Chi­na re­searchers tout in vit­ro da­ta for Gilead­'s an­tivi­ral against Wuhan virus — which they are try­ing to patent

There’s no de­fin­i­tive proof yet that Gilead’s remde­sivir works as a treat­ment for 2019-nCov, but re­searchers in Chi­na clear­ly con­sid­er it promis­ing enough to have ap­plied for a patent on its use to com­bat the coro­n­avirus virus out­break stem­ming from Wuhan.

Amid world­wide vig­i­lance over what many fear is be­com­ing a pan­dem­ic, sci­en­tists from the Wuhan In­sti­tute of Vi­rol­o­gy and Na­tion­al En­gi­neer­ing Re­search Cen­ter for the Emer­gency Drug said they have test­ed a to­tal of sev­en drugs in vit­ro — and found remde­sivir and the malar­ia treat­ment chloro­quine most ef­fec­tive against the nov­el coro­n­avirus.

In a state­ment, the in­sti­tu­tions al­so dis­closed that they filed a patent ap­pli­ca­tion on Jan­u­ary 21, days be­fore Gilead first an­nounced it’s dust­ing off the nu­cle­o­side ana­log — which failed to make the cut as an Ebo­la drug — to test against the new virus.

While ex­perts have in­di­cat­ed that a patent is un­like­ly to be grant­ed, the move high­lights grow­ing con­fi­dence in remde­sivir in the midst of a glob­al race to hunt an­ti­bod­ies and ther­a­pies for 2019-nCoV, for which there is no ap­proved treat­ment. The high­ly con­ta­gious virus has killed more than 490, most­ly in Chi­na.

The up­date al­so comes as the FDA is­sued its first Emer­gency Use Au­tho­riza­tion (EUA) since the De­part­ment of Health and Hu­man Ser­vices de­clared a pub­lic health emer­gency in the US on Jan­u­ary 31. The EUA means that the 2019-nCoV di­ag­nos­tic pan­el that’s been in use at CDC labs can now be used at any CDC-qual­i­fied lab across the coun­try.

Gilead — which has been in a patent dis­pute with the US gov­ern­ment over its HIV fran­chise — didn’t an­swer di­rect­ly whether it knew about the patent fil­ing be­fore the an­nounce­ment or what it thought about the Chi­nese re­searchers’ grounds.

Gilead in­vent­ed remde­sivir and has patent­ed it in Chi­na, in­clud­ing fil­ing patent ap­pli­ca­tions for use on coro­n­avirus­es. We are aware of re­ports of the Wuhan In­sti­tute for Vi­rol­o­gy’s patent ap­pli­ca­tion. Our fo­cus at this time, is on rapid­ly de­ter­min­ing the po­ten­tial for remde­sivir as a treat­ment for 2019-nCoV and ac­cel­er­at­ing man­u­fac­tur­ing in an­tic­i­pa­tion of po­ten­tial fu­ture sup­ply needs.

Af­ter US doc­tors re­port­ed us­ing remde­sivir as part of the reg­i­men for the first do­mes­tic case of 2019-nCoV, Gilead said it’s work­ing with Chi­nese au­thor­i­ties to start a ran­dom­ized con­trolled tri­al.

Nine tri­als are al­ready un­der­way to eval­u­ate dif­fer­ent com­bi­na­tions of al­ready ap­proved an­tivi­rals and cor­ti­cos­teroids, Bio­Cen­tu­ry not­ed, in­clud­ing HIV drugs such as Ab­b­Vie’s Kale­tra/Alu­via and Gilead’s De­scovy.

Remde­sivir, on the oth­er hand, is an ex­per­i­men­tal com­pound that’s been test­ed in hu­man tri­als. In a Q4 earn­ings call, Gilead CEO Daniel O’Day in­di­cat­ed that it may be de­ployed as an emer­gency treat­ment. In re­sponse to a ques­tion about man­u­fac­tur­ing prepa­ra­tions in the event that they need to scale up pro­duc­tion quick­ly, he had this to re­port:

In terms of man­u­fac­tur­ing, our team has re­al­ly been work­ing night and day, it’s been very im­pres­sive to watch this team over the past cou­ple of weeks re­al­ly ramp up to the ex­tent that we can. Our ca­pac­i­ty is go­ing up every day. We’re look­ing at all the op­tions we have ex­pect­ing to be pre­pared for what may come.

Ob­vi­ous­ly we are wait­ing for da­ta, both in vit­ro and then in peo­ple to en­sure that the drug ac­tu­al­ly works. And it’s im­por­tant just for every­one to keep that in mind that this is still in­ves­ti­ga­tion­al and we are still wait­ing for more da­ta to know. But at risk, we are in­vest­ing pret­ty heav­i­ly to make sure that we’re pre­pared as best as we can.

Around the same time, some in vit­ro da­ta were be­ing pub­lished on Na­ture as a let­ter to the ed­i­tor.

“No­tably, two com­pounds remde­sivir (EC50 = 0.77 μM; CC50 > 100 μM; SI > 129.87) and chloro­quine (EC50 = 1.13 μM; CC50 > 100 μM, SI > 88.50) po­tent­ly blocked virus in­fec­tion at low-mi­cro­mo­lar con­cen­tra­tion and showed high SI,” they wrote.

Giv­en its po­ten­tial, the Wuhan In­sti­tute of Vi­rol­o­gy said in a state­ment, it’s ap­plied for a patent in Chi­na and plans to dis­trib­ute to oth­er coun­tries via the Patent Co­op­er­a­tion Treaty. But should “the rel­e­vant over­seas com­pa­ny” be will­ing to con­tribute to the out­break con­trol, they would tem­porar­i­ly sus­pend ex­er­cise of their patent rights.

But ex­perts in­ter­viewed by lo­cal me­dia point out that the ap­pli­ca­tion may not go through. Not on­ly does Gilead hold the foun­da­tion­al patent to the drug, but it al­so ap­plied for one to cov­er remde­sivir’s use in coro­n­avirus­es back in 2016 — which didn’t spec­i­fy but could ar­guably in­clude this new strain.

Sanofi brings in 4 new ex­ec­u­tives in con­tin­ued shake-up, as vac­cines and con­sumer health chief head out the door

In the middle of Sanofi’s multi-pronged race to develop a Covid-19 vaccine, David Loew, the head of their sprawling vaccines unit, is leaving – part of the final flurry of moves in the French giant’ months-long corporate shuffle that will give them new-look leadership under new CEO Paul Hudson.

The company also said today that Alan Main, the head of their consumer healthcare unit, is out, and they named 4 executives to fill new or newly vacated positions, 3 of whom come from both outside both Sanofi and from Pharma.

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As­traZeneca trum­pets the 'mo­men­tous' da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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Ab­b­Vie wins an ap­proval in uter­ine fi­broid-as­so­ci­at­ed heavy bleed­ing. Are ri­vals My­ovant and Ob­sE­va far be­hind?

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

As tislelizum­ab gains trac­tion in Chi­na, BeiGene pulls the cur­tain on NSCLC da­ta sup­port­ing the PD-1 drug

In a world now brimming with checkpoint inhibitors, companies often struggle to make a mark given a raft of therapies have already captured a considerable portion of the vast oncology market.

BeiGene’s tislelizumab was the fourth PD(L)-1 inhibitor to secure approval in China — and as it works on expanding its share the company has put out detailed data on the use of the drug in certain patients with lung cancer.

David Chang, Allogene CEO (Jeff Rumans)

Head­ed to PhII: Al­lo­gene CEO David Chang com­pletes a pos­i­tive ear­ly snap­shot of their off-the-shelf CAR-T pi­o­neer

Allogene CEO David Chang has completed the upbeat first portrait of the biotech’s off-the-shelf CAR-T contender ALLO-501 at virtual ASCO today, keeping all eyes on a drug that will now try to go on to replace the first-wave personalized pioneers he helped create.

The overall response rate outlined in Allogene’s abstract for treatment-resistant patients with non-Hodgkin lymphoma slipped a little from the leadup, but if you narrow the patient profile to treatment-naïve patients — removing the 3 who had previous CAR-T therapy who didn’t respond, leaving 16 — the ORR lands at 75% with a 44% complete response rate. And 9 of the 12 responders remained in response at the data cutoff, offering a glimpse on durability that still has a long way to go before it can be completely nailed down.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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