Flex­ion nabs FDA OK for its po­ten­tial block­buster os­teoarthri­tis drug, trig­ger­ing new buy­out buzz

The buy­out buzz around Flex­ion $FLXN is spik­ing this week­end, af­ter the FDA came through with an ap­proval of its in­jectable drug for os­teoarthri­tis-re­lat­ed knee pain.

The agency’s OK of Zil­ret­ta in­tro­duces a new pain ther­a­py at a time the feds are bend­ing over back­wards to fight a na­tion­wide opi­oid cri­sis. And at about $500 a shot, RBC — which is push­ing up the odds of an ac­qui­si­tion again — had mod­eled peak sales at just over the $1 bil­lion-a-year mark, which would qual­i­fy as a hot­ly sought af­ter block­buster.

Mike Clay­man

There’s been dead si­lence on the M&A front, though, since Fier­cePhar­ma re­port­ed back in March that Sanofi was in on­go­ing talks re­lat­ed to a po­ten­tial buy­out. Noth­ing has come of that, so far, but the ap­proval for a one-prod­uct com­pa­ny will on­ly sharp­en spec­u­la­tion about deal talks to come.

Fur­ther help­ing Flex­ion in max­i­miz­ing the val­ue of this prod­uct, the biotech was able to get re­cent da­ta demon­strat­ing how this drug, un­like steroids, won’t cause a sud­den spike in blood sug­ar on­to the la­bel. As di­a­bet­ics are one of the prime groups like­ly to turn to this ther­a­py for the pro­gres­sive and in­cur­able con­di­tion, the FDA just helped give a big boost to their mar­ket­ing plans.

More than 4 mil­lion peo­ple suf­fer­ing from os­teoarthri­tis get these steroid shots, Flex­ion CEO Michael Clay­man told me re­cent­ly, and 20% of them have di­a­betes — about 800,000 pa­tients. Hav­ing some da­ta that il­lus­trates the dif­fer­en­ti­a­tion in the blood glu­cose pro­file — where hy­per­glycemia, even quick­ly flushed away as it is with steroids, is to be avoid­ed wher­ev­er pos­si­ble — could help per­suade vig­i­lant pay­ers to opt for a much more ex­pen­sive brand­ed ther­a­py.

Flex­ion’s share price jumped 10% on Fri­day af­ter­noon, af­ter news of the ap­proval came through.

The Burling­ton, MA-based biotech’s an­nounce­ment of the ap­proval in­cludes a range of en­dorse­ments from key opin­ion lead­ers in the field, which Flex­ion has been cul­ti­vat­ing for years now.

“As OA pro­gress­es, many pa­tients ex­pe­ri­ence in­tractable joint pain, which can ul­ti­mate­ly lead to the need for a to­tal joint re­place­ment,” said John Rich­mond, med­ical di­rec­tor for net­work de­vel­op­ment, New Eng­land Bap­tist Hos­pi­tal. “As a re­sult, health­care providers are ea­ger for new, non-opi­oid ther­a­pies that may help pa­tients man­age their OA pain for ex­tend­ed pe­ri­ods of time. Zil­ret­ta gives us an im­por­tant new non-sur­gi­cal in­ter­ven­tion.”

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Fast on Glax­o­SmithK­line's heels, Au­rinia wins OK to steer a sec­ond lu­pus nephri­tis drug straight to the mar­ket

GlaxoSmithKline’s Benlysta isn’t alone in the small circle of approved lupus nephritis drugs anymore.

Little Aurinia Pharmaceuticals has gotten the green light from the FDA to start marketing its first and only program, voclosporin, under the brand name Lupkynis — something CEO Peter Greenleaf says it’s been ready to do since December.

Regulators went right down to the wire on the decision, keeping the company and the entire salesforce it’s already assembled on its toes.

Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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