Organovo's Breakthrough In Hepatotoxicity Testing

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In late April 2013, Organovo (NASDAQ:ONVO) presented data from its all cellular (scaffold free) 3D liver model at the Experimental Biology 2013 conference in Boston. Based on the wide range of in vivo like properties reported at the meeting, and the flexibility and power of bioprinting technology, we expect this product to be a game-changer in the critically important field of drug hepatotoxicity testing.

In an era of ballooning R&D budgets and declining R&D productivity, the inability to accurately predict liver toxicity is a critical issue for the pharmaceutical industry. Drug-induced hepatotoxicity accounts for about one-fourth of withdrawals of approved drugs. Most of these cases are "idiosyncratic," occurring in one of every 1,000 to 250,000 patients after 5 weeks or more of therapy. Insufficient statistical power makes it nearly impossible to identify such rare events during a typical drug development program.

Hypothetical situation: A large pharmaceutical company has spent hundreds of millions or even billions in R&D dollars to bring a compound into late-stage clinical trials, only to see that compound fail (or have restricted use / dose) based on hepatotoxicity. Well, it's not hypothetical, because it's happened many times before. In fact, liver toxicity is the second leading reasons why drugs are pulled from the market.

Recent examples include Pharmasset's Hepatitis C polymerase inhibitor PSI-938, which was terminated from clinical development only weeks after Gilead (GILD) agreed to buy the company for over $11B, and the identification of increased ALT levels as the dose-limiting toxicity in three of seven hepatitis C protease inhibitors now in late stage clinical development. Another example, in March 2000 the U.S. FDA forced Warner-Lambert to withdraw Rezulin (troglitazone) from the market due to severe adverse liver toxicity. Rezulin was approved in January 1997. Warner-Lambert spent hundreds of millions to develop the drug. One month before the withdrawal, Pfizer (

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