Zhong Nanshan, CGTN via YouTube

Har­vard joins coro­n­avirus fight with $115M 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.

The Chi­nese side of the ini­tia­tive is led by Zhong Nan­shan, head of the Chi­nese 2019-nCoV Ex­pert Task­force and the sci­en­tist who iso­lat­ed the SARS virus in 2003. He is al­so di­rec­tor-gen­er­al of the Chi­na State Key Lab­o­ra­to­ry of Res­pi­ra­to­ry Dis­eases.

“Har­vard Med­ical School is unique­ly po­si­tioned to con­vene ex­perts in vi­rol­o­gy, in­fec­tious dis­ease, struc­tur­al bi­ol­o­gy, pathol­o­gy, vac­cine de­vel­op­ment, epi­demi­ol­o­gy, and pub­lic health to con­front this rapid­ly evolv­ing cri­sis,” George Da­ley, dean of the Har­vard Med­ical School, said in a state­ment.

The ini­tia­tive will fo­cus on five ar­eas. That in­cludes de­vel­op­ing tests for rapid di­ag­no­sis, vac­cines, an­tivi­ral treat­ments to short­en the du­ra­tion of the dis­ease and mit­i­gate symp­toms, and oth­er treat­ments for pa­tients with se­vere dis­ease. Re­searchers will al­so try to un­der­stand how the body in­ter­acts with the virus. The hope is that they can find bio­mark­ers that will tell doc­tors if the in­fec­tion is wors­en­ing or will lead to life-threat­en­ing com­pli­ca­tions.

These ar­eas rep­re­sent the con­stel­la­tion of needs and un­knowns for a virus pub­lic health of­fi­cials in­creas­ing­ly fear will reach pan­dem­ic lev­els, and could be­come an an­nu­al in­fec­tion like the flu. Al­though the virus may yet dis­si­pate, ex­perts have em­pha­sized the need for long-term fund­ing that can im­prove readi­ness for fu­ture out­breaks, a need Har­vard un­der­scored in its an­nounce­ment.

The “re­sponse needs to be glob­al, rapid, and dri­ven by the best sci­ence,” Har­vard provost Alan Gar­ber said. “The lessons we learn from this out­break should en­able us to re­spond to in­fec­tious dis­ease emer­gen­cies more quick­ly and ef­fec­tive­ly in the fu­ture.”

Di­ag­no­sis has proven to be a con­tin­u­al chal­lenge through­out the virus’ spread. In Wuhan and the sur­round­ing Hubei province, the num­ber of pa­tients re­port­ing symp­toms rapid­ly out­stripped the sup­ply of nu­cle­ic acid test­ing kits used to con­firm the pres­ence of a virus. De­lays in di­ag­no­sis meant de­lays in quar­an­tine and treat­ment.

At the be­hest of Chi­nese doc­tors, of­fi­cials moved to CT scans to de­tect pneu­mo­nia, a symp­tom of the in­fec­tion, and then lat­er us­ing the test­ing kits as con­fir­ma­tion. But some in­fect­ed pa­tients show up neg­a­tive in CT scans, and as the virus has spilled out be­yond Chi­na’s bor­ders, how to test pa­tients in the fastest and most ac­cu­rate man­ner has be­come an is­sue of glob­al con­cern and a ma­jor point of dis­cus­sion at the World Health Or­ga­ni­za­tion and the US Cen­ter for Dis­ease Con­trol.

Har­vard has not said what forms of treat­ments they will in­ves­ti­gate. Thus far, most of the treat­ments used are an­tivi­rals orig­i­nal­ly de­vel­oped for oth­er pur­pos­es – in­clud­ing remde­sivir, the Gilead drug orig­i­nal­ly de­vel­oped for Ebo­la and Mar­burg virus, and lopinavir, an HIV drug – but doc­tors have flung a wide range of spec­u­la­tive ther­a­pies hop­ing to see what sticks. That in­cludes plas­ma treat­ments, an­ti­bod­ies oth­er coro­n­avirus pa­tients de­vel­oped in re­sponse to the virus and a tra­di­tion­al Chi­nese rem­e­dy drawn from ex­tracts of For­syth­iae fruc­tus. The ear­li­est drugs de­vel­oped specif­i­cal­ly for the virus are at least 5 months away from clin­i­cal tri­als.

Vac­cines ap­pear clos­er, with Mod­er­na and the NIH gun­ning for a clin­i­cal tri­al to start in the spring. How­ev­er, that us­es a tech­nol­o­gy that has yet to pro­duce an ap­proved vac­cine. Oth­er ef­forts, such as Glax­o­SmithK­line’s and Clover’s new part­ner­ship, are us­ing more tra­di­tion­al ap­proach­es but have longer time­lines.

In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.