In­dus­try groups call to block WTO IP waiv­er ex­pan­sion to Covid-19 ther­a­peu­tics

The WTO’s TRIPS Coun­cil in mid-Oc­to­ber is ex­pect­ed to de­bate whether to ex­tend the IP waiv­er for Covid-19 vac­cines to ther­a­peu­tics and di­ag­nos­tics too.

While the Biden ad­min­is­tra­tion backed the orig­i­nal vac­cine waiv­er, which crit­ics note has not done much to ex­pand ac­cess to vac­cines as de­mand has dried up, US trade of­fi­cials haven’t of­fered any per­spec­tive yet on whether to ex­pand the waiv­er to Covid treat­ments.

The US Cham­ber of Com­merce, as well as in­dus­try groups BIO and EF­PIA, this week ex­pressed “strong op­po­si­tion” to any ex­pan­sion of the WTO TRIPS waiv­er to ther­a­peu­tics or di­ag­nos­tics, ar­gu­ing that waived IP pro­tec­tions dam­age the na­tion’s abil­i­ty to in­no­vate and com­pete.

Kevin O’Con­nor

Illi­nois-based IP at­tor­ney Kevin O’Con­nor at Neal, Ger­ber & Eisen­berg told End­points News in a phone in­ter­view that he doesn’t think the vac­cine waiv­er has done much so far.

“I don’t think it was the right so­lu­tion for a de­mand prob­lem,” O’Con­nor said. And an ex­ten­sion to ther­a­peu­tics “would dou­ble down” on the same con­cept, ex­cept small mol­e­cule man­u­fac­tur­ing is more straight­for­ward than vac­cine man­u­fac­tur­ing. There’s al­so the ques­tion of whether there is a need for an ex­ten­sion giv­en the vol­un­tary li­cens­ing al­ready in place.

BIO al­so not­ed that the ex­pan­sion of a TRIPS waiv­er to ther­a­peu­tics can cre­ate prob­lems for ther­a­peu­tics used for oth­er in­di­ca­tions too as these oth­er in­di­ca­tions “may be their on­ly path to fi­nan­cial vi­a­bil­i­ty and sus­tained in­vest­ment to fund fu­ture R&D ini­tia­tives.”

The in­dus­try group al­so not­ed the lack of a “sup­ply and de­mand chal­lenge glob­al­ly that jus­ti­fies the ex­ten­sion of an IP waiv­er” con­sid­er­ing the fact that man­u­fac­tur­ers are sup­ply­ing ther­a­peu­tics at a rate that out­paces de­mand.

The US Cham­ber of Com­merce al­so not­ed that in the case of Covid-19 vac­cine IP, “the waiv­er’s re­al­iza­tion came long af­ter its os­ten­si­ble pur­pose was moot­ed by a large and grow­ing sur­plus of COVID-19 vac­cine sup­plies.”

Pe­ter May­bar­duk

But Pub­lic Cit­i­zen’s Pe­ter May­bar­duk told End­points these are “spe­cious ar­gu­ments and scare tac­tics,” adding, “Phar­ma is wor­ried and that is a good thing for peo­ple.”

WTO mem­bers and de­vel­op­ing coun­tries pledged sup­port for the waiv­er ex­ten­sion last sum­mer, ac­cord­ing to a read out of a meet­ing. Some even called for this ex­ten­sion to be dis­cussed “with a sense of ur­gency giv­en the fact that many least de­vel­oped coun­tries (LD­Cs) lack ac­cess to life-sav­ing drugs and test­ing ther­a­peu­tics.”

But oth­er mem­ber coun­tries “cau­tioned that more time was need­ed to con­duct do­mes­tic con­sul­ta­tions on a pos­si­ble ex­ten­sion of the waiv­er to ther­a­peu­tics and di­ag­nos­tics” while:

Some mem­bers al­so flagged the im­por­tance of an ev­i­dence-based ne­go­ti­a­tion as there was no ev­i­dence that in­tel­lec­tu­al prop­er­ty did in­deed con­sti­tute a bar­ri­er to ac­cess­ing COVID-19 vac­cines. Some al­so re­it­er­at­ed the need for mem­bers to ful­ly make use of all the flex­i­bil­i­ties that al­ready ex­ist in the TRIPS Agree­ment (in­clud­ing com­pul­so­ry li­cens­ing) be­fore re­quest­ing new flex­i­bil­i­ties.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls

Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.