Palais de Justice in Paris, France (Shutterstock)

French court over­turns €444M an­titrust fine against Roche, No­var­tis

An an­ti-com­pet­i­tive­ness fine has just been re­voked against neigh­bor­ing Swiss phar­ma gi­ants Roche and No­var­tis.

A rul­ing from the Paris Court of Ap­peal Thurs­day cleared Roche and No­var­tis of a fine in the hun­dreds of mil­lions of dol­lars, which was orig­i­nal­ly brought against the two sev­er­al years ago amid ac­cu­sa­tions that the com­pa­nies worked to dis­par­age un­ap­proved use of a cheap­er drug in lieu of a more ex­pen­sive drug.

The fine was first levied against the phar­ma neigh­bors — on­ly lo­cat­ed about 1.7 miles apart in Basel — back in 2020. France’s an­ti-com­pet­i­tive­ness watch­dog had charged the pair of con­spir­ing to in­crease sales of Lu­cen­tis, a drug for wet age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD) that Roche makes and No­var­tis mar­kets in Eu­rope.

The suit at the time said that the com­pa­nies had con­spired to keep and in­crease the mar­ket share of the ther­a­py to butt out Avastin, a drug made by Genen­tech and in­di­cat­ed for re­cur­rent glioblas­toma in adults. How­ev­er, de­spite be­ing around 2-4% of Lu­cen­tis’ price, Avastin was re­port­ed to have sim­i­lar ef­fi­ca­cy in wet AMD.

Avastin is not ap­proved for wet AMD. Yet, a 2012 NIH study con­clud­ed that Avastin and Lu­cen­tis are “equiv­a­lent in treat­ing age-re­lat­ed mac­u­lar de­gen­er­a­tion.”

Fast for­ward to 2023, and the Paris Court of Ap­peal over­turned the fine, which was orig­i­nal­ly €385.1 mil­lion ($411.9 mil­lion) against No­var­tis and €59.7 mil­lion ($63.9 mil­lion) against Roche and its sub­sidiary Genen­tech.

The 121-page rul­ing from this week said that com­mu­ni­ca­tions from the com­pa­nies can­not be con­sid­ered “alarmist or even mis­lead­ing,” and that cer­tain ac­tions done on Roche’s part could not have had any an­ti-com­pet­i­tive ef­fect.

A Roche spokesper­son tells End­points News that Roche “wel­comes the de­ci­sion of the Paris Court of Ap­peal to re­voke in all re­spects the de­ci­sion of the FCA,” which added that the FCA had “con­demned Roche and No­var­tis for abuse of a col­lec­tive dom­i­nant po­si­tion on the AMD treat­ment French mar­ket.”

No­var­tis said in a state­ment to End­points that the phar­ma gi­ant “strong­ly con­test­ed these al­le­ga­tions from the out­set and firm­ly be­lieves the com­pa­ny has act­ed ap­pro­pri­ate­ly and in com­pli­ance with com­pe­ti­tion law and the in­ter­ests of pa­tients at all times.”

The phar­ma added that “No­var­tis firm­ly be­lieves that mea­sures en­cour­ag­ing wide­spread off-la­bel use and re­im­burse­ment of a med­i­cine in an un­li­censed in­di­ca­tion, de­spite the pres­ence of li­censed med­i­cines on the mar­ket, are a threat to the es­tab­lished le­gal, med­ical and reg­u­la­to­ry sys­tem that is in place to guar­an­tee the ap­proval and use of ef­fec­tive and safe med­i­cines in pa­tients.”

Forge Bi­o­log­ics’ cGMP Com­pli­ant and Com­mer­cial­ly Vi­able Be­spoke Affin­i­ty Chro­matog­ra­phy Plat­form

Forge Biologics has developed a bespoke affinity chromatography platform approach that factors in unique vector combinations to streamline development timelines and assist our clients in efficiently entering the clinic. By leveraging our experience with natural and novel serotypes and transgene conformations, we are able to accelerate affinity chromatography development by nearly 3-fold. Many downstream purification models are serotype-dependent, demanding unique and time-consuming development strategies for each AAV gene therapy product1. With the increasing demand to propel AAV gene therapies to market, platform purification methods that support commercial-scale manufacturing of high-quality vectors with excellent safety and efficacy profiles are essential.

Mathai Mammen, FogPharma's next CEO

Math­ai Mam­men hands in J&J's R&D keys to lead Greg Ver­dine’s Fog­Phar­ma 

In the early 1990s, Mathai Mammen was a teaching assistant in Greg Verdine’s Science B46 course at Harvard. In June, the former R&D head at Johnson & Johnson will succeed Verdine as CEO, president and chair of FogPharma, the same month the seven-year-old biotech kickstarts its first clinical trial.

After leading R&D at one of the largest drugmakers in the world, taking the company through more than half a dozen drug approvals in the past few years, not to mention a Covid-19 vaccine race, Mammen departed J&J last month and will take the helm of a Cambridge, MA biotech attempting to go after what Verdine calls the “true emperor of all oncogenes” — beta-catenin.

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Jeff Bluestone (R), Sonoma Biotherapeutics CEO

Jef­frey Blue­stone brings his start­up haul to $400M+, join­ing forces with Re­gen­eron on cell ther­a­pies

These days, when Jeffrey Bluestone gets together with his contemporaries in science, the conversation often turns to retirement plans.

But a little more than three years ago, Bluestone reached a momentous turning point in his career, exiting a prestigious post at UCSF, where he had spent decades in the scientific pursuit of new therapies. And it had nothing to do with retirement anytime in the near future.

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CSL CEO Paul McKenzie (L) and CMO Bill Mezzanotte

Q&A: New­ly-mint­ed CSL chief ex­ec­u­tive Paul McKen­zie and chief med­ical of­fi­cer Bill Mez­zan­otte

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer re­ports ro­bust sales led by type 2 di­a­betes and pul­monary drugs, promis­es more to come high­light­ing obe­si­ty

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”

FDA ap­proves Nar­can opi­oid over­dose re­ver­sal spray for over-the-counter sale

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

J&J bows out of RSV vac­cine race, end­ing PhI­II study and ced­ing to Pfiz­er, GSK

Johnson & Johnson announced Wednesday morning it is ending development of its adult RSV vaccine that was in the middle of a 27,200-patient trial, giving up a big slice of what’s expected to be the next multibillion-dollar pharma market.

The decision came down to the shifting RSV “competitive landscape,” a company spokesperson tells Endpoints News, adding the “breadth of options” was much different than when J&J first started its pivotal study. The spokesperson declined to comment on the Phase III data, saying only the shot is undergoing an “ongoing assessment.”

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Es­pe­ri­on sues Dai­ichi Sankyo, de­mand­ing pay­ment of $300M mile­stone for car­dio drug

Esperion is suing its business partner Daiichi Sankyo, saying the Japanese drugmaker is improperly refusing to pay a $300 million milestone that the biotech company will be owed after reporting positive data from a large trial of its cardiovascular drug Nexletol.

The 2019 deal between the companies had Daiichi Sankyo pay $150 million upfront plus another $150 million after the first sales of the drug. But another major payout was tied to an outcomes study reported this month, known as CLEAR. Esperion, in its suit against Daiichi, argues that the drug’s more than 20% reduction of heart attack risk is enough to trigger a $300 million payout from Daiichi once it’s added to the drug’s label.

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Sally Susman, Pfizer EVP and chief corporate affairs officer

Q&A: Pfiz­er cor­po­rate com­mu­ni­ca­tions chief Sal­ly Sus­man dis­cuss­es book craft­ed in pan­dem­ic and per­son­al lessons

From the political arena to the finance and beauty industries to pharmaceuticals, Pfizer’s Sally Susman has broken barriers, stereotypes and conventions. And now the chief communicator is “Breaking Through,” the title of her first book about effective and innovative communications launching today. The full official title is “Breaking Through: Communicating to Open Minds, Move Hearts, and Change the World.”

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