2009 August

gooseliverBiotechnology

Oct 22, 2013 (4 years and 19 days ago)

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2009 August

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

2009 August


MYRIAD Genetics

Bryan Czyzewski

August 24
th
, 2009

2009 August

Cancer Molecular Diagnostics Markets


The
total U.S. Cancer

Molecular Diagnostics market
generated revenues of $271 million in 2007.


The
Breast

Cancer

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.

2009 August

Cancer Molecular Diagnostics Market Growth


2009 August

US Breast Cancer Diagnostic Market Leaders

2009 August

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.

2009 August

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.

2009 August

2009 August


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



2009 August

2009 August

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).


2009 August

BRCAnalysis


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)

2009 August

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


2009 August

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

2009 August

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

2009 August



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

2009 August

DNA Repair Pathways

2009 August

Synthetic lethality due to the dependence

between the function of PARP and BRCA1/2

2009 August

PARP Inhibitors in the clinic

2009 August

80

95

76

3

Myriad not only fulfills a public demand but also a pharma
and regulatory demand

2009 August

Determining MYGN value


Use modified rNPV tied to success of drugs


2009 August

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

2009 August

MYGN Scenario I


Value per share of 17.5 which equals 75 percent of
MYGN current value


Analysts are probably doing their jobs.

2009 August

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

2009 August

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
)

2009 August

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.