Medical Device Daily

Of late, device-based therapies often have trumped pharmaceuticals as the treatment of choice when it comes to treating those who suffer from obesity.

A declining interest from pharma after too many risky therapies, and less-invasive treatments on the device side have led toward a stronger pushback into previously drug-designed solutions.

During a nearly hour-long panel meeting hosted by RBC Capital Markets at its annual Healthcare Conference at the Westin Times Square Hotel in New York, a four-person panel discussed upcoming pharma solutions to a condition that affects two out of three adults.

The panel said that while medical devices might be deemed a lot safer, pharma could be making a comeback in the obesity market.

"The total economic cost of obesity in the U.S. is estimated to cost at least $117 billion a year," Ken Trbovich, a specialty pharmaceutical analyst for RBC and moderator of the panel, said during a Wednesday webcast. "And I say at least, because from what I can tell of that statistic it was generated back in the year 2000 and considering that obesity rates have continued to climb and the rate of inflation, one would expect it's much more than $117 billion. Included in that is $50 billion in avoidable medical expenses."

It's no secret that pharma took a tremendous hit in treating obesity in 1997 when the FDA decided to pull fen-phen, an anti-obesity medication consisting of fenfluramine and phentermine. Fenfluramine, and later a related drug, dexfenfluramine, was marketed by American Home Products, now known as Wyeth (Madison, New Jersey).

Reports of valvular heart disease and hypertension in users caused the FDA to order the drug to be pulled off the market.

"The alternative in terms of options available to patients today ... the most preferred method at this point is gastric bypass or some form of surgery, whether that is laparoscopic or open specifically," Trbovich said. "The procedures involve a three- to six-day hospital stay and the fact of the matter is that it doesn't come without risk."

Companies such as GI Dynamics (Lexington, Massachusetts) are developing devices that can mimic the effects of gastric bypass surgery on a patient's metabolism, resulting in weight loss and remission of Type 2 diabetes.

The EndoBarrier, creates a mechanical bypass of the duodenum and proximal jejunum. It allows food to pass through the device, and allows bile and pancreatic enzymes to travel outside the liner, allowing bile and intestinal hormones to travel around the liner without touching the food until later in the gut (Medical Device Daily, June 27, 2008).

Allergan's (Irvine, California) Lap-Band, a minimally invasive surgical device also is a front-runner among devices that treat obesity.

With these options and the negative cloud that swarms around pharmaceutical companies in treating obesity, is there still a strong enough market"

The panel's answer was a resounding "Yes," despite big pharma companies cancelling or pulling out of late-stage programs in recent months.

"As it relates to Vivus, we don't think it really changes the game too much," said Tim Morris, CFO of Vivus (Mountview, California). "Clearly obesity is here to stay. Diabetes is here to stay, we think these are large markets any pharmaceutical company would want to be in."

"It's hard for a pharmaceutical company to entertain taking on another Phase III asset when they've got a Phase III asset in the same therapeutic area," Graham Cooper, CFO of Orexigen Therapeutics, countered. "So I think at least for a couple of companies it increases their odds in forming a partnership."

"We don't believe there's going to be a one-size-fits-all solution for obesity," said Gil Van Bakkelen, CEO/chairman of Athersys (Cleveland).

One of Athersys' solutions is the Multi-Stem product platform, a stem cell product for the treatment of multiple distinct disease indications including myocardial infarction and bone marrow transplant support.

Another issue addressed is the FDA having much stricter standards regarding safety and efficacy for pharmaceutical approaches over device-driven therapies for obesity. Trbovich asked specifically about the differences and what the FDA deemed as a safe risk for pharmaceutical obesity treatments.

"When patients undergo surgery there are surgical risks and the FDA has deemed that to be acceptable, even in instances when it might be as high as a 1% fatal consequence," he said. "Clearly on the obesity side as it relates to pharmaceuticals, it appears as though there is a much higher bar. Is that safety bar zero? What's an acceptable level of risks from your interactions with the [FDA]?"

Van Bakkelen suggested that there was a slight difference but that it was up to the company to work closely with the FDA and to have a greater since of the risk of the proposed product for approval.

"If you have a very large benefit, they'll be able to accept a little more risk," he said. "But it's more important in that risk that you know what it is; how does it occur; how did you monitor it; how do you control it; and how do you inform patients; and what do you do post-approval."

Despite such obstacles, smaller drug companies have come in fill the gap left open by bigger companies departing. But whether pharma approaches truly top device therapies remains to be seen.