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Welcome! February 28, 2011
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What is biotech? FDA process Investor concern Stock profile
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Biotechnology is a broad term that applies to all practical uses of living organisms -- anything from microorganisms used in the fermentation of beer to the most sophisticated application of gene therapy.
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Risky Market Uncertainty Switch from Biotech to Pharma. Affect of Economic Fluctuations
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The Mapping of Human Genome Fast Drug Approval Convergence of Nanotechnology with Biotechnology Advanced Computer Technology Databases Partnerships and Collaborations New financing in Biotechnology Increase in Biotech IPO’s
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What is FDA (Food and Drug Administration)
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Studies in cell cultures and animals 1 in 1000 make it to human testing Patents last 20 years from this point Last average about 5 years
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First use of drug in humans Test for safety and side effect Limited number of patients Ranges from 1 to 3 years Chances just under 30%
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Test for ideal dosing range of the drug Larger number of patients Last average of 2 years 60% of chance to be approved
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Treatments compared to common or standard therapies Random choosing Goal ; experimental therapy more beneficial than standard therapy Double blind therapies At least 1000 patients Averages between 3 and 4 years 70% chance of being approved at this point
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To continue evaluation of the drug’s safety This stage starts after the drug is on the market
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Costs and time consuming Ranges between $350 million and $500 million Companies with many product on the market Large pipeline Cash for funding new drugs
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A Small Part of a Well-Diversified Portfolio Products That are in Late Stage Clinical Trials Significant Partnership Arrangements Stocks with Broad Pipelines Avoid Stocks That are Hyped in the Press
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Be Passionate Learn All About Your Company's Biotechnology Know Your Risk Tolerance Invest Money That You Don’t Need
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Don’t Forget About the Business Don’t Buy a One-Hit Wonder Don’t Buy on Margin
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Ernst and Young’s Biotech 99 Report Access Excellence by National Health Museum Tutorials at Street.com Scientific American Articles BioMedNet.com’s Daily Newsletter
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Red Herring Magazine FDA Approval Process Center Watch web page (tracks clinical trials) BioSpace.com FDA Web Site (upcoming meetings) Pay Attention to Alliances
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Amarin Corporation
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http://www.cnbc.com/id/15840232?play =1&video=1734730914 http://www.cnbc.com/id/15840232?play =1&video=1734730914
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Glaxosmithkline’s Lovaza is only indicated for patients with triglyceride levels greater than 500 mg/dl, while AMR101 is being targeted for patients with triglyceride levels from 200 to 2000mg/dl Lovaza sales have been increasing for GSK - - it recently surpassed $1 billion in global sales -- so the market potential for Amarin is obvious.
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In late December Wedbush raised their target price from $7 to $10 Expect Amarin to report positive top-line data from the ANCHOR study in Q2 and that with this could possibly lead to a buyout of the company in 2011.
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Bigger pharma companies are willing to give a premium to Amarin because they see that a lot of generic drugs will be entering the market soon. On Jan 11, Bloomberg reported that Amarin reported that talks had continued to grow amongst at least a dozen interested parties who were said to be interested. The CEO of Amarin commented he had more companies interested in Amarin than the 17 employees he currently staffed.
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What are your questions?
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