As it ex­pands its foot­print, Mod­er­na reach­es deal to com­mer­cial­ize Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the high­est per­cent­age of res­i­dents vac­ci­nat­ed, neigh­bor­ing Sau­di Ara­bia — home to near­ly 35 mil­lion peo­ple — has lagged be­hind sig­nif­i­cant­ly. On Fri­day, Mod­er­na an­nounced that it has part­nered with the Sau­di phar­ma­ceu­ti­cal com­pa­ny Tabuk to com­mer­cial­ize its jab and fu­ture vari­ant-spe­cif­ic boost­ers in the coun­try.

Tabuk will hold mar­ket­ing au­tho­riza­tion for the vac­cine in Sau­di Ara­bia, and the agree­ment gives them the pos­si­bil­i­ty of dis­trib­ut­ing fu­ture Mod­er­na mR­NA prod­ucts.

Sau­di Ara­bia has vac­ci­nat­ed just 6% of its pop­u­la­tion. The coun­try has had a steady num­ber of around 1,000 cas­es per day since May 20. Since the start of the pan­dem­ic, 7,503 Sau­di Ara­bi­ans have died from the virus, while 461,000 peo­ple have test­ed pos­i­tive.

“As part of our role and mis­sion in Tabuk to de­liv­er unique health so­lu­tions and pre­serve lives for the peo­ple of Sau­di Ara­bia and coun­tries we op­er­ate in es­pe­cial­ly dur­ing the cur­rent pan­dem­ic, our part­ner­ship with Mod­er­na comes in as an ev­i­dent choice to fur­ther sup­port our mis­sion in line with Sau­di vi­sion 2030 re­gard­ing biotech­nol­o­gy in as­so­ci­a­tion with such a dis­tin­guished & renowned com­pa­ny as Mod­er­na,” said Mo­hammed Al­hag­bani, the pres­i­dent of As­tra In­dus­tri­al Group, which owns Tabuk.

Mod­er­na has been busy. The com­pa­ny an­nounced a plan to pro­duce as many as 3 bil­lion dos­es of its vac­cine per year, in a move that CEO Stéphane Ban­cel said in an in­ter­view with End­points News was dri­ven by the com­pa­ny’s sense of oblig­a­tion in help­ing the rest of the world with vac­cines. At the start of May, though it was late to the par­ty, Mod­er­na pledged 500 mil­lion dos­es to Gavi, the vac­cine al­liance.

Since then, it’s an­nounced part­ner­ships to man­u­fac­ture vac­cines in Spain, South Ko­rea, Aus­tralia and Switzer­land, as well as bol­stered its US op­er­a­tions with ex­pan­sions in Mass­a­chu­setts. Just Thurs­day, Mod­er­na filed for emer­gency use au­tho­riza­tion to get its vac­cine in the arms of teens be­tween the ages of 12 and 17. Ear­li­er that week, it filed for au­tho­riza­tion with EU and Cana­di­an reg­u­la­tors as well.

The com­pa­ny an­nounced in May that its Phase II/III study of the vac­cine in ado­les­cents met the pri­ma­ry end­points in near­ly 2,500 pa­tients and showed an ef­fi­ca­cy of 100% against se­vere symp­to­matic Covid-19. The tri­al al­so looked at milder cas­es than were ex­am­ined in the adult study, since chil­dren are less like­ly to de­vel­op se­ri­ous side ef­fects. The study found that the vac­cine was 93% ef­fec­tive at stop­ping mild cas­es 14 days af­ter pa­tients were dosed with their first shot.

A pre­vi­ous ver­sion of this sto­ry stat­ed that Mod­er­na and Ma­gen­ta had reached a deal to man­u­fac­ture vac­cines in Sau­di Ara­bia. That has been cor­rect­ed.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Elisabeth Stampa, Medicines for Europe president

As win­ter ap­proach­es, a Eu­ro­pean gener­ics group rais­es alarm over en­er­gy prices for man­u­fac­tur­ers

While colder temperatures are fast approaching, the situation surrounding the rise of energy prices in Europe is hitting businesses of every kind, including generic drug manufacturers.

Medicines for Europe, a group that represents the generic industry on the continent, sent a letter addressed to energy ministers and commissioners concerning inflation and the costs of energy on the supply of generic medicines.

Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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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.

Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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Covid-19 roundup: Swiss biotech halts in-pa­tient PhII study; Hous­ton-based vac­cine and Chi­nese mR­NA shot nab EUAs in In­done­sia

Another Covid-19 study is hitting the brakes as a Swiss biotech is pausing its Phase II trial in patients hospitalized with Covid-19.

Kinarus Therapeutics announced on Friday that the Data and Safety Monitoring Board (DSMB) has reviewed the company’s Phase II study for its candidate KIN001 and has recommended that the study be stopped.

According to Kinarus, the DSMB stated that there was a low probability to show statistically significant results as the number of Covid-19 patients that are in the hospital is lower than at other points in the pandemic.