TheracosBio aims to challenge Big Pharma blockbusters with newly-approved SGLT2 for diabetes
TheracosBio is squaring up for its little-engine-that-could moment. Its type 2 diabetes med Brenzavvy nabbed FDA approval on Friday, landing the privately-funded, little-known biotech in a big arena already populated by Big Pharma players.
Johnson & Johnson’s Invokana, AstraZeneca’s Farxiga, and Boehringer Ingelheim and Eli Lilly’s co-marketed Jardiance are long-established SGLT2 inhibitors. Invokana was first approved in 2013, followed by Jardiance and AstraZeneca in 2014, giving them a head start of almost a decade on Brenzavvy.
And they’re all blockbusters — Jardiance notched sales of $4.3 billion, Farxiga $3 billion and Invokana $563 million in 2021.
Still, TheracosBio CEO Al Collinson is optimistic. While declining to outline specific commercialization plans yet, Collinson is confident in Brenzavvy with its “very cost-effective approach to development.” He said the drug will launch in the first half of the year.
“You’re right, we are playing on a playground with some rather large companies. And those rather large companies have development and marketing budgets that are, let’s just say, larger than mine,” he said, adding, “We’ve taken a very careful, structured approach to how we developed Brenzavvy, and I’m very pleased that the FDA has seen to approve the drug … We think it’s a wonderful place for us to be starting.”
TheracosBio, known as simply Theracos until last year, began developing bexagliflozin in 2009 based on internal research. Funded by private investors — along with compensation from licensing deals, including one with Elanco Animal Health — Brenzavvy will be TheracosBio’s first commercial product, and it plans on taking a similar “lean and mean” approach to its sales and marketing efforts, Collinson said.
Its FDA approval comes after Phase III studies found reduced AIC and fasting blood sugar after 24 weeks when used as a monotherapy, in combination with metformin or as an add-on to other standard-of-care regimens. Brenzavvy is approved for adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than 30 mL/min/1.73 m2.
Mason Freeman, director of the Translational Research Center at Massachusetts General Hospital who participated in all the clinical trials for Brenzavvy, said the “very robust” cardiovascular outcomes study showed results as good as any of existing SGLT2 drugs on-market, noting “comparing apples to apples, it’s really good.”
He also added, “I’m not in the commercialization part of that world, but while there are some really good drugs out there and Brenzavvy is coming a little late to the party, it’s a really, really effective SGLT2 inhibitor.”
Brenzavvy’s approval follows bexaglifozin’s approval in December as Bexacat to treat feline diabetes under a TheracosBio licensing deal with Elanco Animal Health.
While Brenzavvy is not approved for weight loss or blood pressure reduction, those benefits were seen in the trial. Collinson said TheracosBio is open to future studies for additional indications.
Jardiance, Farxiga and Invokana all were approved for additional indications for cardiovascular risk reductions, while both Farxiga and Invokana are approved for chronic kidney disease (CKD) treatment with Jardiance currently under FDA review for CKD.
On price, Collinson declined detailed comment, but TheracosBio’s website pointedly talks about its mission in providing drug access to patients, noting that the current US drug development scene “presumes that a small fraction of eligible patients will be able to afford the latest medications.”
“TheracosBio believes that appropriate pricing can meet its business needs while enabling improved access to the latest therapeutic technologies. The company is employing this strategy for the marketing of Brenzavvy (bexagliflozin), a new medication approved by the U.S. Food and Drug Administration,” the website reads.