Te­va and Al­ler­gan reach an­oth­er opi­oid set­tle­ment, this time for $54M with San Fran­cis­co

An­oth­er set­tle­ment in the lit­i­ga­tion of the opi­oid cri­sis has been reached.

David Chiu

Ac­cord­ing to David Chiu, San Fran­cis­co’s city at­tor­ney, the city reached a com­bined $54 mil­lion set­tle­ment agree­ment against both Te­va and Ab­b­Vie’s Al­ler­gan on Wednes­day. Un­der the agree­ment in prin­ci­ple, opi­oid man­u­fac­tur­ers Al­ler­gan and Te­va will pay San Fran­cis­co $34 mil­lion in cash pay­ments.

Ac­cord­ing to a state­ment from Te­va, the man­u­fac­tur­er is pro­vid­ing $24.8 mil­lion over 13 years from their end as well as $20 mil­lion worth of Nar­can over the next 10 years. Ab­b­Vie’s Al­ler­gan was not im­me­di­ate­ly avail­able for com­ment.

Ac­cord­ing to the city at­tor­ney, the set­tle­ments stem from on­go­ing lit­i­ga­tion San Fran­cis­co brought on be­half of the peo­ple of the state of Cal­i­for­nia against the opi­oid in­dus­try. Fol­low­ing this agree­ment, Al­ler­gan and Te­va will be sev­ered from the tri­al.

How­ev­er, Te­va and Al­ler­gan are not the on­ly tar­gets that San Fran­cis­co is go­ing af­ter. Clos­ing ar­gu­ments against the re­main­ing de­fen­dant in the case, phar­ma­cy chain Wal­greens, will be­gin to­day. The wider suit al­leges that Wal­greens over-dis­pensed opi­oids with­out prop­er due dili­gence and failed to iden­ti­fy, di­vert and re­port sus­pi­cious or­ders.

“Un­der this agree­ment, our city will re­ceive sig­nif­i­cant re­sources to com­bat the opi­oid cri­sis and bring re­lief to our com­mu­ni­ties. We look for­ward to pre­sent­ing clos­ing ar­gu­ments in our tri­al against the re­main­ing de­fen­dant, Wal­greens, to make sure they are al­so held ac­count­able for the cri­sis they fu­eled,” Chiu said in a state­ment.

The city at­tor­ney’s of­fice has al­so se­cured over $120 mil­lion in cash pay­ments and oth­er ben­e­fits from the opi­oid in­dus­try to go to­wards opi­oid abate­ment and over­dose pre­ven­tion in San Fran­cis­co.

Ac­cord­ing to the at­tor­ney’s of­fice, San Fran­cis­co has been hit hard by the over­all cri­sis. In the pe­ri­od be­tween 2006 to 2014, San Fran­cis­co Coun­ty saw more than 163 mil­lion opi­oids dis­trib­uted, or enough for 22 pills per per­son per year. And, be­tween 2015 and 2020, San Fran­cis­co saw a 478% in­crease in opi­oid-re­lat­ed over­dose deaths.

The city has been in­volved in sev­er­al oth­er opi­oid-re­lat­ed cas­es as it has pre­vi­ous­ly se­cured a $10 mil­lion set­tle­ment with En­do. It al­so se­cured a $60 mil­lion set­tle­ment with J&J as well as dis­trib­u­tors McKesson, Car­di­nal and Amerisource­Ber­gen. The city is al­so like­ly to re­ceive fund­ing from the bank­rupt­cy es­tate of Pur­due Phar­ma and the Sack­ler fam­i­ly as well.

For Al­ler­gan and Te­va, this is on­ly the lat­est in a string of set­tle­ments in opi­oid-re­lat­ed cas­es. In May, the com­pa­nies reached a set­tle­ment worth $161.5 mil­lion in West Vir­ginia. The deal would re­solve claims that the com­pa­nies helped fu­el the state’s opi­oid epi­dem­ic.

The com­pa­nies were al­so hint­ing at a will­ing­ness to pay a com­bined $5 bil­lion-plus to set­tle more than 3,500 law­suits over opi­oid-re­lat­ed cas­es.

How­ev­er, the bat­tles are still look­ing as if they won’t slow down any­time soon as New York at­tor­ney gen­er­al Leti­tia James on Mon­day ac­cused Te­va of ly­ing about how it con­trolled its Amer­i­can sub­sidiary and re­lat­ed opi­oid sales, say­ing the par­ent com­pa­ny made “sig­nif­i­cant and in­ten­tion­al” mis­rep­re­sen­ta­tions.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

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Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

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Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

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iECURE CEO Joe Truitt and founder Jim Wilson

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This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

Tim Walbert, Horizon Therapeutics CEO (via YouTube)

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Amgen, J&J’s Janssen and Sanofi are all in talks to acquire Horizon Therapeutics, the rare disease biotech disclosed late Tuesday.

Horizon confirmed “highly preliminary discussions” with those companies regarding a potential buyout offer after the Wall Street Journal reported takeover interest.

Although the company — which commands a market cap of close to $18 billion — emphasized that “there can be no certainty that any offer will be made for the Company,” shares $HZNP still surged 31% in after-hours trading to near $103, bringing it to the point where it started the year.

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