Mas­ter deal­mak­er? Medi­va­tion CEO David Hung’s overzeal­ous PARP as­sault falls flat

Medi­va­tion doesn’t look any fur­ther ahead now that the CEO is pub­licly de­fend­ing the as­set like a dog de­fends a bone


John Car­roll, Ed­i­tor

Back when David Hung was build­ing Medi­va­tion as a pipeline com­pa­ny, he per­suad­ed Pfiz­er to fork over $225 mil­lion as an up­front to part­ner on dime­bon, a Russ­ian an­ti­his­t­a­mine that had shown some ac­tiv­i­ty for Alzheimer’s in ear­ly stud­ies. Dime­bon went on to be­come an em­bar­rass­ing fi­as­co, fail­ing two ex­pen­sive Phase III stud­ies. And I can re­call Hung dis­count­ing the sig­nif­i­cance of the pro­gram to his com­pa­ny when he was be­tween late-stage flops. Af­ter all, he told me, Pfiz­er had paid for that work al­ready.

Hung and Medi­va­tion went on to glo­ry with Xtan­di, and the CEO clear­ly nev­er lost the abil­i­ty to tout ear­ly da­ta and look for an edge wher­ev­er he can find it. He is wide­ly re­gard­ed as one of the best deal­mak­ers in the busi­ness, and now that he’s bar­gain­ing over the sale of his com­pa­ny with Sanofi and like­ly Pfiz­er, Cel­gene and oth­ers, he’s pulling out all the stops to go for the high­est pos­si­ble price he can get – and then some.

That win-at-all-costs men­tal­i­ty was on dis­play Wednes­day evening, as Hung went to work on the one as­set he has with a wild­ly un­cer­tain val­ue: Medi­va­tion’s PARP in­hibitor ta­la­zoparib. Tak­ing a frag­ment of da­ta, he claimed that ta­la­zoparib was clear­ly the best of four con­tenders, far sur­pass­ing Tesaro’s ni­ra­parib, As­traZeneca’s Lyn­parza (ola­parib) and Ab­b­Vie’s veli­parib.

Ta­la­zoparib, he told an­a­lysts on a call, is a “multi­bil­lion-dol­lar op­por­tu­ni­ty.”

The drug, he ex­plained, is a PARP trap­per, far bet­ter at de­stroy­ing can­cer cells that an enyzme in­hibitor. There was more. Lots more. And he went far be­yond the com­pa­ny’s first stab at high­light­ing the drug’s spe­cial po­ten­tial.

David Hung, Medi­va­tion CEO

The oth­er drugs failed to mea­sure up, he said. There were safe­ty is­sues and so on. He said every­thing pos­si­ble that could build up the val­ue of ta­la­zoparib as the “best-in-class” op­por­tu­ni­ty in a de­vel­op­ing $30 bil­lion mar­ket. And he made a short at­tack on the com­pe­ti­tion as sor­ry, sec­ond-raters.

Here’s the full Pow­er­Point pre­sen­ta­tion.

Bot­tom line: If Sanofi ex­ecs think they can get that drug for a $3 CVR, they have to be dream­ing.

Medi­va­tion got this drug just a year ago, pay­ing out $410 mil­lion up­front. That’s a sig­nif­i­cant amount, and it suc­cess­ful­ly fo­cused a lot of at­ten­tion as the top prospect in the clin­ic. It cer­tain­ly war­rants more than the pass­ing men­tion re­served for pidilizum­ab, the PD-1 drug that em­bar­rass­ing­ly proved not to be a PD-1 drug. The FDA tem­porar­i­ly halt­ed work on a tri­al so reg­u­la­tors could get a bet­ter fix on the drug. (Medi­va­tion’s at­ti­tude: Hey, it works some­how, so it’s im­por­tant.)

The CEO is in the fight of his pro­fes­sion­al ca­reer. With the com­pa­ny in play, the best out­come for Hung here is that some­body pays a record price for his as­sets. And he’ll say any­thing to make that hap­pen.

The PARP war, though, is far from over. Medi­va­tion’s stock is up just a few cents this morn­ing. These bid­ders can as­sess the val­ue of a Phase III prospect as well as any­one. And Medi­va­tion doesn’t look any fur­ther ahead now that the CEO is pub­licly de­fend­ing the as­set like a dog de­fends a bone. If any­thing, he may have dam­aged his case by go­ing over­board on the zeal­ous as­sault.

— John Car­roll @John­Cendpts

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.

NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

No, sci­en­tists are not any clos­er to pig-to-hu­man trans­plants than they were last week

Steve Holtzman was awoken by a 1 a.m. call from a doctor at Duke University asking if he could put some pigs on a plane and fly them from Ohio to North Carolina that day. A motorcyclist had gotten into a horrific crash, the doctor explained. He believed the pigs’ livers, sutured onto the patient’s skin like an external filter, might be able to tide the young man over until a donor liver became available.

UP­DAT­ED: Agenus calls out FDA for play­ing fa­vorites with Mer­ck, pulls cer­vi­cal can­cer BLA at agen­cy's re­quest

While criticizing the FDA for what may be some favoritism towards Merck, Agenus on Friday officially pulled its accelerated BLA for its anti-PD-1 inhibitor balstilimab as a potential second-line treatment for cervical cancer because of the recent full approval for Merck’s Keytruda in the same indication.

The company said the BLA, which was due for an FDA decision by Dec. 16, was withdrawn “when the window for accelerated approval of balstilimab closed,” thanks to the conversion of Keytruda’s accelerated approval to a full approval four months prior to its PDUFA date.

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How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data are messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data are exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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Marty Duvall, Oncopeptides CEO

On­copep­tides stock craters as it pulls can­cer drug Pepax­to from the mar­ket

Shares of Oncopeptides crashed more than 70% in early Friday trading after the company said it’s pulling its multiple myeloma drug Pepaxto (melphalan flufenamide) from the US market after failing a confirmatory trial. The move will force the company to close its US and EU business units and enact significant layoffs.

The FDA had scheduled an adcomm meeting next Thursday to discuss Pepaxto, which first won accelerated approval in February and costs about $19,000 per course of treatment. The committee was to weigh in on whether the confirmatory trial demonstrated a worse overall survival in the treatment arm compared to the control arm.

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Pfiz­er pitch­es its Covid-19 vac­cine for younger chil­dren ahead of ad­comm next week

Pfizer will present its case to the FDA’s vaccine adcomm next week, seeking authorization for a lower-dose version of its Covid-19 vaccine for kids ages 5 through 12, which the Biden administration said will likely begin rolling out early next month.

Two primary doses of the 10 µg vaccine (the dose for those ages 12 and up is 30 μg) given 3 weeks apart in this group of children “have shown a favorable safety and tolerability profile, robust immune responses against all variants of concern including Delta, and vaccine efficacy of 90.7% against laboratory-confirmed symptomatic COVID-19,” the company said in briefing documents ahead of next Tuesday’s meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

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