Ex­clu­sive: The cu­ri­ous case of the BioN­Tech pri­or­i­ty re­view vouch­er

Ear­li­er this week, the FDA ful­ly ap­proved Mod­er­na’s Covid-19 vac­cine, and with that ap­proval, the com­pa­ny was award­ed what is al­most cer­tain­ly a lu­cra­tive pri­or­i­ty re­view vouch­er.

The vouch­ers can be used for a pri­or­i­ty re­view of a new drug, of­fer­ing a short cut to an FDA de­ci­sion, or can be sold on the open mar­ket — for up­wards of $100 mil­lion.

The PRV for Mod­er­na was is­sued by the FDA un­der its ma­te­r­i­al threat med­ical coun­ter­mea­sure PRV pro­gram, and that pro­gram has al­lowed FDA to pro­vide a PRV for all ful­ly ap­proved prod­ucts used to treat or pre­vent Covid-19.

But the on­ly oth­er two Covid-re­lat­ed prod­ucts that have been ful­ly ap­proved by the FDA are the Pfiz­er-BioN­Tech vac­cine and Gilead’s Vek­lury.

In­deed, the FDA’s up­dat­ed list now in­cludes both Mod­er­na’s Covid vac­cine and Gilead’s Vek­lury.

But cu­ri­ous­ly, Pfiz­er’s vac­cine is not list­ed by the FDA un­der its MCM PRVs [Up­date as of 2/3/22, the FDA has now up­dat­ed its list to in­clude the BioN­Tech vouch­er, which was grant­ed by FDA on Aug. 23, 2021] but the ap­proval let­ter for the vac­cine did not in­clude any men­tion of the PRV (even though Mod­er­na’s ap­proval let­ter does men­tion its PRV).

A Pfiz­er spokesper­son told End­points News that BioN­Tech is the mar­ket­ing au­tho­riza­tion hold­er for the vac­cine, and a BioN­Tech spokesper­son told us that the com­pa­ny did re­ceive the vouch­er, but did not is­sue a press re­lease on it.

A BioN­Tech spokesper­son lat­er clar­i­fied: “FDA didn’t men­tion our vouch­er in the ap­proval let­ter be­cause we re­quest­ed it af­ter the ini­tial BLA was ap­proved.”

So why the lack of trans­paren­cy from the FDA ini­tial­ly? Why not men­tion the PRV in the Pfiz­er-BioN­Tech vac­cine ap­proval let­ter? An FDA spokesper­son did not ini­tial­ly re­spond to ques­tions, but then said, “Ad­di­tion­al ques­tions about this top­ic should be di­rect­ed to Pfiz­er-BioN­Tech.”

As the agency’s vouch­er pro­gram has aged, and added dif­fer­ent types of vouch­ers like the MCM PRVs, more and more com­pa­nies have gone silent on what they’re do­ing with the PRVs, how many are be­ing used in­ter­nal­ly, and how many are be­ing sold, and at what price.

While de­tails even­tu­al­ly do emerge, as with BioN­Tech, the com­pa­nies have no in­cen­tive to be clear on what’s go­ing on, par­tic­u­lar­ly when a com­pa­ny is big enough that $100 mil­lion might not be note­wor­thy.

Up­dat­ed to in­clude ad­di­tion­al com­ment from BioN­Tech. BioN­Tech has since filed a 6-K with the SEC that pub­lish­es this sto­ry in full. Fol­low­ing the SEC fil­ing, the FDA up­dat­ed its list of MCM PRVs on Feb. 3, 164 days af­ter first is­su­ing the PRV.

Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.