Takeda has launched its chronic weight management drug Contrave onto the US market, four years after first licensing the treatment from originator Orexigen Therapeutics.
Contrave (naltrexone and bupropion) was finally approved last month after a three-year delay caused by requests for more data on cardiovascular safety.
In doing so it becomes the third weight-loss drug to be cleared by the FDA in recent years after a hiatus of more than a decade.
Contrave is indicated for use in tandem with a reduced-calorie diet and increased physical activity for chronic weight management in adults with a body mass index (BMI) of 30 or more, or 27 or more with an additional complication such as high blood pressure, diabetes or high cholesterol.
The drug has been bundled with a patient support programme called Scale Down, which make use of a wireless scale that provides advice and feedback via personalised text messages based on weigh-ins.
Despite being third to market among the new generation of obesity therapies after Eisai and Arena’s Belviq (lorcaserin) and Vivus’ Qsymia (phentermine/topiramate), both approved just over a year ago, Orexigen believes it will benefit from the market being developed by its competitors over the last year, which have yet to make significant sales gains despite the paucity of weight-loss therapies available on the market.
In the first six months of the year Vivus reported a little over $20m in Qsymia sales while Belviq added around $40m to Eisai’s coffers between April and June 2014.
Orexigen’s chief commercial officer Mark Booth told the Bank of America/Merrill Lynch Global Healthcare Conference last month that it has had the opportunity to watch the “game tape” of the market over the last few months, and has seen from the competition what worked and what did not.
“We think we’re launching at a great time,” he said, pointing to the ongoing increase in formulary coverage for Belviq and Qsymia to reach around 60% coverage across the US.
“One thing that drives reimbursement is demand, and Contrave is going to drive, I think, a great deal of demand,” he said.
Pricing is comparable to its rivals at around $200 per month, while a key advantage for the drug is that it did not require scheduling as a controlled substance, which means reps will be able to provide samples to doctors to help generate interest.
Despite the optimistic appraisal, Takeda‘s ties to Contrave were called into a question somewhat after it added a clause into its contract with Orexigen allowing it to reduce it commitment to the alliance in terms of sales and marketing activities if gross sales in the first 12 months fail to reach an undisclosed threshold.
Takeda is however coming to market with a hefty salesforce behind Contrave – around 900 representatives – which is more than twice the number put behind Belviq in its first year on sale (it now has around 600 reps backing the drug) and several times the 150 or so reps pushing Qsymia.
The company will also be able to promote Contrave alongside Nesina (alogliptin), its DPP-4 inhibitor for diabetes, and there has also been discussion about potentially developing the two drugs together as a combination therapy.
Contrave could also face near-term competition from Novo Nordisk’s Saxenda (liraglutide), which was backed for approval by an FDA advisory committee last month and could be approved any day now.