A 'dis­ori­ent­ed' Pain Ther­a­peu­tics flips out af­ter FDA re­jects ap­peal on Re­moxy

Pain Ther­a­peu­tics has had the last word on its four-time re­ject Re­moxy — and it’s a bit­ter one.

Af­ter a meet­ing with the FDA, the biotech says, “we be­lieve we are no clos­er to­day to prod­uct ap­proval than we were over a year ago” thanks to “sham­bol­ic reg­u­la­tions” at the agency.

Its stock $PTIE prompt­ly fell 20%, tum­bling fur­ther in­to pen­ny­s­tock low­land.

Re­mi Bar­bi­er

The dis­pute here cen­ters around how eas­i­ly Re­moxy — an ex­tend­ed re­lease gel for­mu­la­tion of oxy­codone — can be abused, at a time the dead­ly opi­oid cri­sis has led to calls for height­ened vig­i­lance over ap­proval of new pain drugs.

That con­cern led an ex­pert pan­el to vote over­whelm­ing­ly against the drug be­fore the FDA hand­ed a for­mal slap­down.

Con­trast that with the sol­id en­dorse­ment Acel­Rx re­ceived for its pain med Dsu­via, which was lat­er ap­proved — trig­ger­ing vo­cal crit­i­cism from an ex­pert on the com­mit­tee who ac­cus­es the FDA for lack­ing in trans­paren­cy.

Pain Ther­a­peu­tics con­tend­ed the agency mis­led the ad­vi­so­ry com­mit­tee with “math er­rors, ma­te­r­i­al mis­takes and mis­rep­re­sen­ta­tions,” an al­le­ga­tion that reg­u­la­tors de­nied in their re­cent meet­ing with the com­pa­ny.

Be­fore they go silent about their fu­ture plans for the drug, CEO Re­mi Bar­bi­er of­fered a part-eu­lo­gy that’s most­ly FDA bash­ing:

Re­moxy re­mains an odyssey with­out a home­com­ing. We had hoped for a fair, neu­tral and im­par­tial re­view of the Re­moxy da­ta. In­stead, we walked out of this meet­ing feel­ing a bit dis­ori­ent­ed by FDA’s lack of trans­paren­cy, clar­i­ty or help­ful­ness. It’s a rare oc­ca­sion when two par­ties can’t agree on sim­ple math. We can’t work with sham­bol­ic reg­u­la­tions. This is not how you win sup­port for in­no­va­tion.

As pre­vi­ous­ly re­port­ed, fol­low­ing a re­or­ga­ni­za­tion, the biotech plans to fo­cus its re­main­ing re­sources on a drug for Alzheimer’s, a dis­ease that has de­feat­ed every ther­a­py thrown at it for more than a decade.

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

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

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Genen­tech plots $53M dis­cov­ery quest aimed at spark­ing a 'Holy moly' piv­ot in neu­ro R&D

Genentech has committed $53 million to back a 10-year quest aimed at going back to the drawing board to use new technology and fresh scientific insights to generate a pipeline of drugs for neurological diseases.

Roche’s big South San Francisco hub will mix it up with the scientists drawn together for the Weill Neurohub — formed in 2019 as a joint research partnership involving UCSF, Berkeley and the University of Washington — in an exploration of the field to develop new therapies for some of the toughest diseases in drug R&D: Alzheimer’s, Parkinson’s, Huntington’s, ALS and autism.

Am­gen, As­traZeneca speed to­ward fil­ing next-gen an­ti­body for asth­ma af­ter un­cork­ing full late-stage da­ta

On the hunt for a novel competitor to Sanofi and Regeneron’s Dupixent in severe asthma, Amgen and AstraZeneca posted “exciting” results from their next-gen antibody late last year. Now, the partners are showing their hands, and the results look good enough for approval.

Amgen and AstraZeneca’s tezepelumab plus standard of care cut the rate of severe asthma attacks by 56% at the one-year mark compared with SOC alone, according to full data from the Phase III NAVIGATOR study presented Friday at the virtual American Academy of Allergy, Asthma & Immunology meeting. And those significant results were consistent regardless of patients’ baseline eosinophil counts.

With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Glax­o­SmithK­line re­thinks strat­e­gy for Covid-19 an­ti­body — not the Vir ones — af­ter tri­al flop. Is there hope in high-risk pa­tients?

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.