Ab­b­Vie gets its first ap­proval for a drug ex­ecs be­lieve could be worth up to $5B in an­nu­al sales

Ab­b­Vie has tacked down its first reg­u­la­to­ry ap­proval for risankizum­ab as it be­gins what it hopes is a glob­al roll­out for the pso­ri­a­sis drug in 2019 with a plan to quick­ly at­tain megablock­buster sta­tus.

Japan be­came the first coun­try to stamp an OK on the drug, which has been dubbed Skyrizi for the mar­ket­ing cam­paign. Eval­u­ate has tagged this IL-23 drug as the num­ber 3 block­buster on its list of heavy­weight drugs look­ing at a 2019 launch. They be­lieve this drug could earn more than $2 bil­lion in 2024.

That’s peanuts com­pared to the $4 bil­lion to $5 bil­lion rev­enue es­ti­mates of­fered by the Ab­b­Vie team, who are anx­ious to have a suc­ces­sor to Hu­mi­ra as it winds down to the US patent cliff, like­ly in 2023.

Ab­b­Vie paid Boehringer $595 mil­lion up­front to li­cense rights to risankizum­ab in ear­ly 2016. In a Phase III dou­ble head­er re­port­ed in the fall of 2017, re­searchers pit­ted the drug against Ste­lara (ustek­inum­ab) and Hu­mi­ra (adal­i­mum­ab). Their top prospect came through on all scores, out­pac­ing the oth­er two in clear­ing pso­ri­a­sis while the place­bo arm com­par­i­son num­bers bare­ly budged. It’s a hy­per com­pet­i­tive field, though, with a num­ber of new drugs carv­ing up the mar­ket­place.

Glob­al Da­ta high­light­ed the “im­por­tant” first step, but notes that this ap­proval will do lit­tle in terms of hit­ting that block­buster goal. Their an­a­lysts es­ti­mate 2027 rev­enue in Japan at $28 mil­lion.

The big mon­ey awaits in the US and then Eu­rope, where reg­u­la­tors are now pon­der­ing Ab­b­Vie’s ap­pli­ca­tions. Japan’s ap­proval is an in­di­ca­tion of good odds on both sides of the At­lantic.

Bar­clays, mean­while, looked over the hy­per com­pet­i­tive land­scape and raised ques­tions about the drug’s po­ten­tial.

Ab­b­Vie’s Hu­mi­ra con­tin­ues to dom­i­nate de­spite the in­tro­duc­tion of new­er bi­o­log­ics in­clud­ing: JNJ’s an­ti-IL23 Trem­fya, JNJ’s an­ti-IL12/23 Ste­lara, and Lil­ly’s an­ti-IL-17 Taltz (see Fig­ure 1 and 2)—with its own an­ti-IL23 mirik­izum­ab in phase 3 de­vel­op­ment for both pso­ri­a­sis and ul­cer­a­tive col­i­tis. More­over, de­spite be­ing po­si­tioned as a best-in-class op­tion, risankizum­ab failed in a proof-of-con­cept anky­los­ing spondyli­tis study, rais­ing ad­di­tion­al ques­tions over its pro­file as Ab­b­Vie ex­pands late-stage de­vel­op­ment in­to Crohn’s dis­ease, ul­cer­a­tive col­i­tis, pso­ri­at­ic arthri­tis, and asth­ma.

The PDU­FA date should be on or close to April 25th.

Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Bris­tol My­ers Squibb fi­nal­ly gets in the front­line NSCLC game dom­i­nat­ed by Mer­ck, adding a sec­ond Op­di­vo/Yer­voy-based op­tion

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Stymied by the pan­dem­ic, Im­munomedic­s' new CEO bows out, tak­ing a mil­lion bucks plus perks as he heads out the vir­tu­al ex­it

Just a little more than a month since taking over as the latest CEO to helm Immunomedics, $IMMU Harout Semerjian is exiting the company after being confronted by “logistical” obstacles thrown up by the pandemic that made it impossible for him to move from London to carry out the job. And he’s getting a little over a million dollars in cash plus perks to grease the skids on the way out.

Word of the changeup arrived right after the market closed Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 82,400+ biopharma pros reading Endpoints daily — and it's free.