Dou­bling down on the Keytru­da fran­chise, Mer­ck pays $300M and promis­es $5B-plus to part­ner with Ei­sai on its bud­ding can­cer star

Im­pressed by the po­ten­tial of a com­bo fea­tur­ing Keytru­da with Ei­sai’s star can­cer drug Lenvi­ma (lenva­tinib me­sy­late), Mer­ck $MRK has stepped up with $300 mil­lion in cash and a com­mit­ment of more than $5 bil­lion in mile­stones to kick off a full slate of tri­als for the duo.

Roger Perl­mut­ter, Mer­ck

An oral TKI al­ready ap­proved for thy­roid can­cer and in com­bi­na­tion with everolimus for kid­ney can­cer, Ei­sai not­ed a lit­tle more than a month ago that their drug scored well in a Phase III study for first-line liv­er can­cer. And Mer­ck sees a big fu­ture for this drug tied to Keytru­da, which is now in­volved in more than 700 clin­i­cal tri­als.

In this pact, Ei­sai and Mer­ck will de­vel­op Lenvi­ma as a monother­a­py and in com­bi­na­tion with the check­point, with the two shar­ing de­vel­op­ment costs. Ei­sai will book glob­al sales while the two com­pa­nies share rev­enue. And they’ll work to­geth­er now on a pipeline of their own tar­get­ing en­dome­tri­al can­cer, non-small cell lung can­cer, he­pa­to­cel­lu­lar car­ci­no­ma, head and neck can­cer, blad­der can­cer and melanoma, as well as a bas­ket tri­al tar­get­ing mul­ti­ple can­cer types.

This deal fol­lows Mer­ck CEO Ken Fra­zier’s vow to fol­low up on his $8.5 bil­lion part­ner­ship with As­traZeneca on Lyn­parza with more such rev­enue-gen­er­at­ing pacts.

In a break­down of the mon­ey at stake, Mer­ck will be on the hook for $650 mil­lion for op­tions through 2020 and will pro­vide $450 mil­lion to re­im­burse Ei­sai on its share of the re­search costs. There’s an­oth­er $385 mil­lion on the ta­ble in de­vel­op­ment mile­stones and close to $4 bil­lion for sales goals.

What got them here?

In the RCC co­hort of Study 111/KEYNOTE-146, re­searchers tracked an ORR af­ter 24 weeks of treat­ment of 63%, with tu­mor re­gres­sion ob­served in 93% (28/30) of RCC pa­tients since the ini­ti­a­tion of treat­ment.

From their state­ment:

The re­sults of the in­ter­im analy­sis (n=23) of the en­dome­tri­al can­cer co­hort in Study 111/KEYNOTE-146 as of De­cem­ber 1, 2016, in­di­cat­ed ORR Week 24 of 52.2 per­cent (95% CI, 30.6-73.2) based on in­de­pen­dent ra­di­o­log­ic re­view and 47.8 per­cent (95% CI, 26.8-69.4) based on in­ves­ti­ga­tor re­view. Ad­di­tion­al­ly, tu­mor re­gres­sion was ob­served re­gard­less of the state of mi­crosatel­lite in­sta­bil­i­ty (MSI). An­ti-PD-1 an­ti­bod­ies are gen­er­al­ly less ef­fec­tive in pa­tients with low fre­quen­cy of MSI, which is a bio­mark­er for the in­abil­i­ty to re­pair er­rors in the base se­quence of DNA, or who are MSI neg­a­tive.

“To­geth­er with Ei­sai, we aim to max­i­mize the val­ue of Lenvi­ma for its cur­rent in­di­ca­tions while joint­ly pur­su­ing ad­di­tion­al ap­provals in com­bi­na­tion with Keytru­da across a wide range of can­cers,” said Mer­ck R&D chief Roger Perl­mut­ter. “There is strong sci­en­tif­ic ev­i­dence sup­port­ing syn­er­gis­tic ef­fects of Keytru­da when used in com­bi­na­tion with Lenvi­ma, and the com­pa­nies have al­ready re­ceived Break­through Ther­a­py Des­ig­na­tion from the U.S. FDA for the Keytru­da/Lenvi­ma com­bi­na­tion in re­nal cell car­ci­no­ma. Through this col­lab­o­ra­tion, we will both broad­en our on­col­o­gy port­fo­lio and have the op­por­tu­ni­ty to help even more can­cer pa­tients around the world.”

Im­ple­ment­ing re­silience in the clin­i­cal tri­al sup­ply chain

Since January 2020, the clinical trials ecosystem has quickly evolved to manage roadblocks impeding clinical trial integrity, and patient care and safety amid a global pandemic. Closed borders, reduced air traffic and delayed or canceled flights disrupted global distribution, revealing how flexible logistics and supply chains can secure the timely delivery of clinical drug products and therapies to sites and patients.

In fi­nal days at Mer­ck, Roger Perl­mut­ter bets big on a lit­tle-known Covid-19 treat­ment

Roger Perlmutter is spending his last days at Merck, well, spending.

Two weeks after snapping up the antibody-drug conjugate biotech VelosBio for $2.75 billion, Merck announced today that it had purchased OncoImmune and its experimental Covid-19 drug for $425 million. The drug, known as CD24Fc, appeared to reduce the risk of respiratory failure or death in severe Covid-19 patients by 50% in a 203-person Phase III trial, OncoImmune said in September.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

Al­ny­lam gets the green light from the FDA for drug #3 — and CEO John Maraganore is ready to roll

Score another early win at the FDA for Alnylam.

The FDA put out word today that the agency has approved its third drug, lumasiran, for primary hyperoxaluria type 1, better known as PH1. The news comes just 4 days after the European Commission took the lead in offering a green light.

An ultra rare genetic condition, Alnylam CEO John Maraganore says there are only some 1,000 to 1,700 patients in the US and Europe at any particular point. The patients, mostly kids, suffer from an overproduction of oxalate in the liver that spurs the development of kidney stones, right through to end stage kidney disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Bob Nelsen (Photo by Michael Kovac/Getty Images)

Bob Nelsen rais­es $800M and re­cruits a star-stud­ded board to build the 'Fox­con­n' of biotech

Bob Nelsen spent his pandemic spring in his Seattle home, talking on the phone with Luciana Borio, the scientist who used to run pandemic preparedness on the National Security Council, and fuming with her about the dire state of American manufacturing.

Companies were rushing to develop vaccines and antibodies for the new virus, but even if they succeeded, there was no immediate supply chain or infrastructure to mass-produce them in a way that could make a dent in the outbreak.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 94,100+ biopharma pros reading Endpoints daily — and it's free.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Leonard Schleifer, Regeneron CEO (Andrew Harnik/AP)

Trail­ing Eli Lil­ly by 12 days, Re­gen­eron gets the FDA OK for their Covid-19 an­ti­body cock­tail

A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.

Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.

Bahija Jallal (file photo)

TCR pi­o­neer Im­muno­core scores a first with a land­mark PhI­II snap­shot on over­all sur­vival for a rare melanoma

Bahija Jallal’s crew at TCR pioneer Immunocore says they have nailed down a promising set of pivotal data for their lead drug in a frontline setting for a solid tumor. And they are framing this early interim readout as the convincing snapshot they need to prove that their platform can deliver on a string of breakthrough therapies now in the clinic or planned for it.

In advance of the Monday announcement, Jallal and R&D chief David Berman took some time to walk me through the first round of Phase III data for their lead TCR designed to treat rare, frontline cases of metastatic uveal melanoma that come with a grim set of survival expectations.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Simeon George, SR One CEO (SR One)

Scoop: SR One crew com­pletes a com­pli­cat­ed spin­out from Glax­o­SmithK­line. And now they have a $500M fund to in­vest on their own

It’s taken close to 2 years, but Simeon George and his team at SR One have completed their spinout from GlaxoSmithKline, ending a saga as one of the longest running venture arms of Big Pharma as they go out on their own to forge the next chapter with a new and independent $500 million fund.

GSK is sticking with the spinout, this time as a minority investor — though a big one. And I’m told that the R&D group at GSK will remain involved in evaluating their new plays, helping with the scientific due diligence involved in scouting the world for new opportunities during a period of explosive growth in biotech investing.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.