OREX Tumbles on Halted Heart Trials

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OREX Tumbles on Halted Heart Trials

 

Orexigen Therapeutics (NASDAQ: OREX) announced news that it would be terminating their heart benefit testing trials of cardiovascular drug, Contrave. Contrave showed promising results of its ability to assist in preventing heart attacks upon completion of a portion of its study earlier in the year all while sparking controversy. Shares of OREX traded sharply lower in Monday’s session closing down 13.56% at $5.93

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The Story

Orexigen Therapeutics made the decision to end the trials after an independent committee of cardiovascular experts said that OREX leaked data early in the trial, compromising the study known as LIGHT, a study created to determine the effectiveness of Contrave. In early 2014, The Food and Drug Administration conditionally approved Contrave after 25% of the trial was complete and preliminary results showed a positive effect. Then, just a few months ago in March, OREX publicly released the results based only on the preliminary data and went on to apply for a patent. This public disclosure of early results created a whirlwind of controversy in that final results of a study can vastly change from the initial trials.


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Steve Nissen, the lead researcher and chair of the Cleveland Clinic Cardiovascular unit noted

 

“These results show neither benefit nor harm for patients taking the drug, but are consistent with the requirement by the FDA that the Light Trial demonstrate an absence of a doubling of cardiovascular risk for patients taking the drug. The inconsistency of effects on cardiovascular outcomes between the first 25 percent and the second 25 percent of the Light Study clearly illustrates the risks inherent in pre-judgment of clinical trial results based upon an interim analysis and demonstrate why interim results should remain confidential during any ongoing trial.”

 

This news is quite devastating to OREX as they now will be required to start anew with cardiovascular studies with a 2022 end date. That is nearly an additional 7 years of unexpected expenses OREX which with it will now be burdened. The question really boils down to if investors can stay along for the ride, or is it too long of a journey to bear.


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About Orexigen Therapeutics

Orexigen Therapeutics, Inc., a biopharmaceutical company, focuses on the development of pharmaceutical products in the United States. The company offers Contrave for the treatment of obesity. It has a collaboration agreement with Takeda Pharmaceutical Company Limited to develop and commercialize Contrave in Canada and Mexico. Orexigen Therapeutics, Inc. was founded in 2002 and is headquartered in La Jolla, California. Yahoo! Finance

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