PHYTOASSAY Plant-based technology for toxicity screening in drug discovery 3R Laboratories, LLC. All Rights Reserved.
2 3R LABORATORIES’ MISSION STATEMENT Our mission is to improve drug safety and reduce animal experiments by using plant models in predictive toxicology. The company is named after The Principle of 3Rs: Reduce, Refine and Replace animal experiments with suitable alternatives. (Russell and Burch, 1959)
3 THE PROBLEM There is a high demand for reliable toxicity screening in pharmaceutical industry The cost of developing a successful drug is $1.4 billion; 72% of this cost is wasted on failures. Improving the prediction of failures before clinical trials by only 10% could save $100 million in development costs per drug Safety-related drug withdrawals: Merck lost 11% of its revenue ($2.5B) when it pulled Vioxx off the market in 2003; additionally, Merck funded $4.5B in settlement payouts Pfizer's Celebrex sales dropped 48% ($1.5B) in 2004 due to safety concerns
4 THE PROBLEM Animal experiments – costly, lengthy, and unethical Cell culture-based methods – failed to meet the industry expectations, poor reproducibility "Previously, in vivo evaluations of toxicity were used sparingly in discovery. Now, we perform early in vivo studies on every compound being advanced into development, because catching liabilities earlier is extremely important. " Bruce Car, PhD, Bristol-Myers Squibb
5 STRATEGIC OPPORTUNITY Plant Respiration Test Highly Reproducible and Sensitive The only test that can rank compounds according to toxicity "The definitive answer is really at the end of the clinical trials. What we want to do early on is to proceed to a rank-ordering exercise and select the candidates with an optimal toxicology profile to move into a preclinical safety study." Eric Blomme, PhD, Abbott Laboratories Ethical The US Animal Welfare Act requires manufacturers and researches to explore all possible alternatives before resorting to animal testing.
6 STRATEGIC OPPORTUNITY Plant Respiration Test Preliminary results show better correlation with animal models than cell cultures Regardless of the mechanism of action, toxic substances affect cellular structures of an organism and disrupt normal cellular processes Cellular respiration is used as a measure of the disruption in cellular metabolism
7 MARKET SIZE US market for toxicology in vitro, 2007 (early phase drug discovery only) $1.1 billion, AAGR 15%