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Kancure, LLC is a start-up biotechnology company aiming at the development of an anti-cancer drug treatment for Chronic Myeloid Leukemia, created as part of a mock assignment in the Entrepreneurial Biotechnology course.
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Making Cancer More Treatable
Company Overview: Ruchi Shah, CEO
Research and Development: Ramola Chendvankar, CSO
Marketing and Commercialization: Mridula Shukla, CMO
Financial Outlook: Jennie McCollum, CFO
Company Overview
• Start-up Biotechnology Company• Orphan Drug (4000 people in the
US)• Specializes in the Development of
drug against CML: LeukX• Aims to triumph over the
resistance developed towards Gleevec
• Clinical Trials: Phase I • Expected sales of $ 13M in 2012
About the Company
Company Structure LLC
Location Rockville, MD
Science Advisory Board Dr. Jack Chirikjian
Dr. Milton Brown
Venture Capitalists $14,000,000
Exit Strategy IPO
Acquisition
Intellectual property
• The technology belongs to
Georgetown University and has
been patented in 2005• Up-front fees: $ 50,000• 2% of sales
TM
TM
Chronic Myeloid Leukemia
• Unregulated growth of Myeloid cells in the body.
• 40% people have developed resistance towards drugs available.
• Philadelphia Chromosome
• P210 protein is produced which acts as tyrosine kinase domain.
• Activates series of proteins
• Genetic instability.
Gleevec Ineffectiveness
• Bcr-Abl gene amplified
• Over expression of the protein.
• Mutations in kinase domain which affects the Gleevec binding.
• Allosteric mutations causing conformational change. • Ineffective in blast crisis.
• Heart failure in some patients
LeukX
• Doxorubicin
• Prevents amplifications & replications of Bcr-Abl gene.
• Natural compound B phenyl isothiocyanate.
• Degradation of the over expressed protein.
• Activates transcription factor for the differentiation of proteins in blast crisis stage.
• Heterocyclic compound called 2 phenyl amino pyrimidine that acts as kinase inhibitor.
• Binds to T315I mutated domain
Research studies
• Compared the efficacy with Imatinib, Disatinib, Nicotinib.
• T315I mutated cell lines were obtained treated with LeukX.
• Binds tightly to the T315I mutated kinase domain.
• Activates transcription factor for differentiation of immature cells in blast crisis stage.
• P210 level compared on electrophoresis
Clinical Research
• Phase I
• Determine side effects of the LeukX on healthy patients.
• Minimum Side effects.
• Effect on left ventricle of the heart Monitored.
• Phase II & III
• Both Imatinib resistance and imatinib sensitive patients would be tested.
• Different doses of the drug would be administered
• Efficacy would be compared with Gleevec, Sprycel & Tasigna.
Competition
Gleevec Sprycel Tasigna
Novartis Bristols-myers Squibs
Novartis
1800 millions in 2008
142 millions in 2008
29 million in 2008
Not effective in Blast crisis
Not Effective in Blast crisis
Not effective in Blast crisis.
Not effective against T315I
mutation.
Not effective against T3151
mutation.
Not effective in T315I
mutation.
Our Product & Patients
LeukX is a unique treatment for Chronic Myeloid Leukemia (CML). It works by targeting, and turning off, specific proteins in cells that cause the cancer cells to grow and multiply
CML mostly affects adults, although 2 percent of CML patients are children.
Kancure would target the patients with normal genes, mutated genes T315I and patients those who are within the age range of 45-80
Our Product & Patients
Marketing Channels
http://www.Kancure.com
Marketing Channels
LeukX Marketing Plan - Stages
Completed: Pre-Clinical Trial
LeukX Development Timeline
Marketing Activity
2009Phase I
Market Research
Fund Raising Managing
relations with investors
2010Phase II
2011Phase III
2012Product Launch
Develop Product Profile
Research on alternative uses of LeukX
Plan Brand campaign
Develop Marketing message
Start Product Promotion
Plan Launch Campaign
Manage sales and distribution
Product Launch Campaign
Monitor performance
2 Resources 3 Resources 5 Resources 7 resourcesMarketing Team
LeukX Price ComparisionPrice of 1-month of Therapy
$2,700
$2,800
$3,300
$3,600
$0 $1,000 $2,000 $3,000 $4,000
LeukX
Tasigna
Gleevec
Sprycel
LeukX Competitor & Pricing
Competitor Sales Volume
Gleevec 1,800 Million
Sprycel 142 Million
Tasigna 29 Million
LeukX Price: $30 per 100 mg
“Oncology is the top of the bill when it comes to new products in development..”USA Today – May 2008
CML Drug market was more than $7 billion globally in 2008
LeukX Sales Forecast
Assumptions: CML Drug Market was $7 Billion in 2007 100% of the sales will be from US
Markets in 2012 LeukX sales forecast is based on Gleevec
sales in the last 4 yrs LeukX will capture a conservative 0.22%
of Gleevec sales, which is projected to be $5.9 Billion in 2012
LeukX Sales Forecast
Year 2012 2013
Sales ($) $ 13 M $ 15 M
SWOT Analysis
Strengths Effective
treatment for CML
Competitive Pricing
Weakness Early
phase development
Unknown brand
Opportunity Growing
Market for Cancer Drug
Possibility of alliances & collaboration
Threats Competitive
Marketplace Current
market conditions – reduced funding
Sources of Capital
Investment Owner 1 $60,000 Investment Owner 2 $60,000 Investment Owner 3 $60,000 Investment Owner 4 $60,000 Angel Funds $300,000 VC Funds $14,000,000 SBIR Grant 1 (NIH) $100,000 SBIR Grant 2 (NIH) $750,000 FDA Orphan Drug Grant $200,000 Total $15,590,000
Projected Income Statement
2009 2010 2011 2012 2013RevenueGross Sales - - - $13,140,000 $15,000,000FDA Orphan Drug grant 200,000 200,000 200,000 - -Gov Grants $100,000 $750,000 - -Angel Fund $300,000Total Revenue $600,000 $950,000 $200,000 13,140,000 15,000,000
Operating ExpensesWages $440,000 $440,000 $440,000 $462,000 $485,100Payroll Taxes $88,000 $88,000 $88,000 $92,400 $97,000Equipment $100,000Legal Fees $20,000 $20,000 $20,000 - -Marketing and Advertising - 250,000 $350,000 $420,000 $660,000Insurance $5,000 $5,000 $5,000 $5,000 $5,000Rent & Utilities $100,000 $100,000 $100,000 $100,000 $100,000Liscensing Fee $50,000 - - $2,628,000 $3,300,000Research and Clinical Trials $163,734 $226,824 $455,192 - -Outsourcing & - - 1,500,000 $2,628,000 $2,860,000ManufacturingTotal Expenses 1,047,134 $1,129,824 $1,458,192 $6,335,400 $7,507,100
2009 2010 2011 2012 2013
Sales -$ -$ -$ 13,140,000$ $15,000,000Cost/ Goods Sold (COGS) - - - $6,335,400 $7,347,100Gross Profit -$ -$ -$ 6,804,600$ $7,652,900
Operating ExpensesSalary (Office & Overhead) 440,000$ 440,000$ 440,000$ $462,000 $485,100Payroll (taxes etc.) $88,000 $88,000 $88,000 $92,400 $97,000Research and Clinical Trials $163,734 $226,824 $455,192 - -
Outsourcing $ Manufacturing - - - $2,628,000 $2,860,000Advertising - 250,000 350,000 420,000 $500,000Accounting and Legal 20,000 20,000 20,000 - -Rent 100,000 100,000 100,000 100,000 100,000Liscensing Fee $50,000 - - 2,628,000 3,300,000Insurance 5,000 5,000 5,000 5,000 5000Total Expenses 1,047,134 $1,129,824 $1,458,192 $6,335,400 $7,347,100
Profit Projection
Break Even Analysis
• Fixed Costs: $3,635,150
• Variable Cost (Per Unit): $17
• Selling Price (Per Unit): $3000
• Time Period: Annually
• Annually Break Even: 2,452 units
• Break Even In 1st Year of Sales
Break Even Analysis
VC Funding
Round # Of Shares %Company Price/Share Valuation
Initial 1,000,000 100% $ .54 $540,000
VC Phase I 1,350,000 74.07% $ 2.963 $4 M
VC Phase II 1,900,000 52.63% $ 7.37 $10M
Total: $14,000,000
Thank You