Sanofi ($SNY) today mapped out a new and much longer path to the U.S. market for its GLP-1 diabetes hopeful lixisenatide, which has been tapped as one of its top late-stage prospects and is already being sold in Europe as Lyxumia.
The company says that after it had the chance to sit down with the FDA and review its proposed regulatory strategy, the pharma giant has decided to drop its application for now and wait until all the data from an ongoing Phase III study--ELIXA--are in before they move for an FDA approval. And that will push back a new application to 2015.
The delay was necessitated by Sanofi's fears about publicly releasing early interim data for the diabetes therapy, a key element in its strategy to protect a global drug franchise dominated by the blockbuster Lantus.
"Sanofi believes that potential public disclosure of early interim data, even with safeguards, could potentially compromise the integrity of the ongoing ELIXA study," the company said in a statement. "Sanofi's decision is not related to safety issues or deficiencies in the NDA."
Shares of Sanofi were dented by the news, while its partner Zealand Pharma took a 20% hit on its stock as investors responded to the news. Analysts have estimated potential peak sales at $500 million to about $900 million a year--not a blockbuster but not insignificant either.
But Sanofi says they have to wait or risk disrupting and possibly destroying any accurate readout from the crucial Phase III trial, much the way an early call in an election before the polls close can affect voter turnout.
"The interim data consist of less than 20% of the total available data at the end of the study," says spokesman Jack Cox in an email to FierceBiotech. "If positive, neutral or negative results from the ongoing ELIXA study are made public, the study's integrity and unbiased conduct could be affected. For example, people who might have withdrawn from the study could request to remain in, and people who might have remained in the study might wish to withdraw. In addition, healthcare professionals involved in studies could also be impacted by results, making it difficult or impossible to ensure that there are no unintentional biases. Studies such as ELIXA will be much more likely to provide important scientific and clinical information if the results are not revealed until after completion."
Some skeptics, though, believe there may be more to this story than meets the eye.
"Since no one but Sanofi and the FDA knows what the CV data is, today's decision tells us the data wasn't good," writes Diabetic Investor's David Kliff in a client note, according to a report in Pharmalot. In what he called "a stunning turn of events" Kliff added that "…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."
Sanofi clearly feels that it's worth the wait, though. The pharma giant has run a full slate of studies on the therapy, a basic requirement for any developer looking to market a new diabetes therapy to a booming patient population. The FDA is more demanding about the safety and efficacy data here than virtually any other field. Sanofi, however, will lose ground in the GLP-1 race, which pits the company against every top contender in the busy arena.
Novo Nordisk's ($NVO) Victoza as well as Byetta and Bydureon from the Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN) team are already angling for market share in the same GLP-1 class. GlaxoSmithKline ($GSK) was just told it will have to wait a few more months before it gets the final regulatory decision from the FDA on albiglutide. And Eli Lilly's ($LLY) late-stage dulaglutide has garnered considerable enthusiasm from analysts who have inspected the late-stage data. Dulaglutide emerged from the American Diabetes Association in June as the clear frontrunner in the Phase III group, especially after albiglutide was bested by Takeda's Actos in a head-to-head study. Patients taking albiglutide also faced more gastrointestinal side effects, which is also likely to limit its market potential.
Sanofi is also working on a combination of lixisenatide and Lantus--LixiLan.
- here's the press release
- see the story from Pharmalot
Special Report: Top diabetes drug pipelines of 2012 - Sanofi--Lyxumia