Pur­due Phar­ma pleads guilty in fed­er­al Oxy­Con­tin probe, for­mal­ly rec­og­niz­ing it played a part in the opi­oid cri­sis

Pur­due Phar­ma, the pro­duc­er of the pre­scrip­tion painkiller Oxy­Con­tin, ad­mit­ted Tues­day that, yes, it did con­tribute to Amer­i­ca’s opi­oid epi­dem­ic.

The drug­mak­er for­mal­ly plead­ed guilty to three crim­i­nal charges, the AP re­port­ed, in­clud­ing get­ting in the way of the DEA’s ef­forts to com­bat the cri­sis, fail­ing to pre­vent the painkillers from end­ing up on the black mar­ket and en­cour­ag­ing doc­tors to write more painkiller pre­scrip­tions through two meth­ods: pay­ing them in a speak­ers pro­gram and di­rect­ing a med­ical records com­pa­ny to send them cer­tain pa­tient in­for­ma­tion. Pur­due’s plea deal calls for $8.3 bil­lion in crim­i­nal fines and penal­ties, but the com­pa­ny is on­ly li­able for a frac­tion of that to­tal — $225 mil­lion.

Re­ports that the deal had been close were pre­vi­ous­ly float­ed twice in Oc­to­ber, and the pleas are a part of the set­tle­ment deal an­nounced by the Jus­tice De­part­ment last month.

Mem­bers of the bil­lion­aire Sack­ler fam­i­ly did not per­son­al­ly plead guilty to any crimes, and they have agreed to pay $225 mil­lion of their own mon­ey to set­tle civ­il claims. The plea deal signed Tues­day leaves open the pos­si­bil­i­ty they may be charged in the fu­ture, how­ev­er.

Pur­due has been caught up in opi­oid leg­is­la­tion for more than a decade and a half, with pros­e­cu­tors in Pres­i­dent George W. Bush’s ad­min­is­tra­tion rec­om­mend­ing felony charges for the com­pa­ny and prison time for top ex­ec­u­tives af­ter a four-year in­ves­ti­ga­tion con­clud­ed in 2006. But the Jus­tice De­part­ment set­tled that case the next year — Pur­due plead­ed guilty to “mis­brand­ing” Oxy­Con­tin and agreed to $600 mil­lion in fines, while the ex­ecs al­so plead­ed guilty and paid $34.5 mil­lion in penal­ties.

The cen­tral claim of that case dealt with Oxy­Con­tin’s sup­posed long-act­ing for­mu­la. Pur­due claimed that be­cause of its time-re­lease for­mu­la­tion, Oxy­Con­tin had a low­er po­ten­tial for abuse than oth­er opi­oid painkillers like Per­co­cet or Vi­codin while ag­gres­sive­ly mar­ket­ing the drug to doc­tors and pa­tients.

Lit­i­ga­tion mount­ed over the last sev­er­al years, and Pur­due ul­ti­mate­ly filed for Chap­ter 11 in 2019 as part of a deal be­ing ne­go­ti­at­ed at the time that would have cov­ered about $10 bil­lion in pay­ments. In the bank­rupt­cy case, Pur­due has pro­posed trans­form­ing in­to a pub­lic ben­e­fit cor­po­ra­tion with its pro­ceeds go­ing to help ad­dress the opi­oid cri­sis, per the AP.

Tues­day’s deal is un­like­ly to sa­ti­ate the claims of crit­ics that say Pur­due should have faced harsh­er penal­ties and calls for charg­ing the Sack­ler fam­i­ly for prof­it­ing off Oxy­Con­tin sales.

Pur­due was the first of three ma­jor opi­oid drug­mak­ers to de­clare bank­rupt­cy, with In­sys and Mallinck­rodt fol­low­ing in their foot­steps. The com­pa­nies have faced fur­ther crit­i­cism for go­ing down this route, with op­po­nents say­ing the moves can freeze lit­i­ga­tion and leave those lit­i­gants com­pet­ing for pay­outs with a com­pa­ny’s cred­i­tors.

Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

An Endpoints Zoom meeting; and the email header employees will see if your company is a Premium subscriber

What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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Covid-19 roundup: Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls; US recom­mits to WHO un­der Biden ad­min­is­tra­tion

As reports crop up that deliveries of Pfizer and BioNTech’s Covid-19 vaccine are being unexpectedly cut, Italy wonders if it can take the vaccine developers to court, according to the Wall Street Journal. 

After its shipment for this week was cut by 29%, the Italian government consulted its attorney general about taking legal action, the WSJ reported. Pfizer and BioNTech had warned the EU and Canada last week that their allocations would be reduced as Pfizer upgrades its Belgium factory. What Italy says it doesn’t appreciate, though, is the short notice.

Mike Grey, Plexium chairman (Horizon Therapeutics)

Plex­i­um adds in­dus­try vet Mike Grey to the brain trust with new in­vestor cash fund­ing its pro­tein degra­da­tion play

About 15 months since closing a $28 million Series A, a San Diego protein-degradation upstart returned to the venture well Thursday with an extension of that round and some new hires, including one of the city’s best-connected biotech execs.

Plexium has bagged an additional $35 million in financing, the biotech said, money that will push undisclosed oncology and immuno-oncology programs into the clinic. In addition, longtime industry vet Mike Grey is jumping on as chairman of the board, and two others from Thursday’s leads — Adam Goulburn from Lux Capital and Rob Hopfner from Pivotal BioVentures — joined the board too.

Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.