Project name: canagliflozin
Disease: Type 2 diabetes
Peak sales estimate: $650 million
Approved: March 29
Company: Johnson & Johnson
Johnson & Johnson's ($JNJ) Invokana has blazed a trail among a new class of diabetes treatments, becoming the first SGLT2 inhibitor to win FDA approval and giving the pharma giant what it hopes will be a cornerstone of its in-development diabetes franchise. But being a pioneer in diabetes still doesn't warrant blockbuster projections for the pharma giant.
The drug, née canagliflozin, blocks a certain sodium-glucose transport protein (SGLT2), halting sugar absorption in the kidneys and flushing excess glucose out through the urine. That slashes blood sugar, and SGLT2 drugs have been linked to reductions in the all-important hemoglobin A1c levels, which are used as a measure of blood glucose control.
And, considering the FDA's stringent safety requirements for diabetes treatments, Invokana's victory was no small feat. In early 2012, the FDA rejected a similar treatment born out of AstraZeneca ($AZN) and Bristol-Myers Squibb's ($BMY) diabetes alliance, citing safety concerns and casting doubts on the whole SGLT2 class. But J&J remained undaunted, circling its wagons and conducting 9 late-stage studies of Invokana involving more than 10,000 patients.
The reward is first-mover status in the race to cash in on a new treatment pathway for Type 2 diabetes, but creeping competition may make for a short time at the top for J&J. On its approval, analysts expected peak sales of around $650 million for Invokana, but competitors are charging ahead with SGLT2 blockers of their own that promise to cut into the drug's sales. After that initial rejection, AstraZeneca and Bristol-Myers stormed back with more data on their dapagliflozin, winning over an FDA panel last month and expecting a final agency decision by Jan. 11. Meanwhile, Sanofi ($SNY), Eli Lilly ($LLY), Boehringer Ingelheim and others are toiling on late-stage studies in the SGLT2 field.
However, beyond sales estimates and market placement, Invokana's lasting legacy may be its anchoring of a hoped-for diabetes revolution over at J&J. The company has never before produced a diabetes drug, and the heads of its Janssen unit hope Invokana's success will galvanize their other pipeline efforts, which are largely the result of partnerships with the likes of Metabolex and Evotec. Of course, outside of R&D, J&J has a lot of catching up to do on the marketing side, and because of its lack of experience in the diabetes field, Janssen is reaching out to J&J's glucose monitor units LifeScan and Animas to help commercialize Invokana.
It remains to be seen whether the blood sugar-lowering drug is just a blip amid years of failure or the first big splash from an inchoate diabetes juggernaut, but, with a multibillion-dollar R&D budget and Janssen chief Paul Stoffels steering the effort, J&J will always have a fighting chance to muscle its way into a new space. -- Damian Garde (email | Twitter)
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