Drug­mak­ers 'inch­ing ahead' in in­creas­ing ac­cess to drugs world­wide, with Glax­o­SmithK­line lead­ing the pack

Top drug de­vel­op­ers are “inch­ing ahead” in im­prov­ing ac­cess to much-need­ed drugs around the world — an is­sue that has been un­der­scored by the Covid-19 pan­dem­ic. But there’s still more work to do, Ac­cess to Med­i­cine Foun­da­tion ex­ec­u­tive di­rec­tor Jayas­ree Iy­er said.

Every two years, the Ac­cess to Med­i­cines In­dex ranks the top 20 biotechs lead­ing the push for bet­ter ac­cess to med­i­cines in low- and mid­dle-in­come coun­tries. This year’s re­port, pub­lished Tues­day, looks at drug ac­cess in 106 coun­tries.

Glax­o­SmithK­line led the pack for an­oth­er year, close­ly trailed by No­var­tis. John­son & John­son ranked third, with Pfiz­er and Sanofi right be­hind it.

Jayas­ree Iy­er

But al­though com­pa­nies are “inch­ing ahead” in their ef­forts, we’re still far from where we need to be, Iy­er said in a state­ment.

“… Ac­tiv­i­ty still con­cen­trates on too few dis­eases and too few coun­tries, thus ben­e­fit­ing on­ly a frac­tion of the peo­ple in need,” Iy­er said. “What is more, most of the ef­fort is be­ing made by on­ly a small num­ber of firms, cre­at­ing a frag­ile sit­u­a­tion where any re­treat could have dire con­se­quences.”

The rank­ings were pub­lished as re­ports emerge that it could be years be­fore those in low-in­come coun­tries get Covid-19 vac­cines. Last month, Reuters ac­cessed in­ter­nal pa­pers re­gard­ing the WHO, CEPI and Gavi-led CO­V­AX pro­gram that warned a lack of funds, sup­ply risks and com­plex con­trac­tu­al arrange­ments could leave those in poor na­tions with­out vac­cines un­til 2024.

“Too many peo­ple lack ac­cess to in­no­v­a­tive health prod­ucts emerg­ing from R&D pipelines,” Iy­er said.

In a state­ment, she en­cour­aged com­pa­nies to “be­come a cat­a­lyst, not a bar­ri­er” to eq­ui­table drug ac­cess. And the in­dus­try ap­pears to be mov­ing in the right di­rec­tion.

Eight of the 20 com­pa­nies ranked in the in­dex are now de­vel­op­ing sys­tem­at­ic ap­proach­es to ac­cess plan­ning — a vast in­crease from the sin­gle com­pa­ny do­ing so (No­var­tis) when the last re­port came out in 2018. But that still leaves 12 com­pa­nies with­out strate­gies for bet­ter ac­cess. And less than half of key prod­ucts con­trolled by the 20 com­pa­nies are of­fered through ac­cess strate­gies in low­er-mid­dle or low-in­come coun­tries.

To take a clos­er look, the foun­da­tion ze­roed in on 199 med­i­cines, vac­cines, di­ag­nos­tics and vec­tor con­trol prod­ucts deemed “es­sen­tial for a well-func­tion­ing health­care sys­tem.” Of those, on­ly 13% of prod­ucts that need to be ad­min­is­tered by health care pro­fes­sion­als (like in­jectable treat­ments for can­cer) are cov­ered by ac­cess strate­gies in at least one low-in­come coun­try. And for self-ad­min­is­tered meds (like pills) that num­ber is 26%, ac­cord­ing to the in­dex.

Just un­der half (42%) of the self-ad­min­is­tered and pro­fes­sion­al­ly ad­min­is­tered prod­ucts weren’t tied to ac­cess strate­gies in any of the 106 coun­tries the in­dex eval­u­at­ed.

“This re­veals a wide­spread lack of con­sid­er­a­tion for how peo­ple liv­ing in these coun­tries will gain ac­cess to these prod­ucts, which are large­ly con­trolled by the phar­ma­ceu­ti­cal com­pa­nies in ques­tion,” the re­port states.

The com­pa­ny with the most can­di­dates cov­ered by ac­cess plans is GSK, which has com­mit­ted to de­vel­op­ing ac­cess plans for all projects that yield pos­i­tive Phase II re­sults. Pfiz­er, which ranked third for most can­di­dates cov­ered by ac­cess strate­gies, be­gins such plan­ning for all prod­ucts two years be­fore launch, ac­cord­ing to the foun­da­tion.

While such ini­tia­tives are a step in the right di­rec­tion, the foun­da­tion point­ed out that on­ly small num­bers of peo­ple per coun­try are ben­e­fit­ing from them.

“Af­ter years of en­cour­ag­ing ac­cess plan­ning, we are now see­ing a strate­gic shift in this di­rec­tion by phar­ma com­pa­nies. This could rad­i­cal­ly change how fast ac­cess to new prod­ucts is achieved — if com­pa­ny lead­er­ship is de­ter­mined to en­sure peo­ple liv­ing in low- and mid­dle-in­come coun­tries are not last in line,” Iy­er said.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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Thank you, next: Take­da hands Ovid $196M cash to rein back in Phase III-ready seizure drug, re­viv­ing bat­tered stock

Soticlestat made it.

Takeda is bringing the drug back into its fold more than four years after first entrusting the team at Ovid with the mid-stage clinical work. For all that — generating what they saw as positive Phase II data in Dravet syndrome and Lennox-Gastaut syndrome — the biotech has been rewarded with $196 million in upfront cash, with another $660 million reserved for regulatory and commercial milestones.

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Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Presage teams with Mer­ck on its Phase 0 test­ing; Kem­Pharm AD­HD drug wins ap­proval in chil­dren aged 6 and up

Seattle-based Presage Biosciences, which approaches drug development through its microdosing platform, has some new partnerships and cash to come with them.

Presage closed a $13 million financing round Tuesday, aiming to expand its network of clinical trial sites and advance development of its microdosing injection devices. They also closed partnership deals with Merck and Maverick Therapeutics.

The financing included $7 million from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners. An additional $6 million convertible note from Takeda Ventures will convert to equity.