Human recAP - Acute Kidney Injury (AKI)

Question 1

Competitor advantages / Disadvantages

Answer 1

Only 2 competitive assets in Ph 2, and none for sepsis-associated AKI.

Question 2

Pfizer Asset advantages / disadvantages

Answer 2

No other alkaline phosphatases in development for AKI or any other indication, so strong first in class potential

Question 3

Competitors (All MOA)

Answer 3

None in-class, Ph 2: THR-184 (Thrasos, BMP/smad); QPI-1002 (Quark, p53); Bendavia (Stealth, mitochondria). Ph 1: KP-100IT (Kringle, HGF). Also, a number of late stage assets for sepsis, primarily antibiotics which could reduce incidence of sepsis-associated AKI.

Question 4

What phase of development is Pfizer Asset?

Answer 4

Ph 2

Question 5

When/what is next milestone for Pfizer Asset?

Answer 5

NONE

Question 6

Indication Standard of Care

Answer 6

Fenoldopam (dopamine-1 receptor agonist to increase renal blood flow), Activated Protein C (APC, anti-thrombotic and agonist of PAR-1, blocks cytokine signaling, adhesion molecule expression, vascular permeability, apoptosis and leucocyte migration)

Question 7

Indication Prevalence

Answer 7

19% of patients with moderate sepsis experience AKI, 23% of severe sepsis patients, and 51% with septic shock when blood cultures are positives

Question 8

peak projected sales

Answer 8

xxx

Question 9

Financial Burden of Disease

Answer 9

Average cost of $22,100 per case, annual total cost of $16.7 billion, patients have an approx. $9,000 increase in hospital costs compared with septic patients who don’t develop AKI.