Diet Drug Study Crashes And Burns In The Wake Of Leaked Results Reply

The ill-fated Light trial, which was supposed to examine the cardiovascular outcomes of the weight loss drug Contrave, a combination of naltrexone and bupropion marketed by Orexigen and Takeda, came to a spectacular halt today. The action was probably inevitable given the extreme controversy generated earlier this year when it became known that Orexigen had widely disseminated results from an early interim analysis of the study.

The news about the trial was announced in a press release from the companies and a press release from the Cleveland Clinic, the home institution of Steve Nissen, the trial’s chairman.

Click here to read the full post on Forbes.

 

Previous Coverage:

Steven Nissen (AP Photo/Judi Bottoni)

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Orexigen ‘Crying All The Way To The Bank’ After ‘Egregiously Unethical’ Actions Reply

On Tuesday morning the members of the Data Monitoring Committee of Orexigen’s Light study began a planned meeting in a hotel in Chicago. They had no way of knowing that in a few hours their routine duties would be completely interrupted by the news that data from the trial– which they thought was known only to them and a very few other people within the company and the FDA– had been revealed to the world by Orexigen. When the news sank in the meeting broke into a scene of high drama and emotion. “I’ve never seen anything like this in 20 years,” said one participant. At one point, I’ve been told, the DMC members were reading my initial story about the data release on a monitor in the meeting room.

The disclosure of the data unleashed a firestorm of criticism directed at Orexigen but also a dramatic 40% increase in the company’s stock, adding about $400 million to Orexigen’s market capitalization. But some believe that despite the short term gain ultimately there may be important negative consequences for the company and its leaders. Certainly the company hasn’t made any friends this week at the FDA or among the doctors and statisticians who perform clinical trials.

The Tuesday meeting was extraordinarily eventful, but in truth the DMC’s activities throughout the trial had never been a day at the beach.

Click here to read the full post on Forbes.

 

Takeda Disagrees With Orexigen Over Data Disclosure Reply

(Updated)

On Tuesday Orexigen sparked a firestorm by disclosing the interim results of an ongoing clinical trial of its weight loss drug Contrave. Takeda, which markets the drug in the US, has released a statement in which it states that it does not support the release of the interim data.

Here is the Takeda statement:

“Pursuant to the Collaboration Agreement between Takeda and Orexigen, Orexigen has the sole right and responsibility for the drafting, prosecution and issuance of Orexigen patent filings.  Takeda respects the need to vigorously protect intellectual property relating to pharmaceutical products; however, Takeda does not support the issuance of patents that contain and disclose interim data results of an ongoing clinical trial.  Takeda is working with the academic leadership of the Light trial (Data Monitoring Committee, Executive Steering Committee) and the FDA to determine the most appropriate next steps for the LIGHT trial.”

Update:

And here is Orexigen’s mildly updated statement about the events:

Orexigen conducted a large cardiovascular outcomes trial in order to file for approval, with the study planned to continue after approval to serve a postmarketing regulatory requirement for additional risk exclusion. We observed an unexpected result in the interim analysis. We filed patent applications based on the results in order to preserve the potential for additional intellectual property. Prior to approval in September 2014, the FDA informed us it had determined that the Light Study would not serve as the postmarketing requirement for Contrave; an entirely new trial would be required. At that point, the company decided to continue with the patent prosecution. The second cardiovascular outcomes trial is expected to start later this year. We are confident that this trial can be enrolled and conducted successfully and we look forward to the results, which are expected by 2022.

On March 3 2015 the USPTO published an issued patent and supporting documentation, and we believed it was appropriate and necessary to make sure this information was equally available to all investors.
Orexigen proactively discussed the challenges inherent in using interim data from ongoing trials for regulatory approvals, and has been, and continues to be, committed to working with FDA and others to support its regulatory obligations to thoroughly explore Contrave’s therapeutic profile. Just as important, Orexigen is committed to its obligation to patients to fully explore the drug’s profile.
Orexigen is also committed to simultaneously meeting its obligations to other regulatory authorities in the U.S., such as the SEC, and abroad, such as the EMA, which are relevant to, and have authority over, its business. The Company is similarly committed to meeting its fiduciary duties to shareholders.

I will have much more to report about this story soon.

 

 

Orexigen Released Interim Data Without Approval Of Trial Leaders Reply

Earlier today Orexigen Therapeutics disclosed positive results from a clinical trial of Contrave, its weight loss pill (a combination of naltrexone and bupropion) that it markets with Takeda. (You can read a good summary of the findings by Adam Feuerstein on TheStreet.)

The surprising thing about the Orexigen disclosure, which was contained in a Form 8-K filed with the SEC, is that it consisted of data derived from an interim analysis of the company’s ongoing Light trial. Normally, interim results are performed by an independent data monitoring committee and the results are known only to the members of the DMC. Occasionally, when important regulatory issues are at stake, the FDA may also be involved. But the detailed results of the analysis are never made public until the trial is stopped.

In this case neither the DMC nor the trial Executive Committee, headed by the Cleveland Clinic’s Steve Nissen, knew about or approved the release of the data. Here’s a statement Nissen sent me:

Click here to read the full post on Forbes.

 

FDA Approves New Weight Loss Drug From Orexigen And Takeda Reply

The FDA announced today that it had approved Contrave, the long-awaited and much-disputed weight loss drug.  The drug is a combination of two drugs already approved for other indications: naltrexone hydrochloride, which is used to combat alcohol and opioid dependence, and bupropion, which is used to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment. Contrave is manufactured by Orexigen and will be distributed by Takeda.

Click here to read the full post on Forbes.