In an­oth­er win for ri­val Aim­mune, FDA press­es pause on DB­V's peanut patch with ad­di­tion­al ques­tions

An­oth­er reg­u­la­to­ry set­back has strayed DBV Ther­a­peu­tics’s peanut al­ler­gy patch off the path to ap­proval.

On Mon­day, the com­pa­ny dis­closed that the FDA, which is cur­rent­ly re­view­ing the mar­ket­ing ap­pli­ca­tion for the patch, had ques­tions re­gard­ing the patch’s ad­he­sion and ef­fi­ca­cy con­cerns if the patch was not ful­ly ad­hered to the pa­tient’s skin. Con­se­quent­ly, the FDA ad­vi­so­ry com­mit­tee meet­ing sched­uled for May 15 will not be tak­ing place — al­though no changes to the FDA’s ac­tion date of Au­gust 5 were an­nounced.

DBV al­ready has the da­ta nec­es­sary to an­swer the FDA’s ques­tions, has pre­vi­ous­ly found that patch ad­he­sion did not have a sig­nif­i­cant im­pact on clin­i­cal ef­fi­ca­cy and is con­fi­dent that no ad­di­tion­al stud­ies will be re­quired, it said in a con­fer­ence call fol­low­ing the press re­lease.

“Though DB­VT may sat­is­fy FDA’s ques­tions with sup­ple­ment da­ta in hand (sub­mis­sion tim­ing un­cer­tain), we ex­pect a fur­ther de­lay in po­ten­tial ap­proval (from Aug.), par­tic­u­lar­ly as it’s be­ing re­viewed at the same di­vi­sion work­ing on COVID-19 vac­cines,” Jef­feries an­a­lysts said.

Baird’s Bri­an Sko­r­ney has long sug­gest­ed that giv­en ri­val Aim­mune’s Pal­forzia ap­proval, DBV’s “there is noth­ing else avail­able” ar­gu­ment for its peanut al­ler­gy patch — and its com­par­a­tive­ly weak­er ef­fi­ca­cy pro­file — will pre­vent it from pass­ing muster at the agency.

“(A)t this point we view DB­VT as ef­fec­tive­ly dead in the wa­ter,” he wrote in a note. “We con­tin­ue to an­tic­i­pate FDA will not ap­prove this ther­a­py, which could po­ten­tial­ly make Aim­mune’s Pal­forzia the on­ly FDA-ap­proved peanut al­ler­gy ther­a­py for the fore­see­able fu­ture.”

Sko­r­ney ex­pects the new coro­n­avirus could al­so im­pact the near-term launch of Pal­forzia.

DBV and Aim­mune were ini­tial­ly locked in a race to the fin­ish line to mar­ket their peanut al­ler­gy treat­ments in the Unit­ed States. Aim­mune ef­fec­tive­ly leapfrogged DBV when the lat­ter re­scind­ed an ap­pli­ca­tion to mar­ket its Vi­askin Peanut patch in 2018 in re­sponse to FDA con­cerns about the state of man­u­fac­tur­ing and qual­i­ty con­trol da­ta sub­mit­ted. In ear­ly 2020, the FDA sanc­tioned the use of Aim­mune’s ther­a­py.

Tra­di­tion­al­ly, peanut al­ler­gies are man­aged by avoid­ance, but the threat of ac­ci­den­tal ex­po­sure can­not be nul­li­fied. In a bid to build up some im­mu­ni­ty, some physi­cians have al­so been dos­ing pa­tients with peanut pow­der oral­ly, al­beit off-la­bel.

DBV’s Vi­askin Peanut is a patch ap­plied dai­ly to the up­per back that de­liv­ers peanut anti­gen to de­sen­si­tize the pa­tient. The patch must be worn for longer pe­ri­ods as time pass­es and used every day to main­tain de­sen­si­ti­za­tion. Pal­forzia is ef­fec­tive­ly peanut flour, which must be mixed in­to pud­ding, ap­ple­sauce or oth­er foods. Dos­ing is es­ca­lat­ed grad­u­al­ly, and the ther­a­py must be con­tin­ued dai­ly to main­tain de­sen­si­ti­za­tion.

Based on sur­ro­gate out­comes — oral food chal­lenges — Pal­forzia ap­pears to be more ef­fec­tive than Vi­askin Peanut, but car­ries more ad­verse ef­fects, cost-ef­fec­tive­ness watch­dog ICER con­clud­ed in its analy­sis last year.

Da­ta Lit­er­a­cy: The Foun­da­tion for Mod­ern Tri­al Ex­e­cu­tion

In 2016, the International Council for Harmonisation (ICH) updated their “Guidelines for Good Clinical Practice.” One key shift was a mandate to implement a risk-based quality management system throughout all stages of a clinical trial, and to take a systematic, prioritized, risk-based approach to clinical trial monitoring—on-site monitoring, remote monitoring, or any combination thereof.

Mer­ck scraps Covid-19 vac­cine pro­grams af­ter they fail to mea­sure up on ef­fi­ca­cy in an­oth­er ma­jor set­back in the glob­al fight

After turning up late to the vaccine development game in the global fight against Covid-19, Merck is now making a quick exit.

The pharma giant is reporting this morning that it’s decided to drop development of 2 vaccines — V590 and V591 — after taking a look at Phase I data that simply don’t measure up to either the natural immune response seen in people exposed to the virus or the vaccines already on or near the market.

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Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Matt Gline (L) and Vivek Ramaswamy

Scoop: Vivek Ra­maswamy is hand­ing the CEO job to a top lieu­tenant at Roivant — but he’s not ex­act­ly leav­ing the biotech scene

Over the past 7 years since founding Roivant, Vivek Ramaswamy has been a constant blur of biotech building motion.

He launched his first biotech with an Alzheimer’s drug he picked up cheap, and watched the experiment implode in one of the highest profile pivotal disasters seen in the last decade. But it didn’t slow the 30-something exec down; if anything, he hit the accelerator. Ramaswamy blazed global paths and went on to raise billions to spur the creation of a large lineup of little Vants promising big things at a fast pace. He sold off a section of the Vant brigade to Sumitomo Dainippon for $3 billion. And more recently the relentless dealmaker has been building a computational discovery arm to add an AI-driven approach to kicking up new programs and companies, supplementing the in-licensing drive while pursuing advances that have created more than 700 jobs at Roivant, with $2 billion in reserves.

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José Baselga, AstraZeneca cancer chief (Brent N. Clarke/FilmMagic via Getty Images)

As­traZeneca's Calquence nabs an­oth­er win against Im­bru­vi­ca, but Eli Lil­ly is on its heels

Three years after first launching Calquence as a second generation BTK inhibitor, AstraZeneca continues to tout new data to compete with J&J and AbbVie’s first generation blockbuster Imbruvica.

The British pharma announced on Monday that Calquence passed a head-to-head Phase III study against Imbruvica in chronic lymphocytic leukemia, proving non-inferior — i.e. just as good — as the older drug. Although AstraZeneca did not break down any of the numbers, they said the drug proved superior on safety, triggering fewer cases of atrial fibrillation, an irregular heartbeat that can lead to stroke or heart failure.

Ron Cooper, Albireo CEO

Al­bireo just ad­vanced down to the 10-yard line at the FDA. And Ron Coop­er’s team is get­ting prepped for the next big play

When Albireo Pharma’s board $ALBO moved to bring in Ron Cooper as the CEO more than 5 years ago, the development-stage company went with an experienced commercial player who had a big-time position on his resume after running Bristol Myers’ commercial ops in Europe.

Now, after successfully navigating a pivotal study, putting them in a foot race with a rival toward an FDA OK, Cooper is getting a boost from regulators on the last drive back to an arena he understands completely.

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Roche amps up its bis­pe­cif­ic at­tack on Eylea with more PhI­II da­ta — but just how threat­en­ing is it?

Roche has another stack of data to back up its longer-acting challenger to Eylea — although it’s still far from certain just how much they can threaten Regeneron’s dominance.

The latest Phase III results come from two trials that enrolled 1,329 patients with neovascular age-related macular degeneration. With 45% of people in both studies getting faricimab 16 weeks apart during the first year, the bispecific still induced the same level of gains in visual acuity as Eylea every 8 weeks did, Roche’s Genentech reported.

Can strug­gling Iterum turn the cor­ner to an an­tibi­ot­ic suc­cess sto­ry? They will know in six months

More than five years after Corey Fishman and Michael Dunne dusted sulopenem off Pfizer’s shelves — the second castoff antibiotic they’ve brought out of the pharma giant — and founded Iterum Therapeutics around that single drug, they have lined up a quick shot at approval with priority review from the FDA.

The decision, six months from now, will mark a make-or-break moment for a struggling biotech that has just enough cash to keep the lights on until the third quarter.

Bahija Jallal, Immunocore

Buried in Im­muno­core's IPO fil­ings? A kick­back scheme from a now for­mer em­ploy­ee

Immunocore spent much of 2019 dealing with the fallout of the Neil Woodford scandal, as the former star investor’s fall crashed the biotech’s valuation out of unicorn range. Now it turns out that the company spent 2020 dealing with another internal scandal.

The longtime UK biotech darling disclosed in their IPO filing last week that they had fallen victim to an alleged kickback scheme involving one of their employees. After a whistleblower came forward, they said in their F-1, they spent the summer and spring investigating, finding fraud on the part of an employee and two outside vendors.