March 4, 2015
By Mark Terry, BioSpace.com Breaking News Staff
La Jolla, Calif.-based Orexigen Therapeutics yesterday filed a Form 8-K with the U.S. Securities and Exchange Commission that contained interim data from its ongoing LIGHT trial, causing the U.S. Food and Drug Administration (FDA) to scold the company for releasing too much preliminary data.
The company was not supposed to release the data publically because the study is ongoing. The key issue appears to be a line from the filing: “The 371 Patent and the Provisional Patent Applications contain claims related to a positive effect of Contrave on CV outcomes. The observed effects on CV outcomes were unexpected and appear to be unrelated to weight change.” Contrave is a treatment for obesity. The cardiovascular (CV) benefits appear to have been announced prematurely.
“In order to protect the integrity of an ongoing trial, preserving confidentiality of the interim results is essential,” an FDA spokesman wrote in a statement. “Disclosure of such results could negatively impact the conduct of the remaining portion of the trial by contributing to unanticipated changes in recruitment and/or retention, treatment administration, other aspects of study conduct, or loss of objectivity in safety reporting.”
The LIGHT study involves 9,000 patients and is focused on determining the heart-safety profile of Contrave. As part of Tuesday’s filing, the company reported for the first time that patients receiving Contrave experienced 35 major adverse cardiac events (MACE) compared to 59 MACE events in patients that received placebo. The FDA has forced the company to conduct a second, interim study of half of the events and a second heart-safety study as a condition of U.S. FDA approval of the drug.
The news resulted in a 32 percent jump in stock price to $7.64 at the end of trading day in New York. It is currently selling for $8.00 per share.
Orexigen reportedly released the data without consulting Steve Nissen, the chair of cardiology at the Cleveland Clinic, who is the lead investigator of the study. “The interim results of the Light Trial were released to a small unblinded Orexigen team by the Data Monitoring Committee under strict rules that allowed access for the purposes of regulatory filing,” Nissen said in a statement. “No public release of these data was anticipated and was not approved by the DMC or Executive Committee. It would not be appropriate for me to comment on preliminary interim data derived from an ongoing outcomes trial that is still underway.”
Part of the concern on the FDA’s part is that if data is released mid-study, participants may drop out of the study early, will would decrease the likelihood of acquiring accurate data. It’s also likely that there are concerns that the positive data was prematurely released specifically to manipulate stock prices. The company, which has not yet made a statement, likely felt the need to file a patent extension, which required disclosure of at least some of the data. It may have been unintentional on the part of the company, but the FDA is unlikely to take that into consideration.
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Last week controversy erupted over the compensation package for Sanofi’s new CEO, Olivier Brandicourt, with several French government officials decrying the amount, calling it “incomprehensible.” Brandicourt could walk off with as much as $4.5 million in a “golden handshake” payment in addition to making $4.76 million a year. That base figure is comprised by a fixed annual salary of $1.36 million a year, which is supplemented by a performance-related bonus of between 150 to 250 percent, as well as stock options and performance shares.
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