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.

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.