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.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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David Meline, incoming Moderna CFO

Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

We found out a few weeks ago that Moderna CFO Lorence Kim isn’t waiting around to see how the biotech wunderkind makes out in its frantic race to field a messenger RNA vaccine that can quell Covid-19. And now we know who’s stepping on board to take his place in the latest move in the executive suite.

David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

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