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.

The agree­ment be­tween the two par­ties, ac­cord­ing to the law­suit, con­tains an ar­bi­tra­tion clause stat­ing that “the ar­bi­tra­tors shall de­ter­mine what dis­cov­ery will be per­mit­ted, based on the prin­ci­ple of lim­it­ing the cost and time which the par­ties must ex­pend on dis­cov­ery.”

In Feb­ru­ary 2019, No­var­tis be­gan pay­ing BMS roy­al­ties, un­der protest, on two drugs de­vel­oped us­ing the trans­genic mice. But even as it did, No­var­tis claimed the roy­al­ties were com­pen­sa­tion for a li­cense to ex­pired patents and there­fore un­en­force­able.

No­var­tis then filed a de­mand for ar­bi­tra­tion to re­solve the roy­al­ty dis­pute in March 2019. BMS and No­var­tis ini­tial­ly agreed to amend the agree­ment to re­solve the dis­pute through a pan­el of three neu­tral and in­de­pen­dent ar­bi­tra­tors, with BMS fil­ing an an­swer to No­var­tis’s ar­bi­tra­tion de­mand in May 2019, and the par­ties even­tu­al­ly reach­ing an agree­ment.

Af­ter the con­clu­sion of dis­cov­ery, BMS filed a mo­tion for sum­ma­ry de­ter­mi­na­tion and af­ter sev­er­al cross-mo­tions were filed, the pan­el de­nied No­var­tis’s claims and re­quests for re­lief. How­ev­er, while No­var­tis said it would file the award, it has not been signed and val­i­dat­ed.

BMS is ask­ing the court to con­firm the pan­el’s de­ci­sion and di­rect en­try of judg­ment against No­var­tis per the de­ci­sion.

Trans­genic mice are ones that have had DNA from an­oth­er source put in­to their DNA. They’re of­ten used in lab stud­ies, and have been be­hind many ap­proved drugs. Joseph Bryant, ad­junct pro­fes­sor at the In­sti­tute of Hu­man Vi­rol­o­gy at the Uni­ver­si­ty of Mary­land School of Med­i­cine told End­points News that de­vel­op­ers are like­ly watch­ing this case, as it’s a com­pli­cat­ed process.

This suit comes at a time when Greece is look­ing to hold No­var­tis ac­count­able for ac­tions that got them in trou­ble with the US gov­ern­ment.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Am­gen takes next step with its Chi­na am­bi­tions, out-li­cens­ing drugs to Fo­s­un Phar­ma

In a bid to increase its market share in China, Amgen has agreed to a partnership with a Shanghai biotech — a collaboration and out-licensing agreement for two of its drugs.

Amgen and Fosun Pharma announced a deal Monday in a bid to increase Amgen’s presence in the country. The stated goal so far is to commercialize Amgen’s blockbuster psoriasis drug Otezla alongside Parsabiv, a drug for secondary hyperparathyroidism in adults with chronic kidney disease and on a specific type of dialysis.

As court case looms, Bris­tol My­ers touts la­bel ex­pan­sion for Breyanzi

As Bristol Myers Squibb braces for a court battle over a costly delay — at least for Celgene shareholders — for its CAR-T lymphoma treatment Breyanzi, the pharma giant is touting a label expansion in the second-line setting.

Breyanzi, also known as liso-cel, snagged a win on Friday in adults with large B-cell lymphoma (LBCL) who: don’t respond to chemotherapy, or relapse within 12 months; don’t respond or relapse after 12 months; or are not eligible for hematopoietic stem cell transplant after chemo due to their age or comorbidities.

Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

As­traZeneca de­buts first con­sumer cam­paign for its Covid-19 pro­phy­lac­tic Evusheld — and a first for EUA drugs

AstraZeneca’s first consumer ad for Evusheld is also a first for drugs that have been granted emergency use authorizations during the pandemic.

The first DTC ad for a medicine under emergency approval, the Evusheld campaign launching this week aims to raise awareness among immunocompromised patients — and spur more use.

Evusheld nabbed emergency authorization in December, however, despite millions of immunocompromised people looking for a solution and now more widespread availability of the drug.

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