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

Grow­ing ac­cep­tance of ac­cel­er­at­ed path­ways for nov­el treat­ments: but does reg­u­la­to­ry ap­proval lead to com­mer­cial suc­cess?

By Mwango Kashoki, MD, MPH, Vice President-Technical, and Richard Macaulay, Senior Director, of Parexel Regulatory & Access

In recent years, we’ve seen a significant uptake in the use of regulatory options by companies looking to accelerate the journey of life-saving drugs to market. In 2018, 73% of the novel drugs approved by the U.S. Federal Drug Administration (FDA) were designated under one or more expedited development program categories (Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval).ᶦ

Sanofi out­lines big API plans as coro­n­avirus out­break re­port­ed­ly threat­ens short­age of 150 drugs

As the world becomes increasingly dependant on Asia for the ingredients of its medicines, Sanofi sees business to be done in Europe.

The French drugmaker said it’s creating the world’s second largest active pharmaceutical ingredients (API) manufacturer by spinning out its six current sites into a standalone company: Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France). They have mapped out €1 billion in expected sales by 2022 and 3,100 employees for the new operations headquartered in France.

UP­DAT­ED: NGM Bio takes leap for­ward in crowd­ed NASH field

South San Francisco-based NGM Bio may have underwhelmed with its interim analysis of a key cohort from a mid-stage NASH study last fall — but stellar topline data unveiled on Monday showed the compound induced significant signs of antifibrotic activity, NASH resolution and liver fat reduction, sending the company’s stock soaring.

There are an estimated 50+ companies focused on developing drugs for non-alcoholic steatohepatitis, or NASH, a common liver disease that has long flummoxed researchers. The first wave of NASH drug developers struggled with efficacy as well as safety — and companies big and small have crashed and burned.

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Mickey Kertesz, KidsandArtOrg via YouTube

Soft­Bank's newest, $165M biotech in­vest­ment looks for in­fec­tious traces in the blood

SoftBank has found its newest biotech investment.

The Japanese bank has invested $165 million into Karius, a company that uses blood tests to diagnose infectious diseases, as part of its new Vision Fund 2. The full scope of the new fund has yet to be announced, but the first and newly-beleaguered Vision Fund poured $100 billion into technology companies, including the biotechs Vir Biotechnology and Roivant and the sequencing company 10x Genomics.

Methicillin-resistant Staph aureus (Shutterstock)

FDA grants ‘break­through’ sta­tus to an­tibi­ot­ic al­ter­na­tive as Con­tra­Fect rush­es to join fight against su­per­bug

An experimental drug that promises to be the first anti-infective agent to prove superior to vancomycin — an antibiotic approved in 1958 — has notched the FDA’s “breakthrough” status.

ContraFect said the designation was based on Phase II data in which exebacase was tested against a superbug known as methicillin-resistant Staph aureus, or MRSA. In a subgroup analysis, the clinical responder rate at day 14 was 42.8% higher than that among those treated with standard of care, the company said (p=0.010).

Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115 mil­lion and a high-pro­file Chi­nese part­ner

For two months, as the novel coronavirus swelled from a few early cases tied to a Wuhan market to a global epidemic, most of the world’s focus and dollars have flowed toward emergency initiatives: building vaccines at a record pace, plucking experimental antivirals out of freezers to see what sticks and immunizing mice for new antibodies.

Now a new and well-funded collaboration between Harvard and a top Chinese research institute will play the long game. In a 5-year, $115 million initiative backed by China Evergrande Group, researchers from the Harvard Medical School, Harvard T.H. Chan School of Public Health and Guangzhou Institute for Respiratory Health will study the virus in an effort to develop therapies against infections by the novel coronavirus, known as SARS–CoV-2, and to prevent new ones.

No­var­tis gets a boost in block­buster mul­ti­ple scle­ro­sis race with Roche

In the first step of what’s likely to be a long and uphill battle for the drugmaker, the FDA has accepted Novartis’s BLA submission for a new multiple sclerosis drug and given it priority review. The PDUFA date for the potential blockbuster drug is in June.

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Juergen Horn

An­i­mal health vet Juer­gen Horn makes new an­ti­body play for pets, rak­ing $15M in Se­ries A haul

Zoetis forked over $85 million in 2017 to acquire Nexvet Biopharma and its pipeline of monoclonal antibodies. Juergen Horn, Nexvet’s former chief product development officer, has now secured $15 million for his own biologic company for animals: Invetx.

Buoyed by emerging advances in gene therapies for humans, scientists have started looking at harnessing the technology for animals setting up companies such as Penn-partnered Scout Bio and George Church-founded Rejuvenate Bio. But akin to Nexvet, Invetx is working on leveraging the time-tested science of monoclonal antibodies to treat chronic diseases that afflict man’s best friend.

As coro­n­avirus out­break reach­es 'tip­ping point,' GSK lends ad­ju­vant tech to Chi­nese part­ner armed with pre­clin­i­cal vac­cine

As the coronavirus originating out of Wuhan spreads to South Korea, Italy and Iran, stoking already intense fears of a pandemic, GlaxoSmithKline has found another pair of trusted hands to place its adjuvant system. China’s Clover Biopharmaceuticals will add the adjuvant to its preclinical, protein-based vaccine candidate against SARS-CoV-2.

Clover, which is based in the inland city of Chengdu, boasts of a platform dubbed Trimer-Tag that produces covalently-trimerized fusion proteins. Its candidate, COVID-19 S-Trimer, resembles the viral spike (S)-protein found in the virus.