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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Terrie Curran, Phathom CEO (Credit: Arcutis)

Phath­om's old Take­da drug bests Pre­vacid in a PhI­II GI tri­al. Next stop? The FDA

There’s no time for rest in biopharma — at least not at Phathom Pharmaceuticals. Just over a month after submitting two NDAs for its lead acid-fighter vonoprazan, the biotech is already lining up a third, and collecting an extra $50 million to push things along.

Vonoprazan met its primary non-inferiority endpoints in a Phase III study comparing it to standard-of-care Prevacid in a type of gastroesophageal reflux disease (GERD) called erosive esophagitis (EE). It also proved superior to the popular heartburn drug by multiple measures, including healing rate and maintenance of healing.

Thomas Lingelbach, Valneva CEO

Small biotech says its Covid-19 vac­cine spurs more an­ti­bod­ies than As­traZeneca’s. Will sup­ply deals come now?

In a first, a small runner-up vaccine developer says its own Covid-19 jab has induced “superior neutralizing antibody titer levels” over AstraZeneca’s AZD1222 when pitted head-to-head in a Phase III trial.

That and non-inferiority in seroconversion rate were the co-primary endpoints of the trial, which recruited 4,012 adult volunteers across the UK.

But on the exploratory endpoint of Covid-19 case counts, Valneva notes that both treatment groups saw a similar number of infections.