FORM 8-K. Filed 05/07/12 for the Period Ending 05/07/12.
A PowerPoint presentation that Ventrus Biosciences, Inc. will present at the 37th Annual Deutsche Bank Health Care Conference in Boston, MA on Monday, May 7, 2012.
1) Ventrus has completed enrollment in its first pivotal Phase III trial of VEN 307 (2% and 4% diltiazem cream) for the treatment of anal fissures. Data is expected in May 2012.
2) If results are positive, Ventrus plans to meet with the FDA in mid-2012 and launch a second Phase III trial to support an NDA filing for VEN 307 in 2013.
3) Ventrus is also developing extended release formulations of diltiazem cream to extend product exclusivity and plans to evaluate some of these in human trials in 2012.
This document discusses a pharmaceutical company focused on developing drugs for gastrointestinal disorders. It provides estimates and forward-looking statements about 3 late-stage clinical trials investigating treatments for hemorrhoids, anal fissures, and fecal incontinence. It notes risks and uncertainties that could influence projections, and that actual results may differ from estimates. Key company leadership and development team members are also summarized.
Ventrus Biosciences is a Phase 3 biopharmaceutical company focused on developing products for gastrointestinal disorders. It has two late-stage products targeting large underserved markets: VEN 309, a topical treatment for hemorrhoids entering Phase 3 trials in 2011; and VEN 307, a topical treatment for anal fissures which recently initiated a Phase 3 trial in Europe. Near-term milestones include Phase 3 trial initiations and data readouts in 2012, as well as patent actions, which could position the company for strategic partnerships or independent commercialization.
VEN 307 is a 2% topical diltiazem cream being developed for the treatment of anal fissures. Diltiazem is a calcium channel blocker that relaxes the internal anal sphincter to reduce pain and increase blood flow. A pivotal Phase III trial found VEN 307 significantly reduced pain compared to placebo. A second Phase III trial and extended release formulations are being explored. If successful, VEN 307 has the potential to become the standard first-line treatment for anal fissures, addressing the large underserved market.
Ventrus is a Phase III biopharmaceutical company focused on developing products for anal disorders. Its lead product, VEN 309, is a topical rectal ointment containing the selective 5HT2a antagonist iferanserin, which is being studied in Phase III trials for the treatment of hemorrhoids. Preclinical and clinical data to date have shown VEN 309 to be well-tolerated and effective at rapidly reducing hemorrhoid symptoms like bleeding, itching, and pain with twice daily application. Upcoming milestones include reporting pivotal Phase III efficacy data in 2Q 2012.
Ventrus Biosciences has three late-stage gastrointestinal drug programs that could provide significant commercial opportunities. VEN 309, a topical drug for hemorrhoids, is entering a Phase III trial with results expected in the first half of 2012. VEN 307, a topical drug for anal fissures, is in Phase III trials in Europe. VEN 308, a topical drug for fecal incontinence, has potential but is on hold due to limited resources. The analyst believes these programs could generate peak annual sales of $600 million, $55 million, and $75 million, respectively, and initiates coverage of Ventrus with an Outperform rating based on the clinical and commercial prospects.
Ventrus Biosciences is initiating coverage with a "Buy" rating and $24 price target. Ventrus is developing treatments for large gastrointestinal disorders that currently lack effective prescription treatments. Its lead drug candidates, VEN 309 for hemorrhoids and VEN 307 for anal fissures, have the potential to be important new therapies with little competition. A Phase III trial for VEN 309 in 2012 and a European Phase III trial for VEN 307 in the same year are key catalysts. The analyst believes Ventrus' market cap understates the stage of development and proof of concept of its lead drugs.
Ventrus Biosciences reported third quarter earnings that were above estimates. They provided an update on their Phase III trials for iferanserin (VEN 309) for hemorrhoids and diltiazem (VEN 307) for anal fissures, pushing back the timeline for results of VEN 309 by three months to June 2012 but maintaining the timeline for VEN 307 in May 2012. Additionally, initial findings from a large consumer survey found the hemorrhoid market to be large and response to the VEN 309 product concept to be favorable, validating the drug's market potential. Ventrus expects to acquire full global rights for VEN 309 today from the licensor as conditions have been met. The analyst maintains a
1) Ventrus has completed enrollment in its first pivotal Phase III trial of VEN 307 (2% and 4% diltiazem cream) for the treatment of anal fissures. Data is expected in May 2012.
2) If results are positive, Ventrus plans to meet with the FDA in mid-2012 and launch a second Phase III trial to support an NDA filing for VEN 307 in 2013.
3) Ventrus is also developing extended release formulations of diltiazem cream to extend product exclusivity and plans to evaluate some of these in human trials in 2012.
This document discusses a pharmaceutical company focused on developing drugs for gastrointestinal disorders. It provides estimates and forward-looking statements about 3 late-stage clinical trials investigating treatments for hemorrhoids, anal fissures, and fecal incontinence. It notes risks and uncertainties that could influence projections, and that actual results may differ from estimates. Key company leadership and development team members are also summarized.
Ventrus Biosciences is a Phase 3 biopharmaceutical company focused on developing products for gastrointestinal disorders. It has two late-stage products targeting large underserved markets: VEN 309, a topical treatment for hemorrhoids entering Phase 3 trials in 2011; and VEN 307, a topical treatment for anal fissures which recently initiated a Phase 3 trial in Europe. Near-term milestones include Phase 3 trial initiations and data readouts in 2012, as well as patent actions, which could position the company for strategic partnerships or independent commercialization.
VEN 307 is a 2% topical diltiazem cream being developed for the treatment of anal fissures. Diltiazem is a calcium channel blocker that relaxes the internal anal sphincter to reduce pain and increase blood flow. A pivotal Phase III trial found VEN 307 significantly reduced pain compared to placebo. A second Phase III trial and extended release formulations are being explored. If successful, VEN 307 has the potential to become the standard first-line treatment for anal fissures, addressing the large underserved market.
Ventrus is a Phase III biopharmaceutical company focused on developing products for anal disorders. Its lead product, VEN 309, is a topical rectal ointment containing the selective 5HT2a antagonist iferanserin, which is being studied in Phase III trials for the treatment of hemorrhoids. Preclinical and clinical data to date have shown VEN 309 to be well-tolerated and effective at rapidly reducing hemorrhoid symptoms like bleeding, itching, and pain with twice daily application. Upcoming milestones include reporting pivotal Phase III efficacy data in 2Q 2012.
Ventrus Biosciences has three late-stage gastrointestinal drug programs that could provide significant commercial opportunities. VEN 309, a topical drug for hemorrhoids, is entering a Phase III trial with results expected in the first half of 2012. VEN 307, a topical drug for anal fissures, is in Phase III trials in Europe. VEN 308, a topical drug for fecal incontinence, has potential but is on hold due to limited resources. The analyst believes these programs could generate peak annual sales of $600 million, $55 million, and $75 million, respectively, and initiates coverage of Ventrus with an Outperform rating based on the clinical and commercial prospects.
Ventrus Biosciences is initiating coverage with a "Buy" rating and $24 price target. Ventrus is developing treatments for large gastrointestinal disorders that currently lack effective prescription treatments. Its lead drug candidates, VEN 309 for hemorrhoids and VEN 307 for anal fissures, have the potential to be important new therapies with little competition. A Phase III trial for VEN 309 in 2012 and a European Phase III trial for VEN 307 in the same year are key catalysts. The analyst believes Ventrus' market cap understates the stage of development and proof of concept of its lead drugs.
Ventrus Biosciences reported third quarter earnings that were above estimates. They provided an update on their Phase III trials for iferanserin (VEN 309) for hemorrhoids and diltiazem (VEN 307) for anal fissures, pushing back the timeline for results of VEN 309 by three months to June 2012 but maintaining the timeline for VEN 307 in May 2012. Additionally, initial findings from a large consumer survey found the hemorrhoid market to be large and response to the VEN 309 product concept to be favorable, validating the drug's market potential. Ventrus expects to acquire full global rights for VEN 309 today from the licensor as conditions have been met. The analyst maintains a
2024 State of Marketing Report – by HubspotMarius Sescu
https://www.hubspot.com/state-of-marketing
· Scaling relationships and proving ROI
· Social media is the place for search, sales, and service
· Authentic influencer partnerships fuel brand growth
· The strongest connections happen via call, click, chat, and camera.
· Time saved with AI leads to more creative work
· Seeking: A single source of truth
· TLDR; Get on social, try AI, and align your systems.
· More human marketing, powered by robots
ChatGPT is a revolutionary addition to the world since its introduction in 2022. A big shift in the sector of information gathering and processing happened because of this chatbot. What is the story of ChatGPT? How is the bot responding to prompts and generating contents? Swipe through these slides prepared by Expeed Software, a web development company regarding the development and technical intricacies of ChatGPT!
Product Design Trends in 2024 | Teenage EngineeringsPixeldarts
The realm of product design is a constantly changing environment where technology and style intersect. Every year introduces fresh challenges and exciting trends that mold the future of this captivating art form. In this piece, we delve into the significant trends set to influence the look and functionality of product design in the year 2024.
How Race, Age and Gender Shape Attitudes Towards Mental HealthThinkNow
Mental health has been in the news quite a bit lately. Dozens of U.S. states are currently suing Meta for contributing to the youth mental health crisis by inserting addictive features into their products, while the U.S. Surgeon General is touring the nation to bring awareness to the growing epidemic of loneliness and isolation. The country has endured periods of low national morale, such as in the 1970s when high inflation and the energy crisis worsened public sentiment following the Vietnam War. The current mood, however, feels different. Gallup recently reported that national mental health is at an all-time low, with few bright spots to lift spirits.
To better understand how Americans are feeling and their attitudes towards mental health in general, ThinkNow conducted a nationally representative quantitative survey of 1,500 respondents and found some interesting differences among ethnic, age and gender groups.
Technology
For example, 52% agree that technology and social media have a negative impact on mental health, but when broken out by race, 61% of Whites felt technology had a negative effect, and only 48% of Hispanics thought it did.
While technology has helped us keep in touch with friends and family in faraway places, it appears to have degraded our ability to connect in person. Staying connected online is a double-edged sword since the same news feed that brings us pictures of the grandkids and fluffy kittens also feeds us news about the wars in Israel and Ukraine, the dysfunction in Washington, the latest mass shooting and the climate crisis.
Hispanics may have a built-in defense against the isolation technology breeds, owing to their large, multigenerational households, strong social support systems, and tendency to use social media to stay connected with relatives abroad.
Age and Gender
When asked how individuals rate their mental health, men rate it higher than women by 11 percentage points, and Baby Boomers rank it highest at 83%, saying it’s good or excellent vs. 57% of Gen Z saying the same.
Gen Z spends the most amount of time on social media, so the notion that social media negatively affects mental health appears to be correlated. Unfortunately, Gen Z is also the generation that’s least comfortable discussing mental health concerns with healthcare professionals. Only 40% of them state they’re comfortable discussing their issues with a professional compared to 60% of Millennials and 65% of Boomers.
Race Affects Attitudes
As seen in previous research conducted by ThinkNow, Asian Americans lag other groups when it comes to awareness of mental health issues. Twenty-four percent of Asian Americans believe that having a mental health issue is a sign of weakness compared to the 16% average for all groups. Asians are also considerably less likely to be aware of mental health services in their communities (42% vs. 55%) and most likely to seek out information on social media (51% vs. 35%).
AI Trends in Creative Operations 2024 by Artwork Flow.pdfmarketingartwork
Creative operations teams expect increased AI use in 2024. Currently, over half of tasks are not AI-enabled, but this is expected to decrease in the coming year. ChatGPT is the most popular AI tool currently. Business leaders are more actively exploring AI benefits than individual contributors. Most respondents do not believe AI will impact workforce size in 2024. However, some inhibitions still exist around AI accuracy and lack of understanding. Creatives primarily want to use AI to save time on mundane tasks and boost productivity.
Organizational culture includes values, norms, systems, symbols, language, assumptions, beliefs, and habits that influence employee behaviors and how people interpret those behaviors. It is important because culture can help or hinder a company's success. Some key aspects of Netflix's culture that help it achieve results include hiring smartly so every position has stars, focusing on attitude over just aptitude, and having a strict policy against peacocks, whiners, and jerks.
PEPSICO Presentation to CAGNY Conference Feb 2024Neil Kimberley
PepsiCo provided a safe harbor statement noting that any forward-looking statements are based on currently available information and are subject to risks and uncertainties. It also provided information on non-GAAP measures and directing readers to its website for disclosure and reconciliation. The document then discussed PepsiCo's business overview, including that it is a global beverage and convenient food company with iconic brands, $91 billion in net revenue in 2023, and nearly $14 billion in core operating profit. It operates through a divisional structure with a focus on local consumers.
Content Methodology: A Best Practices Report (Webinar)contently
This document provides an overview of content methodology best practices. It defines content methodology as establishing objectives, KPIs, and a culture of continuous learning and iteration. An effective methodology focuses on connecting with audiences, creating optimal content, and optimizing processes. It also discusses why a methodology is needed due to the competitive landscape, proliferation of channels, and opportunities for improvement. Components of an effective methodology include defining objectives and KPIs, audience analysis, identifying opportunities, and evaluating resources. The document concludes with recommendations around creating a content plan, testing and optimizing content over 90 days.
How to Prepare For a Successful Job Search for 2024Albert Qian
The document provides guidance on preparing a job search for 2024. It discusses the state of the job market, focusing on growth in AI and healthcare but also continued layoffs. It recommends figuring out what you want to do by researching interests and skills, then conducting informational interviews. The job search should involve building a personal brand on LinkedIn, actively applying to jobs, tailoring resumes and interviews, maintaining job hunting as a habit, and continuing self-improvement. Once hired, the document advises setting new goals and keeping skills and networking active in case of future opportunities.
A report by thenetworkone and Kurio.
The contributing experts and agencies are (in an alphabetical order): Sylwia Rytel, Social Media Supervisor, 180heartbeats + JUNG v MATT (PL), Sharlene Jenner, Vice President - Director of Engagement Strategy, Abelson Taylor (USA), Alex Casanovas, Digital Director, Atrevia (ES), Dora Beilin, Senior Social Strategist, Barrett Hoffher (USA), Min Seo, Campaign Director, Brand New Agency (KR), Deshé M. Gully, Associate Strategist, Day One Agency (USA), Francesca Trevisan, Strategist, Different (IT), Trevor Crossman, CX and Digital Transformation Director; Olivia Hussey, Strategic Planner; Simi Srinarula, Social Media Manager, The Hallway (AUS), James Hebbert, Managing Director, Hylink (CN / UK), Mundy Álvarez, Planning Director; Pedro Rojas, Social Media Manager; Pancho González, CCO, Inbrax (CH), Oana Oprea, Head of Digital Planning, Jam Session Agency (RO), Amy Bottrill, Social Account Director, Launch (UK), Gaby Arriaga, Founder, Leonardo1452 (MX), Shantesh S Row, Creative Director, Liwa (UAE), Rajesh Mehta, Chief Strategy Officer; Dhruv Gaur, Digital Planning Lead; Leonie Mergulhao, Account Supervisor - Social Media & PR, Medulla (IN), Aurelija Plioplytė, Head of Digital & Social, Not Perfect (LI), Daiana Khaidargaliyeva, Account Manager, Osaka Labs (UK / USA), Stefanie Söhnchen, Vice President Digital, PIABO Communications (DE), Elisabeth Winiartati, Managing Consultant, Head of Global Integrated Communications; Lydia Aprina, Account Manager, Integrated Marketing and Communications; Nita Prabowo, Account Manager, Integrated Marketing and Communications; Okhi, Web Developer, PNTR Group (ID), Kei Obusan, Insights Director; Daffi Ranandi, Insights Manager, Radarr (SG), Gautam Reghunath, Co-founder & CEO, Talented (IN), Donagh Humphreys, Head of Social and Digital Innovation, THINKHOUSE (IRE), Sarah Yim, Strategy Director, Zulu Alpha Kilo (CA).
Trends In Paid Search: Navigating The Digital Landscape In 2024Search Engine Journal
The search marketing landscape is evolving rapidly with new technologies, and professionals, like you, rely on innovative paid search strategies to meet changing demands.
It’s important that you’re ready to implement new strategies in 2024.
Check this out and learn the top trends in paid search advertising that are expected to gain traction, so you can drive higher ROI more efficiently in 2024.
You’ll learn:
- The latest trends in AI and automation, and what this means for an evolving paid search ecosystem.
- New developments in privacy and data regulation.
- Emerging ad formats that are expected to make an impact next year.
Watch Sreekant Lanka from iQuanti and Irina Klein from OneMain Financial as they dive into the future of paid search and explore the trends, strategies, and technologies that will shape the search marketing landscape.
If you’re looking to assess your paid search strategy and design an industry-aligned plan for 2024, then this webinar is for you.
5 Public speaking tips from TED - Visualized summarySpeakerHub
From their humble beginnings in 1984, TED has grown into the world’s most powerful amplifier for speakers and thought-leaders to share their ideas. They have over 2,400 filmed talks (not including the 30,000+ TEDx videos) freely available online, and have hosted over 17,500 events around the world.
With over one billion views in a year, it’s no wonder that so many speakers are looking to TED for ideas on how to share their message more effectively.
The article “5 Public-Speaking Tips TED Gives Its Speakers”, by Carmine Gallo for Forbes, gives speakers five practical ways to connect with their audience, and effectively share their ideas on stage.
Whether you are gearing up to get on a TED stage yourself, or just want to master the skills that so many of their speakers possess, these tips and quotes from Chris Anderson, the TED Talks Curator, will encourage you to make the most impactful impression on your audience.
See the full article and more summaries like this on SpeakerHub here: https://speakerhub.com/blog/5-presentation-tips-ted-gives-its-speakers
See the original article on Forbes here:
http://www.forbes.com/forbes/welcome/?toURL=http://www.forbes.com/sites/carminegallo/2016/05/06/5-public-speaking-tips-ted-gives-its-speakers/&refURL=&referrer=#5c07a8221d9b
ChatGPT and the Future of Work - Clark Boyd Clark Boyd
Everyone is in agreement that ChatGPT (and other generative AI tools) will shape the future of work. Yet there is little consensus on exactly how, when, and to what extent this technology will change our world.
Businesses that extract maximum value from ChatGPT will use it as a collaborative tool for everything from brainstorming to technical maintenance.
For individuals, now is the time to pinpoint the skills the future professional will need to thrive in the AI age.
Check out this presentation to understand what ChatGPT is, how it will shape the future of work, and how you can prepare to take advantage.
The document provides career advice for getting into the tech field, including:
- Doing projects and internships in college to build a portfolio.
- Learning about different roles and technologies through industry research.
- Contributing to open source projects to build experience and network.
- Developing a personal brand through a website and social media presence.
- Networking through events, communities, and finding a mentor.
- Practicing interviews through mock interviews and whiteboarding coding questions.
Google's Just Not That Into You: Understanding Core Updates & Search IntentLily Ray
1. Core updates from Google periodically change how its algorithms assess and rank websites and pages. This can impact rankings through shifts in user intent, site quality issues being caught up to, world events influencing queries, and overhauls to search like the E-A-T framework.
2. There are many possible user intents beyond just transactional, navigational and informational. Identifying intent shifts is important during core updates. Sites may need to optimize for new intents through different content types and sections.
3. Responding effectively to core updates requires analyzing "before and after" data to understand changes, identifying new intents or page types, and ensuring content matches appropriate intents across video, images, knowledge graphs and more.
A brief introduction to DataScience with explaining of the concepts, algorithms, machine learning, supervised and unsupervised learning, clustering, statistics, data preprocessing, real-world applications etc.
It's part of a Data Science Corner Campaign where I will be discussing the fundamentals of DataScience, AIML, Statistics etc.
Time Management & Productivity - Best PracticesVit Horky
Here's my presentation on by proven best practices how to manage your work time effectively and how to improve your productivity. It includes practical tips and how to use tools such as Slack, Google Apps, Hubspot, Google Calendar, Gmail and others.
The six step guide to practical project managementMindGenius
The six step guide to practical project management
If you think managing projects is too difficult, think again.
We’ve stripped back project management processes to the
basics – to make it quicker and easier, without sacrificing
the vital ingredients for success.
“If you’re looking for some real-world guidance, then The Six Step Guide to Practical Project Management will help.”
Dr Andrew Makar, Tactical Project Management
2024 State of Marketing Report – by HubspotMarius Sescu
https://www.hubspot.com/state-of-marketing
· Scaling relationships and proving ROI
· Social media is the place for search, sales, and service
· Authentic influencer partnerships fuel brand growth
· The strongest connections happen via call, click, chat, and camera.
· Time saved with AI leads to more creative work
· Seeking: A single source of truth
· TLDR; Get on social, try AI, and align your systems.
· More human marketing, powered by robots
ChatGPT is a revolutionary addition to the world since its introduction in 2022. A big shift in the sector of information gathering and processing happened because of this chatbot. What is the story of ChatGPT? How is the bot responding to prompts and generating contents? Swipe through these slides prepared by Expeed Software, a web development company regarding the development and technical intricacies of ChatGPT!
Product Design Trends in 2024 | Teenage EngineeringsPixeldarts
The realm of product design is a constantly changing environment where technology and style intersect. Every year introduces fresh challenges and exciting trends that mold the future of this captivating art form. In this piece, we delve into the significant trends set to influence the look and functionality of product design in the year 2024.
How Race, Age and Gender Shape Attitudes Towards Mental HealthThinkNow
Mental health has been in the news quite a bit lately. Dozens of U.S. states are currently suing Meta for contributing to the youth mental health crisis by inserting addictive features into their products, while the U.S. Surgeon General is touring the nation to bring awareness to the growing epidemic of loneliness and isolation. The country has endured periods of low national morale, such as in the 1970s when high inflation and the energy crisis worsened public sentiment following the Vietnam War. The current mood, however, feels different. Gallup recently reported that national mental health is at an all-time low, with few bright spots to lift spirits.
To better understand how Americans are feeling and their attitudes towards mental health in general, ThinkNow conducted a nationally representative quantitative survey of 1,500 respondents and found some interesting differences among ethnic, age and gender groups.
Technology
For example, 52% agree that technology and social media have a negative impact on mental health, but when broken out by race, 61% of Whites felt technology had a negative effect, and only 48% of Hispanics thought it did.
While technology has helped us keep in touch with friends and family in faraway places, it appears to have degraded our ability to connect in person. Staying connected online is a double-edged sword since the same news feed that brings us pictures of the grandkids and fluffy kittens also feeds us news about the wars in Israel and Ukraine, the dysfunction in Washington, the latest mass shooting and the climate crisis.
Hispanics may have a built-in defense against the isolation technology breeds, owing to their large, multigenerational households, strong social support systems, and tendency to use social media to stay connected with relatives abroad.
Age and Gender
When asked how individuals rate their mental health, men rate it higher than women by 11 percentage points, and Baby Boomers rank it highest at 83%, saying it’s good or excellent vs. 57% of Gen Z saying the same.
Gen Z spends the most amount of time on social media, so the notion that social media negatively affects mental health appears to be correlated. Unfortunately, Gen Z is also the generation that’s least comfortable discussing mental health concerns with healthcare professionals. Only 40% of them state they’re comfortable discussing their issues with a professional compared to 60% of Millennials and 65% of Boomers.
Race Affects Attitudes
As seen in previous research conducted by ThinkNow, Asian Americans lag other groups when it comes to awareness of mental health issues. Twenty-four percent of Asian Americans believe that having a mental health issue is a sign of weakness compared to the 16% average for all groups. Asians are also considerably less likely to be aware of mental health services in their communities (42% vs. 55%) and most likely to seek out information on social media (51% vs. 35%).
AI Trends in Creative Operations 2024 by Artwork Flow.pdfmarketingartwork
Creative operations teams expect increased AI use in 2024. Currently, over half of tasks are not AI-enabled, but this is expected to decrease in the coming year. ChatGPT is the most popular AI tool currently. Business leaders are more actively exploring AI benefits than individual contributors. Most respondents do not believe AI will impact workforce size in 2024. However, some inhibitions still exist around AI accuracy and lack of understanding. Creatives primarily want to use AI to save time on mundane tasks and boost productivity.
Organizational culture includes values, norms, systems, symbols, language, assumptions, beliefs, and habits that influence employee behaviors and how people interpret those behaviors. It is important because culture can help or hinder a company's success. Some key aspects of Netflix's culture that help it achieve results include hiring smartly so every position has stars, focusing on attitude over just aptitude, and having a strict policy against peacocks, whiners, and jerks.
PEPSICO Presentation to CAGNY Conference Feb 2024Neil Kimberley
PepsiCo provided a safe harbor statement noting that any forward-looking statements are based on currently available information and are subject to risks and uncertainties. It also provided information on non-GAAP measures and directing readers to its website for disclosure and reconciliation. The document then discussed PepsiCo's business overview, including that it is a global beverage and convenient food company with iconic brands, $91 billion in net revenue in 2023, and nearly $14 billion in core operating profit. It operates through a divisional structure with a focus on local consumers.
Content Methodology: A Best Practices Report (Webinar)contently
This document provides an overview of content methodology best practices. It defines content methodology as establishing objectives, KPIs, and a culture of continuous learning and iteration. An effective methodology focuses on connecting with audiences, creating optimal content, and optimizing processes. It also discusses why a methodology is needed due to the competitive landscape, proliferation of channels, and opportunities for improvement. Components of an effective methodology include defining objectives and KPIs, audience analysis, identifying opportunities, and evaluating resources. The document concludes with recommendations around creating a content plan, testing and optimizing content over 90 days.
How to Prepare For a Successful Job Search for 2024Albert Qian
The document provides guidance on preparing a job search for 2024. It discusses the state of the job market, focusing on growth in AI and healthcare but also continued layoffs. It recommends figuring out what you want to do by researching interests and skills, then conducting informational interviews. The job search should involve building a personal brand on LinkedIn, actively applying to jobs, tailoring resumes and interviews, maintaining job hunting as a habit, and continuing self-improvement. Once hired, the document advises setting new goals and keeping skills and networking active in case of future opportunities.
A report by thenetworkone and Kurio.
The contributing experts and agencies are (in an alphabetical order): Sylwia Rytel, Social Media Supervisor, 180heartbeats + JUNG v MATT (PL), Sharlene Jenner, Vice President - Director of Engagement Strategy, Abelson Taylor (USA), Alex Casanovas, Digital Director, Atrevia (ES), Dora Beilin, Senior Social Strategist, Barrett Hoffher (USA), Min Seo, Campaign Director, Brand New Agency (KR), Deshé M. Gully, Associate Strategist, Day One Agency (USA), Francesca Trevisan, Strategist, Different (IT), Trevor Crossman, CX and Digital Transformation Director; Olivia Hussey, Strategic Planner; Simi Srinarula, Social Media Manager, The Hallway (AUS), James Hebbert, Managing Director, Hylink (CN / UK), Mundy Álvarez, Planning Director; Pedro Rojas, Social Media Manager; Pancho González, CCO, Inbrax (CH), Oana Oprea, Head of Digital Planning, Jam Session Agency (RO), Amy Bottrill, Social Account Director, Launch (UK), Gaby Arriaga, Founder, Leonardo1452 (MX), Shantesh S Row, Creative Director, Liwa (UAE), Rajesh Mehta, Chief Strategy Officer; Dhruv Gaur, Digital Planning Lead; Leonie Mergulhao, Account Supervisor - Social Media & PR, Medulla (IN), Aurelija Plioplytė, Head of Digital & Social, Not Perfect (LI), Daiana Khaidargaliyeva, Account Manager, Osaka Labs (UK / USA), Stefanie Söhnchen, Vice President Digital, PIABO Communications (DE), Elisabeth Winiartati, Managing Consultant, Head of Global Integrated Communications; Lydia Aprina, Account Manager, Integrated Marketing and Communications; Nita Prabowo, Account Manager, Integrated Marketing and Communications; Okhi, Web Developer, PNTR Group (ID), Kei Obusan, Insights Director; Daffi Ranandi, Insights Manager, Radarr (SG), Gautam Reghunath, Co-founder & CEO, Talented (IN), Donagh Humphreys, Head of Social and Digital Innovation, THINKHOUSE (IRE), Sarah Yim, Strategy Director, Zulu Alpha Kilo (CA).
Trends In Paid Search: Navigating The Digital Landscape In 2024Search Engine Journal
The search marketing landscape is evolving rapidly with new technologies, and professionals, like you, rely on innovative paid search strategies to meet changing demands.
It’s important that you’re ready to implement new strategies in 2024.
Check this out and learn the top trends in paid search advertising that are expected to gain traction, so you can drive higher ROI more efficiently in 2024.
You’ll learn:
- The latest trends in AI and automation, and what this means for an evolving paid search ecosystem.
- New developments in privacy and data regulation.
- Emerging ad formats that are expected to make an impact next year.
Watch Sreekant Lanka from iQuanti and Irina Klein from OneMain Financial as they dive into the future of paid search and explore the trends, strategies, and technologies that will shape the search marketing landscape.
If you’re looking to assess your paid search strategy and design an industry-aligned plan for 2024, then this webinar is for you.
5 Public speaking tips from TED - Visualized summarySpeakerHub
From their humble beginnings in 1984, TED has grown into the world’s most powerful amplifier for speakers and thought-leaders to share their ideas. They have over 2,400 filmed talks (not including the 30,000+ TEDx videos) freely available online, and have hosted over 17,500 events around the world.
With over one billion views in a year, it’s no wonder that so many speakers are looking to TED for ideas on how to share their message more effectively.
The article “5 Public-Speaking Tips TED Gives Its Speakers”, by Carmine Gallo for Forbes, gives speakers five practical ways to connect with their audience, and effectively share their ideas on stage.
Whether you are gearing up to get on a TED stage yourself, or just want to master the skills that so many of their speakers possess, these tips and quotes from Chris Anderson, the TED Talks Curator, will encourage you to make the most impactful impression on your audience.
See the full article and more summaries like this on SpeakerHub here: https://speakerhub.com/blog/5-presentation-tips-ted-gives-its-speakers
See the original article on Forbes here:
http://www.forbes.com/forbes/welcome/?toURL=http://www.forbes.com/sites/carminegallo/2016/05/06/5-public-speaking-tips-ted-gives-its-speakers/&refURL=&referrer=#5c07a8221d9b
ChatGPT and the Future of Work - Clark Boyd Clark Boyd
Everyone is in agreement that ChatGPT (and other generative AI tools) will shape the future of work. Yet there is little consensus on exactly how, when, and to what extent this technology will change our world.
Businesses that extract maximum value from ChatGPT will use it as a collaborative tool for everything from brainstorming to technical maintenance.
For individuals, now is the time to pinpoint the skills the future professional will need to thrive in the AI age.
Check out this presentation to understand what ChatGPT is, how it will shape the future of work, and how you can prepare to take advantage.
The document provides career advice for getting into the tech field, including:
- Doing projects and internships in college to build a portfolio.
- Learning about different roles and technologies through industry research.
- Contributing to open source projects to build experience and network.
- Developing a personal brand through a website and social media presence.
- Networking through events, communities, and finding a mentor.
- Practicing interviews through mock interviews and whiteboarding coding questions.
Google's Just Not That Into You: Understanding Core Updates & Search IntentLily Ray
1. Core updates from Google periodically change how its algorithms assess and rank websites and pages. This can impact rankings through shifts in user intent, site quality issues being caught up to, world events influencing queries, and overhauls to search like the E-A-T framework.
2. There are many possible user intents beyond just transactional, navigational and informational. Identifying intent shifts is important during core updates. Sites may need to optimize for new intents through different content types and sections.
3. Responding effectively to core updates requires analyzing "before and after" data to understand changes, identifying new intents or page types, and ensuring content matches appropriate intents across video, images, knowledge graphs and more.
A brief introduction to DataScience with explaining of the concepts, algorithms, machine learning, supervised and unsupervised learning, clustering, statistics, data preprocessing, real-world applications etc.
It's part of a Data Science Corner Campaign where I will be discussing the fundamentals of DataScience, AIML, Statistics etc.
Time Management & Productivity - Best PracticesVit Horky
Here's my presentation on by proven best practices how to manage your work time effectively and how to improve your productivity. It includes practical tips and how to use tools such as Slack, Google Apps, Hubspot, Google Calendar, Gmail and others.
The six step guide to practical project managementMindGenius
The six step guide to practical project management
If you think managing projects is too difficult, think again.
We’ve stripped back project management processes to the
basics – to make it quicker and easier, without sacrificing
the vital ingredients for success.
“If you’re looking for some real-world guidance, then The Six Step Guide to Practical Project Management will help.”
Dr Andrew Makar, Tactical Project Management
2. UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 7, 2012
VENTRUS BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
Delaware 001-35005 20-8729264
(State or other jurisdiction of incorporation) (Commission File (IRS Employer ID Number)
Number)
99 Hudson Street, 5 th Floor, New York, New York 10013
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code (646) 706-5208
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
3. Item 8.01. Other Events.
Attached hereto as Exhibit 99.1 is a PowerPoint presentation that Ventrus Biosciences, Inc. will present at the 37 th Annual Deutsche Bank
Health Care Conference in Boston, Massachusetts, on Monday, May 7, 2012, and which is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
99.1 Slide presentation of May 7, 2012, to be presented at the 37 th Annual Deutsche Bank Health Care Conference.
4. SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
VENTRUS BIOSCIENCES, INC.
Date: May 7, 2012 /s/ David J. Barrett
David J. Barrett, Chief Financial Officer
5. Exhibit 99.1
Ru sse ll H. El li so n, M D, MSc C h ie f Ex ec u ti ve Offic er a n d Ch a irma n of th e Bo a rd
6. 1 Th is mat eri al co n ta in s est ima te s a n d forwa rd - lo o ki n g sta te men t s. T h e wo rd s “be li ev e, ” “ may , ” “ mig h t, ” “ wi ll , ” “aim , ” “ est ima te , ” “ co nt in u e, ” “ wo u ld , ” “ an ti ci pa te , ”“ in te nd , ” “ ex pe ct , ” “ pl an ” an d sim il ar wo rd s a re i nt en d ed to i de n ti fy est ima te s a n d forwa rd - lo o ki n g sta te men t s. Ou r e st ima te s a nd fo rward - lo o ki n g sta te men t s a re ma in l y b ase d on ou r c urre nt e xp e ct at io n s a nd e st ima te s o f fu tu re ev en ts an d t ren d s, wh i ch a ffe ct o r mi g ht a ffe ct o u r b usi n esse s a n d op e ra ti o ns . Al th o u gh we b el ie v e t h at t he se est im ate s a n d forwa rd - lo o ki n g sta te men t s a re b as ed u p on re aso n ab l e a ssu mp ti o ns, t he y a re su b je ct t o man y ri sk s a nd u n ce rta in ti es an d a re ma d e i n l ig h t of in forma ti o n cu rren tl y av a il ab le t o u s. Ou r e sti ma te s a nd fo rward - lo o ki n g sta te men t s ma y b e in flu en c ed b y t he fo ll owi n g fac to rs, amo n g o th ers : ri sk s rel at ed to t he c os ts, t imi ng , reg u la to ry rev i ew a n d re su lt s o f o u r st ud i es an d cl in i ca l t ria ls; o u r ab i li ty t o o b ta in FDA ap p ro v al o f o u r p ro d u ct ca n di d at es; d iffere n ces b et ween hi st ori cal s tu d ie s o n wh ic h we h a ve b as ed o u r p la nn e d cl in ic al t rial s an d ac tu al re sul t s from o ur tri als ; ou r a nt ic ip a te d ca pi ta l ex p en d it ure s, ou r e sti mat es reg ard i ng o u r c ap it al req u ire men t s, a n d o ur n e ed fo r fu tu re cap i ta l; o u r li q ui d it y an d wo rki n g ca pi ta l req u irem en ts; o u r ex p ec ta ti o ns reg ard in g o u r rev en u es , e xp e ns es an d o th er re su lt s o f o p erat io n s; th e u n pre di ct ab i li ty o f t he si ze o f t he ma rke ts fo r, an d ma rk e t acc ep t an ce o f, a n y o f ou r p ro du c ts, i nc lu d in g VE N 3 09 ; o u r ab il it y t o sel l an y a pp ro ve d p rod u ct s a n d th e p ri ce we are ab l e re al iz e; o u r n eed to o b ta in a d di ti o na l fu n d in g t o d ev el op ou r p ro du c ts, an d o u r ab i li ty t o o b ta in fu tu re fun d in g o n a cce p ta bl e te rm s; ou r a b il it y to re ta in a n d hi re ne ce ssary e mp lo y ee s a nd to st aff o u r o p erat io n s a p pro p ri at el y ; ou r a bi l it y to c o mp ete i n o ur in d us try a nd i n no v at io n b y o u r co mp e ti to rs; ou r a b il it y to s ta y ab rea st of an d co mp l y wit h n ew o r m od i fi ed la ws an d re gu l at io n s t ha t cu rren tl y ap p ly or be co me ap p li ca b le to ou r b u sin e ss; est im at es a n d est im at e m eth o d o lo g ies u sed i n p rep ari ng ou r fi na n ci al st ate me nt s; th e fut u re t rad in g p ric es o f o ur c o mmo n st oc k an d t he i mp ac t of s ecu ri ti es an al y sts ’ re p ort s o n t he se pri ce s; an d t he ris ks set o u t in o u r
fi li n gs wit h t he SEC , in c lu d in g o u r Ann u al R ep o rt on Fo rm 10 - K. E sti mat es an d fo rwa rd - lo o ki n g sta te men t s i nv o lv e risk s an d u n cert ai nt i es a n d are n ot g u ara nt ee s o f fu tu re pe rfo rma nc e. As a re su lt o f k no wn a nd un k n own ri sk s a nd u n ce rta in ti es , i n cl ud i ng t h os e d e scri be d ab o v e, th e est im at es an d forwa rd - lo o ki n g sta te men t s d is cu ssed in t hi s mat eria l mig h t n ot o cc u r an d o u r fut u re re su lt s an d o u r p erfo rman ce mi g ht d iffe r mat eri al ly fro m t h ose e xp re ssed i n t he se fo rward - lo o ki n g sta te men t s d u e t o , i n cl ud i ng , b ut n o t li mit ed to , th e fact o rs me nt io n ed a b ov e . E sti mat es an d fo rward - lo o ki n g sta te men t s sp ea k o n ly a s o f t he d at e th ey were mad e , a n d, ex c ep t to t h e e x te nt re qu i re d b y la w, we u n d erta k e n o o b li g at io n to up d at e or to re vi ew an y es ti mat e an d/ o r fo rwa rd - lo o ki n g sta te men t b ec au se o f ne w i n fo rma ti on , fut u re e v en ts o r ot h er fa ct ors. Fo rward Lo o k in g St at eme nt s
7. » A Ph ase III b io p ha rmac eu ti ca l co mp an y fo cu se d ex cl u siv el y o n g ast ro en te ro l o gy ; sp ec ifi ca ll y, a na l di so rde rs - a n e gl ec te d area o f d ru g de v el op me nt » De v el op me nt ri sk st ra ti fie d ac ross th ree l at e - sta ge p ro du ct s NC E an d 5 0 5(b )2 reg is trat io n p a th way s Two p iv o ta l Pha se III re ad - ou t s fo r two s ep arat e p ro d u ct s e xp e cte d i n 2Q 2 01 2 Poss ib le v al id a ti on o f t wo l ead pro g ra ms Ra ng e o f co - pro mo ti o n/ p artn e rsh i p o pp o rtu n it ie s c ou l d fol lo w da ta » Pro d u ct s a dd ress la rge , un d erse rve d , a n d un t ap p ed ma rke ts 3 of th e to p 1 0 GI d is ord ers Sig n ific an t ma rk e t p o te n ti al s i n sp ec ia lt y p ha rma an d p ri ma ry care » Wel l fu n d ed t h ro u g h ke y mi le sto n es Ca sh an d c ash e q ui v al en ts of $ 3 6. 9 M il (Dec 3 1 , 2 0 1 1) $ 20 m m IPO (wi th o v eral lo c at io n ) i n Dec 2 0 10 ; $ 5 0 mm fo ll o w - on i n Ju ly 20 1 1 2 C o mpa n y Ov erv ie w
8. Pip el in e 3 Pro gra m (Pat h way ) In di ca ti o n Cl in i ca l Pha se Pot en t ia l NDA Fil in g C o mmerc ia l Ri gh t s I II III VE N 3 09 Ife ran seri n ( NC E ) He mo rrh o i ds 2 01 4 Wo rld Wid e , Un p art ne red VEN 3 07 Di lt ia ze m (5 0 5(b )2 ) An al Fi ssu res 20 1 3 No rt h Ame rica , Un p artn ere d VEN 30 8 (5 05 (b )2) Fec al Inc o nt in e nc e 20 1 5 No rth Ame ric a , Un p artn e re d La te St ag e Pip el in e wit h Two Piv o ta l Ph a se III R e ad - ou t s Ex p ec te d in 2Q 20 1 2 fo r Val id at io n o f T wo Lea d Pro gra ms
9. VE N 3 0 9: Ifera ns erin NC E for Hemo rrho i ds
10. 5 Hemo rrho i ds : A La rg e , Un d erse rv e d M ark et » 10 ,0 0 0 co n su mer su rv e ye d , 1 ,1 2 5 rep o rt su ffe ri n g fro m h emo rrho i ds 1 : Past t wo ye ars 11 . 0% 2 5 .8 mi ll io n 2 Past y ea r 9 .3 % 21 . 7 mil li o n 2 Da y o f su rv ey 2 .9 % 6 .7 mi ll io n 2 » Cu rren t trea tm en t op t io n s: In v asi v e pro ce du res : ba nd i ng , sc le ro si n g ag en t s, s urg ery fo r p ro lap se d h emo rrho i ds Rx : No FDA a pp ro ve d R x d ru g s 4+ mil li o n p re scri p ti on s of no n - ap pro v ed a n d no n - DE SI i nt ra - an al st ero id s 3 Mi n ima l to n o rei mb u rs eme nt ; No o th er kn o wn d ru g s in d ev . in US, E U* or Jap an OT C: 2 0 - 22 m il li on 3 , 4 OTC u n it s so l d an n ua ll y i n US (e. g. , Pre p arat io n H ®) 85 % rep o rted us in g OTC o r R x tre at men t at l ea st on c e (8 6 % OTC /1 4 % Rx )^ 1 0% o f a ll p at ie nt s re p ort ed h av i ng an i nv a siv e p ro c ed u re (6 1 % s urg ery ) wi th 7 5 % rep o rt in g re cu rre n ce o f sy mp to ms afte r su rg ery ^ 3. IM S 2 0 03 4. IM S 2 0 09 * Ora l Dafl on h a s a h emo rrho i d in d ic at io n i n Fran ce ^ PB E surv ey of 10 ,2 0 2 c on su me rs 2 01 1 1 . Prin ce to n B ran d Ec o no me tri cs S urv ey 2 0 1 1. 2 : ca lc ul at ed fro m t h e 20 1 0 US Ad u lt p o pu l at io n – 23 4 ,5 6 4, 0 00 (2 0 1 0 US ce n su s )
11. 6 Phy si o lo g y o f Hemo rrh oi d s In crea sed in tra - pe lv ic p ress ure Dil at at io n o f t h e h e morrh o id al p le x us , i n crea sed p res su re , swel li ng L o cal s ero to n in (5 HT) re lea se 5 HT2 a re ce pt o r ac ti v at io n Effere nt v en o u s c on st ric ti on & p la te le t ag g re g at io n In te rn a l he mo rrh o id E x tern al h e mo rrh o id VE N 3 0 9 Prima ry Sy mp to ms: B le ed in g , It ch i ng & Pa in
12. 7 VEN 3 0 9 ( i fe ran seri n ) Su mma ry To p ic al rec ta l o i nt me nt a pp l ie d in t ra - an al ly B ID x 2 we ek s (wi th p ro p ri et ary si n g le - use a pp l ic at or) M e ch an i sm o f Ac ti on » Sele ct iv e 5 HT2 a an ta g on i st » Do e s n o t cro ss t h e b l oo d b rai n b arrie r ex c ep t at d os es muc h h ig h er t h an t o b e use d t he rap eu ti ca ll y Prec li n ic al Safe ty » Syst em ic ex p o su re i s < 10 % » Th erap e ut ic rat io is > 1 7 x Cl in i ca l Ph a rm ac ol o gy » Me ta b ol iz ed b y C YP2 D6 in l iv e r » No acc u mu la ti on o f t h e dru g o n twi ce d ai ly do si ng Cl in i cal Da ta » Sev en c li n ica l tri al s i n 3 59 s ub j ec ts (2 2 0 ex p o su re s) » No SAEs, li mi ted AEs (ma in l y GI), si mi lar AE p ro fil e v s. p la ce bo » Sig n ific an t im pro v eme n ts in sy mp t oms rel at ed t o h emo rrho i d s i nc lu d in g b le ed i ng , p ai n an d i tch i n g
13. 8 Effic acy Pha se IIb (Ge rman s tu d y 1 ) 12 1 p at ie n ts ra n do mi ze d to VE N 3 0 9 ( ife ran seri n ) B ID v s. p l ac eb o o in tm en t x 1 4 da y s Wee kl y v isi t s fo r 2 wee k tre at men t ; fo l lo w - up a t 45 da y s Sym pt o ms rec o rde d in d a il y d ia ri es (sca le o f 1 - 10 ; 1 = no s ym pt o ms) Stat i sti ca ll y sig n ifi ca nt i mp rov e men t in s ym pt o ms: b le ed in g , i t ch in g , p a in 1 2 3 4 5 6 7 M e a n ( B l e e d ) 0 1 2 3 4 5 6 7 8 9 10 1 1 12 1 3 14 Day VEN 3 09 PL ACE BO M ean (B l eed ) Pri mary e n dp o in t B LEE DING (n=1 1 1 p at ie n ts) P < 0 .0 5 1 . Hero ld A, Di et ri ch J , Ai tc h iso n R . In t ra - an al i fe ran seri n 1 0 mg B ID for he mo rrh o id di sea se: a p ros pe ct iv e, ra nd o miz ed , d ou b le - bl in d , pl ac eb o - co nt ro ll ed t ri al . Cl in Th er . 2 0 12 ; 34 (2 ): 3 29 - 34 0 . p<0 .0 0 0 1 p < 0 . 00 7 5
14. 9 1 2 3 4 5 6 7 M e a n ( P a i n ) 0 1 2 3 4 5 6 7 8 9 10 1 1 1 2 1 3 14 Day E ffi ca cy Ph as e IIb (Germa n st ud y 1 ) Sec on d ary e nd p o in t s: ra p id , sus ta in ed e ffect 1 2 3 4 5 6 7 M e a n ( I t c h ) 0 1 2 3 4 5 6 7 8 9 1 01 1 1 21 3 1 4 Day * = P < 0 .0 5 * ITC HING (n =60 pa ti en t s) PAIN (n =40 pa ti en t s) P < 0. 0 5 DAY 7 P < 0 .0 0 08 ; DAY 1 4 P < 0 .0 2 * M e an (Itc h) Me an (Pa in ) VE N 3 09 PLAC EB O 1 . He rol d A, Die tric h J, Ait ch i so n R. In tra - an al i fe ran seri n 1 0 mg B ID for he mo rrh o id di sea se: a p ros pe ct iv e, ra nd o miz ed , d ou b le - bl in d , pl ac eb o - co nt ro ll ed t ri al . Cl in Th er . 2 0 12 ; 34 (2 ): 3 29 - 34 0 .
15. 10 M o d el in g o f Ph ase IIb 1 Da ta for Pha se III En d po i nt s * Ab se n ce o f sy mp to m Da y 7 t hro u g h Day 1 4 M aj o rit y o f resp o nd e rs in th e trea tm en t arm re sp on d b y Da y 3 * Po st ho c » Seco n d ary En d p o in ts It ch i ng : 59 % v s. 32 % p<0 .0 3 4 Pain : 50 % v s. 18 % p<0 .0 3 2 5 7 % 20 % 0 % 10 % 2 0 % 30 % 4 0% 5 0 % 6 0% Ifera nse rin Pl ac eb o P = ≤ 0 . 00 0 1 PR IM AR Y E NDP OINT : No Bl ee di n g fro m Day 7 t o Da y 14 (2 n d wee k o f Tre at men t) Re sp on se 1 . Hero ld A, Die tri ch J, Ai tc hi so n R . In tra - an al i fe ran seri n 1 0 mg B ID for he mo rrh o id di sea se: a p ros pe ct iv e, ra nd o miz ed , d ou b le - bl in d , pl ac eb o - co nt ro ll ed t ri al . Cl in Th er . 2 0 12 ; 34 (2 ): 3 29 - 34 0 .
16. Ro b us t, Disc ip l in ed P ha se III Tria l En dp o in t s M ea n in g ful i mp ro v em en t (p ro p ose d b y FDA) • Pri mary en dp o in t : ce ssat io n o f b le ed i ng d a y 7 – 14 (>9 9 % po we re d ) • Seco n d ary e nd p o in ts : c ess at io n o f p ai n, i tc hi n g da y 7 – 14 (>9 5 % po we re d ) Desi g n Th ree arms : • 7 da y / 1 4 d ay / p la ce bo • 20 0 p ts p er a rm • Op e n la b el ex t en sio n t o 1 y ea r to trea t recu rren ce Si te s 7 0 US sit es Inc lu si on crit eri a M e an in g fu l s ym pt o ms ( b l ee di n g, i tc hi n g, p ai n fo r 2 d ay s ) to c le arly de mo n strat e th era p eu ti c effec t Pro g ress • Di sc uss io n wit h FDA o n a ll ma jo r e le men t s o f t he p rot o co l • En ro l li ng co rre ct p at ie n ts • Co n ti nu o u s d at a rev ie w (b li nd ) • Mi n ima l lo ss of ke y o ut co me d at a • En ro l lme n t c o mp le te en d Ap ril 2 0 12 • Re po rti n g o f resu lt s e x pe ct ed l at e Ju ne / e arly J ul y 2 0 12 1 1
17. 12 De v el op me nt Pl an : Nex t Ste p s C h ro n ic re pe at ed u se p rod u ct (FDA d e fi n it io n , m ay n o t ap p ly i n Jap a n/ EU) » 1, 50 0 su b je ct s n e ed ed fo r c omp l et e safet y p rofi le (US a nd po ssi b ly E U) 7 cl in ic al t ri al s i n 3 5 9 su bj ec ts (22 0 e x po su res) 60 0 p at ie n ts in Ph as e III st u dy de sig n ed to p ro vi d e p ro gra m v al i da ti on Seco n d p iv o ta l Pha se III tri al p la nn e d (an d d ou b le b li n d Ph ase III rec urren c e t ria l to d e termi n e safet y /e ffi ca cy a n d tre atm en t for re cu rren ce fo r th e US) – wi ll g e ne rat e a p ro gra m t ot al o f > 15 0 0 p ts ex p o sed t o d ru g » Cl in ic al p h arma co lo g y p rog ram in c lu d in g : DDI , PK in p o o r me tab o l ize rs ( re su lt s e xp e ct ed Q2 ), QT a n d sp ec ial p o p ul at io n s » Pre cl in i cal : Ch ro n ic To x a nd C a rc in o g en ic it y st ud i es (t wo sp ec ie s fo r 2 y rs) » Ca rc in o g en ic it y i s cri ti ca l pa th fo r NDA, cl in i ca l t ria ls ca n b e d o n e s eria ll y
18. 13 Pa ti en t /Pres crib e r Re sp on se t o VEN 3 0 9 1 » Stro ng wi ll i ng n ess to ask t he ir do c to r fo r VEN 3 0 9 a t t h e ne x t v i sit For p a ti en ts wh o are h av in g sy mp t om s n o w , (e st ima te d at 6 .7 m m) 80 % wo ul d * req u est a p re scri p ti on In t h e who l e sa mp le : 66 % rec ei vi n g a pre scri pt io n wo u ld fi ll t he R x at a $ 3 5 ou t - of - po ck e t co - pa y * 78 % wit h h o use h ol d i nc o me a b ov e $ 5 0k / ye ar wo u ld fi ll t h e R x a t a $ 3 5 co p ay * » He al th care p rov i de rs sh o wed h i gh wi ll i ng n ess to pre scrib e an d m in ima l co - pa y p ri ce se n sit iv i ty Pro b ab i li ty o f HC Ps t o g ran t a pa ti en t R x re q ue st ran g ed fro m . 88 - .92 * 1 . Prin ce to n B ran d Ec on o me tric s Su rv ey 2 0 1 1. * PB E fa ct o re d
19. VE N 3 0 7: Di lt ia ze m C rea m No v el Trea tm en t for An a l Fissu res
20. 15 An a l Fi ssu res: C au se a nd M a na g eme nt In cre ase d sp hi n ct er t o ne L oc al i sch em ia Te ar (fis sure ) in an al c an al C au se Sev e re p ai n o n d efec at io n T re at men t o p ti on s Co n tro l co n sti p at io n , t o pi ca l ste roi d s R ed u ce sp h in ct er t o ne C o mp ou n d ed T op i cal d ru gs : • GT N* • di lt ia ze m B o to x Su rge ry Sp hi n ct ers (mu sc le s) An al fis sure 1 .1 mm o ffi ce v is it s/y e ar An al fi stu la * R e cti v (to p ic al GT N) rece n tl y ap p rov e d by FDA b u t n o t y et la u nc h ed
21. 16 VE N 3 0 7 ( d il ti az em ) Su mmary 2 % t op i cal d i lt ia zem cre am ap p li ed p eri - an al ly T ID M ec ha n ism o f Act io n » Ca lc iu m c h an n el b lo ck e r Re la xe s t h e i n te rn a l a n al sp h in ct er, red u ci ng pa in a n d in cre asi n g ti ssu e bl o od fl o w Prec li ni ca l Safet y » Pre cl in i cal t o pi ca l safet y wi th 2 % d il ti az em twi ce d ai ly fo r n in e ty d a ys C li ni ca l Pha rmac ol o gy » To pi ca l ha s < 1 0% sy st emi c ex p o sure as o ral d os e b u t sig n ifi ca nt ly gre at er e ffe ct o n sp h in ct er to n e – i.e ., b lo o d le v el s d o n ot p red i ct ac ti v it y. L ow ex p os ure = b e tt er t o lera b il it y th an ora l di lt ia ze m C li n ic al Dat a » Ten c li n ic al tri al s i n 4 53 in d iv id u al s » In freq u en t mil d AEs rep o rted » Simi la r o r b et te r red uc ti o n in p a in , sig n ifi ca nt ly be tt er t o le rab il it y th a n GTN
22. 17 Pi v ot al Ph a se III T ri al » FDA (an al g esi a d i vi si on ) p re - IND mee ti ng co n du ct ed in Au g us t 2 0 0 7 Ac h ie ve d cl ari ty o n p rim ary en d p oi n t: red u ct io n i n p ai n Co n fi rmed safet y d at ab as e a n d to x req u ire men t NDA fil in g p o ssib l e 2 0 1 3 » Pha se III tria l co n du c te d by SLA (E x - NA li ce ns or) 3 arms, 1 55 pt s p e r arm: 2 % 4 % d i lt ia ze m TID , a n d pl ac eb o i n 3 1 sit es in E u ro p e Pri mary en dp o in t : re d uc ti o n in p a in o n d efe cat i on u si n g a va li d ate d sc al e ( Lik e rt , NR S) Ve n tru s re vi ew of bl in d ed d a ta an d st u dy op e ra ti o ns 1 0/ 2 01 1 : Co rrec t pa ti en t s e nro ll ed , d at a c o mp li an ce an d GC R P are g o od , d at a a re b e in g rev i ewed co n ti nu o u sly En ro l lme n t c o mp le ted ; d at a re ad o u t ex pe ct ed i n M ay 20 1 2 » Plan n ed Seco n d Ph ase III t ri al (s): De v el op i ng 4 po ssi b le ex t en d ed re le ase formu l at io n s: may te st som e o r a ll i n h um an ma no me try t ria l in 2 0 12 . Nex t p h ase co u ld be 2 PH III t ria ls wit h ex t en d ed rel ea se formu l at io n if on e i s ac ce p ta bl e, o r 1 wi th o rig i na l fo rmu la ti o n
23. 18 C o mp et it iv e Trea tm en ts for An a l Fissu re 1 C ro ss, KLR . , et al ., (2 00 8 ) Th e M an ag e men t o f An al Fis su re : ACPGB I Po si ti on St at em en t . C o lo rec ta l Dise ase , 1 0 (Su p pl . 3 ), 1 - 7. 2 M ad o ff , RD. , & Fl esh ma n , J W . (2 00 3 ) AGA T ech n i cal R ev i ew o n t h e Di ag n o sis an d C are o f Pat ie nt s Wit h An al Fis su re . Gast ro en te rol o gy , 1 24 , 2 35 – 24 5 Di lt ia zem i s t he rec o mmen d ed fi rst - li ne t re at men t fo r an a l fi ssu res amo n g GIs a nd C R S Th e l au n ch o f R ec ti v ™ c o ul d a ll ow co st effec ti v e t arg et in g o f p resc rib ers an d i nc rea se AF awa ren ess Wi th o u r AE ad v an ta ge , VEN 3 0 7 co u ld ra p id ly est ab li sh ma rke t do mi n an ce o n ce la u nc he d R ec ti v ™ 0 . 4% GT N o in tm en t BID (T op i ca l Ni tro g ly c erin e ) App ro v ed i n th e US fo r mo d erat e an d se ve re pa in o f c h ro n ic a na l fissu re, l au n ch ed M a rc h 2 0 12 Pri ce d at $ 7 30 WAC p er 8 we ek c ou rse Ex t en siv e l it erat u re rep o rti n g imp ro ve d p ai n b ut d i ffi cu lt si d e effec t p ro fil e: h ig h rat e of he ad a ch es (6 4 % o f p at ie nt s, oft en se v ere), flu sh in g , na u sea a nd d i zz in ess M ed i cal a sso ci at io n s ’ gu i de li n es h a ve c on si ste n tl y d irec te d p hy si ci an s to t o pi ca l di lt ia ze m o v er GT N a s 1 st li n e t h erap y 1 , 2 C al ci um Ch a nn e l Bl oc k ers C o mp o un d ed n i fe d ip in e i s u sed t o a le sse r ex t en t th an d i lt ia ze m Le ss li te ra tu re av ai la b le B ot o x Out o f p o ck et c o st fo r p a ti en ts Su rg e ry Forc ib le d i la tat i on a n d sp hi n ct ero to my M o st o ft en cu rat iv e, b u t fe ca l i n co n ti ne n ce is a p ro b le m
25. 20 T arg et M ark et s Pro v id e Op ti mal St ra te g ic Fl ex ib i li ty » Spe ci al ty sa le s fo rce a nd DT C ca n b e h i gh l y effec ti v e Di lt i aze m i s t h e re co mme n de d first - li ne t re at men t i n foc u sed ma rke t o f sp eci al is ts 50 % o f cu rren t h emo rrho i d scri pt s (4 m il li on ) a re c o nc en t ra te d in 21 ,0 0 0 p resc ri b ers No da ta t o su pp o rt th e us e o f i n tra an al st ero i ds as effec ti v e t rea tme nt ; n ot a pp ro v ed Di rec t To C on su me r (DTC ) ad v ert isi n g co u ld b e h ig h ly i mp ac tfu l fo r VE N 3 0 9 1 » Partn e rsh i ps We in te n d to se ek a ma rke ti n g p artn e r for VEN 3 0 9 for ex - US te rri t ori es Co - pro mo ti o n op p o rtu n it ie s ex i st for bro ad e r PCP co v erag e o f VEN 30 9 » Pri ci n g an d R ei mb urse men t VE N 3 0 9: No o t he r d rug s in c la ss o r i n di ca ti on : M ed i ca re Pa rt D an d ma na g ed c are imp l ic at io n s VE N 3 0 7: Pa rit y p ri ci n g to R ec ti v ® ($ 73 0 t wo mo nt h su p pl y ) i s p o ssib l e; Ex p ec t maj or sh are of ex ist in g c o mpo u n de d R x, n ew Re ct iv ™ p at ie n ts, p lu s ad d it io n al p at ie nt s 1 : Pri n ce to n B ra n d Ec on o met ric s fo rec ast mo d el 2 0 12
26. Ri gh t s a nd Ex cl usi v it y R ig h ts » Ve n tru s h as al l rig h ts an d t it le , W orl d - wi d e, p ay in g ro y al ti es be twe en 1 % an d 4 % M ark et a nd Dat a E xc lu si v it y » Ne w c on c en tra ti on ra n ge p at en t fil ed wi th USPT O & PTC (Au g ust 2 0 1 0) » Co mp o sit io n o f ma tt er e x pi res Aug u st 2 01 5 » 5 ye ars an d 1 0 y ea rs o f d at a e x cl usi v it y in th e US u n de r Hat ch - Wax ma n Act an d E U, re sp ect iv e ly » To pi ca l GI Prod u ct wi th l o w b io av a il ab il it y 2 1 VEN 30 9 VE N 3 07 Ri gh t s » No rt h Ameri can ri g ht s p a y in g mi d to u p p er si n gl e d ig it ro y al ti es Ma rke t an d Dat a Ex cl u siv i ty » Me th o d o f u se pa te n t e x pi res Feb 2 0 1 8; a pp ro x. 1 6 mo n th s HW e xt en si on » To pi ca l GI p ro d u ct ; s ys te mic l ev el s d o n o t pre di ct a ct iv it y » Ex te nd e d re le ase fo rmu la ti on s (B ID) u n de r d ev el o pm en t to e xt en d e x clu si v it y
27. 22 E xp e ct ed M i le sto n es H1 20 1 2 H2 2 0 12 » PH 3 en ro ll men t c omp l et io n » Re sul t s from PH 3 t ria l (e x pe ct ed J un e) » Cl in ic al p h arma co lo g y resu l ts » Pub l ic ati o n o f p re cl in i cal p h arma co lo g y » FDA mee ti n g » Re cu rre n ce d at a re ad - ou t s from 1 st p iv o tal » Lau n ch s eco n d p iv o ta l an d rec urre nc e tria l » Da ta p u b li cat io n /p res en ta ti o n » Pate n t offic e ac ti on VEN 3 0 9 VEN 3 0 7 » Da ta re ad - ou t from first p iv o ta l PH 3 t ri al (e xp e ct ed i n M ay ) » Go / no go d e ci sio n a nd sel ect i on o f e x te nd ed re le ase fo rmu la ti on » FDA mee ti n g » Lau n ch o f se co n d p iv o ta l » Re sul t s o f n ew fo rmu la ti o n » Da ta p u b li cat io n /p res en ta ti o n
28. 23 Fi n an ci al s » Na sd aq (IPO 2 0 1 1): VTUS » Ca sh b al an ce Ca sh an d c ash e q ui v al en ts YE 2 0 1 1 * $ 3 6 .9 M il » Sto ck d a ta Ful ly di lu t ed sh are s o u tst an d in g 1 5 .3 M i l Sha res ou t sta nd i ng 12 .4 Mi l * In clu d es $ 12 . 5 mil p ay me n t fo r ri gh t s fo r VEN 30 9 t o Amer & C o .
29. » De v el op me nt ri sk st ra ti fie d ac ross th ree l at e - sta ge p ro du ct s NC E an d 5 0 5(b )2 reg is trat io n p a th way s Two p iv o ta l Pha se III re ad - ou t s fo r two s ep arat e p ro d u ct s e xp e cte d i n 2Q 2 01 2 Poss ib le v al id a ti on o f t wo l ead pro g ra ms Ra ng e o f co - pro mo ti o n/ p artn e rsh i p o pp o rtu n it ie s c ou l d fol lo w da ta » Pro d u ct s a dd ress la rge , un d erse rve d , a n d un t ap p ed ma rke ts 3 of th e to p 1 0 GI d is ord ers Sig n ific an t ma rk e t p o te n ti al s i n sp ec ia lt y p ha rma an d p ri ma ry care » Wel l fu n d ed t h ro u g h ke y mi le sto n es Ca sh an d c ash e q ui v al en ts of $ 3 7 mm (De c. 3 1, 2 0 11 ) $20 m m IPO (wi th o v eral lo c at io n ) i n Dec 2 0 10 ; $ 5 0 mm fo ll o w - on i n Ju ly 20 1 1 2 4 C on c lu sio n
30. Ru sse ll H. El li so n, M D, MSc C h ie f Ex ec u ti ve Offic er a n d Ch a irma n of th e Bo a rd