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Meeting Topics

Meeting Topics. New members event NYAS panel series Personalized Medicine in Healthcare Reform The Changing role of the PhD in Industry Steering Committee Advisory Panel Myriad Analysis. MYRIAD Genetics. Bryan Czyzewski August 24 th , 2009. Cancer Molecular Diagnostics Markets.

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Meeting Topics

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  1. Meeting Topics • New members event • NYAS panel series • Personalized Medicine in Healthcare Reform • The Changing role of the PhD in Industry • Steering Committee • Advisory Panel • Myriad Analysis

  2. MYRIAD Genetics Bryan Czyzewski August 24th, 2009

  3. Cancer Molecular Diagnostics Markets • The total U.S. Cancer Molecular Diagnostics market generated revenues of $271 million in 2007. • The BreastCancer Molecular Diagnostics market generated revenues of $174.0 million in 2007. • The Colorectal Cancer Molecular Diagnostics market generated revenues of $41.0 million in 2007. • The Other Cancer Molecular Diagnostics market generated revenues of $53.5 million in 2007. • The Prostate Cancer Molecular Diagnostics market generated revenues of $2.5 million in 2007.

  4. Cancer Molecular Diagnostics Market Growth

  5. US Breast Cancer Diagnostic Market Leaders

  6. MYRIAD Genetics • From their Website • Myriad Genetics is a healthcare company focused on the development and marketing of novel molecular diagnostic products. We are committed to improve patient healthcare through the commercialization of predictive medicine, personalized medicine, and prognostic medicine products. • Our goal is to introduce new molecular diagnostic products that provide life-saving information, improve the quality of life, and save the healthcare system money.

  7. A predictive medicine product for hereditary breast and ovarian cancer. A predictive medicine product for hereditary colorectal and uterine cancer. A predictive medicine product for adenomatous polyposis colon cancer syndromes. A predictive medicine product for hereditary melanoma. A personalized medicine product to measure a patient's exposure to 5-FU chemotherapy. A personalized medicine product to assess the status of the PTEN gene. A personalized medicine product to predict toxicity to 5-FU-based chemotherapy.

  8. Over 75% of profits come from • Myriad sequences the entire Brca1 and Brca2 genes, identifying disease associated mutations and polymorphisms, and scans for 5 different chromosomal rearrangements

  9. Breast and Ovarian Cancer • One of every 8 women in the United States will develop breast cancer in her lifetime (American Cancer Society, 2003). 192,370 cases and 40,170 deaths last year • Ovarian cancer is the fifth most common cancer in US women, occurring in 1% to 2% of women, and is the fifth leading cause of death (American Cancer Society, 2003). 21,550 cases and 14,000 deaths last year • 5% to 10% of breast and ovarian cancers are inherited. The most common cause of heritable breast and ovarian cancer is a mutation in either the BRCA1 or BRCA2 gene occurring in up to 5% of all cases (Miki et al., 1994; Wooster et al., 1995).

  10. The test costs $3,140 and is reimbursed 96% of the time by insurance. Analysts at RBC Capital estimate that the test is used by 10% of OB/GYN’s in the US raking in $30 million dollars a year. These same analysts estimate $300 million dollar market potential based on above statistic (unlikely for a product that has been on the market 10 years with such low penetrance, plus you would see it in the stocks value) BRCAnalysis

  11. Diagnostic Development has various influencing markets • IVD Company: identifies a genetic market it wants to target • Pharma/Biotech: smaller clinical trials • Regulatory Authority: more efficacious treatments

  12. Unique Position • Myriad’s BRCAnalysis was originally designed to fulfill a genetic testing market demand • The company is now in a unique position to expand that market

  13. Brca1/2 is a genetic test in search of a companion

  14. Binds sites with single strand breaks through its N-terminal zinc fingers and will recruit XRCC1, DNA ligase III, DNA polymerase beta and a kinase to the damage This is known as Nucleotide/Base Excision repair (NER/BER) PARP (Poly (ADP-ribose) polymerase

  15. DNA Repair Pathways

  16. Synthetic lethality due to the dependencebetween the function of PARP and BRCA1/2

  17. PARP Inhibitors in the clinic

  18. Myriad not only fulfills a public demand but also a pharma and regulatory demand 80 95 76 3

  19. Determining MYGN value • Use modified rNPV tied to success of drugs

  20. Determining MYGN value • Scenario I • BiPar compound is the most advanced compound in the clinic (PIII) • A Phase 3, Multi-Center Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer • 15% of all cancer patients are triple negative

  21. MYGN Scenario I • Value per share of 17.5 which equals 75 percent of MYGN current value • Analysts are probably doing their jobs.

  22. Determining MYGN value • Scenario II • Several phase II compounds are in development that have different indications • A Cancer Research UK Phase II Proof of Principle Trial of the Activity of the Intravenous PARP-1 Inhibitor, AG-014699, in Known Carriers of a BRCA 1 or BRCA 2 Mutation With Locally Advanced or Metastatic Breast or Advanced Ovarian Cancer • Up to 40 percent of breast cancer patients are diagnosed as localized or metastatic

  23. MYGN Scenario II • If any of these compounds make it into Phase III, the rNPV increases the stock price to 47. • Maximum potential value of revenue $4.4 billion • Also potential value in PARP inhibitors for treatment outside of only genotyping brca1/2 (RAD51,RAD54, DSS1, RPA1, NBS1, ATR, ATM, CHK1, CHK2, FANCD2, FANCA, or FANCC)

  24. Conclusion • Until there is an action event (therapeutic approval, movement into new phase etc.) the value of the test is probably already accounted for. • If we assume growth in the potential of the testing market coupled with companion diagnostic status there is untapped potential.

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