Sanofi and its top-selling Lantus may have bought some time last month with a legal wrench in Eli Lilly's spokes, but now Merck has bulldozed its way into the conversation with plans to kick off late-stage studies for its own knockoff of the blockbuster drug, further complicating an already heated fight.
You can scratch Eli Lilly's copycat version of Lantus off its short list of near-term approval prospects. Sanofi says it has filed a lawsuit against Lilly claiming that the pharma rival infringed four of its patents, which is likely to delay any launch until the middle of 2016.
Sanofi has peeled back the cover on another chapter of Phase III data for U300, advancing its case that its next-gen diabetes therapy can be safer and just as effective as its blockbuster Lantus as it sets the stage for a regulatory pitch next year. But analysts may be left wondering if the long-acting insulin can successfully beat back rivals with a better set of data.
CHICAGO-- Sanofi has provided the first glimpse at Phase III data for new insulin glargine, which is a next-generation version of its top-selling diabetes drug Lantus.
As a major medical meeting brings the spotlight to new diabetes drugs this month, Sanofi has begun reaching out to the media to secure center-stage status for data on its new therapies. The French drug giant has a next-generation version of its best-selling insulin drug Lantus as well as a combo therapy that have implications for its future in the market.
The two partners are keeping the specific terms under wrap, but Mylan agreed to share the development costs of the three programs in exchange for commercialization rights in the critical European and U.S. markets.
Lars Sorensen's plans to build Novo Nordisk into one of the world's biggest drugmakers got a big boost with the news that the European Commission has approved Tresiba, its long-acting insulin, which will now be positioned as a rival to Sanofi's megablockbuster Lantus. Novo also gained approval in Europe for the insulin Ryzodeg.
Shares of Novo Nordisk took a hit this morning after the FDA released a review of its long-acting insulin Tresiba (degludec) highlighting a warning that the drug presents a greater risk to the heart than other diabetes medications.
Sanofi is making a case for why its experimental diabetes drug Lyxumia stands out from existing GLP-1 therapies, as the French drug giant eyes the new med to build up its Lantus-led diabetes franchise amid relentless competition.
The FDA has decided to schedule an advisory panel review for the long-acting insulin on November 8, past the current PDUFA date.