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

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Giovanni Caforio, Bristol Myers Squibb CEO (Christopher Goodney/Bloomberg via Getty Images)

Here's how Bris­tol My­er­s' CEO Gio­van­ni Caforio com­plet­ed a $13B buy­out: He moved fast, upped the bid quick­ly and de­mand­ed every­one to keep up

Bristol Myers Squibb CEO Giovanni Caforio does not waste time. He also likes everyone around him to keep up.

Anyone reading over the insider account filed with the SEC of the back-and-forth over his $13 billion buyout of MyoKardia $MYOK could reach only one conclusion: The CEO who had willingly crafted a $74 billion Celgene acquisition had found something else he liked — and he was willing to pay a nice premium to get it.

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Derek Chalmers, Cara Therapeutics CEO

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $2 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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UP­DAT­ED: CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

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With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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