Incidence and Prevalence of Obesity
It is a well known fact that obesity is currently a growing concern which affects more than one-third of the American population. It is mainly caused due to the increase in body weight as a result of excessive accumulation of fat in the body. Obesity is linked to many life threatening diseases such as diabetes, hypertension and cardiovascular diseases. Obesity is defined as body mass index (BMI) of 30 or greater. BMI is calculated from a person's weight and height. There has been a remarkable increase in the number of obese people across the globe but the most being in the United States. In the year 2009, apart from District of Columbia and Colorado, which had less than 20% of obesity incidence, all the other states had more than 25% .
With US having the maximum prevalence and incidence of obesity across the globe, it goes without saying that the US market has the biggest potential for weight-loss drugs. Currently there are only 2% of anti-obesity drugs in the market. An anti-obesity drug should not only reduce the occurrence of obesity but also conditions like cardiovascular diseases, hypertension and diabetes. This will not only increase the penetration of anti-obesity drugs in the market but also improve the reimbursement levels, as the US government does not reimburse most of these drugs. Till date, the FDA has approved only two weight loss medications for long-term use, but they too failed to gain a large market share. Sibutramine, a serotonin and noradrenaline reuptake inhibitor controls appetite by producing a feeling of satiety, but because of its prominent side effect being hypertension it is not prescribed widely. Orlistat, manufactured by Roche, reduces weight by limiting the caloric intake by inhibiting the lipid-mediated breakdown of fat in the gastro-intestinal tract, the unfortunate side effect of this being fecal incontinence and urgency limiting the broader use. In the year 2005, Orlistat made sales of about US $450 million of which only 20% was in the US market. Despite having the largest obese population, and highest reimbursement of patient costs, US market penetration was recorded as poor. In 2009, Xenical and Orlistat each had sales between $300 million and $350 million. The generic drugs made additional sales of $300 million to $600 million. Market penetration is also low due to the fact that patients stop taking the pills - most patients who start the anti-obesity medications stop taking it after 90 days. Less than 10% remain on the therapy for a year or more.
QNEXA® as an Anti-obesity Drug
QNEXA® promises to be the most effective anti-obesity drug amongst all others in the market. QNEXA® has completed phase III trials including more than 4500 patients. QNEXA® is also presently in the phase II trial for the treatment of Type-2 Diabetes and in phase II trails for the treatment of obstructive sleep apnea. From the data collected in the phase III trials for the treatment of obesity it was seen that weight loss was greater than 20% in one year. Figure 3 shows some categorical weight-loss data studied over 2400 patients who received mid-dose QNEXA®, top-dose QNEXA® or placebo. QNEXA® patients had significant weight loss at week 56 as compared to placebo. Significant improvements noted in cardiovascular, metabolic and inflammatory risk factors. The side effects noted all the way up to phase III trails were tingling sensation, dry mouth, constipation, upper respiratory tract infection and headache.
A regulatory update after the submission of NDA to FDA from January 2011 resulted in FDA requesting Vivus to run an investigation on birth defects in child when pregnant women were on the trails. VIVUS met with the FDA later in April 2011 to discuss the feasibility of performing a retrospective observational study utilizing existing electronic healthcare databases to assess fetal outcomes, which include major congenital malformations and oral cleft, in the offspring of women who were exposed to topiramate during pregnancy. The company has declared that its goal is to resubmit the QNEXA NDA in the fourth quarter of 2011.
Competitors in the market
The other two main anti-obesity drugs in the pipeline are Contrave developed by the company Orexigen, and Cetilistat developed by Alizyme. Contrave, a combination of bupropion and naltrexone, is currently in phase III trail and is awaiting FDA approval for release in the market. Cetilistat has completed two clinical trails and is moving forward to the phase III development. Each of these drugs is unique in their own way. The phase III, 56 week EQUIP study of the combination drug which forms QNEXA® showed an average weight loss of about 14.7% (37lbs). Contrave has a unique mechanism of action in the CNS, the weight loss seen in this drug was only 4.2% which does not seem very significant. Further studies are being done to getter better results. Cetilistat, a gastrointestinal lipase inhibitor that blocks fat digestion and absorption, leads to reduced energy intake and thus weight loss when consumed. It does not act on the brain to reduce appetite but acts peripherally. Cetilistat helped in reduction of fat in obese patients by 5.3% and is well tolerated with minimal side effects.
Business Model: The product QNEXA® must target the stakeholders, doctors and patients. QNEXA® if approved will be one of the few approved anti-obesity drugs in the market which not only targets obesity but also diabetes and sleep apnea. It benefits patients who are either diabetic, obese or have sleep apnea as a condition. It proves useful to the doctors/hospitals by helping them to make informed decisions. Insurance companies have to seriously consider reimbursement of anti-obesity drugs so as to create a favorable and encouraging atmosphere in the market. Lobbying with decision makers in order to achieve a comfortable reimbursement status for a drug is also essential. High pre launch awareness including high profile clinical trials and media coverage ensuring strong sales on launch is an important factor. QNEXA® must be a value-based priced product as there are only a few drugs presently for obesity.
Marketing Gimmicks:To support the value-based pricing of QNEXA®, Vivus Inc. must come up with their own sales force that can represent the potential of the drug QNEXA®. Also a reimbursement team must be set to support patients and doctors in submitting claims to payers. Finally increase the familiarity of the drug among patients and doctors by distributing flyers, launching a webpage and publish more articles about the drug in newspapers.
Conclusions and Recommendations
Vivus Inc. is an outstanding mid-sized company with amazing drugs in the pipeline for several conditions. With the huge market for obesity and only a few drugs for the epidemic, QNEXA® surely seems a promising drug.
The basis for this conclusion includes the following
• Considering the efficacy of QNEXA® in comparison to the other drugs in pipeline and market, it sure seems a leader so far.
• It is a multi purpose drug, which targets not just obesity but also diabetes, sleep apnea, cardiovascular conditions and hypertension.
• Side effects observed through all phases of the clinical trials were less and not adverse in comparison to the other drugs.
It should be recognized that this profile and the market must be periodically updated and compared. Failure to achieve any major aspects of the profile important for a successful launch should trigger a reevaluation of the product.
I recommend the following concerns be addressed in the future:
• More trials to be conducted amongst expectant mothers and children.
• Once approved by the FDA the drug should be competitively priced.
• Adopt a commercialization strategy that is similar to the highly successful MUSE.
About Author / Additional Info:
This is my personal analysis and please do not treat this as an experts advice. Please check with your doctor before using any weight loss product including Qnexaa.