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.

Janet Woodcock may have one of the most historically long and drug-intense tenures in FDA history, but her new role is outside of all things pharma and the once-acting FDA commissioner isn’t looking back.

“No I really don’t look back,” Woodcock told Endpoints News via email on Monday morning. “Yes I will be transitioning. Longer discussion on infrastructure needed.”

Pfizer and BioNTech said Monday that they’re ready to approach the FDA this week with early data for their booster shot for Covid-19 vaccine in the youngest age group (6 months to under 5 years), which showed 80.3% efficacy based on 10 symptomatic Covid cases identified beginning seven days after the third dose.

“The study suggests that a low 3-ug dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains,” Uğur Şahin, CEO and co-founder of BioNTech said in a statement. “We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to EMA and other regulatory agencies to follow within the coming weeks.”

Early on in the Covid-19 pandemic, Vir Biotechnology enlisted China’s powerhouse CDMO WuXi Biologics for cell line development, process and formulation development as well as initial manufacturing of its antibodies, a deal that CEO George Scangos said would help Vir move more quickly.

Now that one of those antibodies, sotrovimab, is authorized in more than 40 countries and entangled in a partnership with GSK, Vir is axing the WuXi deal. The FDA pulled the EUA for sotrovimab, or Xevudy, last month because of the Omicron subvariant BA.2.

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.