Acknowledgements

Thank you to Dr. Bagajewicz and the School of Chemical Engineering.

Conclusions•High Cholesterol is a Growing Epidemic in the U.S.

•40 mg/day of SQ1 will Reduce the Serum Cholesterol Level by 60% •Higher Efficacy•Lower Side Effects

•Demand for this Price of Drug is Close to 800,000 Patients

•Best Price to a Corresponding High Demand and NPV of the Project is $1.33 for 10 mg/day.

Aim

The objective of this project is to determine the feasibility of manufacturing and commercialization of a novel enzyme inhibitor of cholesterol synthesis. The goal is to propose a drug capable of lowering at least 50% of the total cholesterol level in patients dealing with high serum levels with the highest efficacy. This is done by

•Analyzing the FDA

• Manufacturing processes,

•Equipment pricing.

Introduction

According to the Center for Disease Control, heart diseases and strokes are the first and third leading causes of death in the United States. In this presentation Squalestatin 1 is being evaluated as a new enzyme inhibitor for lowering cholesterol.

•Selective Inhibitor of Squalene Synthase•Key Enzyme in Cholesterol Biosynthesis

•SQ1 will be used to lower serum cholesterol level•By Controlling the Flux of Cholesterol Biosynthesis

This work mainly focuses on the eradication of these diseases by using a new enzyme to lower the cholesterol level in humans.

Marketing and Pricing

Equation below is used to determine the demand for our drug:

•Demand evaluates

• Effectiveness of the drug (beta)• d1; Demand for the New Product• ; Market Demand

• Assumed 0.78• Y; Consumer Budget• P1 and P2 ; New and Old Product Price

• Alpha is Awareness Function

Evaluation of Squalestatin 1 as an Enzyme Inhibitor for Lowering Cholesterol*

Samaneh Noor**, Daniel Feze** and Dr. Miguel BagajewiczUniversity of Oklahoma, College of Engineering,

School of Chemical, Biological and Materials Engineering

(*) This work was done as part of the capstone Chemical Engineering class at the University of Oklahoma, (**) Capstone Undergraduate Students  

Demand of Two Prices Examined: $1.33 is the Starting Selling Price

Business Economics of the $1.33 Project

Demand (Percent) vs. Time

0

20

40

60

80

100

0 2 4 6 8 10 12

Time

% D

eman

d

$1.33

$1.70

Discussion

•The chances of passing FDA are estimated at 69%

•The total cost is $69.3 millions for 10 years

•31% Risk of failing FDA approval for a total loss of $138 millions

 Cost ($)

In Millions Length Participants

Phase I 1.22 1 year 70

Phase II 5.2 2  years 200

Phase III 61.8 6  years 900

•SQ1 is orally introduced into the organism and will inhibit cholesterol synthesis in the hepatic cells

• In 24 hours 99% of the daily dose of SQ1 ingested will be eliminated by the kidneys.

• Due to its lower molecular size and dosage SQ1 presents a higher clearance than the other statins. This will considerably decrease the risk of side effects.

Squalestatin Pathway

Arthralgia

•43% of statins produce severe side effects such as myalgia and athralgia (figure below) were related to their impact on ATP biosynthesis.

• The replacement of these statins by SQ1 will eliminate the occurrence of these side effects.

FDA summary

11

2

11211 ][][0 d

P

dPYPdP

Satisfaction vs. % SCL Based on Data

S = -0.0116C + 1.2645

R2 = 0.9746

0

0.2

0.4

0.6

0.8

1

1.2

0.2 0.4 0.6 0.8 1 1.2

% cholesterol level

Satis

factio

n

Effectiveness of the Drug

•Price of the New Drug•$1.33 or $1.70 for 10 mg/day (one tablet)

NPV vs. Years

$(500,000,000)

$-

$500,000,000

$1,000,000,000

$1,500,000,000

$2,000,000,000

0 5 10 15 20

Years

NPV

1

2

3

4

NPV Values for 20 years

FDA-Fixed One Time Cost $69,000,000

Fixed Capital Investment $76,018,956

Working Capital $1,239,458

Total Capital Investment $77,258,415

Beta

Weight Y1 Y2

Efficacy 0.95 1.26 0.74

Side effects 0.05 0.5 0.5

H= (weight*y) 1.22 0.73

0.6

Beta Values Used to Evaluate the Demand

ReferencesBaxter A., Fitzgerald B.J., Huston J.L., McCarthy A.D, Motteram J. M., Ross B. C., Sapra M., Snowden M.A., Watson N.S., Williams R.J., and Wright C., Squalestatin 1, a Potent Inhibitor of Squalene Sunthase, Which Lowers Serum Cholesterol in vivo, The journal of biological chemistry, Vol. 267, No. 17, Issue of June 15, pp. 11705-11708, 1992

Harl C. Erica, Martin Melissa, Financial and Technological Risk Analysis for the Development of New Drug, May 5, 2006

Bagajewicz M.J., On the Role of Microeconomics, Planning, and Finances in Product Design, Wiley Interscience, October 16, 2007.