Overview of GBM Presentation - National Brain Tumor Society

[Pages:13]Advancing Research to Treatments: Unmet Needs In Glioblastoma

Skip Irving Partner and Managing Director

Health Advances, LLC BOSTON SAN FRANCISCO ZURICH



May 8, 2013

Unmet Need

Senator Kennedy's tragic death brought greater visibility to the tremendous need for improved brain tumor treatment options.

Senator Ted Kennedy - 2008 Democratic National Convention in Denver, Colorado August 25, 2008. ?

REUTERS

? 76 years old at diagnosis

? May 17, 2008: Seizure at his home in Hyannis, MA

? Medflight from Cape Cod Hospital to Mass General Hospital in Boston

? Diagnosed with Glioblastoma Multiforme

? August 25, 2009: Died15 months after diagnosis

Unmet Needs in Glioblastoma

CONFIDENTIAL -- May 8, 2013

2

Unmet Need

By annual incidence, glioblastomas are the most common type of malignant brain tumor.

100%

US Distribution of Brain and CNS Tumor Incidence By Histology

2005-2009

Glioblastomas Most malignant, most

aggressive and shortest survival

Percentage

75% 50%

NonMalignant

25%

Other Malignant Gliomas

0% Brain Tumors

Source: CBTRUS, American Brain Tumor Association website.

Unmet Needs in Glioblastoma

CONFIDENTIAL -- May 8, 2013

Gliomas

3

Other Gliomas Oligoastrocytic Tumors Pilocytic Astrocytomas Anaplastic Astrocytomas Oligodendrogliomas Ependymal Tumors Diffuse Astrocytomas Glioblastomas

Unmet Need Glioblastomas progress rapidly without therapy.

Relative Survival Rates

120%

Relative Survival Rates for Primary Malignant Gliomas

100%

80%

60%

40%

20%

0% 0

12

24

36

60

96

120

Months After Diagnosis

Clinical history is less than three months in majority of patients; Prognosis worse for

elderly patients

Mixed Glioma Oligodendroglioma Anaplastic Astrocytoma Glioblastoma Ependymoma Astrocytoma, NOS

Note: Relative survival rates for primary malignant gliomas are from SEER, 1973-2004. Source: DataMonitor, CBTRUS, SG Cowen, Medscape.

Unmet Needs in Glioblastoma

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Therapeutic Options The best current standard of care extends overall survival to about 14 to 16 months.

Median Overall Survival Time of Glioblastoma Patients by Therapy

24

18

Months

12

6

0

Surgery + Radiotherapy

+ RT +

+ RT +

+ RT +

+ RT +

Only

(RT)

Carmustine Carmustine Temozolomide Temozolomide +

Implant

Bevacizumab*

Treatment Regimen

* Data for bevacizumab represents newly-diagnosed glioblastoma and is from a phase II clinical trial with no placebo control. Source: UpToDate; Gil-Salu, J., Neurocirugia, 2004; Walker, M., J. Neurosurgery, 1978; Westphal, M., Neuro-Oncology, 2003; Stupp, R., NEJM, 2005; Athanassiou, H., JCO, 2005;

Stewart, L., Lancet, 2002; Lai, A., JCO, 2011.

Unmet Needs in Glioblastoma

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Treatment Paradigms Temozolomide with radiation is the first line treatment of choice.

MRI and/or CT Suggestive of Glioblastoma

Biopsy

Surgical Resection

Confirmation of Glioblastoma

GLIADEL WAFER

Radiotherapy

(polifeprosan 20 with carmustine implant

Nitrosoureas

Unmet Needs in Glioblastoma

CONFIDENTIAL -- May 8, 2013

First-Line Therapies

Second-Line Therapies

Clinical Trials

6

Current Therapies The basic patent on Temodar will expire in 2014.

GLIADEL WAFER

(polifeprosan 20 with carmustine implant

? Implant

? Approved 1996

8% ~$110

? IV

? Approved for 2nd line glioblastoma in 2009

? Evaluation as addition to 1rst line

25% ~$350

67% ~$920

Total Market: ~ $1.4B

Source: Compant 10ks, websites, Datamonitor, UpToDate, Analyst Reports.

Unmet Needs in Glioblastoma

CONFIDENTIAL -- May 8, 2013

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? Oral and IV ? Approved 2005 ? Generic launch in

August 2013

Drug Development Challenges Anticipating the path to market involves a series of connected questions.

Basic Research

Pathway and

Targets

Translational Medicine

Proof-of-Concept Evidence

Clinical Trial

Endpoints

Differentiated Clinical Utility

Label Claims

Revenue Potential

Unmet Needs in Glioblastoma

CONFIDENTIAL -- May 8, 2013

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