The wild card: Just how much is Medi­va­tion’s ta­la­zoparib worth?


Now that Sanofi has backed off its saber rat­tling and won a seat at the bar­gain­ing ta­ble with a sweet­ened of­fer for Medi­va­tion, much of the fo­cus will turn to the ex­per­i­men­tal PARP in­hibitor ta­la­zoparib. Medi­va­tion bought the drug last year from Bio­Marin for $410 mil­lion cash, adding $160 mil­lion on the back end of the deal. And it’s proven to be the wild card in this high-stakes game of biotech M&A.

Medi­va­tion made a rep­u­ta­tion for it­self de­vel­op­ing Xtan­di, the block­buster prostate can­cer drug. It’s build­ing its rep­u­ta­tion around grow­ing sales. And any­one who comes in with a win­ning bid — whether that’s Sanofi or Pfiz­er or Cel­gene or any oth­er com­pa­ny — is go­ing to have to pay a pre­mi­um for that.

Ta­la­zoparib, though, is the one thing in Medi­va­tion’s pipeline that can add a thick ex­tra lay­er of cash to any win­ning bid, and its ex­ecs have been mak­ing the case that this is a new block­buster in the mak­ing with multi­bil­lion-dol­lar sales po­ten­tial.

Jen­nifer Jar­rett, CFO of Medi­va­tion

“Ta­la­zoparib can be an even big­ger prod­uct” than Xtan­di, Medi­va­tion CFO Jen­nifer Jar­rett tells me. Jar­rett’s brand new to the com­pa­ny, but she’s now part of the front­line crew at Medi­va­tion that is look­ing to go far past Sanofi’s lat­est bid of $58 a share plus a $3 CVR for ta­la­zoparib sales be­fore it ac­cepts an of­fer.

Val­u­a­tions on these prod­ucts are all over the map. Gold­man once fore­cast peak sales of ta­la­zoparib at a mod­est $325 mil­lion. When As­traZeneca was fight­ing off Pfiz­er, it bold­ly put a $2 bil­lion peak sales fig­ure on Lyn­parza (ola­parib). And now a chas­tened Clo­vis is pur­su­ing a rolling sub­mis­sion for its PARP in­hibitor ru­ca­parib, hop­ing it can save the com­pa­ny af­ter a midair ex­plo­sion for rocile­tinib.  Ab­b­Vie is al­so in this race.

The leader is Tesaro, which just un­veiled promis­ing da­ta for ni­ra­parib and is now on its way to the FDA with an ap­pli­ca­tion for ovar­i­an can­cer. Their da­ta high­light a clear im­pact for the tar­get­ed drug in a pop­u­la­tion of germline BR­CA mu­ta­tion car­ri­ers, with a me­di­an PFS of 21 months in the drug group com­pared to 5.5 months in the con­trol arm — a 15.5-month ad­van­tage.

I talked to Jar­rett ahead of the lat­est de­vel­op­ments with Sanofi and Tesaro, but Medi­va­tion was prepped for pos­i­tive da­ta on the ri­val drug. Tesaro’s suc­cess, she says, would help de­risk the whole field.

“It’s pos­i­tive for the class,” she says, and there’s a case that can be made that “we think ours is more po­tent.”

In a se­ries of slides, Jar­rett — who de­clined to pro­vide a peak sales es­ti­mate for ta­la­zoparib — went on to com­pare some of the safe­ty and ef­fi­ca­cy da­ta that’s avail­able for the four con­tenders in this mar­ket.

Medi­va­tion doesn’t have a lot of da­ta to go by. But in a small Phase I study in­ves­ti­ga­tors tracked a 57% over­all re­sponse rate for BR­CA-mu­tat­ed ovar­i­an can­cer. There were al­so sev­er­al re­spons­es in non-BR­CA mu­tat­ed cas­es, in­di­cat­ing a po­ten­tial­ly broad­er use for this drug.

 


Ola­parib, which is al­so in line for a bad­ly need­ed Phase III up­date soon, was ap­proved by the FDA with a 34% ORR, says Medi­va­tion.

Medi­va­tion al­so tai­lored some safe­ty da­ta to look at ad­verse events among more than 10% of the pa­tients stud­ied. Not sur­pris­ing­ly, it looked pret­ty good for ta­la­zoparib.

Any fi­nal an­swers on the val­u­a­tion ques­tions will have to wait on late-stage da­ta. There’s the Phase III Em­bra­ca tri­al for BR­CA-mu­tat­ed breast can­cer which reads out in the first half of 2017. There’s a reg­is­tra­tion study be­ing prepped with the FDA on prostate can­cer — which would put it in com­pe­ti­tion with J&J, which re­cent­ly land­ed the prostate can­cer rights to ni­ra­parib. There’s al­so a Phase III for small cell lung can­cer — where they’ve tracked sin­gle-agent ac­tiv­i­ty — that could get go­ing lat­er this year. And Medi­va­tion is def­i­nite­ly in­clud­ing the chance for an ac­cel­er­at­ed ap­proval.

Who­ev­er wins the auc­tion for Medi­va­tion will like­ly wind up in a head-to-head bat­tle with As­traZeneca, still work­ing with a weak case that couldn’t win over the FDA’s out­side ex­perts, as well as an up-and-com­ing Tesaro, part­nered with J&J. Clo­vis can’t af­ford yet an­oth­er de­ba­cle, and will be play­ing for its life. And Ab­b­Vie will be wait­ing in the wings with a less­er known drug of its own.

That won’t make it easy for the sales team to de­liv­er on Medi­va­tion’s best case sce­nario. So don’t be sur­prised if Medi­va­tion tries hard to fight off the CVR, look­ing for an up­front pay­ment on its block­buster case for ta­la­zoparib.

In biotech, it’s of­ten eas­i­er to make a case for an ex­per­i­men­tal drug than it is to de­liv­er on one. But this game is get­ting clos­er to a wrap. And the com­pa­ny plans to fol­low up with a spe­cial pre­sen­ta­tion on this top­ic lat­er to­day as it con­tin­ues to press its ar­gu­ment.

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In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

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