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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Livingston (Credit: Michael Sazel for CeMM)

Renowned Dana-Far­ber sci­en­tist, men­tor and bio­phar­ma ad­vi­sor David Liv­ingston has died

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.

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

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.

Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

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.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Hedge fund jumps in with Avoro ac­tivists in an at­tempt to de­rail Mer­ck­'s $11B Ac­celeron buy­out

Avoro Capital, which made its bones blowing up the Seagen-Immunomedics deal and then selling the smaller biotech for $21 billion, is getting an assist in its quest to derail Merck’s $11 billion buyout of Acceleron $XLRN.

Wednesday morning one of Acceleron’s biggest investors joined the opposition. Darwin Global Management, a hedge fund which owns about 4% of Acceleron, blasted the Merck deal, saying the Big Pharma is getting the company for billions less than what it’s worth. Earlier, Holocene Advisers, reportedly a top-20 investor in Acceleron, said it would not tender its stock after criticizing the $180-per-share deal.

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Man­u­fac­tur­ing woes for No­vavax’s Covid jab bad­ly dis­rupt plans for roll­out to the poor — re­port

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.