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.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; 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.

Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Albert Bourla, Pfizer CEO (Evan Vucci, AP Images)

Covid-19 roundup: Pfiz­er tees up 500M vac­cine dos­es for do­na­tion in ex­pand­ed US pact; Ear­ly remde­sivir helps stave off hos­pi­tal­iza­tions

Pfizer and BioNTech will sell 500 million doses of their Comirnaty Covid-19 vaccine to the US at cost as part of an expanded agreement to drive donations to low- and middle-income nations, the drugmaker said Wednesday.

The expanded pact doubles Pfizer/BioNTech’s commitment to the US effort, which will ship donations to COVAX, a global clearinghouse for up to 92 target nations, as well as the 55 member states of the African Union, Pfizer said. Deliveries started in August and are expected to run through September 2022.