Jean-Pierre Sommadossi, Atea president and CEO (file photo)

Roche wades deep­er in­to Covid-19 fight, ink­ing an­tivi­ral pact with $350M cash fol­low­ing Re­gen­eron deal

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 (Greg Nash/Pool via AP Images)

'I re­al­ly don’t look back': Janet Wood­cock on her tran­si­tion away from drugs

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.”

Özlem Türeci, BioNTech co-founder and Uğur Şahin, BioNTech CEO

Third dose bumps up ef­fi­ca­cy of Pfiz­er-BioN­Tech's Covid-19 vac­cine in youngest group of chil­dren to 80%

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.”

Mark Iwicki, Kala Pharmaceuticals CEO (Merus)

Al­con takes a crack at multi­bil­lion-dol­lar dry eye mar­ket, picks up 2 drugs from Langer spin­out

Kala Pharmaceuticals may have never come close to the blockbuster dreams it had for its dry eye disease treatment, but Alcon wants to see if it can take the drug further.

After giving commercialization its best shot over the past few years, Kala decided the marketing game is not for it after all. Instead, it will sell both of its commercial eye drop products — Eysuvis for dry eye disease, and Inveltys for post-operative inflammation and pain following ocular surgery — to Alcon for $60 million in cash, plus an undisclosed amount of milestones.

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George Scangos, Vir CEO (BIO via YouTube)

As GSK-part­nered Covid an­ti­body racks up glob­al sales, Vir ax­es WuXi deal and grabs back Chi­na rights

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.

Bay­er sounds re­treat from a $670 mil­lion CAR-T pact in the wake of a pa­tient death

Two months after Atara Biotherapeutics hit the hold button on its lead CAR-T 2.0 therapy following a patient death, putting the company under the watchful eye of the FDA, its Big Pharma partners at Bayer are bowing out of a $670 million global alliance. And the move is forcing a revamp of Atara’s pipeline plans, even as research execs vow to continue work on the two drugs allied with Bayer 18 months ago, which delivered a $60 million cash upfront.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

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.”

Delaware court rules against Gilead and Astel­las in years-long patent case

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.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

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.