Ab­b­Vie do­nates $1M+ of the HIV drug that Chi­na is now rec­om­mend­ing for coro­n­avirus treat­ment

Ab­b­Vie is do­nat­ing more than $1 mil­lion worth of an HIV drug to help com­bat the fast-spread­ing coro­n­avirus out­break in Chi­na, the com­pa­ny an­nounced on Fri­day.

Chi­na’s Na­tion­al Health Com­mis­sion has sug­gest­ed Alu­via, a pill con­tain­ing lopinavir and ri­ton­avir, as one of two pos­si­ble treat­ments for the symp­toms of the virus cur­rent­ly known as 2019-nCoV in the ab­sence of ef­fec­tive an­tivi­ral med­ica­tions. The oth­er part is neb­u­lized al­pha-in­ter­fer­on.

A crop of drug­mak­ers — now in­clud­ing J&J — is rac­ing to add more po­ten­tial weapons to the ar­se­nal.

Gov­ern­ment of­fi­cials are rush­ing to con­tain and find so­lu­tions for an epi­dem­ic that orig­i­nat­ed in the in­land city of Wuhan, Hubei but has since popped up in every oth­er re­gion ex­cept for Ti­bet. The Alu­via reg­i­men — two pills per round, twice dai­ly — was in­clud­ed in the third test ver­sion of the “di­ag­no­sis and treat­ment plan for new coro­n­avirus in­fec­tions.”

Guang­fa Wang, a Bei­jing-based pul­monary ex­pert who con­tract­ed the virus af­ter vis­it­ing Wuhan for an in­ves­ti­ga­tion, told Chi­na’s Time-Week­ly that he took Alu­via as part of his treat­ment and it ap­peared to be ef­fec­tive in his case. Shang­hai of­fi­cials said they have adopt­ed this type of HIV drugs since their first pa­tient.

“So far it seems to have cer­tain ef­fects, but we need more clin­i­cal ob­ser­va­tion,” said Hongzhou Lu of the Shang­hai Pub­lic Health Clin­i­cal Cen­ter.

The the­o­ry, yet to be proven, is that Alu­via works by block­ing a pro­tease that the coro­n­avirus needs for re­pro­duc­tion in the hu­man body. Though it’s not the same pro­tease that the drug was orig­i­nal­ly de­signed to block, it might be sim­i­lar enough to de­lay dis­ease pro­gres­sion. Be­cause of that, Alu­via had pre­vi­ous­ly al­so been test­ed in pa­tients with SARS and MERS.

An anony­mous Wuhan doc­tor in­ter­viewed by Time-Week­ly said that Alu­via is use­ful against the nov­el coro­n­avirus, but it’s “hard to come by.”

Ab­b­Vie said on WeChat that it will do­nate RMB$10 mil­lion (around $1.44 mil­lion) worth of pills in re­sponse to the guid­ance, though it didn’t spec­i­fy how it would dis­trib­ute across the coun­try.

Oth­er drug­mak­ers are al­so rush­ing to the call for ef­fec­tive med­ica­tions. Gilead dust­ed off remde­sivir, an an­tivi­ral that missed the mark on Ebo­la, to see about its po­ten­tial against the new virus. Mod­er­na is al­lied with the NIH to de­vel­op a vac­cine while George Scan­gos’ Vir has brought out an­ti­bod­ies. A raft of small-cap biotechs trig­gered a stock ral­ly over po­ten­tial vac­cine can­di­dates that might take years, if ever, to ma­te­ri­al­ize.

On Mon­day J&J threw its name in the hat, as CSO Paul Stof­fels told CN­BC about its ef­forts to cre­ate a po­ten­tial vac­cine, test­ing at least five dif­fer­ent con­structs in par­al­lel and at the same time build­ing an an­i­mal mod­el and prepar­ing the man­u­fac­tur­ing in­fra­struc­ture.

“We are com­fort­able that can cre­ate a vac­cine and scale it up,” he said on air.

Treat­ments are ur­gent­ly need­ed as the death toll in Chi­na ris­es to 81, five of them out­side Hubei province, with al­most 3,000 con­firmed cas­es and dou­ble that num­ber of sus­pect­ed cas­es even as sev­er­al cities are on lock­down. So far, five 2019-nCoV cas­es have been de­tect­ed in the US.

So­cial im­age: Ab­b­Vie

Jude Samulski, Marianne De Backer

Bay­er buys a biotech ‘race horse’ with a $4B deal — $2B in cash — aimed at go­ing big in­to gene ther­a­py

In the latest sign that Big Pharma wants a leading place in the push to develop a new generation of cell and gene therapies, Bayer is stepping up today with a $2 billion cash deal to buy out one of the fast-moving pioneers in the field, while adding up to $2 billion more in milestones if the new pharma subsidiary can deliver the goods.

As part of a continuing series of deals engineered by Bayer BD chief Marianne De Backer, the pharma player has snapped up Asklepios, more commonly referred to in more casual fashion as AskBio. And they are paying top dollar for a Research Triangle Park-based company that raised $225 million a little more than a year ago to back the brainchild of Jude Samulski, the gene therapy pioneer out of the University of North Carolina Gene Therapy Center.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,600+ biopharma pros reading Endpoints daily — and it's free.

Patrick Soon-Shiong at the JP Morgan Healthcare Conference, Jan. 13, 2020 (David Paul Morris/Bloomberg via Getty Images)

Af­ter falling be­hind the lead­ers, dissed by some ex­perts, biotech show­man Patrick Soon-Sh­iong fi­nal­ly gets his Covid-19 vac­cine ready for a tri­al. But can it live up to the hype?

In January, when dozens of scientists rushed to start making a vaccine for the then-novel coronavirus, they were joined by an unlikely compatriot: Patrick Soon-Shiong, the billionaire doctor most famous for making big, controversial promises on cancer research.

Soon-Shiong had spent the last 4 years on his “Cancer Moonshot,” but part of his project meant buying a small Seattle biotech that specialized in making common-cold vectors, called adenoviruses, to train the immune system. The billionaire had been using those vectors for oncology, but the company had also developed vaccine candidates for H1N1, Lassa fever and other viruses. When the outbreak began, he pivoted.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,600+ biopharma pros reading Endpoints daily — and it's free.

Albert Bourla, AP

UP­DAT­ED: Where's the Pfiz­er ef­fi­ca­cy read­out? CEO Bourla says 'soon,' but you're go­ing to have to wait for it

Pfizer CEO Albert Bourla had promised repeatedly that the pharma giant would know if its leading Covid-19 vaccine is effective by the end of this month — now just a few days away.

Instead, the company reported early Tuesday that it has yet to conduct any interim efficacy analyses. And it won’t now until sometime next month.

The news was included in a slide for their Q3 report.

In the morning Q3 call with analysts, Bourla says that they expect efficacy data “soon,” but noted that they wouldn’t be able to say anything until all the administrative work was done on the interim, which would take about a week. And he added that Pfizer isn’t going to say anything else about that hot topic until they have the data in hand.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,600+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Re­searchers shut­ter 2 Covid-19 stud­ies as mon­i­tors flag Eli Lil­ly an­ti­bod­ies as a flop for pneu­mo­nia, hos­pi­tal­ized pa­tients — but EUA hunt con­tin­ues

Two weeks after the safety data monitoring group advised researchers to hit the hold button on a clinical trial of Eli Lilly’s antibody bamlanivimab (LYCoV55) for patients hospitalized with Covid-19, the trial overseers are back with fresh directions to shutter the study after losing faith that the drug could help this group of patients.

The monitors concluded, however, that there were no safety issues involved, which will likely encourage continued belief that Lilly can still nail down an emergency marketing application for less-sick patients.

Cedric Francois, Apellis CEO (Optum via YouTube)

UP­DAT­ED: So­bi bets $250M cash, about $1B in mile­stones for rights to a C3 ther­a­py be­ing pushed through 5 piv­otal tri­als

A couple years after licensing Novimmune’s emapalumab and turning around a quick FDA OK, Stockholm-based Sobi is betting up to $1.2 billion for rights to another rare disease drug.

The company is shelling out $250 million upfront and adding up to $915 million in milestones for rights to develop and commercialize Apellis Pharmaceuticals’ drug pegcetacoplan outside the US. Together, the companies will see the systemic C3 therapy through five registrational trials in hematology, nephrology and neurology.

Christian Rommel (via Roche)

Bay­er fol­lows R&D deal spree by raid­ing Roche's can­cer group for its new re­search chief

The day after Bayer signed off on a $4 billion deal designed to put the company among the leaders in gene therapy development, the pharma giant has recruited a new chief for its R&D division. And they opted for an expert in the cancer field.

Christian Rommel, Roche’s head of discovery and early-stage oncology development, has been tapped to take over the job. Joerg Moeller, who got the top research post after early and late-stage development roles were combined 2 years ago, is hitting the exit “to pursue other career opportunities.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,600+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: The dis­rup­tors at EQRx have their eyes on the PD-(L)1 mar­ket — tee­ing up $150M cash to grab 2 back­bone ther­a­pies from Chi­na

EQRx is paying top dollar to bring a pair of PD-(L)1 drugs into its portfolio of fast-follow therapies, offering $150 million upfront in what could shape up to be a $1.3 billion alliance with China’s CStone.

As early as 2017 Celgene had bet on a made-in-China PD-1 via its pact with BeiGene, quickly followed by Arcus as the second checkpoint wave was looming; more recently Eli Lilly imported longtime partner Innovent’s PD-1 in a $1 billion deal. All are diving into a space now dominated by Merck’s Keytruda franchise, where six other players are trying to catch up by carving out their own niches — and more are on their way to tap into the various I/O pairings anchored by a PD-(L)1. But none so far has quite shared EQRx’s explicit mission to disrupt the multibillion-dollar market by offering a lower cost option.

Covid-19 roundup: Medicare and Med­ic­aid re­cip­i­ents could re­ceive vac­cines for free — re­port

As Covid-19 cases mount in the US, the White House is expected to announce that Medicare and Medicaid recipients will be able to get an authorized Covid-19 vaccine at no cost to them, per a Politico report.

Four unnamed sources told Politico the following announcement is likely to come from the Centers for Medicare and Medicaid Services this Tuesday or Wednesday: Vaccines granted an EUA will be covered.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,600+ biopharma pros reading Endpoints daily — and it's free.

Charles Baum, Mirati CEO

UP­DAT­ED: Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,600+ biopharma pros reading Endpoints daily — and it's free.