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Welcome! February 28, 2011

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

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Welcome! February 28, 2011

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  1. Welcome! February 28, 2011

  2. Agenda What is biotech? FDA process Investor concern Stock profile

  3. What is Biotechnology 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.

  4. BACKGROUND & OVERVIEW Risky Market Uncertainty Switch from Biotech to Pharma. Affect of Economic Fluctuations

  5. BACKGROUND & OVERVIEW • 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

  6. CLINICAL TRIALS & FDA • What is FDA (Food and Drug Administration)

  7. Pre-Clinical Trials 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

  8. Phase 1 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%

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

  10. Phase 3 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

  11. Phase 4 To continue evaluation of the drug’s safety This stage starts after the drug is on the market

  12. For the investor 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

  13. INVESTING IN BIOTECH STOCKS (DO’S ) 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

  14. CLPA (Nasdaq)dropped 69% in one day

  15. INVESTING IN BIOTECH STOCKS (DO’S Continued) Be Passionate Learn All About Your Company's Biotechnology Know Your Risk Tolerance Invest Money That You Don’t Need

  16. INVESTING IN BIOTECH STOCKS (DONT’S) Don’t Forget About the Business Don’t Buy a One-Hit Wonder Don’t Buy on Margin

  17. HOW TO EDUCATE YOURSELF 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

  18. HOW TO FIND NEXT HOT BIOTECH STOCK Red Herring Magazine FDA Approval Process Center Watch web page (tracks clinical trials) BioSpace.com FDA Web Site (upcoming meetings) Pay Attention to Alliances

  19. A Hot Biotech Stock Amarin Corporation

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

  21. Opportunity Glaxosmithkline’sLovaza 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.

  22. 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.

  23. 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.

  24. Thanks! • What are your questions?

  25. See you next weekIn the meantime, visit ccig.osu.edu

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