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.

 

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Bob Smith, Pfizer

Pfiz­er is mak­ing a $500M state­ment to­day: Here’s how you be­come a lead play­er in the boom­ing gene ther­a­py sec­tor

Three years ago, Pfizer anted up $150 million in cash to buy Bamboo Therapeutics in Chapel Hill, NC as it cautiously stuck a toe in the small gene therapy pool of research and development.

Company execs followed up a year later with a $100 million expansion of the manufacturing operations they picked up in that deal for the UNC spinout, which came with $495 million in milestones.

And now they’re really going for it.

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Video: Putting the AI in R&D — with Badhri Srini­vasan, Tony Wood, Rosana Kapeller, Hugo Ceule­mans, Saurabh Sa­ha and Shoibal Dat­ta

During BIO this year, I had a chance to moderate a panel among some of the top tech experts in biopharma on their real-world use of artificial intelligence in R&D. There’s been a lot said about the potential of AI, but I wanted to explore more about what some of the larger players are actually doing with this technology today, and how they see it advancing in the future. It was a fascinating exchange, which you can see here. The transcript has been edited for brevity and clarity. — John Carroll

As­traZeneca’s Imfinzi/treme com­bo strikes out — again — in lung can­cer. Is it time for last rites?

AstraZeneca bet big on the future of their PD-L1 Imfinzi combined with the experimental CTLA-4 drug tremelimumab. But once again it’s gone down to defeat in a major Phase III study — while adding damage to the theory involving targeting cancer with a high tumor mutational burden.

Early Wednesday the pharma giant announced that their NEPTUNE study had failed, with the combination unable to beat standard chemo at overall survival in high TMB cases of advanced non-small cell lung cancer. We won’t get hard data until later in the year, but the drumbeat of failures will call into question what — if any — future this combination can have left.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.