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.

Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.