Roche is mak­ing its first bet on an an­tivi­ral against Covid-19 in style, shelling out $350 mil­lion in cash to grab ex-US rights.

The drug comes from Atea Phar­ma­ceu­ti­cals, the 7-year-old biotech cre­at­ed by Phar­mas­set co-founder Jean-Pierre Som­ma­dos­si, which es­sen­tial­ly re­brand­ed it­self as a Covid-19 fight­er in May when it closed a whop­ping $215 mil­lion ven­ture round. Over a dozen in­vestors bought in, in­clud­ing mar­quee names like Bain Cap­i­tal and RA Cap­i­tal.

That mon­ey is fund­ing a Phase II clin­i­cal tri­al for AT-527 in hos­pi­tal­ized pa­tients with mod­er­ate Covid-19, with a glob­al Phase III in out­pa­tients to fol­low in ear­ly 2021. Then there are plans for an­oth­er Phase III in the post-ex­po­sure pro­phy­lax­is set­ting.

Tap­ping in­to Roche’s de­vel­op­ment and man­u­fac­tur­ing prowess al­lows Atea to do this at scale, said Som­ma­dos­si, the com­pa­ny’s pres­i­dent and CEO.

A nu­cleotide pro­drug, AT-527 be­longs to the same class as Gilead’s au­tho­rized remde­sivir and the ex­per­i­men­tal drug MK-4482 (for­mer­ly EI­DD-2801), which Mer­ck is now de­vel­op­ing with Ridge­back Bio­ther­a­peu­tics. By in­ter­fer­ing with vi­ral RNA poly­merase, it’s de­signed to in­hib­it repli­ca­tion of SARS-CoV-2.

While remde­sivir is cur­rent­ly on­ly avail­able through in­tra­venous in­fu­sion — Gilead is al­so de­vel­op­ing an in­haled ver­sion — Atea boasts of hav­ing an oral op­tion that can be pro­duced quick­ly.

Af­ter an ef­fort to re­pur­pose the IL-6 an­ti­body Actem­ra all but flopped, Roche be­gan build­ing a port­fo­lio of ex­per­i­men­tal treat­ments, start­ing with Re­gen­eron’s an­ti­body cock­tail. As with Atea, Roche bagged the rest-of-world rights, but in­stead of pay­ing an up­front of­fered man­u­fac­tur­ing ca­pac­i­ty and fund­ing for clin­i­cal stud­ies.

Bill An­der­son

REGN-COV-2, now a well-known pro­gram thanks to a high-pro­file pa­tient in Pres­i­dent Don­ald Trump, is be­ing test­ed as both a pre­ven­tion and treat­ment.

“The on­go­ing com­plex­i­ties of COVID-19 re­quire mul­ti­ple lines of de­fence,” Roche Phar­ma CEO Bill An­der­son said in a state­ment. “By join­ing forces with Atea, we hope to of­fer an ad­di­tion­al treat­ment op­tion for hos­pi­talised and non-hos­pi­talised COVID-19 pa­tients, and pro­vide im­por­tant re­lief for hos­pi­tal in­fra­struc­tures dur­ing a glob­al pan­dem­ic.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

David Livingston, the Dana-Farber/Harvard Med scientist who helped shine a light on some of the key molecular drivers of breast and ovarian cancer, died unexpectedly last Sunday.

One of the senior leaders at Dana-Farber during his nearly half century of work there, Livingston was credited with shedding light on the genes that regulate cell growth, with insights into inherited BRCA1 and BRCA2 mutations that helped lay the scientific foundation for targeted therapies and earlier detection that have transformed the field.

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.

Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.

The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.