The document discusses new cardiovascular drugs that are entering the market to treat high cholesterol and blood thinning. Praluent and Repatha, new PCSK9 inhibitor injections for cholesterol, are the current front-runners but face pricing pressures. Older generic drugs have established safety profiles that some physicians prefer over new drugs. New oral blood thinners also face adoption challenges due to the familiarity of warfarin despite offering simpler dosing. Future oral drugs for cholesterol like anacetrapib and ETC-1002 may have advantages over injections if approved.
The document announces the 12th Annual Pharmacy Purchasing Networking Conference held August 11-14, 2008 at the Las Vegas Hilton Hotel and Convention Center. It lists sponsors who provided grants to cover registration and hotel costs for 51 buyer-attendees. Major sponsors included Cardinal Health, Jace Pharmaceuticals, Med-Search, and PharMEDium (Diamond); Bedford Laboratories, Bioniche Pharma, and Sagent Pharmaceuticals (Silver); and R&S Northeast and X-Gen Pharmaceuticals (Bronze).
Generic medication for glaucoma. pr. nordmannJPNordmann
This document discusses generic glaucoma medications. While generics do not need to demonstrate bioequivalence like systemic drugs, evidence suggests they may differ from brands in composition and efficacy. Specifically, one study found generic latanoprost reduced IOP less than the branded Xalatan. Differences in inactive ingredients between generics and brands before 1992 may also impact tolerability and efficacy. Close monitoring of IOP is recommended when switching patients to a generic drug.
This document provides information about the pharmaceutical industry and some major pharmaceutical companies. It discusses the history and development of the pharmaceutical industry. It also discusses key aspects like research and development, costs of innovation, industry revenues, and some of the largest companies by revenue and sales. Major companies discussed include Pfizer, Merck & Co., Ranbaxy Laboratories, Torrent Pharmaceuticals, and others.
BioEntrepreneurship: Intellectual Property: What Do Investors Look For?MaRS Discovery District
Strong patent protection is essential for a start-up biotechnology company and can be a valuable company asset. However, it is also expensive, with costs ranging from tens to hundreds of thousands of dollars over time. This session will focus on how to get the most out of your patent dollars.
This session presentation is available in audio format here: http://www.marsdd.com/bioent/dec4
This document discusses issues with motivation and productivity in large pharmaceutical companies' drug discovery efforts. It argues that an environment that does not understand or support researchers' intrinsic motivation will lead to demotivated scientists and lower output. Small biotech companies that provide autonomy and focus on scientists' needs often achieve more innovative discoveries as a result. To maximize productivity, companies should create research environments that stimulate excellence among scientists.
The document provides information about Merck's partnership opportunities conference, including:
1) It discusses Merck's focus on partnerships, with about 64% of its 2010 revenue coming from alliance products and patents.
2) It provides key facts about Merck, such as its global operations, revenue, R&D spending, and pipeline of products in development.
3) It emphasizes Merck's large pipeline and willingness to partner on developing and commercializing drug delivery technologies.
The document discusses trials evaluating new drug and device therapies for heart failure, including the EMPHASIS-HF trial which found that the aldosterone antagonist eplerenone reduced cardiovascular mortality and hospitalization for worseness heart failure in patients with mild heart failure and reduced ejection fraction. It also summarizes the SHIFT trial which found that the If inhibitor ivabradine reduced the primary composite outcome of cardiovascular death or hospitalization for worsening heart failure compared to placebo in patients with chronic heart failure, left ventricular systolic dysfunction, and heart rate ≥70 bpm.
A seminar on Molecular mechanisms of drug induced cardio toxicityAkshata Nadgowda
This document summarizes the molecular mechanisms of drug-induced cardiotoxicity. It discusses how drugs can cause cardiotoxicity through several mechanisms, including disrupting ion homeostasis, impairing energy metabolism, and inducing apoptosis and necrosis in heart cells. It describes signaling pathways like mitochondrial permeability transition, Bcl-2 family proteins, caspases, cytokines and p38 MAPK that mediate cell death. Gene regulation pathways like AP-1, TEF-1, SRF and NFATs that are involved in cardiac hypertrophy are also summarized. Specific mechanisms of doxorubicin-induced cardiotoxicity involving oxidative stress, myofibrillar deterioration and calcium dysregulation are also outlined.
The document announces the 12th Annual Pharmacy Purchasing Networking Conference held August 11-14, 2008 at the Las Vegas Hilton Hotel and Convention Center. It lists sponsors who provided grants to cover registration and hotel costs for 51 buyer-attendees. Major sponsors included Cardinal Health, Jace Pharmaceuticals, Med-Search, and PharMEDium (Diamond); Bedford Laboratories, Bioniche Pharma, and Sagent Pharmaceuticals (Silver); and R&S Northeast and X-Gen Pharmaceuticals (Bronze).
Generic medication for glaucoma. pr. nordmannJPNordmann
This document discusses generic glaucoma medications. While generics do not need to demonstrate bioequivalence like systemic drugs, evidence suggests they may differ from brands in composition and efficacy. Specifically, one study found generic latanoprost reduced IOP less than the branded Xalatan. Differences in inactive ingredients between generics and brands before 1992 may also impact tolerability and efficacy. Close monitoring of IOP is recommended when switching patients to a generic drug.
This document provides information about the pharmaceutical industry and some major pharmaceutical companies. It discusses the history and development of the pharmaceutical industry. It also discusses key aspects like research and development, costs of innovation, industry revenues, and some of the largest companies by revenue and sales. Major companies discussed include Pfizer, Merck & Co., Ranbaxy Laboratories, Torrent Pharmaceuticals, and others.
BioEntrepreneurship: Intellectual Property: What Do Investors Look For?MaRS Discovery District
Strong patent protection is essential for a start-up biotechnology company and can be a valuable company asset. However, it is also expensive, with costs ranging from tens to hundreds of thousands of dollars over time. This session will focus on how to get the most out of your patent dollars.
This session presentation is available in audio format here: http://www.marsdd.com/bioent/dec4
This document discusses issues with motivation and productivity in large pharmaceutical companies' drug discovery efforts. It argues that an environment that does not understand or support researchers' intrinsic motivation will lead to demotivated scientists and lower output. Small biotech companies that provide autonomy and focus on scientists' needs often achieve more innovative discoveries as a result. To maximize productivity, companies should create research environments that stimulate excellence among scientists.
The document provides information about Merck's partnership opportunities conference, including:
1) It discusses Merck's focus on partnerships, with about 64% of its 2010 revenue coming from alliance products and patents.
2) It provides key facts about Merck, such as its global operations, revenue, R&D spending, and pipeline of products in development.
3) It emphasizes Merck's large pipeline and willingness to partner on developing and commercializing drug delivery technologies.
The document discusses trials evaluating new drug and device therapies for heart failure, including the EMPHASIS-HF trial which found that the aldosterone antagonist eplerenone reduced cardiovascular mortality and hospitalization for worseness heart failure in patients with mild heart failure and reduced ejection fraction. It also summarizes the SHIFT trial which found that the If inhibitor ivabradine reduced the primary composite outcome of cardiovascular death or hospitalization for worsening heart failure compared to placebo in patients with chronic heart failure, left ventricular systolic dysfunction, and heart rate ≥70 bpm.
A seminar on Molecular mechanisms of drug induced cardio toxicityAkshata Nadgowda
This document summarizes the molecular mechanisms of drug-induced cardiotoxicity. It discusses how drugs can cause cardiotoxicity through several mechanisms, including disrupting ion homeostasis, impairing energy metabolism, and inducing apoptosis and necrosis in heart cells. It describes signaling pathways like mitochondrial permeability transition, Bcl-2 family proteins, caspases, cytokines and p38 MAPK that mediate cell death. Gene regulation pathways like AP-1, TEF-1, SRF and NFATs that are involved in cardiac hypertrophy are also summarized. Specific mechanisms of doxorubicin-induced cardiotoxicity involving oxidative stress, myofibrillar deterioration and calcium dysregulation are also outlined.
The pharmaceutical industry faced a challenging period from 2008-2012 due to numerous major drug patents expiring, resulting in $30 billion in lost annual brand drug revenue. Another peak of patent expirations is projected for 2014-2015, equal to the prior period. Growth in overall drug spending declined 1% in 2012 but is predicted to rebound to 3-4% growth in 2014, driven by new drug approvals and healthcare reform, before slowing again as generics continue to capture a larger share of prescriptions. Demonstrating the value of new drugs through real-world evidence will be important for companies to sustain pricing levels in this challenging environment.
A showcase is presented of the lifecycle analysis of the blockbuster HMG-CoA reductase inhibitor (Statin) drug Crestor, prescribed for hypercholesterolemia and primary prevention of cardiovascular disease. Now considered a "legacy" product, Crestor with its decade history of regulatory and clinical trial milestones has cut out a unique pharma life cycle for itself...see this Slideshare for more details.
Wall Street Mastermind Sector Spotlight - Healthcare (October 2023).pdfSamShiah1
Here are the contents of this month's Healthcare Sector Spotlight:
1. Current Market
2. Ozempic Case Study
3. Pharma vs. FTC
4. Healthcare Strikes
5. Sandoz/Novartis Split
6. Amgen Horizon
7. Appendix
The document summarizes key findings from FirstWord Pharma's analysis of the top 50 pharmaceutical products expected to drive sales growth between 2012-2017. Some of the main points include:
- These 50 products are forecast to contribute $80 billion in additional revenue over the period. The top 15 products will account for over 50% of this growth.
- Gilead's sofosbuvir, Roche's Perjeta, Merck's Januvia, Biogen's Tecfidera and AbbVie's Humira are each expected to contribute over $3 billion individually to industry growth.
- Both large pharmaceutical companies and leading biotechs will benefit, though many "biotech" drugs are now
Overcoming obstacles to repurposing for neurodegenerative diseaseLona Vincent
This document discusses the challenges of repurposing FDA-approved drugs for neurodegenerative diseases. It notes that while repurposing can accelerate development timelines and reduce costs compared to new drug development, it still requires expensive clinical trials. It also notes that by the time a drug is approved, there is typically less than 10 years of patent life remaining, which is not enough time to generate efficacy data for a new indication and achieve commercial returns. Additionally, limited patent protection makes commercialization and reimbursement difficult. The document proposes that philanthropy, industry, and government need to address these challenges through policy changes and targeted funding to promote repurposing as a strategy to increase treatment options for patients.
NON-ALCOHOLIC STEATOHEPATITIS (NASH): AN ANALYSIS OF DISEASE PREVALENCE, DRUG...MP ADVISORS
This report will provide detailed analysis on NASH disease and Drugs in development in broader pharma market. This report list all the drugs in clinical trial and their design and the population recruited, also tells about the pathways representing possible targets for the treatment of NASH
Merck & co., inc. barclays final 3-10-2015Marcel Brussee
What does Merck's $10B buyback plan say about pharma M&A?
Adding $10 billion to its stock buyback program might mean Merck & Co. ($MRK) wants to keep investors happy as its sales continue to shrink. That would be the typical explanation. But The Wall Street Journal sees a different possibility--one the rest of the industry might want to pay attention to.
Source: http://www.fiercepharma.com/story/what-does-mercks-10b-buyback-plan-say-about-pharma-ma/2015-03-26?utm_campaign=SocialMedia
This document discusses PCSK9 inhibitors, a new class of drugs for treating hypercholesterolemia. PCSK9 inhibitors work by blocking the PCSK9 protein and preventing degradation of LDL receptors in the liver, thereby significantly reducing LDL cholesterol levels. Clinical trials showed PCSK9 inhibitors reduced LDL-C by 40-72% when added to statin therapy or used alone, lowering cardiovascular event risk. While effective and generally well-tolerated, PCSK9 inhibitors are also very expensive, costing approximately $14,600 per year. Loss of function mutations in the PCSK9 gene, which naturally inhibit the protein, provide lifelong protection from heart disease.
RETINA COMPANY SHOWCASE- Aerie PharmaceuticalsHealthegy
Panel Discussion by Aerie Pharmaceuticals at OIS@ASRS 2016.
Participant:
Casey Kopczynski, Chief Scientific Officer- Aerie Pharmaceuticals
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
This document summarizes a presentation on strategies for boosting pharmaceutical innovation given by Kenneth Kaitin. It discusses the current challenging environment for drug development, including expiring patents, competitive markets, and high costs. Drug development times are long with low success rates, driving costs upwards. Oncology has become a major focus of R&D investment. The presentation proposes ways to stimulate innovation in areas of high medical need but low commercial appeal, such as through regulatory and legislative incentives.
CRISPR Therapeutics is a healthcare technology company focused on advancing gene-based medicines through CRISPR technology. Key products in development include Exa-cel and Exa-cell for hemoglobinopathies like sickle cell disease and beta-thalassemia. The company is also developing CAR-T immunotherapies for cancer as well as regenerative medicine programs. CRISPR technology has significant potential for treating genetic diseases, enhancing biotechnology, and improving agriculture through precise genome editing.
1) A new heart failure drug called LCZ696 was touted in the media as a "miracle drug" based on a study funded by its manufacturer Novartis.
2) The study halted early so the drug could reach the market faster, which draws media attention but raises integrity concerns since the study was solely funded by Novartis.
3) Novartis strategically compared LCZ696 to an existing gold standard drug to make the new drug's improvements seem larger, even though the actual benefits may be small.
Marketing Presentation For 2011 MBA Programjreidglass1
AstraZeneca is launching a new blood thinner drug called Oxynac to treat cardiovascular diseases as an alternative to the current market leader Plavix. The marketing strategy involves differentiating Oxynac by highlighting its unique benefits over competitors through educational marketing campaigns targeting healthcare providers and the general public. The objectives over three years are to increase product awareness, decrease resistance to purchase, and achieve double digit growth and profitability. The budget allocates $50 million to marketing in 2011 leading up to the 2012 product launch. Controls include legal and compliance oversight of all marketing to ensure regulatory approval.
Global pharmaceutical & biotechnology outlook 2013 rising stars - Reports CornerReports Corner
Innovative and improved drugs therapies developed through novel target discovery and technology platforms have originated from the backyards of small research focused companies (Rising Stars, RS, non-profitable biotech companies). The universe continues to grow despite the high risk and the wait to transform into a successful profitable Mature Biotech is long.
https://www.reportscorner.com/reports/10016/Global-Pharmaceutical-&-Biotechnology-Outlook-2013:-Rising-Stars/
Clinical trials established in 2005 the efficacy of Ranibizumab (Lucentis, Genentech) for the treatment of neovascular age-related macular degeneration (wetAMD), the leading cause of legal blindness in the United States.This disease is affecting people over the age of 65 with a prevalence of 1.6 million and 200000 new cases per year in the USA .While awaiting approval for ranibizumab from the Food and Drug Administration, ophthalmologists began treating neovascular AMD with off-label use of bevacizumab (Avastin, Genentech), since the drug had a target specificity similar to that of ranibizumab and was available at low cost for about 50$ per monthly injection Vs 1950$ for Lucentis monthly injection.
Ranibizumab received the FDA approuval in 2006 to treat specifically the wetAMD,there was a huge debate about the cost effectiveness and the reimbursement of Lucentis in comparaison with Avastin for treating the eye disease.
This paper explores the dilemma from different angles.First,it make the emphasize on the need of realizing a head to head comparative study between the two drugs and the means to finance and to launch this study since many roadblocks have been identified.
Then, it explores and analyzes the Genentech reaction facing this problem and their strategy to emphasize on the higher risk of death with Avastin, as compared to Lucentis in one hand and in the other hand their strategy to extend the ophthalmologic indications for Lucentis, including diabetic macula edema (DME).
Finally it explores what value should be put on safety in health technology assessments HTAs by developing that we can’t just consider the dollar value of medicine alone but we need to consider the cost of adverse events caused by the treatment and the cost of living with these adverse events
Wall Street Mastermind Sector Spotlight - Healthcare (September 2023)SamShiah1
Here are the contents of this month's Healthcare Sector Spotlight:
1. Trading and M&A Comps
2. Obesity Drug Market
3. Illumina/Grail Debacle
4. Royalty Finance
5. J&J Consumer Health IPO
An introduction to PCSK-9 inhibitors: a new therapeutic class of drugs approved by US FDA in July 2015 to treat Heterozygous familial hypercholesterolemia (HeFH) and its superiority over gold standard statins in treatment. Does it have potential to become a blockbuster and emulate Lipitor's success?
We've helped investors navigate the dynamic BioPharma industry for decades. Our flagship Global Pharmaceutical and Biotechnology Outlook maps the highs and lows of the year, assessing the critical success factors that can shape the industry's future.
Based on extensive research and comprehensive data analysis, this volume is a ready reference for monitoring new developments and their investment and strategic implications. From the macro analysis of over 200 companies arise ~60+ actionable capsules categorized into Global Pharma, Japanese Pharma, Mature Biotech, Rising Stars (unprofitable biotech) and Indian Pharma.
The pharmaceutical industry faced a challenging period from 2008-2012 due to numerous major drug patents expiring, resulting in $30 billion in lost annual brand drug revenue. Another peak of patent expirations is projected for 2014-2015, equal to the prior period. Growth in overall drug spending declined 1% in 2012 but is predicted to rebound to 3-4% growth in 2014, driven by new drug approvals and healthcare reform, before slowing again as generics continue to capture a larger share of prescriptions. Demonstrating the value of new drugs through real-world evidence will be important for companies to sustain pricing levels in this challenging environment.
A showcase is presented of the lifecycle analysis of the blockbuster HMG-CoA reductase inhibitor (Statin) drug Crestor, prescribed for hypercholesterolemia and primary prevention of cardiovascular disease. Now considered a "legacy" product, Crestor with its decade history of regulatory and clinical trial milestones has cut out a unique pharma life cycle for itself...see this Slideshare for more details.
Wall Street Mastermind Sector Spotlight - Healthcare (October 2023).pdfSamShiah1
Here are the contents of this month's Healthcare Sector Spotlight:
1. Current Market
2. Ozempic Case Study
3. Pharma vs. FTC
4. Healthcare Strikes
5. Sandoz/Novartis Split
6. Amgen Horizon
7. Appendix
The document summarizes key findings from FirstWord Pharma's analysis of the top 50 pharmaceutical products expected to drive sales growth between 2012-2017. Some of the main points include:
- These 50 products are forecast to contribute $80 billion in additional revenue over the period. The top 15 products will account for over 50% of this growth.
- Gilead's sofosbuvir, Roche's Perjeta, Merck's Januvia, Biogen's Tecfidera and AbbVie's Humira are each expected to contribute over $3 billion individually to industry growth.
- Both large pharmaceutical companies and leading biotechs will benefit, though many "biotech" drugs are now
Overcoming obstacles to repurposing for neurodegenerative diseaseLona Vincent
This document discusses the challenges of repurposing FDA-approved drugs for neurodegenerative diseases. It notes that while repurposing can accelerate development timelines and reduce costs compared to new drug development, it still requires expensive clinical trials. It also notes that by the time a drug is approved, there is typically less than 10 years of patent life remaining, which is not enough time to generate efficacy data for a new indication and achieve commercial returns. Additionally, limited patent protection makes commercialization and reimbursement difficult. The document proposes that philanthropy, industry, and government need to address these challenges through policy changes and targeted funding to promote repurposing as a strategy to increase treatment options for patients.
NON-ALCOHOLIC STEATOHEPATITIS (NASH): AN ANALYSIS OF DISEASE PREVALENCE, DRUG...MP ADVISORS
This report will provide detailed analysis on NASH disease and Drugs in development in broader pharma market. This report list all the drugs in clinical trial and their design and the population recruited, also tells about the pathways representing possible targets for the treatment of NASH
Merck & co., inc. barclays final 3-10-2015Marcel Brussee
What does Merck's $10B buyback plan say about pharma M&A?
Adding $10 billion to its stock buyback program might mean Merck & Co. ($MRK) wants to keep investors happy as its sales continue to shrink. That would be the typical explanation. But The Wall Street Journal sees a different possibility--one the rest of the industry might want to pay attention to.
Source: http://www.fiercepharma.com/story/what-does-mercks-10b-buyback-plan-say-about-pharma-ma/2015-03-26?utm_campaign=SocialMedia
This document discusses PCSK9 inhibitors, a new class of drugs for treating hypercholesterolemia. PCSK9 inhibitors work by blocking the PCSK9 protein and preventing degradation of LDL receptors in the liver, thereby significantly reducing LDL cholesterol levels. Clinical trials showed PCSK9 inhibitors reduced LDL-C by 40-72% when added to statin therapy or used alone, lowering cardiovascular event risk. While effective and generally well-tolerated, PCSK9 inhibitors are also very expensive, costing approximately $14,600 per year. Loss of function mutations in the PCSK9 gene, which naturally inhibit the protein, provide lifelong protection from heart disease.
RETINA COMPANY SHOWCASE- Aerie PharmaceuticalsHealthegy
Panel Discussion by Aerie Pharmaceuticals at OIS@ASRS 2016.
Participant:
Casey Kopczynski, Chief Scientific Officer- Aerie Pharmaceuticals
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
This document summarizes a presentation on strategies for boosting pharmaceutical innovation given by Kenneth Kaitin. It discusses the current challenging environment for drug development, including expiring patents, competitive markets, and high costs. Drug development times are long with low success rates, driving costs upwards. Oncology has become a major focus of R&D investment. The presentation proposes ways to stimulate innovation in areas of high medical need but low commercial appeal, such as through regulatory and legislative incentives.
CRISPR Therapeutics is a healthcare technology company focused on advancing gene-based medicines through CRISPR technology. Key products in development include Exa-cel and Exa-cell for hemoglobinopathies like sickle cell disease and beta-thalassemia. The company is also developing CAR-T immunotherapies for cancer as well as regenerative medicine programs. CRISPR technology has significant potential for treating genetic diseases, enhancing biotechnology, and improving agriculture through precise genome editing.
1) A new heart failure drug called LCZ696 was touted in the media as a "miracle drug" based on a study funded by its manufacturer Novartis.
2) The study halted early so the drug could reach the market faster, which draws media attention but raises integrity concerns since the study was solely funded by Novartis.
3) Novartis strategically compared LCZ696 to an existing gold standard drug to make the new drug's improvements seem larger, even though the actual benefits may be small.
Marketing Presentation For 2011 MBA Programjreidglass1
AstraZeneca is launching a new blood thinner drug called Oxynac to treat cardiovascular diseases as an alternative to the current market leader Plavix. The marketing strategy involves differentiating Oxynac by highlighting its unique benefits over competitors through educational marketing campaigns targeting healthcare providers and the general public. The objectives over three years are to increase product awareness, decrease resistance to purchase, and achieve double digit growth and profitability. The budget allocates $50 million to marketing in 2011 leading up to the 2012 product launch. Controls include legal and compliance oversight of all marketing to ensure regulatory approval.
Global pharmaceutical & biotechnology outlook 2013 rising stars - Reports CornerReports Corner
Innovative and improved drugs therapies developed through novel target discovery and technology platforms have originated from the backyards of small research focused companies (Rising Stars, RS, non-profitable biotech companies). The universe continues to grow despite the high risk and the wait to transform into a successful profitable Mature Biotech is long.
https://www.reportscorner.com/reports/10016/Global-Pharmaceutical-&-Biotechnology-Outlook-2013:-Rising-Stars/
Clinical trials established in 2005 the efficacy of Ranibizumab (Lucentis, Genentech) for the treatment of neovascular age-related macular degeneration (wetAMD), the leading cause of legal blindness in the United States.This disease is affecting people over the age of 65 with a prevalence of 1.6 million and 200000 new cases per year in the USA .While awaiting approval for ranibizumab from the Food and Drug Administration, ophthalmologists began treating neovascular AMD with off-label use of bevacizumab (Avastin, Genentech), since the drug had a target specificity similar to that of ranibizumab and was available at low cost for about 50$ per monthly injection Vs 1950$ for Lucentis monthly injection.
Ranibizumab received the FDA approuval in 2006 to treat specifically the wetAMD,there was a huge debate about the cost effectiveness and the reimbursement of Lucentis in comparaison with Avastin for treating the eye disease.
This paper explores the dilemma from different angles.First,it make the emphasize on the need of realizing a head to head comparative study between the two drugs and the means to finance and to launch this study since many roadblocks have been identified.
Then, it explores and analyzes the Genentech reaction facing this problem and their strategy to emphasize on the higher risk of death with Avastin, as compared to Lucentis in one hand and in the other hand their strategy to extend the ophthalmologic indications for Lucentis, including diabetic macula edema (DME).
Finally it explores what value should be put on safety in health technology assessments HTAs by developing that we can’t just consider the dollar value of medicine alone but we need to consider the cost of adverse events caused by the treatment and the cost of living with these adverse events
Wall Street Mastermind Sector Spotlight - Healthcare (September 2023)SamShiah1
Here are the contents of this month's Healthcare Sector Spotlight:
1. Trading and M&A Comps
2. Obesity Drug Market
3. Illumina/Grail Debacle
4. Royalty Finance
5. J&J Consumer Health IPO
An introduction to PCSK-9 inhibitors: a new therapeutic class of drugs approved by US FDA in July 2015 to treat Heterozygous familial hypercholesterolemia (HeFH) and its superiority over gold standard statins in treatment. Does it have potential to become a blockbuster and emulate Lipitor's success?
We've helped investors navigate the dynamic BioPharma industry for decades. Our flagship Global Pharmaceutical and Biotechnology Outlook maps the highs and lows of the year, assessing the critical success factors that can shape the industry's future.
Based on extensive research and comprehensive data analysis, this volume is a ready reference for monitoring new developments and their investment and strategic implications. From the macro analysis of over 200 companies arise ~60+ actionable capsules categorized into Global Pharma, Japanese Pharma, Mature Biotech, Rising Stars (unprofitable biotech) and Indian Pharma.
Similar to CVijayvergiya CV therapeutic focuspdf (20)
1. Regeneron/Sanofi’s Praluent (alirocumab) andAmgen’s Repatha
(evolocumab) each received an FDA nod for the treatment of high
cholesterol during the summer of 2015. By virtue of winning the
race to market, Praluent is the current front-runner. Nonetheless,
both drugs have garnered excitement and performed well in trials.
New-to-market cardio solutions are coming face-to-face with
a pricing rift. “New products are confronting established—and
often generic—products with proven outcomes benefits and lower
prices,” notes David Day, SVP/account director at Triple Threat
Communications. “The medical community demands that new
products exceed the efficacy and outcomes benefits of established
therapies but also justify a higher cost.”
Therapeutically, there’s a clear role for both older established
drugs and innovative medicines,says Jay Edelberg,MD,PhD,head
of Sanofi’s PCSK9 Development and Launch Unit.“In cholesterol,
physicians first prescribe statins and only consider innovative drugs
like Praluent if additional lowering of LDL cholesterol is required.”
Jeff Berg, SVP/director of client services at AbelsonTaylor, feels
that“years of experience with old drugs carry a greater safety profile
halo.” He indicates the need for new brands to establish a 20% or
greater event reduction over current standard of care to give HCPs
and payers more comfort.
Clot busters and blood thinners
Decades-old anticoagulant anchor warfarin has faced competi-
tion from a steady stream of new products, including Johnson &
Johnson/Bayer’s Xarelto, Boehringer Ingelheim’s Pradaxa, Pfizer/
Bristol-Myers Squibb’s Eliquis and,most recently,Daiichi Sankyo’s
Savaysa.A few factors have driven the tremendous growth in the
blood-thinner market. Among them: an aging population neces-
sitating more hip and knee replacements that require a period of
deep-vein thrombosis prevention and a growing understanding
that arrhythmias carry stroke risk.
For those with atrial fibrillation—a known risk factor for stroke—
novel oral anticoagulants (NOACs) promise a sunnier solution:
way branded and generic clopidogrel has.That could soon change,
as AZ continues to pursue label expansions for its antiplatelet.
Statins and beyond
Statins,which pit the liver against the enzyme responsible for making
cholesterol, have long held the standard-treatment belt. Still, new
entrants are battling cholesterol in combination with statins and
angling to work alone.Some of the mid- and late-stage compounds
knocking on the door include Pfizer’s PCSK9 inhibitor, Esperion
Therapeutics’ novel LDL-lowering drug ETC-1002 and Merck’s
CETP inhibitor anacetrapib (see Clinical Corner, p. 48).
After many starts and stops, the first statin gained approval in
1987 and began the drug class’s rise to stardom in the treatment
of coronary artery disease. Pfizer’s wildly successful Lipitor (ator-
vastatin), which lost patent protection in 2011, handily earned the
distinction of best-selling drug of all time.
Crestor (rosuvastatin),AstraZeneca’s best-selling cardio drug,
saw its sales dip in 2015, likely a precursor to its patent expiration
this year.Aiming to expand its cardio and metabolic portfolios and
strategically offset lost Crestor sales,AstraZeneca announced a $2.7
billion acquisition of ZS Pharma.AstraZeneca stands to gain the
company’s potassium-binding compound ZS-9 for hyperkalemia,
now under FDA review.
If approved in coming years, anacetrapib and ETC-1002 would
already have a leg up on PCSK9 inhibitors, the first injectables in
the sector. In addition to potentially grabbing first-in-class brag-
ging rights, anacetrapib and ETC-1002 offer oral administration.
Finn Partners managing partner Gil Bashe believes the cost/benefit
of using PCSK9s and other high-powered cholesterol fighters is clear
T
he cardio sector continues to roll out new treatments to keep
our blood pumping smoothly, cholesterol at bay and CV risk
at a minimum.And as it does, marketers are striving to find
a balance between brands already nestled in the market and the
highly anticipated wave of cardio products ready to ink invitations
to their launch parties.
All eyes are on PCSK9 inhibitors, the new class of cholesterol-
lowering agents that comes with big promise and equally big price
tags.The monoclonal antibodies are working to establish themselves
among a skeptical crowd of payers and providers who question
whether there’s enough bang for the buck.And then there are the
cardiologists—traditionally a loyal bunch, often sticking with the
familiar safety and efficacy profiles of proven brands in order to
sidestep surprising new side effects.
namely, a simpler patient-management process. But will the con-
venience of these drugs outweigh the associated cost issues, effect
on renal function and bleeding risk?
NOACs, predicted to net $15.3 billion in worldwide sales by
2018, tout superior safety with fewer food and drug interactions,
not to mention no need for constant monitoring. On the flip side,
warfarin (marketed as Coumadin and Jantoven) presents physi-
cians with a familiar profile and promises patients a less startling
sticker price. “While warfarin’s limitations are great, the clinical
community has learned to manage the devil they know,” explains
Chetan Vijayvergiya, PhD, VP/senior medical brand strategist at
Publicis LifeBrands Medicus.
Warfarin is feeling the pressure, especially as its one true line of
defense begins to slip away.Recognized by physicians for its vitamin
K reversal ability, warfarin was trumped by the FDA’s approval of
Pradaxa’s reversal agent and soon-to-be-approved universal Factor
Xa agent. Knowing these options exist should provide comfort to
the slow NOAC adopters, Berg says.
Although Eliquis’s highly anticipated foray into the market
was more sizzle than splash, Bristol-Myers Squibb appears to be
making headway in the cardio category, specifically in congestive
heart failure. BMS is set to acquire Cardioxyl, a company boasting
a CHF drug in Phase-II trials.
Although Bristol-Myers Squibb and Sanofi’s antiplatelet agent
Plavix (clopidogrel) succumbed to patent expiration in 2012, its
generic form continues to reign. Plavix set the gold standard for
success in the category,with peak annual sales exceeding $9 billion.
From Berg’s vantage point,Daiichi Sankyo/Eli Lilly’s Effient (prasu-
grel) andAstraZeneca’s Brilinta (ticagrelor) haven’t caught on the
CARDIOVASCULAR
With clot-busting and blood-thinning brands working to establish themselves as successes,
the next wave of potentially transformative cardio products is set to hit the market in
2016. But with the huge advances in treatment comes a raft of concerns, among
them daunting pricing pressures. Rebecca Mayer Knutsen reports
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THERAPEUTIC
FOCUS
The approval of a reversal agent for the new generation of
blood thinners could address concerns among some doctors
with drugs like BI’s Pradaxa
TOP 25 CARDIOVASCULAR PRODUCTS
Category leaders, ranked by US sales
Vs. prior
12 mos.TRx
Vs. prior
12 mos.
US sales $
(millions)ManufacturerProductRank
1 Crestor AstraZeneca $6,303.9 8.5% 20,483,127 -7.6%
2 Zetia Merck $2,277.8 13.6% 6,700,213 -6.8%
3 EpiPen 2-Pak Mylan $1,155.5 36.1% 2,593,095 3.7%
4 Benicar Daiichi-Sankyo $1,035.4 10.9% N/A N/A
5 Bystolic Forest Laboratories $929.2 20.4% 6,071,122 -8.8%
6 Benicar HCT Daiichi-Sankyo $795.0 9.1% N/A N/A
7 Welchol Daiichi-Sankyo $743.2 9.0% 1,479,836 -14.5%
8 Vytorin Merck $719.3 -9.0% 2,003,704 -25.9%
9 Fenofibrate generic $681.9 -21.6% 14,215,364 -0.8%
10 Ranexa Gilead Sciences $635.9 14.9% 1,702,983 5.0%
11 Atorvastatin Calcium generic $632.0 -11.1% 90,221,960 16.5%
12 Lexiscan Astellas $574.3 3.2% N/A N/A
13 Omega-3 Acid Ethyl Teva $542.2 123.0% 3,392,265 171.1%
14 Metoprolol Succinate generic $541.3 -24.9% 40,518,391 4.1%
15 EpiPen Jr. 2-Pak Mylan $429.7 29.0% 861,733 0.6%
16 Multaq Sanofi $421.2 13.3% 710,318 -9.3%
17 Pravastatin Sodium generic $392.9 -31.2% 32,421,482 -6.3%
18 Azor Daiichi-Sankyo $399.0 5.5% N/A N/A
19 Diovan Novartis $337.4 -80.3% N/A N/A
20 Toprol-XL AstraZeneca $301.5 33.8% N/A N/A
21 Valsartan generic $288.8 -10.3% 8,245,247 324.5%
22 Adcirca Lung Biotechnology $286.7 12.5% N/A N/A
23 Niacin ER generic $271.3 -45.5% 2,134,037 -18.4%
24 Propranolol HCL generic $261.9 35.1% 9,962,223 3.9%
25 Lipitor Pfizer $240.5 -11.2% 761,243 -27.5%
Source: IMS Health
Sales data run from October 2014-September 2015.
List includes lipid regulators, anti-hypertensives and other cardiovasculars.
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for people with extremely high LDL-C,even after using a statin.With
trials like Merck’s Zetia (ezetimibe) Improve-It showing improved life
expectancy, physicians and payers are open to the second-line drug
concept,he says.In combo with Merck’s statin med simvastatin,Zetia
slashed heart risks by 6.4% in patients with acute coronary syndrome.
PCSK9 inhibitors single out patients with familial hypercholes-
terolemia,high rates of LDL that statins alone cannot improve and
known statin intolerance issues, adding up to a narrow segment of
the cardio crowd. Praluent’s Odyssey Outcomes trial, expected to
conclude in 2017, assesses the drug’s potential to reduce cardio-
vascular outcomes. “In our clinical trials, most patients achieved
their LDL cholesterol goals within weeks of commencing therapy,”
Edelberg says.
Pfizer’s third-to-market appearance in that category may not pre-
vent bococizumab from dominating the competition.Some analysts
believe it could achieve best-in-class status due to partner Halo-
zyme’s promise to improve the efficacy of individual subcutaneous
injections and reduce the required dose with its delivery platform.
Looking beyond 2016,Vijayvergiya has his eye onAlnylam’s gene-
silencing technology withALN-PCSsc,an RNAi therapeutic target-
ing PCSK9 that could offer biannual injections and “revolutionize
the management of LDL-C for patients and physicians.” Day, on
the other hand,points to the Medicines Co.’sALN-PCS as another
promising contender.ALN-PCS blocks the PCSK9 gene (PCSK9
inhibitors block the protein) and requires just two annual doses.
Elsewhere in the category,analysts have noted blockbuster poten-
tial for both Novartis’s new heart failure medication Entresto and
Cytokinetics/Amgen’s experimental heart failure agent omecamtiv
mecarbil.Entresto benefits a treatable population much larger than
that of the PCSK9s and shows a significant mortality benefit over
standard treatments.
Drug pricing spillover
In the shadow of the Gilead/AbbVie drama of 2014,new cardio drugs
are contending with their share of price controversy.Though not
on the same scale as the hep.-C price showdown, cardio marketers
might glean some knowledge from the ensuing hubbub.
To justify a price premium, marketers need to demonstrate
real value to payers within a disease state. Day believes makers
of PCSK9s should follow the lead of hep.-C drug developers by
“showing the long-term cost benefits of lowering LDL to levels
not previously attained.”
Determining which agent in a new class of drugs will seize the
most market share often comes down to access, explains Vijayver-
giya.“Expensive drugs for a chronic condition pose a great financial
burden on the healthcare system,creating significant anxiety for the
PBMs,”he observes.“Companies that can leverage portfolio assets
for deep discounts to obtain optimum access will win this battle.”
A formulary battle is brewing between Amgen and Regeneron/
Sanofi over their PCSK9 inhibitors.Although both companies have
brokered deals with Express Scripts,Amgen inked an exclusive deal
with CVS/Caremark to offer Repatha as the only PCSK9 on its plan.
Performance-based pricing may become more prevalent.“Novartis
is considering giving discounts for Entresto when the desired out-
come isn’t achieved and collecting a bonus when outcomes targets
are exceeded,” Day reports.“If Novartis can overcome the many
challenges in this type of arrangement, we could see a rising trend
in payer negotiations.” ■
CLINICALCORNER
THERAPEUTIC FOCUS: CARDIOVASCULAR
In the wake of failures by other contenders in the CETP inhibitor class,
Merck is prepping for a long battle. If anacetrapib meets the last leg
of clinical trials, the market potential of the last-standing cholesteryl
ester transfer protein (CETP) inhibitor is practically immeasurable.
Developed to increase levels of “good” cholesterol (HDL) and
decrease levels of “bad” cholesterol (LDL), Merck’s CETP inhibitors
need to adapt to focus on the LDL piece at this stage in the game.
David Day, SVP/account director at Triple Threat Communications,
sees little prospect for a drug that raises HDL, especially given the
failure of other forms of HDL-raising drugs (like
Abbott’s Niaspan) to show outcomes benefits.
“The Niaspan CV outcomes trial failed to
show additional benefit added to statins in some
patient types and has damaged the HDL benefit
hypothesis,” notes AbelsonTaylor SVP/director
of client services Jeff Berg. Adds Chetan Vijay-
vergiya, PhD, VP/senior medical brand strategist
at Publicis LifeBrands Medicus, “I’m not sure
I can remember a class where the first two agents failed, let alone
the first three, and the next one was a success. That being said, per-
ceived concerns of toxicity may impact the potential for anacetrapib.”
According to Vijayvergiya, concerns stem from anacetrapib’s “accu-
mulation in the body, as drug levels are detected up to 40% at 12 weeks
post cessation of therapy.” Further, detectable drug levels were found
up to four years post-therapy cessation in a small number of patients.
Day, however, sees a glimmer of hope in the size of Merck’s Reveal
trial—which was almost three times as large as Lilly’s Accelerate trial
for evacetrapib, the most recent CETP inhibitor to go down in flames.
Vijayvergiya points out that Reveal also enrolled a healthier patient
population, which may benefit anacetrapib. The study’s Data Monitor-
ing Committee recently completed its planned review, including a
futility analysis, and recommended the study continue. “This means
patients aren’t being exposed to unnecessary risk, efficacy data is
not strong enough to stop the trial and the study is not futile in meet-
ing its objectives,” he explains.
Pfizer’s CETP inhibitor torcetrapib flopped amid safety issues. Lack
of efficacy, on the other hand, led to the discontinuation of evace-
trapib and Roche’s dalcetrapib. According to Berg, a recent interim
analysis of anacetrapib didn’t show safety signals or lack of efficacy.
Positive news has spurred signs of life for other CETP inhibitors.
DalCor may revive development of dalcetrapib and Amgen recently
acquired Dezima and its CEPT inhibitor TA-8995, which is ready for
Phase III trials. Bristol-Myers Squibb is also in the running via its part-
nership with Simcere and its CETP inhibitor BMS-795311.
The anacetrapib futility analysis recently added to the protocol will
offer an early peek at safety and efficacy trends before data reports
out in 2017. “If the findings are solid and the eventual pricing is con-
sistent with value, then Merck will again be a dominant cardiovascular
presence,” notes Finn Partners managing partner, health, Gil Bashe.
Chetan Vijayvergiya