In a stun­ner, Mer­ck lands pos­i­tive PhI­II for its CETP out­cast anace­trapib

Long af­ter many an­a­lysts had giv­en Mer­ck’s CETP heart drug anace­trapib up for dead fol­low­ing a slate of ex­pen­sive buri­als for the first three drugs in the class, the phar­ma gi­ant man­aged to shock the in­dus­try this morn­ing with news that their drug came through a 30,000-pa­tient study with con­vinc­ing da­ta of its ef­fec­tive­ness.

In a brief state­ment on the topline re­sults, the phar­ma gi­ant not­ed that its drug sig­nif­i­cant­ly re­duced the risk of a coro­nary event – a com­pos­ite of coro­nary death, my­ocar­dial in­farc­tion, and coro­nary revas­cu­lar­iza­tion – among high-risk pa­tients who had al­ready been through LDL-low­er­ing ther­a­py ef­fec­tive­ly.

Mer­ck’s shares $MRK jumped 3% in ear­ly trad­ing but then quick­ly flat­tened as skep­tics ze­roed in on the phar­ma gi­ant’s tepid re­marks and skep­tics quick­ly be­gan to of­fer their own as­sess­ments on Twit­ter.

Heart dis­ease R&D has be­come a much changed field over the last few years, as new PC­SK9 cho­les­terol drugs have proved. Am­gen re­cent­ly tried to grab a mar­ket lead with its pos­i­tive out­comes da­ta, but so far has gained lit­tle trac­tion among pay­ers who were un­con­vinced by the num­bers. And sig­nif­i­cant­ly, Mer­ck’s short state­ment notes that the gi­ant play­er is still con­sid­er­ing whether to file for an ap­proval, leav­ing every­one ea­ger to see the hard da­ta at the Eu­ro­pean So­ci­ety of Car­di­ol­o­gy meet­ing Au­gust 29. The an­nounce­ment no­tably is al­so free of the usu­al quote ex­pect­ed from a top R&D ex­ec herald­ing suc­cess and the po­ten­tial for help­ing pa­tients.

But what a sur­prise this is.

“Buy­side was NOT ex­pect­ing this MRK tri­al to “work” …,” not­ed Ever­core ISI’s Umer Raf­fat. “My most re­cent in­vestor sur­vey had 20% odds for this tri­al.” Raf­fat, though, al­so wants to see the hard da­ta to eval­u­ate the com­mer­cial po­ten­tial, es­pe­cial­ly con­sid­er­ing Mer­ck’s hes­i­tan­cy. And Leerink’s Sea­mus Fer­nan­dez spent some time read­ing be­tween the lines of Mer­ck’s re­lease, not­ing that the “cryp­tic lan­guage in the press re­lease sug­gests a less than de­fin­i­tive risk/re­ward pro­file of the drug.”

Mer­ck, how­ev­er, proved that in this field, it ain’t over un­til the da­ta ar­rive — even though the first huge gam­bles on CETP at Roche, Pfiz­er and Eli Lil­ly had all gone bust.

“In base­ball you don’t get four strikes,” not­ed the Cleve­land Clin­ic’s Steve Nis­sen in 2015. He was ready to call game over af­ter Eli Lil­ly killed their drug when it failed to pass muster in a fu­til­i­ty test. At the time, Bern­stein’s Tim An­der­son was one of the few an­a­lysts still will­ing to con­sid­er that Mer­ck’s de­ci­sion to go with the biggest Phase III in the bunch still left the door open to suc­cess.

But he didn’t have much com­pa­ny.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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Neu­rona Ther­a­peu­tics is dash­ing to the clin­ic with its cell ther­a­py for epilep­sy — but first, an­oth­er ven­ture round

Six years ago, a band of neuroscientists from the University of California, San Francisco combined decades of research and jumped into the hunt for an off-the-shelf cell therapy. Now, that team is sprinting toward the clinic with a treatment for epilepsy — but first, it’s making a pit stop at the venture well.

Neurona Therapeutics unveiled a $41.5 million round on Tuesday morning, bringing the San Francisco-based biotech’s total raise to $135 million. The cash will be used to advance the company’s pipeline, including an upcoming Phase I/IIa for its lead candidate, NRTX-1001, in chronic focal epilepsy.

Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.

Roche's Alzheimer's drug spurred bio­mark­er changes but no cog­ni­tive im­pact — pa­per; vTv out-li­cens­es for­mer lead pro­gram

More than a year ago, Roche and Eli Lilly were forced to contend with a Phase II/III failure of their respective Alzheimer’s drugs. But while Eli Lilly essentially threw in the towels, Roche wasn’t ready to give up yet.

The Swiss drugmaker now has some biomarker data to spotlight as investigators continue monitoring patients in an open-label extension study.

Dubbed DIAN-TU, the study had been designed to see whether Roche’s gantenerumab and Lilly’s solanezumab could spur a cognitive benefit for a group of patients who had a rare, inherited form of Alzheimer’s that’d tied to early-onset. In short, they didn’t: Both failed the primary endpoint.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Covid-19 roundup: White House re­veals vac­cine do­na­tion plan; EU opts in for an­oth­er 150 mil­lion dos­es from Mod­er­na

President Joe Biden’s administration on Monday revealed the distribution list for 55 million of the 80 million doses of Covid-19 vaccines America plans to donate to lower-income nations:

Roughly 14 million doses will head to Latin America and the Caribbean, for a list of countries that includes Brazil, Argentina, Dominican Republic, Panama and Costa Rica.
Another 16 million doses are headed to Asia to help the following countries: India, Nepal, Bangladesh, Pakistan, Sri Lanka, Afghanistan, Maldives, Bhutan, Philippines, Vietnam, Indonesia, Thailand, Malaysia, Laos, Papua New Guinea, Taiwan, Cambodia, and the Pacific Islands.