Bio­Haven hopes to soothe Chi­nese headaches with Shang­hai sub­sidiary

Cap­i­tal­iz­ing on the bur­geon­ing bio­phar­ma in­ter­est in Chi­na, neu­ro-fo­cused drug de­vel­op­er Bio­Haven $BHVN is set­ting up shop in Shang­hai with a sub­sidiary called BioShin that will be tasked with shep­herd­ing the Con­necti­cut-based com­pa­ny’s ar­se­nal of late-stage mi­graine and neu­rol­o­gy prod­ucts in mar­kets across the Asia-pa­cif­ic re­gion.

Vlad Coric

Bio­Haven, which ear­li­er this week said it had sub­mit­ted a US ap­pli­ca­tion to mar­ket a sub­lin­gual for­mu­la­tion of the ALS drug rilu­zole, is gear­ing up to re­port key da­ta from a piv­otal late-stage tri­al test­ing its acute mi­graine drug, rimegepant, be­fore the end of the year in the Unit­ed States. The com­pa­ny’s in­ter­est is Chi­na is not un­ex­pect­ed, giv­en that large swathes of the re­gion’s im­mense pop­u­la­tion suf­fer from mi­graine and oth­er cen­tral ner­vous sys­tem dis­or­ders, al­though pa­tients have not ben­e­fit­ed from the heady pace of med­ical in­no­va­tion their US coun­ter­parts have en­joyed.

“Al­most 90 mil­lion in­di­vid­u­als in Chi­na alone suf­fer from mi­graine and could ul­ti­mate­ly ben­e­fit from our late-stage mi­graine de­vel­op­ment plat­form,” said Bio­Haven chief Vlad Coric.

Once a breed­ing ground for sci­en­tists that em­i­grat­ed to the Unit­ed States, Chi­na is now at­tract­ing top re­searchers and en­tre­pre­neur­ial tal­ent back to its shores as fi­nan­cial in­cen­tives, gov­ern­men­tal sup­port, in­dus­tri­al in­fra­struc­ture, reg­u­la­to­ry re­forms and a large, age­ing pop­u­la­tion pro­vide the ide­al back­drop for rapid drug dis­cov­ery and de­vel­op­ment.

Don­nie Mc­Grath

BioShin will be led by Don­nie Mc­Grath, a for­mer Bris­tol-My­ers $BMY ex­ec who has served as Bio­Haven’s chief of cor­po­rate strat­e­gy and busi­ness de­vel­op­ment since 2017, along with fel­low ex-Bris­tol-My­ers ex­ec Karl Lin­tel who has been ap­point­ed COO. With the sup­port of Bio­Haven, BioShin can fur­ther build its team and “raise cap­i­tal from both the pri­vate and pub­lic mar­kets in main­land Chi­na and Hong Kong,” Mc­Grath said in a state­ment on Wednes­day.

BioShin is ex­pect­ed to sub­mit an ap­pli­ca­tion to eval­u­ate rimegepant in hu­man tri­als in Chi­na next quar­ter, and ad­di­tion­al INDs for oth­er in­ves­ti­ga­tion­al drugs are al­so planned for sub­mis­sion in 2019. Mean­while, in the Unit­ed States, pos­i­tive Phase III rimegepant da­ta will al­low Bio­Haven to sub­mit an ap­pli­ca­tion to mar­ket the as-need­ed oral CGRP treat­ment for mi­graine in mid-2019, trail­ing be­hind Al­ler­gan $AGN that has re­cent­ly re­it­er­at­ed it is on track to sub­mit its ap­pli­ca­tion for a ri­val oral CGRP by the first quar­ter of next year.

The mul­ti-bil­lion dol­lar US mi­graine mar­ket is al­ready re­plete with in­jectable med­ica­tions from Te­va $TE­VA, Eli Lil­ly $LLY, and one from Am­gen $AMGN and No­var­tis $NVS, which are all de­signed to be used as pre­ven­ta­tive treat­ments and are cu­ri­ous­ly priced iden­ti­cal­ly. For those pa­tients who still ex­pe­ri­ence mi­graine at­tacks de­spite pre­ven­ta­tive an­ti-CGRP ther­a­py, acute, as-need­ed treat­ments will still be re­quired, which is where rimegepant and Al­ler­gen’s ri­val ubro­gepant could come handy. If ap­proved, the two acute drugs could po­ten­tial­ly al­so be used in com­bi­na­tion with their an­ti-CGRP in­jectable ri­vals.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,700+ biopharma pros reading Endpoints daily — and it's free.

Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.