promising Tech solution providers to Pharma and Life science industry 2014
Healthcare Contract Research Organization (CRO) MarketTom Clark
Global Healthcare Contract Research Organization (CRO) Market is expected to reach USD 51.3 billion by 2024 with CAGR of 6.5% over the future period as the scope and its applications are rising enormously across the globe.
Just to remind you that registrations for our 18th Pharmacovigilance 2019 event, which is taking place at The Pestana Chelsea Bridge Hotel in London, UK on 27-28th Feb are closing soon.For more details email to dinesh@virtueinsightsummits.com
A presentation of Genentech strategic growth options vis-a-vis the current economic and structural challenges the biotech industry is facing.
Team project, December 2008.
According to the latest report by IMARC Group,the global gene expression analysis marketexhibited strong growth during 2015-2020.
Gene expression analysis is extensively used across clinical, research and pharmaceutical settings to study individual genes, gene pathways or greater gene activity profiles.
Movers & shakers interview with vivek trikha head diagnostics onc quest ...oncquest
OncQuest Laboratories Limited (formerly Dabur OncQuest) formally announced its existence as an independent entity, moving away from being a part of Dabur Pharma Limited, on December 31, 2007. OncQuest Laboratories Limited was incorporated in January 2008.
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
The U.S. Biopharmaceutical Industry (2014): Perspectives on Future Growth and...PhRMA
The capability to innovate is fast becoming the most important determinant of economic growth and a nation’s ability to compete and prosper in the 21st century global knowledge-based economy.
The innovative biopharmaceutical industry stands out among high-value knowledge-based industries, including aerospace, automotive, and semiconductors, as a driver for future U.S. economic growth. Aging populations throughout the world and rising purchasing power for medical advances among emerging economies are expected to drive increased demand for prescription medicines in the coming years, providing opportunities to increase production and exports.
Why is the orphan drug area receiving increasing attention? In this presentation you will find the primary reasons explained.
Over the next weeks, Black Swan Consulting will summarise information on this class of drug products. Please also see http://black-swan-consulting.com/what-is-cooking/Orphan-drugs.
Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
Is European market access becoming an incubator for rare disease development?...KateBenson18
FIECON's white paper 'Is European market access becoming an incubator for rare disease development?' explores the hypothesis that successful commercialisation in Europe is the biggest commercial opportunity for orphan drug manufacturers right now.
Strand featured in CIO Review: Pharma and Life Science Special edition - July 2014
Strand Genomics Inc recognised by CIO Review as one among 20 most promising Tech solution providers to Pharma and Life science industry 2014
Healthcare Contract Research Organization (CRO) MarketTom Clark
Global Healthcare Contract Research Organization (CRO) Market is expected to reach USD 51.3 billion by 2024 with CAGR of 6.5% over the future period as the scope and its applications are rising enormously across the globe.
Just to remind you that registrations for our 18th Pharmacovigilance 2019 event, which is taking place at The Pestana Chelsea Bridge Hotel in London, UK on 27-28th Feb are closing soon.For more details email to dinesh@virtueinsightsummits.com
A presentation of Genentech strategic growth options vis-a-vis the current economic and structural challenges the biotech industry is facing.
Team project, December 2008.
According to the latest report by IMARC Group,the global gene expression analysis marketexhibited strong growth during 2015-2020.
Gene expression analysis is extensively used across clinical, research and pharmaceutical settings to study individual genes, gene pathways or greater gene activity profiles.
Movers & shakers interview with vivek trikha head diagnostics onc quest ...oncquest
OncQuest Laboratories Limited (formerly Dabur OncQuest) formally announced its existence as an independent entity, moving away from being a part of Dabur Pharma Limited, on December 31, 2007. OncQuest Laboratories Limited was incorporated in January 2008.
Commercial considerations in early drug developmentSunil Ramkali
It is important in the drug development process that marketers and researchers collaborate early to ensure that products being developed are truly innovative and deliver brand value to the different end users in a way that the product and the subsequent brand messaging is relevant, compelling and differentiating compared to the competition. T
In the market place that is heavily cost constraint, innovation is no longer about a unique mode of action or a new formulation, but more about the incremental brand value offered by new pharmaceutical products over existing treatments (standard of care) and how much healthcare systems are prepared to pay for these incremental benefits. My lecture at the Department of Innovation, Lund University, Sweden explored the importance of R&D functions getter closer to external stakeholders to really understand their needs, how they define brand value and the importance of considering this early in the drug development process.
The U.S. Biopharmaceutical Industry (2014): Perspectives on Future Growth and...PhRMA
The capability to innovate is fast becoming the most important determinant of economic growth and a nation’s ability to compete and prosper in the 21st century global knowledge-based economy.
The innovative biopharmaceutical industry stands out among high-value knowledge-based industries, including aerospace, automotive, and semiconductors, as a driver for future U.S. economic growth. Aging populations throughout the world and rising purchasing power for medical advances among emerging economies are expected to drive increased demand for prescription medicines in the coming years, providing opportunities to increase production and exports.
Why is the orphan drug area receiving increasing attention? In this presentation you will find the primary reasons explained.
Over the next weeks, Black Swan Consulting will summarise information on this class of drug products. Please also see http://black-swan-consulting.com/what-is-cooking/Orphan-drugs.
Sharing my learning in dealing with complexity and uncertainty and shed some light on:
(a) Understanding the ‘biosimilar paradox’
(b) Accelerating our “QbD” Journey – focusing on ‘from Generics to Biosimilars’
(c) In preparing this talk, collect my thoughts to help NIPTE consider ways for developing its program on Biosimilars to help the Nation improve assurance of quality with confidence and lower costs
(D) Invite the audience to get to know NIPTE and provide us ways to collaborate with industry
Lantern Pharma is a clinical stage biotechnology company focused on leveraging artificial intelligence (“A.I.”), machine learning and genomic date to streamline the drug development process and to identify patients who will benefit from their targeted oncology therapies. Their portfolio of therapies consists of compounds that others have tried, but failed, to develop into an approved commercialized drug. Additionally, they develop new compounds with the assistance of their A.I. platform (RADR) and biomarker driven approach. The Company is currently developing four therapeutic programs.
New Product Planning in the Pharmaceutical IndustryAnthony Russell
Lecture presented in the Competitive Intelligence and Pricing course as part of the University of Southern California Master of Science in Healthcare Decision Analysis program. Presented on June 14, 2020 at USC via Zoom. The lectures gives an overview of what new product planning is in the pharmaceutical industry, what tools are used during new product evaluations, and the key elements of a new product business case. The lecture includes a couple of case studies to be worked on by the class.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Visit CANFinfo.com to learn more.
Presently, several drug developers, along with technology providers, are actively engaged in the development of novel peptide therapeutics, such as peptide drug conjugates and cell penetrating peptides. Innovation in this field of research is mostly focused on improving drug delivery methods, API stability, target affinity, and optimizing toxicity profiles.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
Global pharmaceutical & biotechnology outlook 2013 rising stars - Reports CornerReports Corner
Innovative and improved drugs therapies developed through novel target discovery and technology platforms have originated from the backyards of small research focused companies (Rising Stars, RS, non-profitable biotech companies). The universe continues to grow despite the high risk and the wait to transform into a successful profitable Mature Biotech is long.
https://www.reportscorner.com/reports/10016/Global-Pharmaceutical-&-Biotechnology-Outlook-2013:-Rising-Stars/
Unveiling the Secrets How Does Generative AI Work.pdfSam H
At its core, generative artificial intelligence relies on the concept of generative models, which serve as engines that churn out entirely new data resembling their training data. It is like a sculptor who has studied so many forms found in nature and then uses this knowledge to create sculptures from his imagination that have never been seen before anywhere else. If taken to cyberspace, gans work almost the same way.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
RMD24 | Retail media: hoe zet je dit in als je geen AH of Unilever bent? Heid...BBPMedia1
Grote partijen zijn al een tijdje onderweg met retail media. Ondertussen worden in dit domein ook de kansen zichtbaar voor andere spelers in de markt. Maar met die kansen ontstaan ook vragen: Zelf retail media worden of erop adverteren? In welke fase van de funnel past het en hoe integreer je het in een mediaplan? Wat is nu precies het verschil met marketplaces en Programmatic ads? In dit half uur beslechten we de dilemma's en krijg je antwoorden op wanneer het voor jou tijd is om de volgende stap te zetten.
What is the TDS Return Filing Due Date for FY 2024-25.pdfseoforlegalpillers
It is crucial for the taxpayers to understand about the TDS Return Filing Due Date, so that they can fulfill your TDS obligations efficiently. Taxpayers can avoid penalties by sticking to the deadlines and by accurate filing of TDS. Timely filing of TDS will make sure about the availability of tax credits. You can also seek the professional guidance of experts like Legal Pillers for timely filing of the TDS Return.
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
Know more: https://www.synapseindia.com/technology/mean-stack-development-company.html
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
Skye Residences | Extended Stay Residences Near Toronto Airportmarketingjdass
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Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
Memorandum Of Association Constitution of Company.pptseri bangash
www.seribangash.com
A Memorandum of Association (MOA) is a legal document that outlines the fundamental principles and objectives upon which a company operates. It serves as the company's charter or constitution and defines the scope of its activities. Here's a detailed note on the MOA:
Contents of Memorandum of Association:
Name Clause: This clause states the name of the company, which should end with words like "Limited" or "Ltd." for a public limited company and "Private Limited" or "Pvt. Ltd." for a private limited company.
https://seribangash.com/article-of-association-is-legal-doc-of-company/
Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
www.seribangash.com
Liability Clause: It outlines the extent of liability of the company's members. In the case of companies limited by shares, the liability of members is limited to the amount unpaid on their shares. For companies limited by guarantee, members' liability is limited to the amount they undertake to contribute if the company is wound up.
https://seribangash.com/promotors-is-person-conceived-formation-company/
Capital Clause: This clause specifies the authorized capital of the company, i.e., the maximum amount of share capital the company is authorized to issue. It also mentions the division of this capital into shares and their respective nominal value.
Association Clause: It simply states that the subscribers wish to form a company and agree to become members of it, in accordance with the terms of the MOA.
Importance of Memorandum of Association:
Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
https://seribangash.com/difference-public-and-private-company-law/
Binding Authority: The company and its members are bound by the provisions of the MOA. Any action taken beyond its scope may be considered ultra vires (beyond the powers) of the company and therefore void.
Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
LEARNING OBJECTIVES
1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
2. Explore the sustainability implementation model, focusing on effective measures and reporting strategies to track and communicate sustainability efforts.
3. Identify and define best practices and critical success factors essential for achieving sustainability goals within organizations.
CONTENTS
1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Cracking the Workplace Discipline Code Main.pptxWorkforce Group
Cultivating and maintaining discipline within teams is a critical differentiator for successful organisations.
Forward-thinking leaders and business managers understand the impact that discipline has on organisational success. A disciplined workforce operates with clarity, focus, and a shared understanding of expectations, ultimately driving better results, optimising productivity, and facilitating seamless collaboration.
Although discipline is not a one-size-fits-all approach, it can help create a work environment that encourages personal growth and accountability rather than solely relying on punitive measures.
In this deck, you will learn the significance of workplace discipline for organisational success. You’ll also learn
• Four (4) workplace discipline methods you should consider
• The best and most practical approach to implementing workplace discipline.
• Three (3) key tips to maintain a disciplined workplace.
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
Marketplace positioning and preliminary Market forecast
1. TARIS® Market Research: Market
Positioning, Pricing, Sales Forecast
Preliminary Draft
Jody Kalt, Terry York, Gabi Forman
Investor Deck part III
CONFIDENTIAL 1
2. Bladder cancer represents a large and underserved market opportunity that has been devoid
of innovation for many years
Level of interest/development activity have increased dramatically in the past several years
Driven by a better understanding of immune mechanisms at play both systemically and in the
tumor micro-environment
Bladder cancer is complex - represents a number of different patient cohorts with differing
unmet needs
Since the AGN transaction in 2014, TARIS has spent a majority of our time focused on
understanding the nuances of treating this disease and advancing our lead program into
clinical proof-of-concept studies, which are now just starting to readout
CONFIDENTIAL 2
Executive Summary: 1 of 2
3. Our thinking has evolved in several different directions:
Target: Initially only NMIBC, now both NMIBC and MIBC, with the later being higher priority
MOA: Initially improved cytotoxic modality due to PK play, now potential multimodal activity
Our initial proof-of-principle study in MIBC has validated our belief that our approach has the
opportunity to transform the treatment of this disease
TARIS just completed a significant market research study working with Defined Health to try
and better understand the commercial opportunity for this technology
We believe, if successful in development, that this represents a $1B+ opportunity (US) with
several opportunities to pursue a rapid registration pathway
CONFIDENTIAL 3
Executive Summary: 2 of 2
5. 5
Bladder Cancer Treated Patients, 2016
(US Only)
Target for Most
Current I/O
Therapies
Managed By:
Uro-oncologists
Managed By:
Uro-oncologists
Medical Oncologists
Radiation Oncologists
Managed By:
Medical Oncologists
Radiation Oncologists
All Bladder
Cancer
102,546 pts
NMIBC
81,725
MIBC
16,855
Metastatic
3,966
6. TARIS has completed substantial market research in bladder cancer with DefinedHealth
First project: 2012, focused on profiles in NMIBC
Recent project: 2016, focused on profiles in both NMIBC and MIBC
Summary of scope: current project
24 qualitative interviews:
8 KOL uro-oncologists
16 additional interviews: community urologists, medical oncologists, radiation oncologists
60 quantitative interviews via web-based survey
5 payer interviews (Medical/Pharmacy Directors)
Initially tested 4 product profiles in qualitative interviews, after completion of the initial interviews, added a 5th TPP with an
additional 4 qualitative interviews, prioritized 3 to include in quant
TPPs numbered by severity of disease (low to high), not necessarily by internal development priority
TARIS did not evaluate TPPs for low risk NMIBC or treatment-naïve high risk NMIBC
Included in previous 2012 research
These indications represent additional potential upside
CONFIDENTIAL 6
TARS® Market Research Methodology
7. All specialties generally reacted favorably to the TAR-200 product profile as an easily deployed and retracted device in the office setting for
local, sustained delivery of drugs to the bladder
However, they wanted to be assured that TAR-200 would be tolerable and not interfere with follow-up:
Foreign body placement location and rubbing could cause inflammation to the bladder lining
Continuous delivery of gemcitabine could irritate the bladder
Either could cause pain and/or increase urinary urge and voiding frequency, dysuria
♦ Physicians generally understood advantage of longer duration tx (7 days vs. 1 hr of BCG/chemo), support the selection of gemcitabine as agent of choice
However, physicians want to see clinical data on how week-long, sustained, low dose gemcitabine is better than short exposures of multiple
high dose instillations in terms of improvements in efficacy/outcomes
Urologists: having an intravesical product pre-loaded with gemcitabine on the shelf would increase patient access and physician/office
convenience
Community urologists wanted to know if it is economical for a Urology office – what’s the profit margin?
Community radiologist considered TAR-200 as a good option for older, frail (> 80+ yrs in age are not good candidates for surgery or Chemo as
kidney function is not good) that are left with radiation only
Physicians Reacted Quite Positively to The TAR-200 Product
Profile
Source: 1. DH Primary Research
8. CONFIDENTIAL 8
MIBC: ~$2.1B Total Addressable Peak US
Market
Significant market research, including payors, complete
At least 2x potential w/ EU, Japan, ROW
US represents only 17% of WW cases
Additional upside indications, not included in forecast
High risk/metastatic disease (± checkpoint)
High Risk NMIBC: BCG Naïve, BCG Unresponsive
$2,069
$0
$500
$1,000
$1,500
$2,000
$2,500
MIBC
Millions
Total Addressable Market
US MIBC Markets at Peak Patients Cost/Dose Doses/Patient Cost/Patient Total Addressable Market
RC Ineligible 7,285
$14k
9 (18 months) $126k $972M
NAC Ineligible 5,562 2 (upfront) $28k $165M
cT2 Bladder Sparing 6,246 11 (2 years) $156k $932M*
9. EpiLUTS: US population-based survey in adults
Total cost of OAB: $36.5B
CONFIDENTIAL 9
The Economic Impact of OAB is High
$3.0
$4.4
$8.1
$2.5
$14.7
$3.9
0 2 4 6 8 10 12 14 16
Lost Productivity
Consequence of Disease
Pad Use
Drug Costs
Outpatient Costs
Inpatient Costs
US Adult Population-based Cost of OAB ($B, 2009)
Onukwugha E, et al. Am J Manag Care 2009; 15, S90-97
Presented at ICS October 2015
10. A significant unmet medical need exists in both NDO and iOAB
Poor efficacy with orals, low satisfaction & adoption with Botox and neuromodulation
TARIS expects to target ~33% of the currently-treated 3M patients
TARIS system offers a compelling treatment option
Better efficacy and safety, less invasive, potential to expand prescriber base
Strong positive response to product profile in 2 formal qualitative surveys
Ratings: 7/10 and 6/7
Several development pathways exist to capture the broad OAB market
Potential for expedited approach
Potential peak revenue in the US >$500M
CONFIDENTIAL 10
Executive Summary: Key Takeaways
11. The OAB market is a not a top drug-spend category for payers but is still a
significant pharmacy budget
Payers are not actively monitoring pharmacy/medical budget impact or quality
metrics although new CMS metrics exist related to access to treatment for
patients with “urine leakage problems”
3 and 4 Tier benefit designs are most common with payers forcing price
competition for preferred seat in each category; Branded agents require step
through generics
TARIS will go through P&T and Technology Assessment but will not be managed
via pharmacy formulary structures; TARIS will require pre-certification and the
procedure will count against patients’ medical deductible… representing a
potential affordability challenge
Payers believe this to be a “self-regulated” treatment option… only highly
motivated patients will seek this
CONFIDENTIAL 11
Payer Research: TARIS® in Line with Other Urology
Products
12. Model Input
Item / Indication NDO iOAB Comment
Total Treated Patients 1 million 2 million Pfizer, ICD9 codes
Target population (TP)
Addressable by specialist
SCI (38%), MS (36%), SB
(18%), Park & Alz (20%)
25%
Seeing specialists/ Failing orals
&
seeking 3rd line treatment
Growth pre-launch 1.84% 1.84%
Stewart W, et al. World J Urol
2003; 20 327-336
Additional Growth post-launch 3% 3% Marketing effort
Current price (2015 dollars) $2000 ($500 x4 per year) Total cost parity to Mirabegron
Price increase post launch 6% 6% Industry norm
Launch year 2021 2022 Assume 6 year to file NDA
Peak Market Share
20-25% (SCI/SB/MS)
5% (Parkinson’s/Alzh)
15%
Estimated from qualitative
market research, 5 year ramp
Output
PEAK YEAR SALES $205,000,000 $369,000,000 $574,000,000
# of patients treated at peak 81,000 174,000
12
Commercial Modal Assumptions: US Only
13. CONFIDENTIAL 13
OAB Revenue Share and Total Revenues By
Indication
MS
15%
Spina Bifida
2%
SCI
11%
Parkinson's
3%
Alzheimer's
4%
iOAB
65%
Total Revenue Split By Indication
MS Spina Bifida SCI Parkinson's Alzheimer's iOAB
$-
$100
$200
$300
$400
$500
$600
2021 2022 2023 2024 2025 2026 2027
Annual Sales (2027)
iOAB MS Spina Bifida SCI Parkinson's Alzheimer's
$22M
$90M
$173M
$276M
$401M
$529M
$574M
15. Checkpoint Inhibitors (Comparators): Bladder Cancer
Company Drug Indications MOA DOA
Annual
WAC
ORR Study
BMS
Opdivo
(Nivolumab)
Second line Pd-1 Feb, 2017 $130,931 19.6% Checkmate275
Genentech
Tecentriq
(Atezolizumab)
First Line; platinum
refractory cisplatin
ineligible
Pd-l1 May 2016 $150,000 23.5% IMVigor210
Merck
Keytruda
(Pembrolizumab)
Second line;
cisplatin ineligible
Pd-1 May 2017 $110,064 29% KEYNOTE045
Pfizer
Bavencio
(Avelumab)
Second line Pd-l1 March 2017 $156,000 33% JavlinMerkel200
Astrazeneca
Imfinzi
(Durvalumab)
Second line Pd-l1 May, 2017 $156,000 17% DANUBECONFIDENTIAL 15
Insert Source
16. Combination Therapy
CONFIDENTIAL
16
*Single dose immunotherapy for 70kg patient
**cost for complete dosage corresponds to median
number of doses. Wholesale Prices +-17%
Journal of Managed Care & Specialty Pharmacy
Vol 23, No 6
AWP per
dosage *
AWP per course
of treatment
(Base Case) **
Annual WAC Price per
QALY***
Nivolumab $5,732 $85,983 $130,931 $415,950
Ipilimumab $33,162 $132,649 $120,000 $129,000
Nivolumab+
Ipilimumab
$35,073 $140,292 $256,000 $454,092
***$100,000
WTP for 1
QOL
17. CheckMate 067 Trial: significant increase
in PFS Up to a 75% increase in PFS with
Combination
CONFIDENTIAL 17
Yervoy: 2.9
months
Opdivo: 6.9
months
Combination:
11.4 months
18. CPI’s: ~$16.55 B market value
Forecast period: 2014- 2020
Projected CAGR: 24.1%
Shift from CTLA-4 submarket domination
in market share to PD-1 domination
Biggest strides in melanoma and NSCLC
(Non Small Cell Lung Cancers)
CONFIDENTIAL 18
*
Checkpoint Inhibitors for Treating
Cancer: Market Report with Forecasts
2016-2026, Revealing Potentials of
CTLA-4 and PD-1 Inhibitor Drugs and
$16.50
$0.00
$2.00
$4.00
$6.00
$8.00
$10.00
$12.00
$14.00
$16.00
$18.00
INBILLIONS
Checkpoint Inhibitor Projected Value
2020 ($)
Checkpoint Inhibitor projected Value 2020
19. Costs of Check Point Inhibitors High
Avg cost of Immuno-oncology drugs: $137,000 per year
19
$120,000.0
$110,064.0
$130,931.0
$150,000.0
$156,000.0
$165,000.0
0 20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 180,000
Yervoy
Keytruda
Opdivo
Tecentriq
Imfinizi
Bavencio
Annual Wholesale Acquisition Cost for Checkpoint Inhibitors ( $)
AHIP High priced drugs estimated upon annual
patient expenditures
20. Leading Markets for Checkpoint
Inhibitors
1. US**
2. Japan
3. Germany, France, UK, Italy, and Spain
4. Overall EU market
5. APAC region
CONFIDENTIAL 20
25. Number of Anti PD-1/PD-L1 combination
studies 2015 vs 2017
70 73
42
26
268
242
123
83
KEYTRUDA OPDIVO IMFINZI TECENTRIQ
2015 2017
CONFIDENTIAL 25
Jacob & Edwin Elmhirst May
2017: Data from EP Vantage
PD-1 combo report 2015
26. Checkpoint Inhibitors penetrate Market Share for oncology drugs
55%
20%
19%
6%
2014
Cytotoxic Agents
26
9%
10%
4%
8%
68%
1%
2024
Cytoxic agents EGFR inhibitors
Angiogenesis Inhibitors ALK inhibitors
Immune Checkpoint Inhibitors BRAF/MEK inhibitors
Cancer
Immunotherapy:
Building on Initial
Successes to
Improve Clinical
Outcomes ***
27. Combinations of Opdivo + Yervoy
(BMS:75 Studies in Total)
28, 37%
10, 13%5, 7%
4, 5%
3, 4%
3, 4%
2, 3%
2, 3%
2, 3%
16, 21%
Melanoma NSCLC Renal Cancer Head and Neck Cancer Prostate
Mesothelloma Breast Cancer SCLC Uveal Melanoma Other indications27
Evaluate Ltd May 2017
28. Annual WAC vs Price per QALY
avg Price per QALY: $250,155 > >WTP QALY:
$100,000
120,000
130,931
110,064
150,000
129,000
415,950
236,492
219,179
Yervoy Opdivo Keytruda Tecentriq
0
50,000
100,000
150,000
200,000
250,000
300,000
350,000
400,000
450,000
Annual WAC Price per QALY WTP per QALY 28
29. Checkpoint Inhibitors (Comparators)
Company Drug Indications MOA DOA
Annual
WAC
ORR
BMS
Opdivo
(Nivolumab)
Second line
Metastatic
Melanoma
Pd-1 2015 $130,931 32%
Genentech
Tecentriq
(Atezolizumab)
First line
treatment of
Bladder Cancer
Pd-l1 2016 $150,000 14.8%
BMS
Yervoy
(Ipilimumab)
Second line
Metastatic
Melanoma
CTLA-4 2011 $120,0000 10.9%
Merck
Keytruda
(Pembrolizumab)
Second line
NSCLC,HNSCC,
CHL, Bladder
Cancer,
Metastatic
Melanoma, MSI-H
Pd-1 2014 $110,064 19%;69%
Pfizer
Bavencio
(Avelumab)
Second line
Bladder Cancer,
First line
Metastatic Merkel
Cell Carcinoma
Pd-l1 2017 $156,000 16%
Astrazeneca
Imfinzi
Bladder Cancer
(second line Pd-l1 2017 $156,000 26%
CONFIDENTIAL 29
Editor's Notes
*full slide in backup and make one specific to BC – 5 products
2015, the nivolumab and ipilimumab combination therapy showed a higher response rate compared with ipilimumab alone. The results mean that more patients taking the combination therapy experienced melanoma tumor shrinkage if they received nivolumab and ipilimumab versus ipilimumab by itself.
Assuming a 20% co pay- out of pocket cost would be around $51,000 for a round of treatment
Main efficacy endpoint was an increase in PFS11.4 months PFS vs 6.9 months Nivo alone
2.9 months Ipilimab alone
Forecasts checkpoint inhibitors will achieve revenues of 16.55 billion by 2020.
Revenues will expand as new treatments finish development and hit the market
Bavencio has the highest cost, likely has to do with the fact that it is the hottest new cancer drug out on the market .
Currently: Opdivo and Yervoy: Checkmate 142 Study- entering phase 3- for metastatic CRC
Opdivo Sales grew by 835 million from 2015 to 2016 in total.
Opdivo Sales grew by 835 million from 2015 to 2016
Source: Evaluate Ltd May 2017
Most combination Studies in 2017 done with Keytruda
In 2015 the most were done with bavencio
Transition from EGFR inhibitors to Checkpoint Market dominance. CPI’s have rapidly infiltrate cancer settings and are substantially projected to dominate oncology market share
There has been an upsurge in pd-l1 assets combined with othe Mab’s: The single most prolific combo grouping invoves Opdivo + Y Yervoy- with combines a PDL1 and a CTLA4 in has been proven successful but there is significant toxicity attached.
Scientific rationale of hitting more that one immune checkpoint is that increase is that it increases the chances of overcoming multiple resistance pathways might be using to evade immune system attack.
*full slide in backup and make one specific to BC – 5 products