Fourth diet pill makes it to US market
pharmafile | September 11, 2014 | News story | Manufacturing and Production, Sales and Marketing | Contrave, FDA, Orexigen Therapeutics, diet, obesity
Orexigen Therapeutics has gained FDA approval for its new obesity treatment Contrave to help overweight patients reduce their food intake.
The drug is a combination of the antidepressant bupropion and Orexigen’s formulation of naltrexone, a drug designed to prevent drug dependence. The company is not yet saying when the pill would become available in the US or how much it would cost.
The FDA was expected to make a decision on the treatment in June but this was delayed until today, due to concerns about adequate warnings on the packaging. This is because Contrave contains an antidepressant and needs to carry a warning about increased risk of suicidal thoughts (known as suicide ideation) and other behaviours.
But Orexigen will be relieved that the drug is now approved, as in 2011 it was sent a complete response letter for its medicine by the FDA asking for more information on cardiovascular safety.
Now three years’ later and it has finally been given the nod by the US regulator.
Last year French firm Sanofi agreed a deal to manufacture Orexigen Therapeutics’ weight-loss candidate Contrave outside of North America, predominately focussing on Europe.
Lucrative market, but drugs fail to gain traction
According to the US Centers for Disease Control and Prevention, two-thirds of American adults are overweight or obese.
Furthermore, the prevalence of obesity in the US more than doubled among adults from 1980 to 2010, meaning any new – and safe – obesity drugs could be highly lucrative.
This is in fact the fourth such prescription medicine to gain the go-ahead for obesity, and follows the 2012 approvals of Vivus’ Qsymia (phentermine/topiramate) and Arena Pharmaceuticals’ Belviq (lorcaserin).
These were the first new obesity treatments approved in the US since Roche’s Xenical (orlistat) in 1999.
But all of these medicines have suffered a difficult path on the road to approval, with a number of FDA rejections and concerns from doctors over safety, notably the effect of these medicines on the heart.
This has led to poor sales trajectories, despite the high rate of obesity in the US. Arena reported Belviq sales of just $5.7 million in 2013, with $5.3 million of that going to its partner Eisai.
Qsymia’s sales were higher at $23.7 million in the same period, but still weak given the market potential.
“For all the obesity drugs that are out there, only 30% to 40% of the health maintenance organisations pay for obesity coverage,” says Daniel Lang, analyst on RS Investments’ Value Fund, which holds a stake in all three companies.
“That speaks to the relative apathy toward obesity as a serious condition.”
The new generation of therapies have particularly struggled in Europe, however, with Arena withdrawing Belviq’s marketing application in May last year, saying it was clear it would not be approved in its current form. The European Medicines Agency also rejected Vivus’ application for Qsymia in 2012.
But Wells Fargo analyst Matthew Andrews still expects Contrave’s US sales to eclipse that of Belviq and Qsymia by 2016.
Contrave sales are expected to be around $200 million in 2016, slightly higher than Belviq’s $180 million and well ahead of Qsymia’s $150 million, says Andrews, who covers all three companies.
In the US Contrave is partnered with Takeda, and Orexigen is responsible for manufacturing the drug for the North American market via an agreement with Patheon, which will produce both the active pharmaceutical ingredient and the finished dosage form.
Ben Adams
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