John Maraganore, Jeremy Levin, Ron Cohen and Steven Holtzman

Biotech lead­ers ral­ly be­hind Chi­nese sci­en­tists in US, calls for 'mea­sured' poli­cies in wake of purges

A slate of biotech ex­ec­u­tives, ven­ture cap­i­tal­ists and aca­d­e­m­ic re­searchers have lent their voic­es to Chi­nese sci­en­tists work­ing in the US bio­med­ical field, am­pli­fy­ing con­cerns that re­cent sanc­tions could “cre­ate a cli­mate of fear and un­cer­tain­ty.”

The let­ter — draft­ed by Steven Holtz­man, Ron Co­hen, Je­re­my Levin and John Maraganore and signed by well over 100 in­dus­try fig­ures — cau­tions against vil­i­fy­ing or ex­clud­ing an eth­nic group at the ex­pense of the uni­ver­sal ef­fort to fight dis­ease. Levin cur­rent­ly chairs BIO, while Co­hen and Maraganore are past heads of the trade group.

High-pro­file ter­mi­na­tions of three Asian re­searchers at MD An­der­son in April first jolt­ed biotech lead­ers to­ward a re­al­iza­tion that their in­dus­try is not im­mune from na­tion­al vig­i­lance about over­seas in­flu­ence. Sub­se­quent con­tro­ver­sy at Emory in­volv­ing two promi­nent neu­ro­sci­en­tists of Chi­nese ori­gin fur­ther fu­elled wor­ries that re­searchers were be­ing pun­ished for con­duct­ing trans-Pa­cif­ic col­lab­o­ra­tive work that they were pre­vi­ous­ly en­cour­aged to do.

Feng “Franklin” Tao KU

Sig­nal­ing a tough crack­down against aca­d­e­m­ic es­pi­onage, the De­part­ment of Jus­tice has in­dict­ed a Uni­ver­si­ty of Kansas pro­fes­sor of fed­er­al fraud. Feng “Franklin” Tao, who works on sus­tain­able tech­nol­o­gy, was ac­cused of hid­ing his em­ploy­ment with a Chi­nese uni­ver­si­ty while con­duct­ing gov­ern­ment-fund­ed re­search in the US.

In their let­ter, Holtz­man, Co­hen, Levin and Maraganore (CEOs of Deci­bel, Acor­da, Ovid and Al­ny­lam, re­spec­tive­ly) em­pha­sized that they are for ac­tions against for­eign es­pi­onage and IP theft.

But ac­tions must not evolve in­to broad lim­i­ta­tions on col­lab­o­ra­tions be­tween Chi­nese and Amer­i­can sci­en­tists, as it would de­ter Chi­nese sci­en­tists from stay­ing in the US or even com­ing in the first place and thus be “dele­te­ri­ous to our na­tion­al in­ter­ests.”

Echo­ing opin­ions al­ready pub­lished by the ed­i­tors of Na­ture, Na­ture Biotech­nol­o­gy and for­mer NIH di­rec­tor (and ex-Sanofi R&D chief) Elias Zer­houni, they added:

(We) ad­vo­cate for mea­sured poli­cies that will both pro­tect U.S. in­tel­lec­tu­al prop­er­ty and con­tin­ue to fos­ter the di­ver­si­ty and col­lab­o­ra­tion that fu­el our abil­i­ty to ad­vance sci­ence and cure dis­ease. At a min­i­mum, uni­ver­si­ties must ef­fec­tive­ly com­mu­ni­cate and con­sis­tent­ly ap­ply their rules gov­ern­ing sci­en­tif­ic col­lab­o­ra­tions and IP oblig­a­tions, and they, as well as gov­ern­ment agen­cies, must clear­ly jus­ti­fy their ac­tions when they ac­cuse sci­en­tists of malfea­sance or seek to dis­miss them from their po­si­tions.

Last month, Zer­houni point­ed out in his op-ed that US pol­i­cy­mak­ers had ad­vo­cat­ed for sci­en­tif­ic ex­changes with Chi­na for years and in­sti­tu­tions had tac­it­ly sup­port­ed their re­searchers’ in­volve­ment in Chi­na’s Thou­sand Tal­ents Pro­gram.

Elias Zer­houni Sanofi

“The ‘rules,’ now pre­sent­ed and en­forced as se­vere vi­o­la­tions of U.S. ethics and in­tel­lec­tu­al prop­er­ty reg­u­la­tions, were not rig­or­ous­ly im­ple­ment­ed by of­fi­cials at many U.S. in­sti­tu­tions,” he wrote. “The con­ster­na­tion, sense of tar­get­ed dis­crim­i­na­tion, and fear in the Chi­nese-Amer­i­can sci­en­tif­ic com­mu­ni­ty are thus un­der­stand­able.”

While a re­cent sur­vey of End­points read­ers sug­gests a lack of con­sen­sus on the threat that Chi­nese-Amer­i­can sci­en­tif­ic com­mu­ni­ty faces, key play­ers are ap­par­ent­ly ea­ger to speak up be­fore the brain drain hap­pens in earnest.

Check out the full list of sig­na­to­ries here.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 66,100+ biopharma pros reading Endpoints daily — and it's free.

Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 66,100+ biopharma pros reading Endpoints daily — and it's free.

The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 66,100+ biopharma pros reading Endpoints daily — and it's free.

Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 66,100+ biopharma pros reading Endpoints daily — and it's free.

David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 66,100+ biopharma pros reading Endpoints daily — and it's free.

Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.