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.”

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

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The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

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The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

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Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.

US sees spike in Paxlovid us­age as Mer­ck­'s mol­nupi­ravir and As­traZeneca's Evusheld are slow­er off the shelf

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In comparison to this week, about 670,000 courses of the Pfizer pill have been administered across the first five months since Paxlovid has been on the US market, averaging about 33,000 courses administered per week in that time.

Te­va, Al­ler­gan reach yet an­oth­er opi­oid set­tle­ment — ef­fec­tive­ly end­ing WV tri­al

Teva and Allergan have reached settlements with multiple states over their involvement in the opioid crisis. Their latest is worth 9 figures.

West Virginia attorney general Patrick Morrisey announced the newest settlement, worth $161.5 million, at a press conference on Wednesday. The deal would resolve claims that the companies helped fuel the state’s opioid epidemic. If it goes through, it could become the largest state-negotiated settlement in West Virginia’s history, according to Reuters.

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Health experts maintain that the current monkeypox situation is a stark contrast to Covid. Even so, a handful of biotechs have sprung to action, including Roche, who quickly developed a set of three tests to detect the virus.

Roche and subsidiary TIB Molbiol unveiled their Lightmix Modular Virus test kits on Wednesday — three unique test kits that can help track the spread of monkeypox.

The first kit detects orthopoxviruses, including all monkeypox viruses originating from the West African and Central African forms of the virus. The second kit is a specific test that detects monkeypox viruses only, while the third simultaneously tests for both orthopoxviruses and monkeypox viruses.

New law­suit ac­cus­es GSK of 'de­vice hop­ping' to block gener­ic in­haler com­pe­ti­tion

Despite inhalers being on the market for decades, many patients still can’t afford them. A new lawsuit filed in Missouri federal court puts the blame on GSK.

Last week, plaintiff Elliot Conrad Dale — who’s paid for GSK’s Ventolin and Arnuity Ellipta inhalers — filed a class-action lawsuit against the pharma giant, accusing it of scheming to block generic versions of its brand-name inhalers.