Team build­ing. Pipeline re­vamp. For­ward thrust. What does a decade of deals at Gilead tell us about Daniel O’Day’s first M&A moves?

Daniel O’Day during Roche’s annual results media conference in Basel, 2018. AP Images

Today marks the start to Daniel O’Day’s first full week as CEO of Gilead. And if the slate of new hires to the helm of large cap companies over the last 2 years helps highlight the path ahead, one of his first major acts will likely be a full pipeline review with a clean out and some new deals put into play, after he puts his top team together.

Team building is job #1, because the founders are all gone. But with biotech buyouts all the rage right now, can O’Day — a longtime Roche veteran — afford to wait out the M&A game now in full swing?

Gilead has made industry history with 2 big buyouts — the Pharmasset deal, which was incredibly successful though short lived for brilliance, and the more recent Kite acquisition in 2017. Kite vaulted Gilead to the front of the CAR-T line, but it’s brand new, with only a trickle of revenue from a leading drug and lots of questions about new and better rivals in the pipeline.

Their recent $820 million write-off related to Kite has raised alarms about more to come.

The company is seeing dwindling hep C revenue, but has a stable fortune coming in from HIV, where they continue to successfully defend the kingdom with new, easier to use therapies.

That’s not really exciting anyone, though, about a bigger, brighter future. Its big NASH drug selonsertib just flunked a Phase III, as investors are wondering who can really make a dent in that field. As for Gilead, it’s completed a slate of NASH deals, likely in search of a new cocktail that can dominate an emerging market. But that’s going to take time. And while some analysts are speculating about a blockbuster future for filgotinib, Pfizer’s safety issues with its JAK inhibitor Xeljanz has raised serious safety issues for the class.

So where does Gilead turn now?

For some insight, we turned to Chris Dokomajilar at DealForma to give us the panoramic view of Gilead’s dealmaking record over the last 10 years, which you can see in detail below.

The summary:

— 71 deals involving Gilead on either side of the deal since Jan. 2008
— 45 of these with Gilead on the buying side

These include:

— 10 acquisitions
— 23 development and commercialization in-licenses
— 4 R&D partnerships
— 2 academic partnerships
— 6 others, service deals, etc. plus its $125 million deal to buy a priority review voucher

Soon after its Kite deal, Gilead followed up with a pact to scoop up Cell Design Labs for $567 million, fitting squarely into former CEO John Milligan’s plan to remain a leader in the cell therapy field. But Gilead is not typically a blue-sky venturer, looking for lots and lots of discovery deals. The company tends to be highly focused on acquisitions and development deals, with an emphasis on commercialization.

Its R&D group under former research chief Norbert Bischofberger has a reputation for moving fast, efficiently and ruthlessly through Phase III. When they are on track, Gilead can be a very effective R&D machine. But that’s a rep that takes years to build and months to lose.

Just ask Celgene.

Seven of its 23 development and commercialization in-licensing pacts were preclinical, with 9 in the platform realm and the rest scattered from Phase I to Phase III.

We know what Gilead has done. Now it’s up to O’Day to tell us what’s next.

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Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Matt Gline (L) and Pete Salzmann

UP­DAT­ED: Roivant bumps stake in Im­muno­vant with a $200M deal. But with M&A off the ta­ble, shares crater

Roivant has worked out a deal to pick up a chunk of stock in its majority-owned sub Immunovant $IMVT, but the stock buy falls far short of its much-discussed thoughts about buying out all of the 43% of shares it doesn’t already own.

Roivant, which recently inked a SPAC move to the market at a $7 billion-plus valuation, has forged a deal to boost its ownership in Immunovant by 6.3 points, ending with 63.8% of the biotech’s stock following a $200 million injection. That cash will bolster Immunovant’s cash reserves, giving it a $600 million war chest to fund a slate of late-stage studies for its big drug: the anti-FcRn antibody IMVT-1401.

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Rick Pazdur (via AACR)

FDA's on­col­o­gy head Rick Paz­dur de­fends the ac­cel­er­at­ed ap­proval path­way, claim­ing it is 'un­der at­tack'

The FDA is sounding the alarm over its accelerated approval pathway as backlash continues over the recent nod in favor of Biogen’s Alzheimer’s drug Aduhelm, and an ODAC meeting on six such approvals that could potentially be pulled from the market — two of which already have.

“Do you think accelerated approval is under attack? I do,” Rick Pazdur, head of FDA’s Oncology Center of Excellence, said at a Friends of Cancer Research webinar on Thursday.

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Sanofi preps a multi­bil­lion-dol­lar buy­out of an mR­NA pi­o­neer af­ter falling be­hind in the race for a Covid-19 jab — re­port

It looks like Sanofi CEO Paul Hudson is dead serious about his intention to vault directly into contention for the future of mRNA vaccines.

A year after paying Translate Bio a whopping $425 million in an upfront and equity payment to help guide the pharma giant to the promised land of mRNA vaccines for Covid-19, Sanofi is reportedly ready to close the deal with a buyout.

Translate’s stock $TBIO soared 78% after the market closed Monday. A spokesperson for Sanofi declined to comment on the report, telling Endpoints News that the company doesn’t comment on market rumors.

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Bris­tol My­ers pulls lym­phoma in­di­ca­tion for Is­to­dax af­ter con­fir­ma­to­ry tri­al falls flat

Amid an industrywide review of cancer drugs with accelerated approval, Bristol Myers Squibb had to make the tough call last month to yank an approval for leading I/O drug Opdivo after flopping a confirmatory study. Now, a second Bristol Myers drug is on the chopping block.

Bristol Myers has pulled aging HDAC inhibitor Istodax’s indication in peripheral T cell lymphoma after a Phase III confirmatory study for the drug flopped on its progression-free survival endpoint, the drugmaker said Monday.

UP­DAT­ED: Watch out Glax­o­SmithK­line: As­traZeneca's once-failed lu­pus drug is now ap­proved

Capping a roller coaster journey, AstraZeneca has steered its lupus drug anifrolumab across the finish line.

Saphnelo, as the antibody will be marketed, is the only treatment that’s been approved for systemic lupus erythematosus since GlaxoSmithKline’s Benlysta clinched an OK in 2011. The British drugmaker notes it’s also the first to target the type I interferon receptor.

Mirroring the population that the drug was tested on in late-stage trials, regulators sanctioned it for patients with moderate to severe cases who are already receiving standard therapy — setting up a launch planned for the end of August, according to Ruud Dobber, who’s in charge of AstraZeneca’s biopharmaceuticals business unit.

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How the bio­phar­ma in­dus­try is help­ing to pay for the bi­par­ti­san in­fra­struc­ture bill

Senators on Sunday finalized the text of a massive, bipartisan infrastructure bill that contains little that might impact the biopharma industry other than two ways the legislators are planning to pay for the $1.2 trillion deal.

On the one hand, senators are seeking to further delay a Trump-era Medicare Part D rule related to drug rebates, this time until 2026. Senators claim the rule could end up saving about $49 billion, but the PBM industry has attacked it as it would remove rebates from a safe harbor that provides protection from federal anti-kickback laws. The pharmaceutical industry, however, is in favor of the rule and opposes this latest delay as it continues to point its finger at the PBM industry for the rising cost of out-of-pocket expenses.

Not all mR­NA vac­cines are cre­at­ed equal. Does it mat­ter?; Neu­ro is back; Pri­vate M&A af­fair; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As part of our broader and deeper drive, Endpoints has been pairing webinars with our special reports to cover more angles on a given topic. In conjunction with Max Gelman’s neuroscience feature, Kyle Blankenship moderated an insightful panel to discuss where the field is headed. You can register to watch it on demand here.

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FTC pulls re­main­ing case against Ab­b­Vie; New EU clin­i­cal tri­als sys­tem com­ing in 2022; Abing­worth bets big on CymaBay

The Federal Trade Commission on Friday withdrew its remaining case against AbbVie after the Supreme Court declined to review a lower court’s ruling.

The punt by SCOTUS means that while the Illinois pharma company illegally blocked patients’ access to lower-cost alternatives to its testosterone drug AndroGel, the FTC will no longer be able to return about $500 million directly to AndroGel consumers.