The drug and device trends in the treatment of obesity

Several events have set the stage for change in the markets for treatment of obesity. Key among them are the 2012 FDA approvals of (link) of Vivus’ Qsymia (combination of phentermine and topiramate) and Arena Pharmaceuticals’ Belviq (lorcaserin).  In a market that has been dominated by surgical procedures and medical devices, the introduction of two significant pharmaceutical options has served notice that pharma is finally seizing hold of this large and growing opportunity.  The potential addition of yet another obesity drug, Orexigen’s Contrave (combination of naltrexone and bupropion), will only hasten this change.

Combine the advent of obesity drugs (whether or not reimbursement is at optimum levels) with the demand-pinching force of a still somewhat hobbled economy and its impact on the significantly out-of-pocket payment for obesity surgery and device procedures and it becomes clear that the market is shifting away from device and toward pharma. Gastric bypass (e.g., Roux en-Y) will hold stronger than device treatments due to lower cost. As a result, the adjustable gastric band, such as Allergan’s Lap-Band, will see a decline in the total share of obesity surgeries.  See the trend in Europe as an example:

Trend in Metabolic/Bariatric Surgery, Europe, 2003-2013

RYGB= Roux-en-Y gastric bypass
AGB=Adjustable gastric band
BPD/DS= Biliopancreatic diversion with duodenal switch
SG=Sleeve gastrectomy

Source: MedMarket Diligence, LLC; Report #S835.

Established obesity devices such as restrictive devices (e.g., Lap-Band and transoral gastropexy) and artificial fullness devices (e.g., gastric balloon) will represent slower growth than malabsorption devices, gastric emptying devices and appetite suppression devices, but which have thus far gained little presence in the market.  By comparison, appetite suppression drugs are already on the market and, with combination drugs taking off quickly, the share of the future market will be increasingly dominated by appetite suppression and combination drugs.

Source: MedMarket Diligence, LLC; Report #S835.

 

The report, “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019″, may be purchased online at link.

 

 

Allergan Looking to Slim Down

In a move that could be considered ironic, Allergan is looking to shed some excess weight as it looks to sell its Lap-Band business. While Lap-Band initially demonstrated extraordinary growth as the incidence and prevalence of obesity began to skyrocket (along with attention in the press), the product was also tarnished by the aggressive marketing of 1-800-GET-THIN. Lap-Band has also been a victim of the economy because many patients elect to pay for the surgery out of pocket. This is due to the fact that, while third party payers may ultimately be more inclined toward the product’s reimbursement since it may prevent or ameliorate obesity’s co-morbidities (e.g., Type 2 diabetes), current reimbursement levels do not yet reflect this. Allergan now believes that Lap-Band (which only represents only 3% of the company’s revenue) no longer exhibits attractive enough growth.

The future of obesity treatment is forecast in any case to be increasingly divided between devices and drugs.

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MedMarket Diligence has completed a global report on the clinical management of obesity. See link.

VIVUS, Inc., Presses the Case for Obesity Drug Qnexa, Market Success

Qnexa, a drug in development by VIVUS, is one of several promising drugs for the treatment of obesity that received adverse FDA decisions, but which are now receiving additional consideration for potential regulatory approval in exchange for completion of results that demonstrate positive outcomes relative to specific FDA concerns. 

From MedMarket Diligence Report #S835:

Qnexa is an investigational, once a day, proprietary, oral, controlled-release formulation of low dose phentermine and topiramate. Vivus holds that this combination addresses the two main mechanisms that impact eating behavior: appetite and satiety.

In 2010, the FDA rejected Qnexa on the basis that evidence indicated it could cause birth defects in babies born to women who take the drug.  Responding specifically to these concerns, VIVUS has submitted a new application for Qnexa with a commitment to complete a clinical trial (called the "Fortress" trial) of Qnexa to assess fetal outcomes in offspring of women exposed to topiramate during the first trimester of pregnancy.  The initial results from the Fortress trial are due in December 2011.

Obesity drugs represent an enormous untapped opportunity based on their potential to produce significant weight loss without the need of bariatric surgery.  The realizable market for obesity drugs, encompassing satiety drugs, malabsorption drugs, appetite suppression drugs and combination drugs (like Qnexa) will reach almost $16 billion by 2019, while devices in the management of obesity will at that same time reach only $1.7 billion.

The FDA has recently made overtures in the obesity drug market that reflect an apparent recognition that adverse regulatory decisions in 2010 against Qnexa, Arena's Lorcaserin and Orexigen's Contrave may perhaps have overreached.


The MedMarket Diligence, LLC., Report #S835, "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019", is a global analysis of the clinical practice, products, technologies, companies and markets in the field of obesity. The report is described in detail at http://www.mediligence.com/rpt/rpt-s835.htm.

Pharmaceutical research in obesity

The challenges in the treatment of obesity are in providing practical, long-term solutions to a condition that is growing rapidly and is associated with numerous co-morbidities that include diabetes, hypertension (and other cardiovascular diseases), gastroesophageal reflux disease (GERD), osteoarthritis, fatty liver disease, obstructive sleep apnea, and cancer, among others.

Obesity is most commonly addressed, from a clinical solution, in device- and non-device-related bariatric surgery and a very limited number of drugs. Roux-en-Y and other gastric bypass procedure volumes have seen steady increases over the past few years as these procedures have been aggressively marketed and third party reimbursement has become more common.  Obesity device sales (lap-band and others) have grown, and will continue to grow, steadily.

As with most surgeries, however, there are morbidities associated with the procedures, whether or not devices are employed and long-term success has not been high enough to displace demand for pharmaceutical solutions.  Development of pharmaceuticals for obesity has been aggressive, but fraught with uncertainty in the regulatory process that, until only in mid-2011, seemed to make approval to be a moving target, if not unreachable.

Beyond the revived approval process now in play for drugs by Vivus, Orexigen, and Arena, pharmaceutical development in the field of obesity is focusing on several major areas:

  • Melanocortin receptor system
  • Cannabinoid receptor agonists
  • GLP-1 analogs
  • Methionine aminopeptidase 2 (MetAP2) inhibitor
  • Appetite suppression drugs (Arena’s lorcaserin, NeuroSearch’s Tesofensine, Shionogi’s Velneperit)
  • Malabsorption drugs
  • Satiety drugs
  • Combination drugs

We track the market for all obesity drugs and devices on the market and in development in our Report #S835, “Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019.”

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The Obesity Drug Opportunity Remains

Memory is as fleeting in the marketplace as are the FDA's policies. So, when it comes to considering the potential for developing drugs in the treatment of obesity, it should not be a surprise that the obesity market rises and falls in synchrony with the whims of the FDA.

In mid 2010, the thrust was on for obesity drug manufacturers.  Rising prevalence, a heightened sensitivity that obesity is a lynchpin for a litany of healthcare costs and an implicit recognition that a drug will always be less invasive than a gastric bypass were the forces collectively responsible for obesity drug development.  Then, from that black box that drives FDA policy came a conclusion a la fen-phen that obesity drugs are inherently dangerous.  Hence, by early 2011, Motley Fool reports:

Obesity drugs with safety issues are as common as celebrities getting fired for saying (or tweeting) something stupid. The Food and Drug Administration wants a cardiovascular safety trial before it'll approve Orexigen's (Nasdaq: OREX  ) Contrave. Arena Pharmaceuticals' (Nasdaq: ARNA  ) lorcaserin has potential cancer issues. And VIVUS (Nasdaq: VVUS  ) is dealing with the potential for its combination drug, Qnexa, to cause cleft lip in babies whose mothers take the drug.

They, without so much as a mea culpa, in September 2011, the FDA turns around and relaxes its demands for safety data.  Obesity drugs now have a seemingly shorter path to approval than it seemed a scant month ago. Stocks of Arena Pharmaceuticals, Orexigen and Vivus are back on the rise (not where they were, mid-2010) but headed back in that direction.

Below is the global market opportunity for obesity drugs that remains unchanged as a result of the FDA turnaround.

Source: "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019". MedMarket Diligence, LLC; Report #S835.

One cannot say that an opportunity exists irrespective of the stance of the FDA, at least not anyone who witnessed, as Motlely Fool called FDA bullying.  In the U.S., regardless of the latent demand or the amount of efficacy sans safety data, the FDA is a gatekeeper.  Even without the obesity drug barricade that the FDA erected, then has seemingly started tearing down, the capricious, unpredictable and, most of all, drawn-out regulatory approval process has been driving manufacturers elsewhere — the EU, even though it is far more Europe than it is Union, is still a well developed western market, and even South America, with its proximity to U.S. distribution systems, has become very attractive.

Demand for drug treatments for obesity remains high — in some ways it may be even higher than had the FDA not become such a barrier. In a free market economy, even as flawed as that model may seem in today's debt-riddled, recessionary world, demand remains a driver that seems to have much more staying power than anyone previously considered.

 

 

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Obesity Treatment Options Maintaining Steady State… Of Change

Obesity rates are approaching 30% in developed countries, while a recognition of obesity's direct and indirect costs are driving development of treatment options.  Given the size of the problem and its increasing prevalence and costs, one can readily conclude that the problem of obesity remains largely untouched.  A variety of drugs and devices have been developed and are either on the market or the subject of aggressive industry effort to get them introduced.  Thus far, the bulk of the success has come from obesity devices, including "restrictive" devices and "artificial fullness" devices.  

Based on the resilient drivers of drug and device development in obesity, the treatment options available and the manufacturer revenues that are generated will tap into that steady state of demand to result in a rapidly changing market picture for drugs and devices.  Accordingly, a substantial shift in obesity treatment options is going to happen over even just the next four years.

Below is illustrated the distribution of the obesity treatment market across options available in 2011 and in 2015.  

Obesity Treatment Market, Drugs and Devices, 2011 and 2015

 

Source: MedMarket Diligence Report #S835, "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2011-2019."

In the aggregate, drug options, which currently only represent 45% of revenues, will rise to 65% by 2015 with the introduction of several drugs and drug types.  This will mean only a relative reduction in the device market — indeed, select obesity device categories will be increasing at better than 60% annually — since the aggregate market continues to grow as more demand is addressed by drugs and devices.

With Vivus announcing that it has reached agreement with the Endocrine and Metabolic Division of the FDA on an early resubmission of its QNEXA new drug application for the treatment of obesity and, separately, with Arena Pharmaceuticals indicating that it plans to resubmit by year end 2011 its application for Lorcaserin, which was turned down by the FDA in 2010, the obesity drug market will be the major contender in obesity treatments that many expected it to be, despite the FDA's initial resistance.

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Clinical management of obesity (devices, drugs) worldwide

The recent withdrawal by Abbott Labs of its obesity drug, Meridia, and the rejection by the FDA of Arena Phamaceutical’s lorcaserin places even sharper focus on the continuing demand for effective obesity treatment.  Currently, and possibly for some time to come, the clinical intervention in the management of obesity is largely dominated by surgical and device options.

The outlook for manufacturers remains strongly in favor of clinical options as the prevalence of obesity, and its essentially co-morbid partner, diabetes, increases steadily worldwide.

“Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2009-2019″, publishing October 2010 from MedMarket Diligence, details the current status of product development for drugs and devices for treatment of obesity and provides a global market forecast. See link for details.