US gov­ern­ment does not own any remde­sivir patents, GAO re­port finds

The US fed­er­al gov­ern­ment’s con­tri­bu­tions to re­search on Gilead’s Covid-19 an­tivi­ral drug remde­sivir did not re­sult in any patent rights be­cause the re­search did not cre­ate new in­ven­tions, the Gov­ern­ment Ac­count­abil­i­ty Of­fice said in a re­port on Wednes­day af­ter­noon.

The re­port set­tles a long­stand­ing dis­pute over whether the gov­ern­ment might be co-in­ven­tors of remde­sivir, which has lin­gered since be­fore for­mer Cal­i­for­nia at­tor­ney gen­er­al Xavier Be­cer­ra (who’s now Biden’s HHS sec­re­tary) led a group of oth­er AGs last sum­mer in call­ing on the gov­ern­ment to in­ter­vene and low­er the more than $3,000 price tag for remde­sivir be­cause of the gov­ern­ment’s sig­nif­i­cant con­tri­bu­tions to remde­sivir.

The GAO re­port ac­knowl­edges that be­tween 2013 and 2020, the gov­ern­ment pumped $162 mil­lion in­to the de­vel­op­ment of remde­sivir, with the Cen­ters for Dis­ease Con­trol and Pre­ven­tion (CDC), the De­part­ment of De­fense (DOD), and the Na­tion­al In­sti­tutes of Health (NIH) con­duct­ing and fund­ing pre­clin­i­cal re­search. In ad­di­tion, NIH fund­ed three remde­sivir clin­i­cal tri­als, in­clud­ing the one show­ing that the an­tivi­ral short­ened the re­cov­ery time for hos­pi­tal­ized pa­tients with se­vere Covid-19.

Gilead, how­ev­er, al­so con­duct­ed its own re­search that led to the in­ven­tion of remde­sivir and the com­pa­ny said it in­vest­ed $786 mil­lion in remde­sivir R&D from 2000 through De­cem­ber 2020, GAO says. Gilead added in a state­ment that its in­vest­ment in remde­sivir ex­ceed­ed $1 bil­lion in 2020 alone and that cur­rent­ly about half of all hos­pi­tal­ized pa­tients with Covid-19 in the US are treat­ed with the drug.

DOD, NIH and oth­er sci­en­tists at Van­der­bilt and the Uni­ver­si­ty of North Car­oli­na at Chapel Hill ac­knowl­edged to GAO that their sci­en­tists were not co-in­ven­tors of patent­ed remde­sivir dis­cov­er­ies. For in­stance, NIH of­fi­cials told the GAO that Gilead be­gan patent­ing meth­ods of us­ing remde­sivir to treat coro­n­avirus in­fec­tions in 2015, while NIH sci­en­tists be­gan their remde­sivir re­search fo­cus­ing on coro­n­avirus­es in 2016.

“The prin­ci­pal in­ves­ti­ga­tors of NIH-fund­ed coro­n­avirus re­search projects told us that they did not con­sid­er fil­ing in­ven­tion dis­clo­sures be­cause their re­search did not in­volve mak­ing any mod­i­fi­ca­tions to remde­sivir or its par­ent com­pounds. The prin­ci­pal in­ves­ti­ga­tors stat­ed that they viewed such mod­i­fi­ca­tions as the thresh­old for fil­ing such dis­clo­sures,” GAO said.

And even if the gov­ern­ment had filed for a remde­sivir method-of-use patent, DOD and NIH of­fi­cials said that would be of low eco­nom­ic val­ue be­cause the fed­er­al gov­ern­ment did not own the com­pound patents and would have had to li­cense those patents from Gilead if it want­ed to com­mer­cial­ize the method of use or li­cense it to an­oth­er com­pa­ny.

Ac­cord­ing to CDC of­fi­cials, as of last month, they said it was “un­like­ly that CDC would con­duct an in­ven­tor­ship analy­sis or pur­sue in­tel­lec­tu­al prop­er­ty rights giv­en Gilead’s back­ground in­tel­lec­tu­al prop­er­ty and the lim­it­ed po­ten­tial for CDC to li­cense any such rights.”

Chris Morten, a lawyer who cur­rent­ly teach­es at New York Uni­ver­si­ty School of Law, not­ed that the re­port did not clar­i­fy if a CDC sci­en­tist, Michael Lo, co-in­vent­ed Gilead’s remde­sivir com­pound patents, and if so, “CDC would, un­der the de­fault rules of patent law, have a claim to co-own­er­ship. But CDC ap­pears un­in­ter­est­ed in pur­su­ing its le­gal rights.”

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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President Biden (AP Images)

Biden in­vests $3B in­to an­tivi­ral de­vel­op­ment for Covid-19

The Biden administration on Thursday unveiled a new plan to invest more than $3 billion into speeding new antivirals to treat Covid-19.

The plan will allow NIH to evaluate, prioritize and advance antiviral candidates to Phase II clinical trials, using contractors and the NIH’s National Center for Advancing Translational Sciences laboratories to de-risk early stage development.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said NIAID director Anthony Fauci.

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Jeff Albers, Blueprint CEO

Blue­print Med­i­cines nabs 4th ap­proval in bid to­ward prof­itabil­i­ty

Blueprint Medicines’ push to profitability continues.

On Wednesday, the Cambridge biotech announced the FDA approved its longtime lead drug, Ayvakit, for advanced systemic mastocytosis, a group of debilitating rare diseases where one type of immune cell — mast cells — builds up uncontrollably in a particular organ. The decision came on the heels of Phase III trials showing that more than half of late-stage patients who received the drug responded to it and did so for just over three years.

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Franz-Werner Haas, CureVac CEO (Christoph Schmidt/picture-alliance/dpa/AP Images)

UP­DAT­ED: Cure­Vac blames vari­ants as a close­ly-watched Covid vac­cine goes down in flames, fail­ing piv­otal study with woe­ful da­ta

CureVac was widely expected to come in with a late but likely late-stage winner in the race to develop new vaccines for the Covid-19 pandemic. Instead, late Wednesday, the German biotech said their mRNA candidate CVnCoV flat failed a pivotal trial — quashing any hopes for a quick entry in the blockbuster field and gutting their share price.

CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. Initial analyses suggest age and strain dependent efficacy.

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