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.

Vas Narasimhan (Photographer: Jason Alden/Bloomberg via Getty Images)

No­var­tis de­tails plans to axe 8,000 staffers as Narasimhan be­gins sec­ond phase of a glob­al re­org

We now know the number of jobs coming under the axe at Novartis, and it isn’t small.

The pharma giant is confirming a report from Swiss newspaper Tages-Anzeiger that it is chopping 8,000 jobs out of its 108,000 global staffers. A large segment will hit right at company headquarters in Basel, as CEO Vas Narasimhan axes some 1,400 of a little more than 11,000  jobs in Switzerland.

The first phase of the work is almost done, the company says in a statement to Endpoints News. Now it’s on to phase two. In the statement, Novartis says:

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Sanofi to cut in­sulin prices for unin­sured from $99 to $35, match­ing the in­sulin cap com­ing through Con­gress

As the House-passed bill to cap the monthly price of insulin at $35 nationwide makes its way for a Senate vote soon, Sanofi announced Wednesday morning that beginning next month it will cut the monthly price of its insulins for uninsured Americans to $35, down from $99 previously.

The announcement from Sanofi, which allows the uninsured to buy one or multiple Sanofi insulins (Lantus, Insulin Glargine U-100, Toujeo, Admelog, and Apidra) at $35 for a 30-day supply effective July 1, follows House passage (232-193) of the monthly cap in March, with just 12 Republicans voting in favor of the measure.

Peter Marks (Jim Lo Scalzo/Pool via AP Images)

FDA's VRB­PAC votes in fa­vor of adapt­ing the Covid-19 vac­cine to the lat­est Omi­cron vari­ant

The FDA’s Vaccine and Related Biological Products Advisory Committee on Tuesday gave the thumbs up — by a vote of 19-2 — that the FDA should require an Omicron-related component in this next season’s booster dose for Covid-19, which both Pfizer/BioNTech and Moderna are hard at work on.

And while neither booster will likely be ready to go with adequate supplies for all American adults by the beginning of the next school year, the situation is still complex and fluid, with CBER Director Peter Marks telling the committee that it’ll take companies at least three months to ready their supplies for this expected next wave.

Bob Nelsen (Lyell)

As bear mar­ket con­tin­ues to beat down biotech, ARCH clos­es a $3B ear­ly-stage fund

One of the biggest names in biotech investing has a whole lot of new money to spend.

ARCH Venture Partners closed its 12th venture fund early Wednesday morning, the firm said, bringing in almost $3 billion to invest in early-stage biotechs. The move comes about a year and a half after ARCH announced its previous fund, for almost $2 billion back in January 2021.

In a statement, ARCH managing director and co-founder Bob Nelsen appeared to brush off concerns about the broader market troubles, alluding to the downturn that’s seen several biotechs downsize and the XBI fall back to almost pre-pandemic levels.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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(AP Photo/Gemunu Amarasinghe)

Some phar­ma com­pa­nies promise to cov­er abor­tion-re­lat­ed trav­el costs — while oth­ers won't go that far yet

As the US Department of Health and Human Services promises to support the millions of women who would now need to cross state lines to receive a legal abortion, a handful of pharma companies have said they will pick up employees’ travel expenses.

GSK, Sanofi, Johnson & Johnson, BeiGene, Alnylam and Gilead have all committed to covering abortion-related travel expenses just four days after the Supreme Court overturned Roe v. Wade and revoked women’s constitutional right to an abortion.

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Aurobindo Pharma co-founders P. V. Ram Prasad Reddy (L) and K. Nityananda Reddy

Au­robindo Phar­ma re­ceives warn­ing let­ter from In­di­a's SEC fol­low­ing more FDA ques­tion marks

Indian-based generics manufacturer Aurobindo Pharma has been in the crosshairs of the FDA for several years now, but the company is also attracting attention from regulators within the subcontinent.

According to the Indian business news site Business Standard, a warning letter was sent to the company from the Securities Exchange Board of India, or SEBI.

The letter is related to disclosures made by the company on an ongoing FDA audit of the company’s Unit-1 API facility in Hyderabad, India as well as observations made by the US regulator between 2019 and 2022.

Bristol Myers Squibb (Alamy)

CVS re­sumes cov­er­age of block­buster blood thin­ner af­ter price drop fol­lows Jan­u­ary ex­clu­sion

Following some backlash from the American College of Cardiology and patients, Bristol Myers Squibb and Pfizer lowered the price of their blockbuster blood thinner Eliquis, thus ensuring that CVS Caremark would cover the drug after 6 months of it being off the major PBM’s formulary.

“Because we secured lower net costs for patients from negotiations with the drug manufacturer, Eliquis will be added back to our template formularies for the commercial segment effective July 1, 2022, and patient choices will be expanded,” CVS Health said in an emailed statement. “Anti-coagulant therapies are among the non-specialty products where we are seeing the fastest cost increases from drug manufacturers and we will continue to push back on unwarranted price increases.”