Sim­mer­ing feud be­tween blue­bird and a ri­val con­tin­ues with al­le­ga­tions of patent fraud

Blue­bird bio was hit with a patent in­fringe­ment law­suit last week from a Chica­go-based biotech it has had an on­go­ing beef with call­ing for $2 bil­lion to help cure the “ir­repara­ble harm” caused by al­leged will­ful in­fringe­ment.

Blue­bird bio is fac­ing a law­suit from Er­rant Gene Ther­a­peu­tics for vi­o­lat­ing patent law in two in­stances, the com­pa­ny says.

The suit al­leges that blue­bird in­fringed the rights of EGT’s re­com­bi­nant vec­tors used in the gene ther­a­py treat­ment of rare dis­eases such as sick­le cell dis­ease and be­ta tha­lassemia for its drugs Zyn­te­glo and Lenti­Glo­bin. EGT has an ex­clu­sive li­cense from the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter to patents ti­tled “vec­tor en­cod­ing hu­man glob­al gene and use there­of in treat­ment of He­mo­glo­binopathies.”

Nick Leschly

In 2016, Er­rant said that blue­bird and Third Rock, a ven­ture cap­i­tal firm co-found­ed by blue­bird CEO Nick Leschly, blocked their gene ther­a­py from reach­ing the mar­ket. In 2010, Er­rant was set to start clin­i­cal tri­als with MSK and NIH, and Third Rock met with MSK and “ad­mit­ted” that the Er­rant vec­tor was bet­ter than blue­bird’s.

That, Er­rant al­leges, led to a se­cret agree­ment to stall the de­vel­op­ment of Er­rant’s vec­tor. MSK de­mand­ed that Er­rant find a com­mer­cial part­ner as a con­di­tion be­fore start­ing clin­i­cal tri­als — but de­spite Er­rant ful­fill­ing that con­di­tion, MSK re­ject­ed the con­tract and in­stead ini­ti­at­ed ar­bi­tra­tion against Er­rant, the drug de­vel­op­er claimed in the law­suit.

EGT, which changed its name to San Roc­co Ther­a­peu­tics in May, was es­tab­lished in 1993 by CEO Patrick Giron­di af­ter his son Roc­co was di­ag­nosed with be­ta tha­lassemia, an in­her­it­ed blood dis­or­der. Er­rant de­vel­oped the vi­ral vec­tor along­side MSK in 2000. Er­rant con­tact­ed MSK sci­en­tist Michel Sade­lain, who pub­lished a pa­per show­ing the po­ten­tial of the gene ther­a­py in mice, and start­ed to fund his re­search. Five years lat­er, Er­rant bought ex­clu­sive rights of the tech for blood dis­or­ders, and the com­pa­ny patent­ed the vec­tor in 2009.

MSK grant­ed Er­rant an ex­clu­sive com­mer­cial li­cense in 2005, the law­suit states.

The lat­est suit al­leges that blue­bird will­ful­ly in­fringed on two of Er­rant’s patents. In Sep­tem­ber, blue­bird was grant­ed break­through des­ig­na­tion for its gene ther­a­py for be­ta tha­lassemia.

“Blue­bird has en­gaged and con­tin­ues to en­gage in non-reg­u­la­to­ry con­duct and post-FDA sub­mis­sion ac­tiv­i­ties re­lat­ed to the com­mer­cial­iza­tion of the BB305 vec­tor, which in­fringes on the ‘179 and ‘061 patents,” the law­suit states.

This cur­rent law­suit high­lights blue­bird’s ramp-up of com­mer­cial man­u­fac­tur­ing in the US for the BB305 vec­tor, as well as stock­pil­ing and oth­er com­mer­cial­iza­tion ac­tiv­i­ties for the vec­tor that Er­rant says “are not rea­son­ably re­lat­ed to ob­tain­ing FDA ap­proval.”

Ac­cord­ing to the law­suit, EGT claims it has suf­fered ir­repara­ble harm, and asks for $2 bil­lion. It says that its own gene ther­a­py is slat­ed to cost more than $1 mil­lion less than blue­bird’s, which is pro­ject­ed to cost $2 mil­lion per pa­tient. Leschly caused jaws to drop in 2019 when he an­nounced that it would have a price tag of $1.8 mil­lion per pa­tient, just be­hind No­var­tis’ spinal mus­cu­lar at­ro­phy ther­a­py treat­ment Zol­gens­ma for the crown of most ex­pen­sive treat­ment.

The law­suit has been a long time com­ing. In Au­gust 2019, the New York Supreme Court sanc­tioned blue­bird for $25,000, and re­ject­ed its ef­forts to pre­vent EGT from pro­ceed­ing with a law­suit by hold­ing the com­pa­ny in con­tempt.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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