Vivus may have recently received approval in the USA for its obesity drug but the company says it expects the treatment to be rejected in Europe, where it would be sold as Qsiva.
The company says that based on preliminary feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), it expects an opinion recommending against approval of its marketing authorisation application for Qsiva (phentermine/topiramate extended-release) for the treatment of obesity. Vivus president Peter Tam said the firm is waiting for the official decision from the EMA following its October meeting, "and the formal report which should provide us specifics on any additional requirements leading to the approval of Qsiva in Europe".
Vivus adds that if a negative recommendation is issued, "and depending upon the nature of the objections, the company will either resubmit the MAA at a later date or appeal this decision and request a re-examination by the CHMP".
The European setback comes a couple of months after the US Food and Drug Administration approved the therapy, known across the pond as Qsymia, for chronic weight management in adults with a body mass index of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight). Vivus noted it is now available in the USA and is the first FDA-approved once-daily combination therapy, and the first new medication in 13 years, for obesity.
Following the European knock-back, Cowen & Co analysts Simos Simeonidis and Yatin Suneja issued a research note saying they have spoken with Vivus management and "our view based on this discussion is that an eventual approval in the EU seems problematic". They believe the issues raised by the CHMP "seem more related to the lack of comfort with phentermine in Europe, rather than the data itself, a situation that we view as difficult to ameliorate". __
The analysts argue that the largest impact on Vivus stock (which slipped 11.5% to $21.00 on the Europe news) is that it may remove at least some of the acquisition premium assigned by some investors, "since lack of ex-US revenue makes an acquisition by a large pharma less likely, albeit possible".
For 2019, Cowen is projecting $1.6 billion in US sales of the combo and $700 million in the EU. _