Te­va, Al­ler­gan open to set­tling 3500+ law­suits for more than $5B as ne­go­ti­a­tions con­tin­ue — re­port

Sev­er­al com­pa­nies have doled out tens, if not hun­dreds of mil­lions of dol­lars to set­tle lit­i­ga­tion sur­round­ing the role they al­leged­ly had dur­ing the opi­oid epi­dem­ic on the state lev­el. In the case of com­pa­nies like Pur­due Phar­ma, a fed­er­al judge ap­proved a set­tle­ment that would see states re­ceive up to $6 bil­lion over the next 18 years.

Now, a re­port hints that Te­va and Al­ler­gan may be lin­ing up to be the next multi­bil­lion-dol­lar set­tle­ment.

Ac­cord­ing to three sources who spoke with Bloomberg ear­li­er this week, Te­va and Al­ler­gan hint­ed at a will­ing­ness to pay a com­bined $5+ bil­lion to set­tle more than 3,500 law­suits over al­le­ga­tions that their opi­oid painkillers played a role in the opi­oid epi­dem­ic, that the com­pa­nies had en­gaged in mis­lead­ing mar­ket­ing of opi­oids and at least for Te­va, down­played the risks of opi­oid ad­dic­tion.

The sources al­so told Bloomberg that while the drug­mak­ers had been in me­di­a­tion talks with plain­tiffs for over a year, no for­mal of­fer has been made or fi­nal­ized.

Be­fore any­thing can be fi­nal­ized, there’s still a de­tail that needs to be ham­mered out — who pays how much? Bloomberg’s sources said the com­pa­nies are ar­gu­ing over an in­dem­ni­ty agree­ment that Te­va signed back in 2016 when it agreed to pay $40+ bil­lion to buy Al­ler­gan Gener­ics be­fore Al­ler­gan got picked up by Ab­b­Vie. Al­ler­gan claims that the agree­ment Te­va signed shift­ed its opi­oid li­a­bil­i­ties and costs to Te­va.

Te­va de­clined to com­ment on the re­port, and Ab­b­Vie did not re­spond to a re­quest for com­ment be­fore pub­li­ca­tion.

It would be the newest de­vel­op­ment in a long-stand­ing saga af­ter the two drug­mak­ers reached set­tle­ments with states such as Flori­da and Rhode Is­land so far this year. But in some cas­es, they are still show­ing up in courts such as in West Vir­ginia, a state hard-hit by the opi­oid epi­dem­ic and has al­ready seen oth­er drug com­pa­nies such as J&J and En­do set­tle with the state for $99 mil­lion and $26 mil­lion, re­spec­tive­ly.

If the po­ten­tial deal does get of­fered, it would be a ma­jor next step for Te­va CEO Kare Schultz, who al­ready made it clear back in Feb­ru­ary that he thinks a na­tion­al set­tle­ment for opi­oid lit­i­ga­tion is with­in reach by ear­ly 2023. It could take a de­cent chunk out of what is left to be set­tled on a na­tion­al scale af­ter Te­va orig­i­nal­ly of­fered $250 mil­lion in cash and $23 bil­lion in a sup­ply of Nar­can to reach a na­tion­al set­tle­ment in 2019.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

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Co­pay coupons gone wrong, again: Pfiz­er pays al­most $300K to set­tle com­plaints in four states

Pfizer has agreed to pay $290,000 to settle allegations of questionable copay coupon practices in Arizona, Colorado, Kansas, and Vermont from 2014 to 2018.

While the company has not admitted any wrongdoing as part of the settlement, Pfizer has agreed to issue restitution checks to about 5,000 consumers.

A Pfizer spokesperson said the company has “enhanced its co-pay coupons to alleviate the concerns raised by states and agreed to a $30,000 payment to each.”

Delaware court rules against Gilead and Astel­las in years-long patent case

A judge in Delaware has ruled against Astellas Pharma and Gilead in a long-running patent case over Pfizer-onwed Hospira’s generic version of Lexiscan.

The case kicked off in 2018, after Hospira submitted an Abbreviated New Drug Application (ANDA) for approval to market a generic version of Gilead’s Lexiscan. The drug is used in myocardial perfusion imaging (MPI), a type of nuclear stress test.

Taye Diggs (courtesy Idorsia)

Idor­sia inks an­oth­er celebri­ty en­dors­er deal with ac­tor and dad Taye Dig­gs as Qu­viviq in­som­nia am­bas­sador

Idorsia’s latest Quviviq insomnia campaign details the relatable dad story of a well-known celebrity — actor and Broadway star Taye Diggs.

Diggs stopped sleeping well after the birth of his son, now more than 10 years ago. Switching mom-and-dad nightly shifts to take care of a baby interrupted his sleep patterns and led to insomnia.

“When you’re lucky enough to be living out your dream and doing what you want, but because of something as simple as a lack of sleep, you’re unable to do that, it felt absolutely — it was treacherous,” he says in an interview-style video on the Quviviq website.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

The German drug manufacturer is expanding its membrane and filtration manufacturing capabilities in Ireland. The company will invest approximately €440 million ($470 million) to increase membrane manufacturing capacity in Carrigtwohill, Ireland, and build a new manufacturing facility at Blarney Business Park, in County Cork, Ireland.

Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

House Dems to Sen­ate lead­er­ship: Quick­ly move a rec­on­cil­i­a­tion bill with drug price ne­go­ti­a­tion re­forms

Twenty House Democrats, including Reps. Katie Porter of California and Susan Wild of Pennsylvania, are calling on Senate leaders to move quickly with a reconciliation bill (meaning they only need a simple majority for passage) with prescription drug pricing reforms, and to include adding new authority for Medicare to negotiate drug prices.

They also called on the Senate to specifically follow suit with the House passage of a $35 per month insulin cap (as Senate Majority Leader Chuck Schumer’s deadline for a vote on that provision has come and gone), and to cap Medicare Part D costs at $2,000 per year for seniors.

Phillip Gomez, SIGA CEO

UP­DAT­ED: On the back of SIGA Tech­nolo­gies' win with the FDA, the mon­key­pox virus sees the com­pa­ny spring­ing to fur­ther ac­tion

As the cases of monkeypox now sit at well over 100 worldwide and have spread to multiple continents, the orders for any type of vaccine against monkeypox are seeing nations and medical bodies looking to get their hands on anything and everything. And now SIGA Technologies seems to be getting in on the action.

According to Euronews, SIGA Technologies, a pharmaceutical company that is focused on providing medical countermeasures to biological and chemical attacks, is now in talks with several European authorities looking to stockpile its antiviral that can counter monkeypox. The drug known as tecovirimat or Tpoxx was approved by the FDA in 2018 as a vaccine for smallpox but was approved by the European Medicines Agency to also act against monkeypox, cowpox and complications from immunization with vaccinia.

Bris­tol My­ers Squibb sues No­var­tis for roy­al­ties sur­round­ing the use of trans­genic mice

Two Big Pharma companies are going to the mat over genetically modified mice in a licensing dispute.

Bristol Myers Squibb is suing Novartis in New York over a dispute concerning an evaluation, research and commercialization agreement stretching back to the late ’90s initially inked between Novartis and BMS’ predecessor Medarex. The deal in question allowed Novartis to use Medarex’s patented transgenic mice to develop therapeutic drugs. Novartis agreed to pay Medarex – and subsequently BMS – a royalty on sales of drugs it developed using the mice.