Obesity blockbuster drugs

[chantell.reagan]

During the September 2009 Webinar, the following question was submitted and we’d like to open it for a general discussion in our community:

"Under endocrine, I am wondering if there are any blockbusters in the obesity area?"

[chantell.reagan]

Obesity affects a substantial portion of the population, with 1/3 of Americans categorized in this class (and 65% thought to be overweight or obese, according to the NIH). Though typical benefit plans exclude weight-loss drugs, the concept of disease prevention/wellness programs is gaining ground in the employer world. The current “top 5” weight loss agents include phentermine (market-leader at 80%), orlistat, sibutramine, topiramate and bupropion. Of note, there are at least 10 late-stage agents in the pipeline for obesity. To receive approval for any new weight-loss drugs, the FDA requires 1 of the following efficacy requirements: (1) at least a 5% (statistically significant) difference in weight loss after treatment for 1 year or (2) “the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.”

Even after overcoming these regulatory barriers, weight loss products face a sizable challenge on the road towards the “blockbuster” status. There must be a demand, in terms of meeting an unmet need with currently available agents and targeting a large population which has a variety of comorbidities. In addition, sustainability of a blockbuster potential would be driven by payor coverage and confidence in the product’s safety (especially considering issues with sibutramine). Although some financial analysts have predicted that one or more of the late-stage pipeline agents have potential to become blockbusters, there is plenty of analyst skepticism in this therapeutic area. Listed below are the late-stage agents analysts believe to have the greatest blockbuster potential. Please click on the product name to view update for individual products. To access DrugPipelineForecast, you must be a registered user of DrugManagementForum (click here to register)

Lorcaserin

•Clinical - A potential 1st in class selective serotonin 2C receptor agonists; in 4/09, phase III data only showed 3.6% difference in weight loss between the group (not >5% as required by the FDA); however, additional positive phase III 2-year data were published in 6/09. Most recently in 9/09, one-year BLOSSOM trial data showed that lorcaserin met all primary efficacy and safety endpoints, including highly significant categorical and absolute weight loss. Additionally, it was well tolerated and was not associated with depression or suicidal ideation, which some analysts tout as a “safety edge” versus other agents in the pipeline; of note, experts are expecting lorcaserin to be used simultaneously with phentermine if initial weight loss results are not achieved
•FDA/pipeline status - NDA submission is expected in December 2009
•Analyst expectations - FierceBiotech and Seeking Alpha both expect blockbuster potential (no figures listed)

Qnexa (phentermine and topiramate)

•Clinical - In 9/09 results of 2 final phase III studies known as EQUIP and CONQUER, a significant weight loss was demonstrated (with an average reduction of 14.7%), as well as statistically significant reductions in blood pressure, triglycerides and A1C. Also there are indications of a favorable safety profile with no incidence of suicide and same incidence of depression, compared to placebo
•FDA/pipeline status – projected NDA submission in early 2010
•Analyst expectations- JMP Securities and FierceBiotech (no figures listed)

Contrave (bupropion/naltrexone sustained-release)

•Clinical – 3 (COR) trials treating 4500 patients for 1 year showed significant weight reduction, while blood pressure remained unchanged in Contrave group (slightly lower blood pressures in placebo group (results released in 7/09). Since both ingredients are available generically, it will be interesting to see how the drug is positioned to managed care organizations
•FDA/pipeline status – NDA submission expected in early 2010
•Analyst expectations- FierceBiotech (no figures listed)

Sources:
Fierce Biotech news article 9/09
Reuters news article 9/09
Seeking Alpha news article 1 9/09
Seeking Alpha news article 2 9/09
Zacks investment research 6/09
Investors.com news article 9/09
Food and Drug Administration
News article 9/09
Seeking Alpha news article 3 9/09
FierceBiotech news article 9/09