MS in Biotechnology Program – Spring 2015

Peanut Allergy Market : Prevalence, Treatment and Competitive Intelligence for a Pre-clinical Vaccine

Pushkar Vartak1, Colin Magowan2, Eliezer Romeu2, Bill Hearl2

Immunomic Therapeutics, Inc.Immunomic Therapeutics, Inc. (ITI) is a Hershey, PA-based, privately held, clinical stage biotechnology company developing vaccines based on the LAMP technology platform, which was exclusively licensed from Johns Hopkins University. The LAMP-vax vaccine platform aims to increase the immune response to nucleic acid vaccines and simplify vaccine design and delivery for safer, more cost-effective therapies. ITI has the exclusive worldwide license to the LAMP technology patent estate and is commercializing ground-breaking next generation LAMP DNA vaccines, beginning with allergy, cancer and infectious disease. Currently, ITI is focused on developing allergy therapies and is pursuing three initial allergy programs:• ASP 4070 (formerly known as JRC2*-LAMP-vax)-

Japanese Red Cedar Vaccine. Potential solution for Japanese red cedar pollinosis, partnered with Astellas Pharma and currently in Phase I testing.

• ARA-LAMP-vax - A therapeutic peanut allergy vaccine with a goal of mitigating peanut allergy. ITI’s target is to initiate a Phase I study in late 2015/early 2016.

LAMP Vax Technology

Acknowledgements I would like to thank all the members of Immunomic Therapeutics, Inc. especially, Dr. Bill Hearl for his help and support. Also, I would like to thank my mentor, Mr. Colin Magowan and my Co-mentor Eliezer for giving me the opportunity of being part of the marketing management team and for providing me with guidance and support.

Conclusion

Immunotherapies

Figure 1 Illustrates immune response with and without the LAMP technology (Source: Immunomic Therapeutics, Inc.)

References1. Immunomic Therapeutic, Inc. Confidential Information

PR & IR

Medical Impact of Food Allergy

Childhood food allergy results in significant direct medical costs to the health care system, estimated at $20.4 billion dollars, and imposes substantial costs on families. The overall economic cost of food allergy was estimated at $24.8 billion annually ($4,184 per year per child). Direct medical costs were $4.3 billion annually, including clinician visits, emergency department visits, and hospitalizations. A recent analysis of data from U.S. hospital emergency departments (ED) estimated a total of 20,821 hospital ED visits, 2,333 visits for anaphylaxis, and 520 hospitalizations caused by food allergy in just a 2 month period.

Any nut Peanut and Treenut Peanut only Treenut only0

1,000,000

2,000,000

3,000,000

4,000,000

5,000,000

6,000,000

1,718,774

411,360 795,296 466,208278,787

991,241929,289

Prevalence in children Prevalence in adults

Prevalence of Peanut Allergy

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

278,742

105,851172,891

349,310

91,738

257,572

TOTAL PREVALENCE CHILDHOOD PREVALENCE ADULT PREVALENCE

FIGURE 3. Prevalence in United States-Adults and Children.

FIGURE 4. Prevalence In Canada – Children & Adults

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Fixed dose

Monthly

Bi-Weekly

Weekly

Daily

FIGURE 6 Frequency of Dose Escalation (a) and Frequency Location of OIT Administration (b)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Home

Hospital like setting

Office

DBV ARC Sanofi ITI

Product name Viaskin Peanut OIT VLP-Ara-

TLR4ARA-LAMP-

vax

Peanut type Extract Extract rProtein pDNA

Number of doses 365 200 4 4

Treatment length 12 24 4 4

Route of admin. EPIT Oral IM / SC ID

Risk of AEs ~80% ~90% <80% <80%

Target market Children 5-64 5-64 5-64

Response rate (est.) 50% 80% >80% >80%

Expected FDA Approval 2019 2020 2023 2022

Figure 3, above, compares the prevalence of allergies caused peanut and treenut in children and adults in the US. Proportionate to the overall population, these nut allergies are more prevalent in children than adults. Peanut and Treenut can be cross reactive allergens and typically are diagnosed together. Peanut allergies are diagnosed more frequently than allergies to tree nuts in children. Interestingly, the prevalence rate of Peanut and Treenut allergies is almost the same in adults.

Figure 4 shows that in Canada, prevalence of Treenut allergy is high. Peanut/treenut prevalence shows an increase with age from children to adults. For these patients, the prevalence of severe reactions is high. Yes, prescription rates for Epinephrine autoinjectors remains low with important implications for ARA-LAMP-vax market penetration.The self-perception of food allergy is higher than diagnosticaly confirmed food allergy. The allergist uses patient history and confirmatory tests to diagnose true food allergy. The confirmation of food allergy requires a convincing clinical history of an IgE-mediated reaction attributed to food and their physician provided confirmation of a positive SPT .Using Canada as a case study, there are many more people who perceive they have a peanut allergy (336,805) than those whose peanut allergies have been confirmed by “gold standard” diagnostic testing by an allergist (143,715), using such tools as oral food challenge, IgE testing, or skin prick testing.38%

21%

17%

10%5%

9%

Peanut/Nut Milk Shellfish Egg WheatOthers

Peanut allergies account for the majority of the 30,000 severe food-allergy reactions that occur annually, including 2,000 hospitalizations and about 200 deaths each year. Peanut allergy accounts for 25% of the total food allergy cost.

1Department of Biotechnology, Georgetown University Medical Center, 3900 Reservoir Rd., NW, Washington, DC 20057 2Immunomic Therapeutics, Inc. 15010 Broschart Road, Suite 105, Rockville, MD 20850

This research fits into business development, meaning negotiating and licensing new investigational drugs to big biopharma. These data serve as valuable benchmarks for putting together market size estimates (e.g. prevalence), current treatment dynamics, competitiveness of the indication, how the new drug could fit within that landscape, and ultimately to derive valuation metrics, such as net present value and risk-adjusted net present value. Working and helping my mentor during this internship has given me an initial understanding and broad overview of the business development and marketing process behind a clinical stage biotech company.

Diagnosis

FIGURE 5. Prevalence In Europe-children

Peanut Treenut0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

282,410

636,44069,448

98,655

Prevalence (2-5 yrs old) Prevalence(6-17 yrs old)

Extrapolating from Figure 5, Peanut and Treenut allergies decreases significantly with age. Peanut allergy shows a steady decline while for Treenut the risk of allergy drops at a faster rate.

Figure 2. Peanut Allergy-most common food Allergen Trigger

3,374,551

(A) (B)