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.

 

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

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Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

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Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

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Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Bris­tol My­ers Squibb fi­nal­ly gets in the front­line NSCLC game dom­i­nat­ed by Mer­ck, adding a sec­ond Op­di­vo/Yer­voy-based op­tion

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.