Al Collinson, TheracosBio CEO

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.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

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.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

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.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

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 CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

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.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

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One of the paintings from Gilead's latest campaign making AI art to help MBC patients be 'seen and heard.'

Gilead com­bines ar­ti­fi­cial in­tel­li­gence and art to draw at­ten­tion and hope to MBC

What if you could “see” the emotions and feelings of people living with metastatic breast cancer? That’s what Gilead Sciences’ agency VMLY&R Health did last year, using artificial intelligence and sound analytics to turn the interviews of three women living with metastatic triple-negative breast cancer into works of art.

Using the sound waves, a robotic painting device translated their stories of struggle and hope into colors, contours and brush strokes. The result? An art exhibition called “Paintings of Hope” that was first displayed at ESMO in September in Paris, but has since traveled to hospitals and medical conferences in Europe and Spain.

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Sanofi scraps PhI­II tri­al for Prin­cip­ia drug af­ter re­view­ing com­pe­ti­tion

Months after the FDA placed Phase III trials of Sanofi’s BTK inhibitor on hold, the company is winding down one of the studies.

Sanofi reported in its Q4 earnings that the URSA study “was discontinued after careful evaluation of the emerging competitive treatment landscape in” myasthenia gravis, a rare disease that causes muscle weakness.

The Phase III, placebo-controlled trial was testing tolebrutinib in patients with the moderate-to-severe form of the disease. It started in late 2021, according to records on clinicaltrials.gov, and was originally designed to recruit 154 participants who were receiving the standard of care.

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