Medi­va­tion to Sanofi (in trans­la­tion): You don't know beans about can­cer drug de­vel­op­ment(!)

At this stage in a hos­tile M&A game, the best de­fense lies in a great of­fense. And Medi­va­tion is out to be as of­fen­sive as pos­si­ble. To be spe­cif­ic, Medi­va­tion’s ex­ec­u­tive team doesn’t think high­ly of Sanofi, its bid for the com­pa­ny, or its abil­i­ty to eval­u­ate and de­vel­op new can­cer drugs.

In a let­ter to share­hold­ers, shared wide­ly with the busi­ness press, Medi­va­tion com­pared and con­trast­ed Sanofi’s po­si­tion, ridi­cul­ing its 50% pre­mi­um of­fer (that came af­ter the Great Bear Mar­ket hit every­one).

Then there’s the X Fac­tor.

“The me­di­an two-year for­ward rev­enue mul­ti­ple of high growth biotech­nol­o­gy and on­col­o­gy trans­ac­tions in the last five years is 10.4×1,” says Medi­va­tion. “Even Sanofi’s ex­am­ple of Pfiz­er’s ac­qui­si­tion of Ana­cor re­flects an im­plied two-year for­ward rev­enue mul­ti­ple of 24.2x, sig­nif­i­cant­ly high­er than the 6.3×2 mul­ti­ple im­plied by Sanofi’s pro­pos­al.

“Phar­ma­cyclics – the most rel­e­vant high-growth on­col­o­gy peer in our view – was ac­quired at a two-year for­ward rev­enue mul­ti­ple of 11.5x.”

All that is sim­ple math and Medi­va­tion wants the best for­mu­la it can get. Where Medi­va­tion gets down and dirty is when the biotech com­pares its record on can­cer drug de­vel­op­ment with Sanofi’s.

Sanofi fa­mous­ly tried to make on­col­o­gy a big part of the pipeline af­ter ex-CEO Chris Viehbach­er took over. But their big drug foundered in the clin­ic, forc­ing a re­or­ga­ni­za­tion and leav­ing be­hind some con­sid­er­able em­bar­rass­ment that Medi­va­tion is play­ing off of now. Sales in on­col­o­gy dropped by al­most half at the phar­ma gi­ant over the last 4 years, says the biotech, while its block­buster rev­enue has been grow­ing.

Says Medi­va­tion: “Sanofi’s lack of in­sight and suc­cess in on­col­o­gy, in our view, ex­plains its re­luc­tance or in­abil­i­ty to as­cribe ap­pro­pri­ate val­ue to our pipeline.”

The com­pa­ny is talk­ing about ta­la­zoparib, Medi­va­tion’s PARP in­hibitor which is tak­ing on some ma­jor league ri­vals, in­clud­ing J&J.

Ta­la­zoparib is a block­buster op­por­tu­ni­ty, with some ev­i­dence to sug­gest it’s the best PARP in­hibitor out there (see be­low). If Sanofi gets ahold of it, Medi­va­tion says, they’ll just screw it up.

Why?

“Sanofi has had long-stand­ing in­ter­est in ta­la­zoparib’s mech­a­nism of ac­tion (PARP in­hi­bi­tion) but a poor un­der­stand­ing of it, tout­ing a mol­e­cule it ac­quired from Bi­Par in 2009 as a PARP in­hibitor and a pro­gram key to the re­vi­tal­iza­tion of its can­cer busi­ness. How­ev­er, af­ter two failed phase 3 tri­als, it was dis­cov­ered that the Bi­Par PARP in­hibitor (ini­parib) did not in­hib­it PARP and the pro­gram was dis­con­tin­ued less than 18 months be­fore FDA grant­ed ac­cel­er­at­ed ap­proval to ola­parib (Lyn­parza), the first PARP in­hibitor ap­proved in the U.S.”

Here’s the back sto­ry:

Medi­va­tion ac­quired ta­la­zoparib from Bio­Marin last Au­gust for $410 mil­lion up­front and $160 mil­lion in mile­stones. Just a few months ago, J&J struck back by bag­ging the prostate can­cer rights on Tesaro’s ni­ra­parib, set­ting the stage for a new show­down be­tween Medi­va­tion’s Xtan­di fran­chise and J&J’s Zyti­ga.

As­traZeneca gained a pi­o­neer­ing ap­proval for its PARP in­hibitor, Lyn­parza, at the end of 2014. Clo­vis, mean­while, has ru­ca­parib, which earned the FDA’s break­through drug des­ig­na­tion. And Clo­vis has plen­ty to prove af­ter watch­ing its lead pro­gram im­plode amid some prob­ing ques­tions about how the com­pa­ny had pre­sent­ed, or pos­si­bly mis­rep­re­sent­ed, the da­ta on it.

None of this, though, is re­al­ly about Sanofi’s R&D ex­per­tise. Sanofi and Re­gen­eron are now ad­vanc­ing their fa­mous col­lab­o­ra­tion in­to on­col­o­gy. What it is about is the amount the com­pa­ny is of­fer­ing for the buy­out. If they ever can agree on the mon­ey, or some­one else comes along with a bet­ter of­fer, Medi­va­tion and ta­la­zoparib will sim­ply go to the high­est bid­der.

 

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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