After a botched launch for obesity drug Qsymia, a bitter proxy war, a mass exodus of its directors and management and a continued sales struggle, the last thing Vivus ($VVUS) needs is a generic threat. But thanks to Actavis ($ACT), that's exactly what it's getting.
Actavis plans to bring a generic of Qsymia to market--and it's already filed its Abbreviated New Drug Application with the FDA, it told the Mountain View, CA-based drugmaker Wednesday, according to a regulatory filing. And as for the 7 U.S. patents Vivus holds on its key med--the earliest of which expires in June of 2020--they're either invalid, unenforceable or will not be infringed by Actavis' knockoff, the New Jersey company said.
Qsymia hasn't exactly put up the kind of sales performance that usually entices generics makers. While the company this week reported Q1 revenue numbers that handily beat analysts' expectations--including Qsymia sales that more than doubled from last year's haul--it reported falling script numbers, with this quarter's tally shrinking by 3,000 compared with Q4 of 2013.
And those struggles are just a follow-up to what has been quite the rocky road for Qsymia. Last year, investors blamed the drug's slow start on Vivus' decision to market it without a partner, resulting in a proxy contest that ultimately ousted more than half the company's board and its CEO. But no marketing partner has followed since, and competitor Arena ($ARNA), which signed on Eisai to throw some weight behind its launch, is now on its tail with rival Belviq despite Vivus' first-to-market advantage.
|Actavis CEO Paul Bisaro|
But Actavis CEO Paul Bisaro may figure his company could succeed where Vivus has so far failed. Under his guidance, after all, Actavis has built up its position to become a generics heavyweight, trailing only Teva ($TEVA), Novartis' ($NVS) Sandoz, Mylan ($MYL) and Abbott ($ABT) in 2012 copycat revenues.
In the meantime, Vivus has 45 days to decide whether it will file a patent infringement suit, which would automatically put a stay of approval of up to 30 months on the Actavis challenger. But of course, there's no guarantee it will come out on top, and judging by how the last 30 months have gone for the company, that may not be enough time for it to firm up significant market share before a potential generic hits.
"The company intends to vigorously enforce its intellectual property rights, but cannot predict the outcome of this matter," it said.
Special Report: Top 10 generics makers by 2012 revenue - Actavis