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Risks and Rewards of Using Surrogates to Accelerate Commercialization

Executive Summary

Surrogate endpoints, including biomarkers, are a great idea, a legitimate way to speed drug development and thus lower cost and risk. But their use is also problematic from both scientific and, especially, regulatory points of view. Still, the investment proposition is too compelling to ignore, and companies such as KAI Pharmaceuticals, HaptoGuard, and Perlegen are using them in various ways to find drugs, speed their development, or make their eventual marketing more effective.

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Repurposing the Repurposing Business Model

Two recent examples of the difficulties of drug repurposing: Bionaut's ability to find new indications was not sufficient to get a foot in pharma's door without novelty to create barriers to entry to deter fast followers. Sention couldn't generate data fast enough on its L-amphetamine in improving cognitive impairment to counter amphetamine's bad image. (Its second program, even armed with pharma-vetted, baggage-less NCEs in-licensed from Merck, emerged too late to save the company.)

Problems With Biomarkers: A Tale of Three Drugs

Enthusiasm for biomarkers to guide drug development and clinical decision making is high, but given how little we know about them, biomarkers are a risky investment, as shown by experiences with EGFR inhibitors.

KAI Pharmaceuticals Inc.

KAI Pharmaceuticals is the result of one researcher's accumulated wealth of knowledge about the protein kinase C (PKC) family, which plays is involved in such activities as regulation of gene expression, response to ischemic insult, and regulation of hormone responses and ion channels. KAI is investigating the role of PKC in heart function, acute ischemic stroke, heart failure, pain, diabetes and other indications. The company's first drug, a delta PKC inhibitor (KAI-9803), is designed to limit injury during reperfusion by protecting vulnerable tissue, with an initial indication for post-myocardial infarction. It is just entering Phase I/IIa clinical trials. A second indication for limiting reperfusion injury in stroke is in active preclinical stages.

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