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Welcome! February 28, 2011.  What is biotech?  FDA process  Investor concern  Stock profile.

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Presentation on theme: "Welcome! February 28, 2011.  What is biotech?  FDA process  Investor concern  Stock profile."— Presentation transcript:

1 Welcome! February 28, 2011

2  What is biotech?  FDA process  Investor concern  Stock profile

3  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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5  Risky Market  Uncertainty Switch from Biotech to Pharma.  Affect of Economic Fluctuations

6  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

7  What is FDA (Food and Drug Administration)

8  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

9  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%

10  Test for ideal dosing range of the drug  Larger number of patients  Last average of 2 years  60% of chance to be approved

11  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

12  To continue evaluation of the drug’s safety  This stage starts after the drug is on the market

13  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

14  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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16  Be Passionate  Learn All About Your Company's Biotechnology  Know Your Risk Tolerance  Invest Money That You Don’t Need

17  Don’t Forget About the Business  Don’t Buy a One-Hit Wonder  Don’t Buy on Margin

18  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

19  Red Herring Magazine  FDA Approval Process  Center Watch web page (tracks clinical trials)  BioSpace.com  FDA Web Site (upcoming meetings)  Pay Attention to Alliances

20 Amarin Corporation

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22  http://www.cnbc.com/id/15840232?play =1&video=1734730914 http://www.cnbc.com/id/15840232?play =1&video=1734730914

23  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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26  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.

27  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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29  What are your questions?

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