In an unexpected move, Sanofi has withdrawn its application for its lixisenatide diabetes drug with the FDA over concerns that “potential public disclosure” during the agency’s review of interim trial data could compromise the “integrity” of an ongoing study. The drugmaker, though, insists its decision is unrelated to any safety issues concerning the drug or any deficiencies in its new drug application.
Instead, Sanofi plans to resubmit the application in 2015, after its Elixa study is completed in about 15 months. At the same time, the drugmaker told employees this morning that the additional 200 to 300 sales reps that were hired and being groomed to eventually market the drug would remain on staff, according to sources. A Sanofi spokesman declined to comment (here is the Sanofi statement).
The decision is a clear setback for Sanofi, which has been struggling to broaden its diabetes franchise amid tough competition. Although lixisenatide was not seen as a game changer – the once-daily drug is a GLP-1 inhibitor and, essentially, is another example of a me-too medicine – the withdrawal suggests interim results yielded problems, according to David Kliff of Diabetic Investor.
“Since no one but Sanofi and the FDA knows what the CV data is, today’s decision tells us the data wasn’t good,” he writes in a client note in which he called the withdrawal “a stunning turn of events.” “…It’s overstating the obvious that this is just another failure in their diabetes franchise which for all practical purposes is now a one trick pony: Lantus,” the long-acting and best-selling insulin.
The drug is actually marketed elsewhere in the world under the Lyxumia brand name, but FDA approval would have meant that Sanofi could have jointly promoted Lixisenatide with Lantus. In fact, combining the two drugs is a long-range strategy and Sanofi (SNY) made a point of saying today that a Phase III combination trial remains on track to begin in the first half of next year.
The Elixa trial is studying Lixisenatide with a placebo in about 6,000 patients who have Type 2 diabetes and recently experienced a heart attack or other coronary event in order to determine cardiovascular outcomes. The FDA, however, has been much more cautious about the cardiovascular safety of diabetes drugs in the wake of the scandal over the Avandia pill sold by GlaxoSmithKline.
Even so, Lixisenatide faces competitive challenges. Other GLP-1 drugs already on the market include Victoza, which is sold by Novo Nordisk, and Byetta and Bydureon, which are jointly marketed by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN). Bydureon, however, is injected just once a week, which was a central reason that Bristol-Myers and AstraZeneca teamed to purchase Amylin Pharmaceuticals. Meanwhile, Leerink Swann analyst Seamus Fernandez believes "there is a possibility for further delays (in the lixisenatide trial) given the unpredictable nature of event driven outcomes studies," according to his investor note.
“The question now is, with basically nothing in late-stage development and the Lantus patent expiration looming (next year), can the company remain relevant in diabetes?” writes Kliff. “And while the company did note that the lixisenatide/Lantus combination product will move to Phase III in the first half of 2014, this is hardly comforting given half of this combination is now tainted.”
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