Com^3.ppt
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The document discusses strategies for a pharmaceutical company called COM^3. It considers investing in either the obesity drug market or dementia drug market. The obesity market is seen as a safer, quicker option that could double revenue to $400 million within a few years. However, the dementia drug has potential for much higher revenue of $750 million, but would require $85 million in upfront costs and 5 years before seeing a return. The company's strategy is to initially invest in obesity drugs for a safe return, while also investing in dementia to position itself for long term growth and its goal of going public by 2020.
Com^3.ppt
- 1. MAKE THE COMMOM MAN HEALTHY PRESENTED BY SHUBHDA ROY COM^3
- 2. AGENDA Mission Who we are Where we want to be – Vision 2020 SWOT Analysis Emerging Opportunities Our Strategy
- 3. COM^3 MISSION Providing a healthy life for the coMMom Man We do this by providing drugs at an affordable price to the common man. Vision Provide drugs that a common man can buy. PURPOSE: To make the common man healthy.
- 4. WHO WE ARE Private Generic Pharmaceutical Presence only in the USA Last 15 years 200 Million in annual Sales From 2 Diabetic Generic drugs Drugs are the cheapest in the Market
- 5. WHERE WE WANT TO BE – VISION 2020 Expand our market overseas Get into Prescription Drug Market Go Public
- 6. Strengths •Good repution in the generic market •Two great generic product •200 Million in annual Sales •Customer happy Opportunities •Strategic alliances possible with Dimensia Partners •Getting two new Patented drug coming off their patents •Product expansion •Entering the foreign Maket •Become Public Threats •Strong competiton from other generics with better efficacy •Could lose our good reputation •Could lose market presence •May need to increase drug prices Weaknesses •15 years old •Nothing innvotive •Nothing new to offer S W TO SWOT ANALYSIS for COM^3
- 7. HOW WILL WE GET THERE – EMERGING OPPORTUNITIES TWO ANTI – OBESITY DRUGS COMING OFF PATENT (OPTION 1 – OBESITY MARKET) PROJECTED ANNUAL SALES 100% to 400 million dollars SMALLER EUROPEAN COMPANY (OPTION 2 – DIMENSIA MARKET) PRODUCT IN EARLY PHASE II ANTI-DEMENTIA DRUG PROJECTED ANNUAL SALES $750 million
- 8. PRO/CONS – OBESITY MARKET PRO VIABLE CANDIDATE TO ENTER – ANTI OBESITY MARKET EXPAND EXISTING PIPELINES NO UPFRONT INVESTMENT NO RISK SAFE AND A GOOD OPTION PROJECTED SALES INCREASE PROFITABILITY BY ALMOST DOUBLE EXISTING 200 MILLION TO 400 MILLION CONS DOES NOT COMPLETELY ALIGN WITH Vision 2020
- 9. ADDITIONAL RESEARCH - OBESITY MARKET “More than one-third of U.S. adults (34.9%) are obese” “Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, some of the leading causes of preventable death” Obesity is slowly on the downfall because Awareness Exercise Obesity may not be a problem in the far future http://www.cdc.gov/obesity/data/adult.html
- 10. ADDITIONAL RESEARCH - OBESITY MARKET Only ONE PATENT ANTI – OBESITY DRUG IN THE MARKET TWO ADDITIONAL PATENTS DRUGS LOSING PATENTS SOON TWO GENERIC OPTIONS WILL BECOME AVAILABLE SOON http://www.cdc.gov/obesity/data/adult.html
- 11. REGULATIONS – OBSEITY DRUG Need to file ANDA Abbreviated New Drug Application in an electronic format File using eCTD, and can ask for Expedited Review This will help us achieve an approval for the generic drugs quickly Could receive an ANDA approval within ~ 30 Months Per Section 745A(a) of the FD&C Act, applications will have to be submitted electronically. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsS ubmissionRequirements/ElectronicSubmissions/ucm153574.htm http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm319568.htm http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssista http://www.interphex.com/RNA/RNA_Interphex_V2/documents/2013/speaker-presentations/Regulatory_- _GDUFA_Panel.pdf?v=635029417975748363nce/UCM397812.pdf http://www.interphex.com/RNA/RNA_Interphex_V2/documents/2013/speaker-presentations/Regulatory_- _GDUFA_Panel.pdf?v=635029417975748363
- 12. REGULATIONS – OBSEITY DRUG “The Generic Drug User Fee Amendments of 2012 (GDUFA) is designed to speed access to safe and effective generic drugs to the public and reduce costs to industry. The law requires industry to pay user fees to supplement the costs of reviewing generic drug applications and inspecting fees.” Original ANDA Fee - fee is $$51,520 ANDA Backlog Fee $17,434 http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm319568.htm http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssista http://www.interphex.com/RNA/RNA_Interphex_V2/documents/2013/speaker-presentations/Regulatory_- _GDUFA_Panel.pdf?v=635029417975748363nce/UCM397812.pdf http://www.interphex.com/RNA/RNA_Interphex_V2/documents/2013/speaker-presentations/Regulatory_- _GDUFA_Panel.pdf?v=635029417975748363
- 13. REASON TO INVEST IN OBESITY MARKET LOW HANGING FRUIT LOW INVESTMENT QUICKET RETURN ON INVESTMENT (ROI) AFTER GETTING APPROVAL ON THE ANDA WITHIN 2 years generic drug can be marketed with a positive ROI
- 14. PRO/CONS – DIMENTIA MARKET PRO BLOCK BUSTER CANDIDATE TO ENTER – ANTI DEMENTIA MARKET EXPAND EXISTING PIPELINES PROJECTED SALES INCREASE PROFITABILITY BY MORE THAN THREE TIMES EXISTING 200 MILLION TO 750 MILLION EXACTLY ALIGNED WITH VISION 2020 TO EXPAND AND GO OVERSEAS EXCLUSIVE LICENSING AND DISTRIBUTION AGREEMENT CONS HIGH RISK UPFRONT INVESTMENT WITH CLINICAL TRIALS WHICH IS ESTIMATED TO BE AROUND 80 MILLION At least 5 more year before any return on investment when Drug is marketed 30 Months for Phase III Average Filing of the NDA which is average of 2 years. This time may increase because of foreign clinical data
- 15. ADDITIONAL RESEARCH - DIMENTIA MARKET CURRENTLY FOUR DEMENTIA DRUGS AVAILABLE IN THE MARKET – SPECIFICALLY Alzheimer's disease ALL THESE DRUGS ARE LICENCED IN UK BUT NOT AVAILABLE IN THE US ALL FOUR ARE PATENTED WHICH DOES NOT EXPIRE FOR ANOTHER DECADE NONE OF THEM CURE DIMENTIA ALL EXISTING DRUGS SLOW DOWN PROGRESSION OR IMPROVE SYMPTOMS
- 16. ADDITIONAL RESEARCH- DIMENTIA MARKET NO GENERIC OPTIONS AVAILABLE GLOBALLY MORE RESEARCH FUNDING NEEDING
- 17. REGULATION – DEMENTIA DRUG DIMENTIA DRUG CLINICAL TRIALS NOT IN USA WILL NEED TO FILE IND/NDA APPLICATION For the IND/NDA application :- Will need to show compliance to 21 CFR 312.120 - FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND “such studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC) and informed consent from subjects”.(1) (1)http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.p df
- 18. REGULATION – DEMENTIA DRUG Can ask FDA to waive any applicable requirements under 21 CFR 312.120(a)(1) and (b) by submitting a waiver request FDA will decide whether to grant or deny waivers on a case-by-case basis, taking into account all appropriate circumstances.43 Marketing approval of a new drug based solely on foreign clinical data is governed by 21 CFR 314.106. (1)http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM294729.p df
- 19. IMPORTANCE OF CLINICAL TRIALS – PHASE III “The importance of Phase III trials stems from the statutory language in the Federal Food, Drug, and Cosmetic (FD&C) Act. Under Section 505(d) of the act, sponsors of new drug applications must demonstrate “substantial evidence” of the drug’s clinical benefit, with “substantial evidence” being defined as “adequate “ http://www.manhattan-institute.org/html/fda_05.htm
- 20. ESTIMATING UPFRONT INVESTEMENT FOR CLINICAL TRIALS – PHASE III COM^3 needs upfront investment for PHASE III clinical trial for DIMENTIA Below is some research data to help us estimate this cost:- “Phase III clinical trials have become far larger and more complex than they were in the past. “ “From 1999 to 2005, as the Tufts group has shown, the average length of a clinical trial increased by 70 percent;” “The average number of routine procedures per trial increased by 65 percent; and the average clinical trial staff work burden increased by 67 percent.” “On top of that, increasingly stringent enrollment criteria and trial protocols resulted in 21 percent fewer volunteers being admitted into trials and 30 percent more enrollees dropping out before completion of the tests.” “Clinical Trial Phase III cost 40 percent of pharmaceutical companies’ R&D expenditures” http://www.manhattan-institute.org/html/fda_05.htm
- 21. ESTIMATING UPFRONT INVESTEMENT FOR CLINICAL TRIALS – PHASE III Based on the figure below in 2009 the projected dollar value was around 16 M for Phase III Clinical Trial with 60% chances of FDA approval In our case the PHASE II TRIALS SHOWS 90% Chances of FDA Approval Based on that if our PHAST III TRIAL has a 60% chances of FDA Approval AND the PHASE III Costs up about 45% of our total expenditure: On top that, if we still inflate the cost of investment for phase III to be about $80 M, our overall ROI will still be very high http://www.manhattan-institute.org/html/fda_05.htm http://www.nature.com/nrd/journal/v9/n3/extref/nrd3078-s2.pdf http://www.raps.org/focus-online/news/news-article-view/article/1359/report-phase-iii-clinical-trials-behind-increase-in-the-cost- of-pharmaceuticals.aspx
- 22. FEES FOR DEMENTIA DRUGS IND FILING– $500 NDA with Clinical Data – NME FILING - ~ 3200 FDUFA fees Differential for foreign facilities - $15,000 Application Fee with fee with clinical data for 2014 ~ 2.2 Million (3) Establishments ~ 554,600 (3) Products ~ 104,060 (3) Estimated out of pocket capital for Phase III Clinical Trial ~ $80M Out of pocket capital – ~ 85 M http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm093484. http://www.gpo.gov/fdsys/pkg/FR-2013-08-02/pdf/2013-18624.pdf (3) http://www.alzheimersanddementia.com/article/S1552-5260(12)00049-0/fulltext
- 23. REASON TO INVEST – DEMENTIA MARKET No good drug out there For Dementia In the USA - 15% of people have Dementia aged 71 or more (3.8 Million) By 2040 this will increase to 9.1 Million Baby boomers will inundate the coming years with system with the surge of cost and cases of Dementia “There are no treatments to prevent or slow Alzheimer’s, the most common dementia. And it’s unlikely that any one drug will be the silver bullet, so we need to pursue many pathways” http://www.nytimes.com/2013/04/09/opinion/key-to-fighting-alzheimers-costs-new-drugs.html?_r=0
- 24. REASON TO INVEST – DEMENTIA MARKET DIMENTIA CLINICAL TRIALS IN PHASE 2 HAS SHOWN 90% EFFICACY Even with ~ 85M upfront investment, and 5 years of downtime, this blockbuster drug is a great investment for now and the future and will help us make our company go public
- 25. PROJECTED SALES OBESITY, 400 DEMENTIA, 750 0 100 200 300 400 500 600 700 800 PROJECTED SALES OBESITY DEMENTIA
- 26. OUR STRATEGY Initially invest in getting the two patent drugs into our pipeline ROI will increase from 200M to 400M in 2 or three years This is a safe and good option Product Line will diversify, money will come in for further research and investing Will keep these two drugs generic, and cheap This is in alignment with our Company Vision Also keeps us ahead of the competition
- 27. OUR STRATEGY Simultaneously invest in the DIMENTIA MARKET This will enable to increase our ROI within the next 5 years to $750M This will help us go Public and aligns our 2020 strategy This is a high risk but visionary option. Will make this drug cheaper and affordable for the common man This will put us in the forefront of the DIMENTIA MARKET in the US