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UPDATE 1-Orexigen says obesity drug safety trial terminated

(Adds details about Takeda dispute, updates shares)

May 12 (Reuters) - A trial assessing the cardiovascular safety of obesity drug Contrave, made by Orexigen Therapeutics Inc and Takeda Pharmaceutical Co Ltd, was terminated on Tuesday due to unauthorized release of study data.

A statement from Cleveland Clinic, which was conducting the trial, said the study was being halted as unauthorized release of trial data by Orexigen in March may have compromised the integrity of the study.

Takeda has started a formal dispute process and is seeking, among other things, Orexigen to pay the entire cost of the new cardiovascular safety trial which is expected to begin later this year.

Shares of Orexigen fell 12 percent in after-market trading after falling 13.6 percent in regular trading on the Nasdaq on Tuesday.

“We are currently evaluating the assertions made by Takeda and believe they are without merit,” Orexigen said in a statement, adding that it intends to vigorously defend its rights.

As these discussions are ongoing, we cannot further comment, Takeda said in a statement emailed to Reuters.

The obesity drug, Contrave - which was co-developed by Orexigen and Takeda, was approved by the U.S. Food and Drug Administration in last September.

Earlier on Tuesday, the companies said a post-approval marketing study, assessing the cardiovascular safety Contrave had been terminated on the recommendation of the trial’s steering committee.

Orexigen had released confidential data from 25 percent of the study in March and said the drug was superior to its placebo group, while applying for a patent for Contrave.

But data from the next 25 percent of the study released on Tuesday showed 55 cases of heart attacks, strokes and cardiovascular deaths in patients taking Contrave, compared with 43 in the placebo group. (cle.clinic/1PhbmvG)

“These (new) results do not confirm cardiovascular benefits of Contrave claimed by Orexigen in the patent application,” said Steven Nissen, who chaired the study’s executive steering committee.

The results were consistent with the U.S. Food and Drug Administration’s requirement that Contrave must not double “cardiovascular events”. But the inconsistency between the two sets of data showed the risk in prejudgment of clinical trial results, Nissen said. (Reporting by Amrutha Penumudi in Bengaluru; Editing by Joyjeet Das and Diane Craft)

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