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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'

 

Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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FDA ad­comm votes unan­i­mous­ly in sup­port of a J&J Covid-19 boost­er two months af­ter one-dose shot

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Friday voted 19-0 in favor of authorizing a second shot of J&J’s Covid-19 vaccine to follow at least two months after the initial dose.

Regulators don’t have to follow VRBPAC’s recommendation, but they almost always do. Considering that the CDC’s advisory committee has already been set to review the expanded EUA, VRBPAC’s recommendation is likely to be adopted.

Jacob Van Naarden, Senior VP, CEO of Loxo Oncology at Lilly; President, Lilly Oncology

Eli Lil­ly bags FDA nod for Verzenio in ear­ly breast can­cer, but a con­tro­ver­sial di­ag­nos­tic could dog its roll­out

As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?

The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.

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As TRIPS coun­cil meets, the IP waiv­er for vac­cines is on life sup­port ahead of a De­cem­ber dead­line

The WTO’s TRIPS Council is meeting today and tomorrow to discuss a Covid-19 vaccine IP waiver that remains divisive and unlikely to be adopted thanks to European opposition, but which proponents still think could unlock more vaccine doses for low and middle-income countries.

Following the meetings this week, it’s expected there will be a better sense if some kind of waiver can be agreed to by December, Tahir Amin, an IP lawyer and co-executive director of I-Mak, told Endpoints News.