Ex-FDA of­fi­cials ask SCO­TUS to take up J&J talc case; An­no­vis shows da­ta from PhII Parkin­son's tri­al

Eight for­mer FDA of­fi­cials, in­clud­ing for­mer FDA com­mis­sion­er An­drew von Es­chen­bach and mul­ti­ple deputy com­mis­sion­ers, sub­mit­ted an am­i­cus brief to the Supreme Court yes­ter­day — ask­ing for the Court to re­view the Mis­sis­sip­pi Supreme Court de­ci­sion that ruled against J&J ear­li­er this year.

Mis­sis­sip­pi’s com­plaint in 2014 ac­cused the mega-com­pa­ny of vi­o­lat­ing con­sumer pro­tec­tion laws by not dis­clos­ing ovar­i­an can­cer risks to women posed by its ba­by pow­der con­tain­ing talc.

J&J sought sum­ma­ry judg­ment in its ap­peal to the court, ar­gu­ing the Mis­sis­sip­pi Con­sumer Pro­tec­tion Act doesn’t ap­ply to the la­bel­ing of prod­ucts reg­u­lat­ed by the fed­er­al Food and Drug Ad­min­is­tra­tion. The Mis­sis­sip­pi Supreme Court dis­agreed, and af­firmed a low­er court’s pre­vi­ous rul­ing.

The for­mer of­fi­cials ar­gue that no­tice-and-com­ment rule­mak­ing, which the FDA of­fi­cials say is rarely used, sub­verts and up­ends the FDA’s sys­tem and au­thor­i­ty over la­bel­ing.

“By strip­ping the FDA’s la­bel­ing de­ci­sions of pre­emp­tive ef­fect un­less they first un­der­go no­tice-and-com­ment rule­mak­ing, the de­ci­sion leaves the agency with an im­pos­si­ble choice: sac­ri­fice the flex­i­bil­i­ty it needs to over­see thou­sands of prod­ucts in an ever-shift­ing mar­ket, or al­low its sci­en­tif­i­cal­ly sound warn­ings to be crowd­ed out by con­flict­ing state-im­posed la­bels,” the of­fi­cials wrote.

The ex-of­fi­cials fur­ther re­it­er­at­ed that the FDA lacks time and re­sources to run every de­ci­sion through no­tice-and-com­ment rule­mak­ing.

“Ac­cord­ing to the Mis­sis­sip­pi Supreme Court, that re­al­i­ty means FDA must share la­bel­ing au­thor­i­ty with all 50 states, any one of which can re­quire a la­bel specif­i­cal­ly re­ject­ed by FDA as sci­en­tif­i­cal­ly un­sound,” the of­fi­cials wrote.

Ul­ti­mate­ly they want the Supreme Court to “clar­i­fy the law of pre­emp­tion and pre­vent the Mis­sis­sip­pi Supreme Court’s de­ci­sion from dis­rupt­ing FDA’s vi­tal func­tions,” the writ­ers said.

An­no­vis Bio un­veils Phase II ef­fi­ca­cy da­ta for Parkin­son’s dis­ease treat­ment

Penn­syl­va­nia biotech An­no­vis Bio re­leased re­sults from the sec­ond part of a Phase II clin­i­cal tri­al of Parkin­son’s drug can­di­date AN­VS401 in 54 pa­tients, which found that once-dai­ly AN­VS401 was su­pe­ri­or to place­bo in im­prov­ing mo­tor func­tion.

The first part of the study made head­lines and caused share prices to soar up­wards of 140% af­ter pa­tients’ cog­ni­tive im­prove­ment scores in­creased by 30% back in May for sub­jects with ei­ther Parkin­son’s dis­ease or Alzheimer’s dis­ease.

The sec­ond part of the study ex­pand­ed on the orig­i­nal 14 AD and 14 PD pa­tients by re­cruit­ing an ad­di­tion­al 40 PD pa­tients, who were treat­ed with ei­ther 0mg, 5mg, 10mg, 20mg, 40mg or 80mg of AN­VS401 once dai­ly. Safe­ty and two psy­cho­me­t­ric as­sess­ments were con­duct­ed at day 0 and day 25, com­par­ing AN­VS401-dosed PD pa­tients with those dosed with place­bo.

When com­pared to the place­bo group, sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in a WAIS psy­cho­me­t­ric cod­ing test were ob­served in PD pa­tients tak­ing AN­VS401 5mg, 20mg and 80mg once dai­ly, high­light­ing in­creased mo­tor dex­ter­i­ty, as well as speed and ac­cu­ra­cy com­pared to place­bo. PD pa­tients treat­ed with AN­VS401 10mg and 20mg once dai­ly showed sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ments in the UP­DRS psy­cho­me­t­ric test com­pared to base­line.

These re­sults pro­vide guid­ance as to what dosage to use in up­com­ing Phase III stud­ies in both AD and PD pa­tients, ac­cord­ing to a com­pa­ny state­ment.

“We are still an­a­lyz­ing cer­tain bio­mark­er da­ta from the 54 PD pa­tients and will share the re­sults when they are avail­able. We will be ask­ing the FDA for a meet­ing to re­ceive guid­ance on next steps in clin­i­cal de­vel­op­ment in light of the AD/PD Phase II clin­i­cal re­sults,” said An­no­vis founder, pres­i­dent and CEO Maria Mac­cec­chi­ni in a state­ment.

IpiNovyx Bio clos­es $10 mil­lion seed fi­nanc­ing round

With a fo­cus on au­toim­mune and in­flam­ma­to­ry dis­eases, IpiNovyx Bio closed a $10 mil­lion seed fi­nanc­ing round to­day, the com­pa­ny an­nounced in a state­ment.

The fi­nanc­ing, led by Vi­va BioIn­no­va­tor of Vi­va Biotech, al­so had par­tic­i­pants such as Eli Lil­ly and the New York-based IpiNovyx founder Or­ange Grove Bio. Funds raised will go to­ward ad­vanc­ing so-called im­muno­pro­tea­some in­hibitors in­to hu­man tri­als.

“Pa­tients suf­fer­ing from au­toim­mune and in­flam­ma­to­ry dis­eases are faced with lim­it­ed treat­ment op­tions and most ther­a­pies that are avail­able are non-se­lec­tive and car­ry sig­nif­i­cant tox­i­c­i­ty con­cerns. We are ea­ger to con­tin­ue our re­search in this area and work to ad­vance these best-in-class im­muno­pro­tea­some in­hibitors in­to hu­man clin­i­cal tri­als,” said Carl Nathan, a Cor­nell im­mu­nol­o­gist and one of the sci­en­tif­ic founders at IpiNovyx.

“This seed fund­ing will en­able the com­pa­ny to rapid­ly progress through pre­clin­i­cal stud­ies and in­to the clin­ic with the goal of de­liv­er­ing life chang­ing ther­a­pies to pa­tients suf­fer­ing from au­toim­mune and in­flam­ma­to­ry dis­eases,” said Marc Ap­pel, co-founder and CEO of both IpiNovyx and Or­ange Grove Bio, in a state­ment.

Aditxt to ac­quire AiPhar­ma, the rights hold­er of Covid-19 an­tivi­ral Avi­gan by end of No­vem­ber

Vir­ginia biotech Aditxt said to­day that it en­tered a trans­ac­tion agree­ment to reach a de­fin­i­tive agree­ment by the end of No­vem­ber to ac­quire AiPhar­ma, which holds ex­clu­sive rights to Avi­gan and all for­mu­la­tions of an­tivi­ral favipi­ravir, used in dif­fer­ent coun­tries as a Covid-19 an­tivi­ral treat­ment.

The oral an­tivi­ral pill has ei­ther full mar­ket­ing au­tho­riza­tion or EUA in a num­ber of mar­kets as a treat­ment for Covid-19, in­clud­ing Mex­i­co, In­dia, In­done­sia, Thai­land and Malaysia, ac­cord­ing to a com­pa­ny state­ment. Oth­er coun­tries buy­ing the drug un­der com­pas­sion­ate use pro­grams in­clude the Unit­ed King­dom, Unit­ed Arab Emi­rates, Greece, Hun­gary and Sau­di Ara­bia.

“The suc­cess­ful com­ple­tion of this ac­qui­si­tion would ac­cel­er­ate our com­mer­cial­iza­tion plans in the in­fec­tious dis­ease space,” said Aditxt co-founder and CEO Am­ro Al­ban­na. “While ini­tial­ly tar­get­ing COVID-19, our com­bined clin­i­cal and com­mer­cial plat­form would po­ten­tial­ly ad­dress un­met needs in oth­er vi­ral in­di­ca­tions. We look for­ward to part­ner­ing with the team at AiPhar­ma and its con­sor­tium mem­bers.”

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges


Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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vTv Ther­a­peu­tics cuts 65% of em­ploy­ees in shake­up; Freenome bags $300M in Se­ries D to ex­pand mul­ti­omics plat­form

vTv Therapeutics has decided to chop down its workforce by almost two-thirds.

The High Point, NC biotech announced Monday that it would pivot and now prioritize its lead program, the oral glucokinase activator TTP399, as it gears up for Phase III pivotal trials.

The drug was granted breakthrough therapy designation after showing a 40% reduction in hypoglycemic episodes compared to placebo, and back in October vTv announced positive results in a study showing no increased risk for ketoacidosis, a severe complication of diabetes.

Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.