At last. After being the first new agent to gain approval for weight control in the US in more than a decade, Arena Pharmaceutical's novel antiobesity agent Belviq (lorcaserin) was launched on June 7 and is available in pharmacies from June 11. Despite being approved three weeks prior to its rival treatment, Qsymia (Vivus's phentermine /topiramate fixed dose combination), Belviq is only now available to physicians and patients, over 8 months after Qsymia and nearly a year after approval. The cause for the delay was largely due to the Belviq's serotonergic mechanism of action requiring evaluation by the Drug Enforcement Administration (DEA) due to a risk of abuse.
Without doubt, overweight and obese patients will be pleased to know that another treatment is available, and physicians helping to fight the obesity epidemic will be glad to have another weapon in their armamentarium. The Phase III clinical trial results suggest that Qsymia has a considerable efficacy advantage over Belviq, but also more safety concerns, leading to a Risk Evaluation and Mitigation Strategy (REMS) being put in place for Qsymia.
It is still too early to get a clear and reliable picture of the clinical impact that Qsymia is having in practice, and the real world risk-benefit profile of Belviq will also take time to become evident. Earlier Decision Resources blogs, The success of new agents for obesity is a safe bet. Or is it and A CHMP Decision for Belviq is Coming Soon. High Stakes for Arena, But Will It Matter, have highlighted some of the advantages and disadvantages of the new agents. What is also interesting, although perhaps more to investors and the industry than to patients and physicians, is the different approaches taken by Vivus and Arena in bringing their products to market.
Vivus elected to market Qsymia in the United States without the assistance of a larger company, and they also deferred expensive direct-to-consumer advertising. You can see rationale for the thinking: large and growing patient population plus efficacious and novel agent equals blockbuster. Who needs a big marketing partner taking a share of the revenues and costly advertising eating away the profits.
However, since its launch the uptake of Qsymia has been slower than most expected. There are several possible reasons for this: a lack of awareness of the drug among patients and front-line physicians; the market is actually smaller than estimated; the REMS restrictions have limited access to the drug; the cost of Qsymia is holding back prescriptions; or physicians have adopted a wait and see approach owing to the safety concerns that surround obesity pharmacotherapy.
Whether it is one or all of these reasons, Vivus has already discounted the price of Qsymia twice since its launch. Moreover, investors have voiced their concerns to the Vivus board and the search for potential marketing partners has begun.
In contrast, Arena has a well established partnership with Japanese Pharma giant Eisai, with the aim of enhancing sales and marketing in the United States. In addition, Belviq is being offered at a reduced cost from the outset in an attempt to give early prescriptions numbers a boost. It might be argued that the DEA's scheduling delay has given Arena time to see what did and did not work for Vivus.
Of course, only time will tell whether Arena's approach will bear fruit, and perhaps the obesity market is a tougher nut to crack than predicted. In any event, I for one am curious to see if the company that decided to share some of the profits might end up getting a bigger share of the obesity market, and higher shares in the stock market.
Tim Blackstock, M.B. Ch.B., is a business insights analyst with the Cardiovascular, Metabolic and Renal Disorders team at Decision Resources.
An in-depth analysis of the obesity therapeutic area and an epidemiology driven sales forecast model are presented in Decision Resources. Obesity Pharmacor.