Kerry Blanchard, Everest CEO

Trans-Pa­cif­ic pow­er play­er Ever­est jumps on mR­NA vac­cine deal with Prov­i­dence, pay­ing $100M up­front to tap plat­form play

Ever­est is jump­ing aboard the Covid-19 mR­NA vac­cine train.

While Chi­na has used oth­er vac­cine tech­nolo­gies to vac­ci­nate its pop­u­la­tion, com­pa­nies are start­ing to ex­plore the use of mR­NA vac­cines in Asian mar­kets. Ever­est is now the lat­est com­pa­ny to fo­cus on the Chi­nese mar­ket in a deal with Cana­di­an biotech Prov­i­dence Ther­a­peu­tics.

As part of the deal, Prov­i­dence will get $100 mil­lion up­front in cash, com­bined with an ad­di­tion­al up to $400 mil­lion in prof­it-shar­ing on the Covid-19 vac­cines and mile­stone pay­ments on col­lab­o­ra­tive and ad­di­tion­al prod­ucts.

Ever­est will re­ceive the rights to Prov­i­dence’s mR­NA Covid-19 vac­cines in dif­fer­ent Asian mar­kets such as Chi­na, Tai­wan, Sin­ga­pore, Thai­land and In­done­sia.

This is not the first run that Ever­est has made in­to the Asian mar­kets us­ing West­ern drugs. Two years ago, Ever­est paid $65 mil­lion to grab Asian rights to Im­munomedics’ an­ti­body-drug con­ju­gate in April 2019 — a record at the time for Chi­nese biotechs in-li­cens­ing West­ern drugs.

Prov­i­dence’s lead mR­NA Covid-19 vac­cine, known as PTX-COVID19-B, is cur­rent­ly be­ing stud­ied in Phase II clin­i­cal tri­als against the orig­i­nal strain of SARS-CoV-2. So far, vac­ci­na­tion has re­sult­ed in pro­duc­ing neu­tral­iz­ing an­ti­bod­ies against the orig­i­nal strain and oth­er vari­ants, such as Al­pha, Be­ta and Delta, ac­cord­ing to Ever­est.

Ever­est will gain rights to any Covid-19 vac­cine can­di­dates de­signed for spe­cif­ic vari­ants — and those can­di­dates are in pre­clin­i­cal test­ing, ac­cord­ing to a state­ment re­leased by Ever­est.

Ever­est and Prov­i­dence will al­so en­ter in­to an equal glob­al col­lab­o­ra­tion where they will de­vel­op two ad­di­tion­al prod­ucts. Glob­al rights will be joint­ly owned.

Ever­est al­so will have the op­por­tu­ni­ty to cre­ate and de­vel­op ad­di­tion­al prod­ucts us­ing Prov­i­dence’s mR­NA plat­form. This would al­low Ever­est to scale pro­duc­tion and dis­tri­b­u­tion to a lo­cal scale, thus im­prov­ing ac­cess to con­sumers.

Brad Soren­son

“This trans­ac­tion struc­ture with eq­ui­ty con­sid­er­a­tion and prof­it-shar­ing helps to align on­go­ing cor­po­rate in­ter­ests be­tween Ever­est and Prov­i­dence, fos­ter­ing fu­ture col­lab­o­ra­tion for in­no­v­a­tive mR­NA vac­cine de­vel­op­ment across a range of dis­ease ar­eas,” said Prov­i­dence CEO Brad Soren­son in a state­ment.

“Gain­ing ex­clu­sive ac­cess to a unique and clin­i­cal­ly-val­i­dat­ed mR­NA tech­nol­o­gy plat­form through this strate­gic col­lab­o­ra­tion re­dou­bles our com­mit­ment to ac­cel­er­ate glob­al phar­ma­ceu­ti­cal in­no­va­tion and de­liv­er best-in-class med­i­cines to peo­ple in Chi­na and oth­er parts of Asia. The plat­form will en­hance our dis­cov­ery ef­forts and will al­low us to ex­plore the promise of mR­NA ther­a­pies for pa­tients across a va­ri­ety of key dis­ease ar­eas,” said Ever­est CEO Ker­ry Blan­chard.

As this deal moves for­ward, it could es­tab­lish Ever­est as a key play­er in the Asian mR­NA realm — but there will be stiff com­pe­ti­tion for a piece of the mR­NA vac­cine pie. Chi­na’s Abo­gen shocked the biotech world last month with a $700 mil­lion Se­ries C round, and BioN­Tech and Fo­s­un are do­ing clin­i­cal tests of BioN­Tech’s vac­cine in Chi­na with Fo­s­un pay­ing $50 mil­lion up­front.

All this to say, there’s a lot of in­vest­ment in mR­NA — let’s see how it will pan out.

Why it Works: Man­u­fac­tur­ing a Vac­cine in a Mul­ti-Prod­uct Fa­cil­i­ty.

COVID-19 launched the pharmaceutical industry to the frontline in the battle against the fast-spreading global pandemic. The goal: distribute a safe, effective vaccine as quickly as possible. Major players in the vaccine market needed to partner with contract development and manufacturing organizations (CDMOs) to achieve the goal of mass vaccine quantities under expedited timelines. With CDMOs stepping up to play a critical role in the vaccine manufacturing process, multi-product CDMO facilities took the spotlight. Partnerships quickly formed as the race to save lives and fight a pandemic was on.

Habib Dable, Acceleron CEO

Days of heat­ed ru­mors cul­mi­nate in a re­port that Ac­celeron is in ad­vanced buy­out talks

Days of frothy rumors about possible M&A discussions at Acceleron were capped late Friday with a Bloomberg report asserting that the biotech company is in advanced talks for an $11 billion buyout deal.

Bloomberg was unable to identify any bidders in the deal, but speculation has been running rampant that the surging value of Acceleron stock had to be the result of leaks around the auction of the company. As of early Monday morning, we’re still awaiting the final word.

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Merck CEO Rob Davis

Mer­ck emerges as lead bid­der in po­ten­tial Ac­celeron buy­out with deal pos­si­ble this week — re­port

With rumors swirling about a potential buyout of biotech Acceleron and its lead PAH drug sotatercept, market watchers have been keeping close tabs on industry movers and shakers due up for an expensive bolt-on. According to a new report, it appears Merck may be the one.

Merck is in “advanced talks” on a deal to acquire Cambridge, MA-based Acceleron in what previous reports pegged as a potential $11 billion buyout, the Wall Street Journal reported Monday. A deal could come as early as this week, according to the Journal.

Alexander Lefterov/Endpoints News

The coro­n­avirus vac­cine that the world for­got could still help save it

Back at the beginning of the pandemic — back when we still called the virus “novel” and a single case in Washington state could make headlines — there emerged the story of the coronavirus vaccine that the world forgot.

It was an allegory for our pandemic ill-preparedness. At a time when the world had been caught so flat-footed, there were a pair of scientists who had seen the crisis coming, lab-coated Cassandras with an antidote if only the world had listened sooner.

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Safe­ty fears force Pfiz­er to change piv­otal DMD gene ther­a­py tri­al pro­to­col

As one of the biggest players in an increasingly packed gene therapy space, Pfizer has taken an early lead over specialists like Sarepta in taking a Duchenne muscular dystrophy (DMD) candidate into late-stage testing. But new safety fears have led Pfizer to scale back that trial, cutting out patients with certain genetic mutations.

Pfizer has amended its enrollment protocol for a Phase III test for gene therapy fordadistrogene movaparvovec in DMD after investigators flagged severe side effects tied to specific mutations, according to a letter the drugmaker sent to Parent Project Muscular Dystrophy, a patient advocacy group.

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Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Pfiz­er/BioN­Tech sub­mit vac­cine da­ta to FDA for younger chil­dren; Doc­tors kept pre­scrib­ing hy­drox­y­chloro­quine

Pfizer and BioNTech said Tuesday they submitted to FDA positive data from a Phase II/III trial of their Covid-19 vaccine in children aged 5 to less than 12 years old.

A formal EUA submission for the vaccine in these children is expected to follow “in the coming weeks,” the companies said in a statement.

The trial of 2,268 healthy participants aged 5 to less than 12 years old showed the vaccine was safe and elicited robust neutralizing antibody responses using a two-dose regimen of 10 μg doses, which is one-third the dose that’s administered to adults.

Kim Kjøller, Union Therapeutics CEO

In­novent bets $250M+ on Union's PDE4 in­hibitor ahead of a PhII read­out

A year after plucking orismilast from Leo Pharmaceuticals’ pipeline — and without publishing any mid-stage data — Union Therapeutics is already making a pretty penny on the oral PDE4 inhibitor.

Innovent Biologics is shelling out $20 million upfront for development and commercialization rights to Union’s “Phase III-ready” oral formulation of orismilast in China, the companies said early Tuesday morning. Hoping to one-up Amgen’s blockbuster PDE4 inhibitor Otezla in terms of potency, Union’s been pushing the candidate through Phase II trials in skin conditions like psoriasis, atopic dermatitis and hidradenitis suppurativa.

From left to right: Mark Springel, Kristina Wang, Lin Ao, Soufiane Aboulhouda

George Church, his stu­dents, and top VCs go na­tion­wide with a biotech train­ing camp

One night last fall, Floris Engelhardt sat down in her Boston apartment and logged onto a Zoom call, armed with a comic and a vague idea about starting a biotech.

Engelhardt was joining a student-run “match night.” A postdoc at MIT’s Bathe BioNanoLab, where researchers use DNA and RNA like Lego blocks for nanometer-sized structures, Engelhardt wanted to find real-world applications for her work. She sketched out — literally — a plan to use DNA origami, a decade-old technique for precisely folding DNA, to make therapies.

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Kim Smith, ViiV CEO, at GlaxoSmithKline's Investor Day

Bank­ing on in­te­grase in­hibitors as HIV cor­ner­stone, Vi­iV bags 3rd-gen­er­a­tion com­pound from Sh­iono­gi

As a 12% shareholder of ViiV Healthcare, Japan’s Shionogi has commanded a much lower profile than its fellow owners, GlaxoSmithKline and Pfizer. But behind the scenes, it’s played an outsized role in the development of ViiV’s HIV drugs, coming up with the two top programs — the integrase inhibitors dolutegravir and cabotegravir — currently in ViiV’s portfolio.

And it’s time for round three.