PhRMA goes on the of­fen­sive, at­tack­ing the WHO and putting the EU, UK, Aus­tralia and oth­ers on no­tice

Each year, in­dus­try groups like PhRMA of­fer their views on which coun­tries around the globe might be harm­ing bio­phar­ma in­no­va­tion as a re­sult of their in­tel­lec­tu­al prop­er­ty pro­tec­tions or lack there­of, which can con­tribute to a re­port pro­duced by the White House’s trade rep­re­sen­ta­tive on the glob­al state of IP.

This year’s 273 pages worth of com­ments from PhRMA not on­ly take is­sue with the Biden ad­min­is­tra­tion’s pledge to sup­port an IP waiv­er for Covid-19 vac­cines at the WTO, but al­so raise con­cerns about the WHO and oth­er coun­tries on the pri­or­i­ty watch list, like Cana­da, and the in­dus­try group has re­quest­ed that the US trade rep­re­sen­ta­tive add Aus­tralia, Tai­wan, the EU, UK, Egypt and Is­rael to its “watch list.”

For the WHO, PhRMA takes is­sue with the non­prof­it’s Roadmap on Ac­cess for Med­i­cines, which en­vi­sions pro­vid­ing “tech­ni­cal sup­port” to coun­tries that in­tend to en­gage in com­pul­so­ry li­cens­ing, a ma­jor no-no with the in­dus­try group, as well as one re­gion­al WHO of­fice “open­ly as­sert­ing that com­pul­so­ry li­cens­ing is ‘im­por­tant and to be en­cour­aged.’ ”

Com­pul­so­ry li­cens­es, which al­low com­pa­nies to pro­duce a patent­ed prod­uct or process with­out the con­sent of the patent own­er, are men­tioned more than 100 times through­out the re­port.

In ref­er­ence to the WHO di­rec­tor-gen­er­al’s pub­lic sup­port for the Biden-backed IP waiv­er for Covid-19 vac­cines, PhRMA calls it “an ex­treme and un­nec­es­sary pro­pos­al.”

But oth­ers, like the NGO Knowl­edge Ecol­o­gy In­ter­na­tion­al, stress the op­po­site, ex­plain­ing how the pan­dem­ic per­fect­ly il­lus­trates the im­por­tance of shar­ing vac­cine and ther­a­peu­tic man­u­fac­tur­ing know-how and ac­cess to bi­o­log­i­cal re­sources and coun­ter­mea­sures.

“Trade poli­cies that pro­mote the hoard­ing of in­tel­lec­tu­al prop­er­ty and man­u­fac­tur­ing know-how are par­tic­u­lar­ly harm­ful in a glob­al pub­lic health cri­sis like the COVID pan­dem­ic,” KEI notes.

Out­side of the pan­dem­ic, mean­while, PhRMA says its mem­ber com­pa­nies are con­cerned by the di­rec­tion of the Eu­ro­pean Com­mis­sion’s Phar­ma­ceu­ti­cal Strat­e­gy for Eu­rope and op­tions un­der con­sid­er­a­tion re­gard­ing IP and oth­er in­cen­tives for or­phan and pe­di­atric med­i­cines, “which could weak­en IP rights in one of the world’s largest mar­kets.”

The in­dus­try group al­so claims that Eu­ro­pean coun­tries are putting bio­phar­ma in­no­va­tion “at risk” by reg­u­lat­ing phar­ma prices based on the prices in less wealthy coun­tries or based on the prices of old­er and less in­no­v­a­tive prod­ucts deemed com­pa­ra­ble, in­clud­ing gener­ics.

For in­stance, in the Czech Re­pub­lic, the price of a new med­i­cine can­not ex­ceed the av­er­age price of the low­est three coun­tries among 19 EU coun­tries.

As these poli­cies and price reg­u­la­tions “con­tin­ue to ratch­et Eu­ro­pean prices low­er, there are in­creased calls for cross-bor­der shar­ing of con­fi­den­tial price in­for­ma­tion that un­der­mines the abil­i­ty to adapt to the dif­fer­ent needs of each,” PhRMA claims, while not­ing that 86% of new med­i­cines launched glob­al­ly since 2011 are avail­able in the US, com­pared to just 42% in EU mem­ber states, on av­er­age.

In Ger­many, PhRMA notes that due to its re­struc­tured pric­ing and re­im­burse­ment process from about a decade ago, there are “se­ri­ous re­stric­tions on the types of study de­signs and clin­i­cal end­points that are ad­mis­si­ble for demon­strat­ing proof of ad­di­tion­al clin­i­cal ben­e­fit. By 2020, this rigid as­sess­ment process and re­quire­ments re­sult­ed in G-BA deem­ing 60 per­cent of all as­sess­ments of in­no­v­a­tive med­i­cines to demon­strate no ad­di­tion­al clin­i­cal ben­e­fit in the spec­i­fied pa­tient sub­pop­u­la­tion.”

Sim­i­lar con­cerns are high­light­ed else­where too for the oth­er coun­tries PhRMA wants on­to the watch list.

In Aus­tralia, PhRMA notes that its mem­ber com­pa­nies “con­tin­ue to face chal­lenges and un­cer­tain­ty in se­cur­ing pos­i­tive rec­om­men­da­tions from the Phar­ma­ceu­ti­cal Ben­e­fits Ad­vi­so­ry Com­mit­tee,” as well as oth­er chal­lenges re­lat­ed to a lack of ad­vance no­tice on drug ap­pli­ca­tions for po­ten­tial­ly patent-in­fring­ing phar­ma­ceu­ti­cals.

For Tai­wan, PhRMA points out that the drug ap­proval process there “is in­ef­fi­cient” and price ne­go­ti­a­tions “can be lengthy, re­sult­ing in over­all time­lines that can ex­ceed two years.”

And while Tai­wan es­tab­lished a patent link­age sys­tem (i.e. a gener­ic ver­sion of a drug can­not be mar­ket­ed for a cer­tain num­ber of years while the in­no­va­tor’s patent is in place) in Aug. 2019, PhRMA ex­plains that it’s con­cerned that Tai­wan’s FDA is in­ter­pret­ing the sys­tem “in a way that is un­du­ly nar­row. Specif­i­cal­ly, the TF­DA has in­ter­pret­ed Tai­wan’s Phar­ma­ceu­ti­cal Af­fairs Act (PAA) to ex­clude patents pro­tect­ing new dos­es, new dosage forms or new unit strengths from the link­age sys­tem.”

Sim­i­lar to oth­er coun­tries in the Mid­dle East and Asia, PhRMA al­so laments the fact that Egypt lacks ef­fec­tive patent en­force­ment, which al­lows man­u­fac­tur­ers to bring gener­ic drugs to mar­ket pri­or to the ex­pi­ra­tion of the patent(s) on the brand name drug.

Mean­while, in Is­rael, PhRMA calls out a Sep­tem­ber 2021 draft bill that would ex­empt cer­tain gener­ic drugs and biosim­i­lars from patent in­fringe­ment for ex­port pur­pos­es and “would re­duce sig­nif­i­cant­ly IP rights and put in­to ques­tion bi­lat­er­al and in­ter­na­tion­al com­mit­ments.”

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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John Carroll with David Chang, Allogene CEO (Credit: Jeff Rumans Photography)

Al­lo­gene takes the stage in New York to go deep on its off-the-shelf cell ther­a­pies — de­clar­ing a first for sol­id tu­mors

NEW YORK — In most cases, a biotech like Allogene would wait until the next big science conference to offer its latest series of snapshots of its data. But most biotechs aren’t like Allogene, where the veteran leaders from Kite garnered a substantial number of kudos over the years for their in-depth reviews of the company’s progress.

So on Tuesday, the leaders at Allogene converged on Manhattan once again to give a detailed breakdown of their latest steps forward, looking to stay out front in the busy off-the-shelf cell therapy arena, keep a clean bill of health on the safety front and prove that they can not only match the autologous pioneers they helped create but make the all-important leap into solid tumors. It’s another step forward in a journey that has a long way to go before even the first big regulatory finish lines appear on the track. But for CEO David Chang, who spent some time with me running through the data ahead of the Tuesday session, it all amounts to forward momentum toward the desired goal.

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UK reg­u­la­tor warns of se­vere eye re­ac­tions fol­low­ing use of Sanofi and Re­gen­eron's Dupix­ent

The UK’s Medicines and Healthcare Regulatory Agency (MHRA) on Tuesday warned of some new and serious eye-related side effects following the use of Sanofi and Regeneron’s atopic dermatitis and asthma treatment Dupixent (dupilumab).

While Dupixent is already associated with cases of conjunctivitis and allergic conjunctivitis, dry eye and with infrequent cases of keratitis and ulcerative keratitis, the MHRA is calling on health professionals to be on the lookout for any of these eye-related side effects as “it is not currently possible to predict who may experience the rarer and most severe ocular adverse reactions, such as ulcerative keratitis.”

Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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