Is­rael sues Te­va over block­buster MS drug, seek­ing $100M in roy­al­ty pay — re­port

As Te­va is fac­ing opi­oid lit­i­ga­tion and po­ten­tial set­tle­ments in the US, it is now fac­ing more lit­i­ga­tion on the oth­er side of the world — on its own turf.

First re­port­ed by Globes, the State of Is­rael filed a law­suit Wednes­day in a dis­trict court seek­ing a $100 mil­lion judg­ment against Te­va, with the state claim­ing that the com­pa­ny vi­o­lat­ed the state’s rights to cer­tain re­search by not pay­ing roy­al­ties for Co­pax­one, a block­buster mul­ti­ple scle­ro­sis treat­ment that Te­va re­tains mar­ket­ing rights for.

Co­pax­one, al­so known as glati­ramer ac­etate, was de­vel­oped by the Weiz­mann In­sti­tute of Sci­ence back in the 1960s. The mul­ti­ple scle­ro­sis drug was first ap­proved by the FDA in 1996, for a 20mg dai­ly dose. In 2014, the FDA ap­proved a high­er dose — 40mg — but giv­en three times a week.

How­ev­er, the suit from Is­rael claims that the longer in­ter­val dosage was de­vel­oped by re­searchers at the Weiz­mann In­sti­tute, who end­ed up orig­i­nal­ly su­ing the phar­ma in 2018 on this is­sue be­fore the Is­raeli gov­ern­ment got in­volved. Since the claim is that the re­searchers who de­vel­oped the longer in­ter­val dosage were/are neu­rol­o­gists at gov­ern­ment hos­pi­tals, rights for the re­search be­long to the state, the law­suit al­leges.

“The state has no al­ter­na­tive but to take le­gal ac­tion against Te­va to en­sure that it re­ceives suit­able re­mu­ner­a­tion for us­ing pub­lic re­sources that brought Te­va very large scale rev­enue,” ac­cord­ing to the law­suit.

This al­so is around the same time that Te­va start­ed to lose mar­ket share for the drug, thanks to com­pa­nies like My­lan who got their gener­ic forms of Co­pax­one ap­proved back in 2017.

While Te­va did not re­spond to a re­quest for com­ment from End­points News, Te­va told Globes that “We are talk­ing about a re­cy­cled law­suit with ground­less al­le­ga­tions that were claimed against Te­va in the past in a law­suit that has been pend­ing since 2018. Te­va will re­spond to the body of the al­le­ga­tions as part of the le­gal pro­ceed­ings, as is cus­tom­ary.”

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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Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

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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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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.

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.

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.”

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.