Amid Covid-19 hunt, Pfiz­er adds Ly­me dis­ease vac­cine in $308M deal with Val­ne­va

In the midst of their $500 mil­lion pro­gram to build a Covid-19 vac­cine with BioN­Tech, Pfiz­er has an­nounced a siz­able deal to com­mer­cial­ize a vac­cine for a far dif­fer­ent dis­ease.

Pfiz­er and Val­ne­va have agreed to an up-to $308 mil­lion deal on the French biotech’s Ly­me dis­ease vac­cine. The deal in­cludes a $130 mil­lion up­front pay­ment for Val­ne­va, whose can­di­date is now in Phase II. On top of that, there are mile­stones and ul­ti­mate­ly a 19% roy­al­ty on sales. Val­ne­va will still be in charge of 30% of the com­mer­cial­iza­tion costs.

Al­though the vac­cine mar­ket has been ail­ing for years, Pfiz­er has a block­buster in their pneu­mo­coc­cal vac­cine, Pre­vnar 13, and are in late stages on a suc­ces­sor vac­cine. The deal comes at a time of re­newed in­ter­est in the field, a phe­nom­e­non the Covid-19 pan­dem­ic and the drug hunt around it have on­ly ac­cel­er­at­ed. Ear­li­er this month, Affini­vax raised $120 mil­lion in a Se­ries C, and in March, SutroVax raised $110 mil­lion for their at­tempt to ri­val Pfiz­er’s Pre­vnar 13 — both stan­dard sums these days for on­col­o­gy but large in the con­text of in­fec­tious dis­ease re­search.

The hunt for a Ly­me dis­ease vac­cine is decades old, dat­ing to not long af­ter the dis­cov­ery of the tick-born ill­ness and the bac­te­ria that caused it in the 1970s and 80s. In 1998, SmithK­line Beecham beat out Pas­teur Mérieux Con­naught (the Sanofi Pas­teur pre­de­ces­sor) and got LY­MEr­ix, a re­com­bi­nant DNA vac­cine that re­quired 3 shots and was about 80% ef­fec­tive, ap­proved by the FDA.

The ap­proval, though, dove­tailed with the be­gin­nings of the mod­ern an­ti-vac­ci­na­tion move­ment in the Unit­ed States. Grow­ing re­ports of joint pain and oth­er safe­ty com­plaints with the vac­cine led to a class ac­tion law­suit against SmithK­line. Al­though the suit was set­tled with­out com­pen­sa­tion and an FDA re­view found no ev­i­dence for arthri­tis or oth­er un­ex­pect­ed ad­verse ef­fects, sales dropped pre­cip­i­tous­ly. SmithK­line pulled the drug off the mar­ket in 2002, cit­ing poor com­mer­cial per­for­mance.

The con­tro­ver­sy set back the field con­sid­er­ably. Pas­teur Mérieux Con­naught nev­er ap­plied for their vac­cine. To­day, al­though you can in­oc­u­late your dog against Ly­me dis­ease, you can­not in­oc­u­late your­self or your kid.

Thomas Lin­gel­bach

Val­ne­va, cre­at­ed af­ter the failed Aus­tri­an vac­cine com­pa­ny In­ter­cell merged with the French biotech Vi­valis in 2012, be­gan work­ing on a Ly­me dis­ease vac­cine short­ly af­ter its birth. They claim to have the on­ly Ly­me dis­ease vac­cine in de­vel­op­ment.

The vac­cine, VLA15, tar­gets the six most com­mon types of Bor­re­lia bac­te­ria that cause Ly­me dis­ease, mak­ing it a po­ten­tial can­di­date for use across Eu­rope and North Amer­i­ca. It is a pro­tein sub­unit vac­cine, mean­ing it con­tains on­ly the anti­gens from the bac­te­ria that the body will make an­ti­bod­ies against. They have fast-track des­ig­na­tion and are ex­pect­ing re­sults from their Phase II by mid-2020. CEO Thomas Lin­gel­bach has said he ex­pects to bring the prod­uct to mar­ket in 4-5 years.

The num­ber of peo­ple di­ag­nosed with Ly­me dis­ease has ex­pand­ed con­sid­er­ably in Amer­i­ca and Eu­rope in the two decades since LY­MEx­is’s ap­proval, po­ten­tial­ly set­ting up a large mar­ket if the vac­cine is ap­proved.

So­cial: Thomas Lin­gel­bach, Val­ne­va CEO via YouTube

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

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Two months after Yuan Xu steered Legend Biotech to a $424 million public debut on the Nasdaq, founder and chairman Frank Zhang is grabbing the reins as CEO.

In conjunction with the move, Zhang is also stepping down from the helm of GenScript — a position he’s held for 18 years. GenScript, a Hong Kong-listed CRO, hatched Legend as a subsidiary in 2015 before spinning it out, and remains a majority shareholder.

Elizabeth Nabel speaks at a news conference, Oct. 7, 2019 (Elise Amendola/AP Images)

Brigham and Wom­en's pres­i­dent Eliz­a­beth Nabel fol­lows Mon­cef Slaoui off Mod­er­na's board

Amid recent scrutiny on how Moderna’s top executives have been cashing out their increasingly valuable shares, the biotech is parting ways with a board member who’s also heading a hospital where its Covid-19 vaccine is being tested.

Elizabeth Nabel — the president of Brigham and Women’s Hospital — has followed in Moncef Slaoui’s footsteps in resigning from Moderna’s board of directors. She took the role in 2015, two years before the Operation Warp Speed leader did; and as with Slaoui and MIT professor Robert Langer, her term was due to expire in 2021.

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Tony Coles, Cerevel Therapeutics CEO

Adding $445M, Tony Coles and his big Pfiz­er neu­ro spin­out hitch a ride to Wall Street on Per­cep­tive’s SPAC

Two years ago, after Pfizer abruptly shut down its entire neuroscience division, Bain Capital bet $350 million that those assets were still worth something and packaged them into a new biotech: Cerevel Therapeutics. A year later, they got seasoned executive Tony Coles, who had recently jumped back into the C-suite of another neuroscience startup, to run the company.

Now Coles is steering Cerevel public, in what he says is the largest ever transaction of its kind. Cerevel has agreed to merge with Perceptive Advisors’ specialty acquisition company ARYA II. Between the roughly $125 million Perceptive raised through ARYA and an additional investment of $320 million Bain Capital, Perceptive and — yes, really — Pfizer, among others, Cerevel will now move forward with an added $445 million in its coffers.

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Sanofi and GSK say they're near a vac­cine deal with EU hours af­ter fi­nal­iz­ing Warp Speed con­tract

On the heels of landing the largest Warp Speed contract to date, Sanofi and GlaxoSmithKline continued to make moves Friday afternoon.

The two companies announced they are in advanced discussions with the EU to supply up to 300 million doses of their Covid-19 vaccine candidate, coming just a few hours after securing their $2.1 billion deal with the US. Should the agreement be finalized, all EU member states will have the option to purchase the vaccine.

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Roche de­clares a PhI­II fail­ure for Covid-19 as the IL-6 re­pur­pos­ing the­o­ry bites the dust

Another big IL-6 drug has failed to move the needle for Covid-19 patients, leaving that particular field of repurposed drug R&D on the ropes for the pandemic.

This morning it was Roche’s turn to outline a Phase III failure for Actemra, adding compelling data that have now all but extinguished the theory that an IL-6 drug could significantly help the most severely afflicted patients. That comes just weeks after Regeneron and Sanofi hit the red light on their trial for Kevzara after getting back-to-back readouts that made Roche’s trial a long shot at best.

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Sandy Macrae, Sangamo CEO

No­var­tis turns to Sang­amo with a $795M-plus deal aimed at us­ing zinc fin­ger tech for the neu­ro pipeline

When Novartis recruited Ricardo Dolmetsch from Stanford to lead its neuroscience group, great emphasis was placed on decoding genomics and the brain circuitry to find new breakthroughs for the beleaguered field. Seven years and a failed Fragile X therapy later, he has a new tool to go after some of these targets his team has unearthed.

In a new collaboration, Novartis is paying Sangamo Therapeutics $75 million upfront to leverage zinc finger protein transcription factors in the regulation of three genes ties to autism — a core focus of Dolmetsch’s academic research days — intellectual disability and other neurodevelopmental disorders. Another $720 million in milestones are on the table, alongside a pledge to reimburse all of Sangamo’s research work.

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Ludwig Hantson, Alexion CEO

UP­DAT­ED: The lead drug in Alex­ion’s $930M buy­out deal last fall just flopped — adding in­jury to an­a­lysts’ M&A in­sults

When Alexion $ALXN put down $930 million in cash last fall to buy Achillion, the biotech’s top execs were particularly proud of 2 clinical-stage assets, with a spotlight on the lead drug danicopan (ACH-4471) in Phase II. That drug, along with a companion therapy in Phase I, fit right in their R&D wheelhouse, noted CEO Ludwig Hantson.

But now the lead drug, redubbed ALXN2040, is being washed out and repositioned after failing 2 Phase II trials for C3 Glomerulopathy.

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