Free Newsletter
Orexigen wows analysts with IIb obesity data
With its lead obesity drug poised to head to the FDA in search of an approval, Orexigen Therapeutics (OREX) pulled the covers off promising Phase IIb data on a follow-up drug that's now pointed to a late-stage trial.
The San Diego-based developer says that patients taking Empatic--a combination therapy that includes a well-known depression drug--hit the FDA's benchmarks for a successful obesity application. Patients completing 24 weeks of Empatic360 lost 9.9 percent of their baseline body weight, or 22 pounds, compared to 1.7 percent for placebo patients. There were no serious adverse events.
Orexigen is one of several developers pursuing late-stage trials of some of the most closely-watched obesity drugs in the clinic. As the company executives made clear this morning, obesity is a tough condition to treat. Patients are often forced to switch meds and there's a high need for multiple therapies. That significantly enhances the value of the obesity franchise Orexigen has been building.
The company is keeping a tight lid on partnering talks, but its CEO made it clear this morning that Orexigen is looking for a sizeable commitment as it continues to produce convincing trial data. "This is a strategic bet for Big Pharma to make," CEO Mike Narachi told analysts and reporters during a conference call this morning. Some pharma companies likely to be interested in Orexigen's programs are commercializing therapeutics that address ailments "downstream" from obesity--going upstream to a big unmet medical need like obesity "is not a bet taken lightly."
- check out the press release
- read the story from Reuters
Related Articles:
Three biotechs in race to win blockbuster obesity approval
Orexigen shares spike on positive late-stage obesity data
Orexigen names Narachi new CEO
Orexigen's Phase III obesity drug meets endpoints
Comments
By Bruzote | Posted 6:04pm | September 30, 2009
To say that Empatic can help obese people lose weight is insufficient to make this a newsworthy story. This drug will be irrelevant unless it achieves a favorable position in the formularies of managed health care plans. MHC plans look at *cost-effectiveness*. Generic anti-depressants (and psychotherapy/group therapy) are well-studied options for obese people, and they just might be as effective and cheaper than a new 'exciting' drug. How does Empatic stack up against those options? I suspect that Empatic's clinical trials are *never* going to be designed for that assessment because it puts the likelihood of a successful product launch at substantial risk.
By Bruzote | Posted 6:06pm | September 30, 2009
I might have added that existing anti-depressant therapy can be mixed with other well-established treatments to help lose weight, such as weight-loss pills or appetite suppressants.
By James44 | Posted 4:51pm | January 7, 2010
It looks like it will (if approved) not be available for 2-3 years. http://www.tesofensine-information.com/empatic.html I also think a negative for Orexigen (the company working on Empatic) is that what would stop a doctor from simply prescribing the 2 combo generic drugs that are already approved to be taken together? thus eliminating the need for essentially paying for the trademark? Regardless, there seems to be quit a few drugs in the works lately for obesity, but there is no guarantee that any will make it through. The FDA has not been to favorable to obesity medications as of late due to some of the side effects being reported, the fact that Rimonabant was pulled from the EU etc... And don't be fooled into thinking that phase 2 studies give anything the 'all clear'. Phase 3 are really what is needed to indicate if it looks promising or not.
SHARE
WITH: