Fol­low­ing US, Chi­na hos­pi­tal ef­forts, Gilead plots its own PhI­II tri­als for close­ly watched Covid-19 drug

Gilead is launch­ing its own Phase III tri­als of remde­sivir, the re­pur­posed an­tivi­ral that a WHO of­fi­cial called the “one drug right now we think may have re­al ef­fi­ca­cy” against Covid-19 as the nov­el coro­n­avirus orig­i­nat­ing from Wuhan, Chi­na rav­ages the world.

Mer­dad Parsey

An­nounced just a day af­ter the NIH and the Uni­ver­si­ty of Ne­bras­ka Med­ical Cen­ter reg­is­tered their US-based tri­al on­line, Gilead’s pro­gram will com­prise two stud­ies en­rolling around 1,000 pa­tients be­gin­ning in March. They will re­cruit pri­mar­i­ly in Asian coun­tries but will al­so in­clude pa­tients from oth­er lo­ca­tions with “high num­bers of di­ag­nosed cas­es,” the com­pa­ny said.

The news al­so came on the day that the num­ber of new cas­es re­port­ed out­side Chi­na of­fi­cial­ly sur­passed that in­side. The virus dubbed SARS-CoV-2 has now spread to at least 44 oth­er coun­tries, in­clud­ing Brazil and Al­ge­ria.

Since Gilead dust­ed it off in late Jan­u­ary, remde­sivir — a drug orig­i­nal­ly de­vel­oped for Ebo­la — quick­ly emerged as a fron­trun­ner in the race to find an ef­fec­tive treat­ment for res­pi­ra­to­ry dis­ease caused by SARS-CoV-2. Af­ter re­port­ing promis­ing in vit­ro da­ta, sci­en­tists from the Wuhan In­sti­tute of Vi­rol­o­gy even tried to patent the drug while Bright­Gene said it’s mass pro­duc­ing the ac­tive phar­ma­ceu­ti­cal in­gre­di­ent.

Chi­nese of­fi­cials an­nounced on Thurs­day that Gilead has been grant­ed three of the eight patents it’s filed for since 2011, though the one spec­i­fy­ing the use in coro­n­avirus­es is still un­der re­view.

Sev­er­al hos­pi­tals in Chi­na have ini­ti­at­ed clin­i­cal stud­ies with do­nat­ed drug and sci­en­tif­ic in­put from Gilead. The first re­sults are ex­pect­ed in April, de­spite strin­gent re­quire­ments that re­port­ed­ly slowed down en­roll­ment.

“Gilead’s pri­ma­ry fo­cus is on rapid­ly de­ter­min­ing the safe­ty and ef­fi­ca­cy of remde­sivir as a po­ten­tial treat­ment for COVID-19, and this com­ple­men­tary ar­ray of stud­ies helps to give us a more ex­pan­sive breadth of da­ta glob­al­ly on the drug’s pro­file in a short amount of time,” Gilead CMO Mer­dad Parsey said in a state­ment.

The Gilead stud­ies will eval­u­ate two dos­ing du­ra­tions — 5 or 10 days — of remde­sivir. One tri­al is de­signed for 600 pa­tients with se­vere clin­i­cal man­i­fes­ta­tions, who will be giv­en the drug in ad­di­tion to stan­dard of care; the oth­er will in­volve 400 mod­er­ate pa­tients and com­pare the treat­ment to stan­dard of care. Nor­mal­iza­tion of fever and oxy­gen sat­u­ra­tion will be the key met­ric for the first while the sec­ond will pri­mar­i­ly mea­sure pro­por­tion of pa­tients dis­charged.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.

Eu­ro­pean Union aims to es­tab­lish patent workaround in case of emer­gen­cies while try­ing to strength­en its own IP

The European Union is looking at ways to bypass patent protections and make it easier to make generic drugs in cases of emergency such as the Covid-19 pandemic, a new document says.

Normally, under WTO regulations, the practice known as “compulsory licensing” is allowed in exceptional circumstances and could be applied as a waiver to bypass patent holders. Wednesday’s document was published as part of the EU’s plan to shore up the intellectual property rights of its member states.