Am­gen lines up ex­pan­sion to Ote­zla's $13B fran­chise; Chi­na OKs 'break­through' use of PD-1

Am­gen’s $13 bil­lion drug Ote­zla is be­ing lined up for an add-on OK as ri­vals at Bris­tol My­ers cir­cle in with a ri­val ther­a­py.

The Big Phar­ma play­er an­nounced Mon­day that it’s sub­mit­ted an sN­DA for mild-to-mod­er­ate plaque pso­ri­a­sis, look­ing to build on the mod­er­ate-to-se­vere ap­proval al­ready in hand. Am­gen bought out the drug from Cel­gene as the biotech was fin­ish­ing lin­ing up its big merg­er with Bris­tol My­ers. Bris­tol, though, has been fo­cused on its ri­val pso­ri­a­sis con­tender deu­cravac­i­tinib, where re­searchers have been rack­ing up pos­i­tive head-to-head da­ta.

David Reese Am­gen

Just a few weeks ago Bris­tol My­ers ex­ecs took a dig­i­tal turn at JP Mor­gan to high­light some stun­ning­ly bright pro­jec­tions for this drug, claim­ing it as one of 4 ma­jor block­buster pro­grams in the pipeline with the po­ten­tial to earn more than $4 bil­lion a year.

“De­spite treat­ment ad­vances, there re­mains an un­met need for peo­ple with clin­i­cal­ly mild-to-mod­er­ate plaque pso­ri­a­sis who use ex­ist­ing top­i­cal ther­a­pies and still have chal­lenges man­ag­ing their dis­ease, par­tic­u­lar­ly those with dis­ease in hard-to-treat lo­ca­tions. Re­sults from the AD­VANCE tri­al demon­strat­ed the po­ten­tial of Ote­zla to pro­vide an oral, non-bi­o­log­ic op­tion for these pa­tients,” said Am­gen R&D chief David Reese. — John Car­roll

Chi­na OKs ‘break­through’ use of PD-1 in na­sopha­ryn­geal car­ci­no­ma 

Jun­shi Bio­sciences’ tori­pal­imab — the first home­grown PD-(L)1 to be ap­proved in Chi­na — can now claim an­oth­er first: It’s now the first check­point in­hibitor to be OK’d for na­sopha­ryn­geal car­ci­no­ma any­where in the world, the Shang­hai-based biotech said.

Chi­na’s Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion has grant­ed a con­di­tion­al ap­proval to the drug for the treat­ment of pa­tients with re­cur­rent or metasta­t­ic cas­es af­ter fail­ure of at least two lines of sys­temic ther­a­py.

While preva­lent in Chi­na, the rare can­cer ap­pli­ca­tion was so un­com­mon in the US that the FDA had grant­ed Jun­shi break­through ther­a­py des­ig­na­tion for this use last Sep­tem­ber. And days ago, Jun­shi had filed a third sN­DA with the Chi­nese reg­u­la­tors that cov­ers front­line na­sopha­ryn­geal car­ci­no­ma.

In a study, tori­pal­imab had in­duced an ob­jec­tive re­sponse rate of 23.9% among third-line pa­tients; the me­di­an du­ra­tion of re­sponse was 14.9 months while the me­di­an over­all sur­vival was 15.1 months.

“The great vari­abil­i­ty in preva­lence of NPC across the globe is ev­i­dent, which leads to chal­lenges in new drug re­search and de­vel­op­ment on a glob­al scale,” CMO Pa­tri­cia Kee­gan said in a state­ment. “Our da­ta show that NPC is clear­ly re­spon­sive to im­munother­a­py. It is no­table that tori­pal­imab lacks the usu­al side ef­fects of cy­to­tox­ic ther­a­py and is gen­er­al­ly well tol­er­at­ed by pa­tients, show­ing a great po­ten­tial for fur­ther de­vel­op­ment in the treat­ment of NPC.”

Tori­pal­imab’s la­bel al­so cov­ers sec­ond-line un­re­sectable or metasta­t­ic melanoma. — Am­ber Tong

Woburn biotech nabs $93 mil­lion as ex­ecs ne­go­ti­ate to buy a CRO

Se­quoia Cap­i­tal Chi­na and LYFE Cap­i­tal co-led a $93 mil­lion round for Woburn, MA-based AB­clon­al Biotech­nol­o­gy. This is the par­ent com­pa­ny of AB­clon­al Tech­nol­o­gy, which plans to put the cash to work on its “pipeline for in vit­ro di­ag­nos­tic raw ma­te­ri­als and rapid­ly ex­pand pro­duc­tion ca­pa­bil­i­ties of its re­search reagent prod­ucts and ser­vices.”

First, though, the com­pa­ny is plan­ning to buy a CRO work­ing on sin­gle-cell-based mon­o­clon­al an­ti­bod­ies. And it’s cur­rent­ly en­gaged in talks along those lines.

Za­ck Wu, chief ex­ec­u­tive of­fi­cer at AB­clon­al, not­ed:

Reagent qual­i­ty de­ter­mines the ef­fec­tive­ness of down­stream ther­a­peu­tic and di­ag­nos­tic ap­pli­ca­tions. Sim­i­lar­ly, in­no­va­tions in reagents and raw ma­te­ri­als pro­vide the foun­da­tion for tech­no­log­i­cal break­throughs in the life sci­ence in­dus­try. The new fund­ing al­lows us to con­tin­ue to ex­pand and in­no­vate bi­ol­o­gy reagent prod­ucts at a faster pace.

Sig­ma Square Cap­i­tal, King­hall Ven­tures, and Lu­cion Cap­i­tal al­so par­tic­i­pat­ed in the new round. — John Car­roll

Cas­sa­va launch­es ma­jor late-stage Alzheimer’s pro­gram

Re­mi Bar­bi­er

Af­ter a small Phase II Alzheimer’s study, Cas­sa­va Sci­ences CEO Re­mi Bar­bi­er an­nounced to­day that the biotech has “crossed the Ru­bi­con” in­to a ma­jor late-stage pro­gram.

Cas­sa­va plans to re­cruit a to­tal of 1,600 pa­tients for two piv­otal tri­als of simu­fil­am us­ing some well known end­points: ADAS-Cog, a cog­ni­tive scale, and AD­CS-ADL, a func­tion­al scale. The first of the Phase II­Is with 1,000 pa­tients will get start­ed in Q3.

The biotech re­port­ed some pos­i­tive re­sults from their small study, send­ing their stock $SA­VA sharply high­er — de­spite a long his­to­ry of dis­ap­point­ing Phase II­Is in the wake of small Phase II pro­grams. — John Car­roll

The top 100 bio­phar­ma VCs, Bob Brad­way places $2B bet in can­cer, gene edit­ing pi­o­neer's new big idea, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Before diving in, we had some news to share: Endpoints is launching a premium weekly report focusing on all things regulatory. Coverage will be led by our new senior editor, Zachary Brennan, who joins us from POLITICO. Arsalan Arif has more details in his Publisher’s Note.

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Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

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David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Bruce Cozadd, Jazz CEO (Jazz Pharmaceuticals)

Jazz CEO Bruce Cozadd cam­paigned for 6 months to buy GW Phar­ma. A 90% pre­mi­um sealed the deal — along with $17.6M in ‘re­ten­tion’ in­cen­tives

Jazz CEO Bruce Cozadd didn’t beat around the bush.

In his first video meeting with GW Pharma chief Justin Gover last July 8, he offered to pay $172 a share to get the company, which had beaten the odds in getting its remarkable cannabinoid drug Epidiolex across the regulatory finish line for epilepsy. GW’s stock closed at $129 that day.

Cozadd had already done his homework on the financing to make sure he could swing it the way he wanted. He just needed to do some due diligence before making the non-binding bid firm.

Seagen warns in­vestors against TRC Cap­i­tal’s lat­est 'mi­ni-ten­der of­fer'; BeiGene goes af­ter a new in­di­ca­tion for top PD-1 play­er

TRC Capital, which has selected various biotechs like Vertex and Biogen for the “mini-tender” treatment, jumped back into the game last month with an offer to buy shares in Seagen for $151. The problem, says Seagen, is that price was 4.28% lower than what the stock was selling for at the time they made the offer on Feb. 20, giving TRC a shot at an instant windfall.

So why sell for less than what it’s worth? Seagen notes warnings from regulatory authorities that these offers essentially try to trick investors into believing that they’re being offered a premium for the stock.

UP­DAT­ED: Not 3 weeks af­ter tak­ing Hu­ma­cyte pub­lic, Ra­jiv Shuk­la launch­es an­oth­er blank check com­pa­ny

One of biotech’s earliest SPAC investors is back with another blank-check company, less than a month after his last effort announced its intent to merge.

Rajiv Shukla is intending to take a third lucky winner public with Alpha Healthcare Acquisition III, filing to go public Thursday with a $150 million raise penciled in. The move comes just a couple of weeks after Shukla’s second SPAC said it would jump to Nasdaq in tandem with Laura Niklason’s Humacyte in a $255 million new investment.

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Paul Hudson, Getty Images

How does Paul Hud­son's $13.5M comp pack­age stack up against oth­er CEOs? He's in the 'first quar­tile'

Paul Hudson arrived at Sanofi like a hurricane, chopping off duds in the pipeline, shaking up the C-suite, striking big M&A deals and jumping into the Covid-19 vaccine race — all in an attempt to reboot a pharma giant notorious for its setbacks.

Now, we’re getting a look at what the CEO brought home in his first year on the job.

When all is said and done, Hudson will have made about $6.7 million in 2020, about $2.5 million of which has already been paid. The bigger figure includes a $2.3 million bonus that’s subject to approval at an April meeting, and another $1.8 million in variable compensation that has yet to be paid.

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Af­ter three years of courtship (and turn­downs), Mer­ck pounced on the first glance of clin­i­cal da­ta in $1.85B Pan­dion takeover

It’s almost become cliché for biotech executives to talk about the importance of keeping your options open and being prepared to go all the way. But when it comes to negotiating with a giant like Merck, a little patience can indeed go a long way.

Just ask Pandion Therapeutics.

Days ago we already learned that Merck is shelling out $1.85 billion to pick up the biotech and its slate of autoimmune hopefuls. What we didn’t know until the SEC disclosure dropped Thursday is that the deal comes after Pandion turned down two other proposals from Merck over the past three years and held out until the last minute for a sweetened deal.

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