Tedros Adhanom Ghebreyesus, Director General of the WHO (Salvatore Di Nolfi/Keystone via AP Images)

WHO OKs mol­nupi­ravir as treat­ment for Covid-19, af­ter new da­ta from In­dia

The WHO up­dat­ed its guide­lines on Wednes­day to rec­om­mend mol­nupi­ravir, Mer­ck’s an­tivi­ral pill, for treat­ing pa­tients new­ly di­ag­nosed with Covid-19.

It’s the first Covid-19 pill rec­om­mend­ed by the WHO, com­ing be­fore any rec­om­men­da­tion around Pfiz­er’s Paxlovid, de­spite con­tin­ued ques­tions about the pre­cise mag­ni­tude of ben­e­fit and the risks as­so­ci­at­ed with the Mer­ck drug.

The new de­ci­sion, how­ev­er, comes af­ter a tri­al in In­dia on a gener­ic ver­sion of mol­nupi­ravir found the pill re­duced the risk of hos­pi­tal­iza­tion from Covid-19 by 65%. Al­though not con­clu­sive, it was an­oth­er da­ta point in the on­go­ing de­bate over mol­nupi­ravir’s ef­fi­ca­cy. Mer­ck’s ini­tial da­ta showed the pill cut the risk of hos­pi­tal­iza­tion among high-risk Covid-19 pa­tients in half, but lat­er analy­ses of the same tri­al cut that num­ber to just 30% — a drop the com­pa­ny strug­gled to ex­plain to the FDA.

Lab stud­ies show the ef­fi­ca­cy should be un­af­fect­ed by new vari­ants such as Omi­cron.

WHO nod­ded to those risks in its state­ment, ad­dress­ing them in a sim­i­lar fash­ion to how US health agen­cies ad­dressed them. The glob­al health body said the drug should be pre­scribed on­ly for pa­tients with the “high­est risk of hos­pi­tal­iza­tion,” such as the un­vac­ci­nat­ed, the im­muno­com­pro­mised, old­er adults and peo­ple with chron­ic con­di­tions.

And, like the FDA, they ad­vised against pre­scrib­ing it in preg­nant women. That’s be­cause of the drug’s mech­a­nism of ac­tion — it in­duces a lethal num­ber of mu­ta­tions in the coro­n­avirus genome — and it could al­so in­duce mu­ta­tions in hu­mans. Some lab stud­ies sug­gest it’s pos­si­ble, al­though the ex­act risk to pa­tients who take the pill for just the rec­om­mend­ed five days re­mains un­known and Mer­ck has pre­sent­ed ev­i­dence to sug­gest it’s min­i­mal.

Mer­ck has tak­en steps to make the drug avail­able glob­al­ly, sign­ing li­cens­es with gener­ic drug­mak­ers in In­dia and strik­ing an agree­ment with the Med­i­cines Patent Pool, a UN-backed non­prof­it that will work to make the pill avail­able in 105 low- and mid­dle-in­come coun­tries.

Crit­i­cism of the drug has not abat­ed, though. On Thurs­day, James Bro­phy, a pro­fes­sor of med­i­cine at McGill Uni­ver­si­ty, pub­lished an op-ed in the British Med­ical Jour­nal ques­tion­ing the UK’s de­ci­sion to au­tho­rize the drug and point­ing to the safe­ty con­cerns and lin­ger­ing ques­tions over its ex­act ef­fi­ca­cy.

These ques­tions have af­fect­ed up­take in the US. Even as Omi­cron surged in the US, mol­nupi­ravir sat on shelves at many phar­ma­cies across the coun­try. In Feb­ru­ary, the Fi­nan­cial Times re­port­ed that the EMA might de­ny au­tho­riza­tion for the pill over those con­cerns.


M&A: a crit­i­cal dri­ver for sus­tain­able top-line growth in health­care

2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

15 LGBTQ lead­ers in bio­phar­ma; Paul Stof­fels’ Gala­pa­gos re­vamp; As­traZeneca catch­es up in AT­TR; 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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by 1 Jan. 2028.

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AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

Sometimes, being late can give you an advantage.

That’s what Sanofi and GSK are trying to say as the Big Pharma partners report positive results from a late-stage trial of their next-gen bivalent Covid-19 vaccine, which was designed to protect against both the original strain of the SARS-CoV-2 virus and the Beta variant. Specifically, against Omicron, they note, the vaccine delivered 72% efficacy in all adults and 93.2% in those previously infected.

Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

GSK says its drug for chron­ic hep B could ‘lead to a func­tion­al cure’ — but will it be alone or in com­bi­na­tion?

GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

At a presentation at the EASL International Liver Congress, GSK shared that in around 450 patients who received its hep B drug bepirovirsen for 24 weeks, just under 30% had hepatitis B surface antigen and viral DNA levels that were too low to detect.

Stéphane Bancel (AP Photo/Charles Krupa)

Mod­er­na to se­cure a UK pres­ence with $1B+ in new man­u­fac­tur­ing and R&D fa­cil­i­ties

As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

Moderna will establish this new mRNA Innovation and Technology Centre to develop mRNA vaccines for a wide range of respiratory diseases, including Covid-19.

De­spite a slow start to the year for deals, PwC pre­dicts a flur­ry of ac­tiv­i­ty com­ing up

Despite whispers of a busy year for M&A, deal activity in the pharma space is actually down 30% on a semi-annualized basis, according to PwC’s latest report on deal activity. But don’t rule out larger deals in the second half of the year, the consultants said.

PwC pharmaceutical and life sciences consulting solutions leader Glenn Hunzinger expects to see Big Pharma companies picking up earlier stage companies to try and fill pipeline gaps ahead of a slew of big patent cliffs. Though a bear market continues to maul the biotech sector, Hunzinger said recent deals indicate that pharma companies are still paying above current trading prices.