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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Tom Barnes, Orna Therapeutics CEO

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Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

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Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

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The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

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The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

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As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Kate Haviland, Blueprint Medicines CEO

Blue­print met all its end­points in bid for ex­pand­ed Ay­vak­it la­bel — but stock trends low­er any­way

Blueprint Medicines announced this morning that the second part of its study on Ayvakit in non-advanced systemic mastocytosis (SM) — a rare disease in which a type of white blood cells known as mast cells builds up — met all endpoints, but the biopharma left key questions unanswered.

In 212 patients, with 141 in the treatment arm and 71 in the control arm, patients who got Ayvakit saw an average 15.6-point decrease in their symptom scores compared to a 9.2-point decrease in the placebo arm at 24 weeks. In an extension study, those on Ayvakit saw their symptom scores drop by 20.2 points by week 48.

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CSL CEO Paul Per­reault de­ter­mined to grow plas­ma col­lec­tion af­ter full-year sales dip

As the ink dries on CSL’s $11.7 billion Vifor buyout, the company posted a dip in profits, due in part to a drop in plasma donations amid the pandemic.

However, CEO Paul Perreault assured investors and analysts on the full-year call that the team has left “no stone unturned” when assessing options to grow plasma volumes. The chief executive also spelled out positive results for the company’s monoclonal antibody garadacimab in hereditary angioedema (HAE), though he isn’t revealing the exact numbers just yet.

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En­do files for Chap­ter 11 as it looks to fin­ish off its opi­oid lit­i­ga­tion

Irish drugmaker Endo International is entering into bankruptcy as it faces the weight of serious litigation related to its involvement in the opioid epidemic in the US.

The company has filed Chapter 11 proceedings in the US Bankruptcy Court for the Southern District of New York, with the company expected to file recognition proceedings in Canada, the UK and Australia. The company’s bankruptcy filing showed the company had assets and liabilities in the range of $1 billion to $10 billion.