Anti IL-33 Atopic Derm

Question 1

Competitor advantages / Disadvantages

Answer 1

Pipeline Leaders dupilumab and crisaborole are both pipeline leaders in Ph3 development expected to file with FDA in 2016. Competiitve timing is thus high for these assets. Dupilumab is a more relevant competitor given it is intended for use in moderate to severe patients while Crisaborole is intended for use in mild to moderate patients.

Question 2

Pfizer Asset advantages / disadvantages

Answer 2

Highly competitive in class, strong FIC potential compared to other assets targeting IL33

Question 3

Competitors (All MOA)

Answer 3

In-class (all target IL33):

Ph1: AMG-282 (Amgen, asthma)

Preclinical: ANB-020 (Anaptys, atopic dermatitis); anti-IL33(Regeneron); anti-IL33 (Mitsibishi)

In-landscape:

Ph3: Dupilumab (Regeneron/Sanofi, IL4R); Crisaborole (Anacor, PDE4)

Ph2: Lebrikizumab (Roche, IL13); Tralokinumab (AZ, IL13); AQX-1125 (Aquinox, SHIP); CIM331 (Chugai, IL31); DS107G (Dignity Sciences, unknown); HL009 (HanAll Biopharma, nitric oxide synthase); OC459 (Atopix, CRTH2); OPA-15406 (Otsuka, PDE4); Otezla (Celgene, PDE4); QAW039 (Novartis, CRTH2); WBI-1001 (GSK, CCK2); Photocil (Applied Biology; unknown); Q301 (Qurient; unknown); SB011 (Sterna; GATA3); Ligelizumab (Tanox, IgE); DRM-02 (Dermira, ILK);

Ph1: BMS-981164 (BMS, IL31); AM1030 (Anamar AB (serotonin 5-HT2B receptor); CNTO7160 (J&J; unknown); RTU1096 (R-Tech Ueno; VAP1); S-414114 (AnGes, NFkB decoy oligo); BBI-5000 (Brickell, undisclosed)

Question 4

What phase of development is Pfizer Asset?

Answer 4

Phase 1, FIH achieved

Question 5

When/what is next milestone for Pfizer Asset?

Answer 5

POM 5/9/2017

Question 6

Indication Standard of Care

Answer 6

Topical glucocorticosteroids (anti-inflammatory), topical calcineurin inhibitors (tacrolimus and pimecrolimus preferred for exacerbation management and proactive therapy), immune-suppressive treatment is an option for severe refractory cases. Adjuvant therapy: UV irradiation

Question 7

Indication Prevalence

Answer 7

17% of total population. in childhood, 10.7% of overall population, as high as 18.1% in individual states, and 21% across various vountries. Approx. 1 in 3 children with exzema has moderate to severe disease

Question 8

peak projected sales

Answer 8

xxx

Question 9

Financial Burden of Disease

Answer 9

$1,000 per year per patient, National estimated cost of treatement = $3.8 billion per year.