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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Serhat Gumrukçu, Enochian BioSciences co-founder (Seraph Research Institute)

LA biotech founder ar­rest­ed, charged in mur­der-for-hire scheme be­hind 2018 death

A biotech founder has been arrested and charged for his role in a murder-for-hire scheme that resulted in the death of a man in Vermont back in 2018.

Serhat Gumrukçu, the co-founder of Enochian BioSciences, was arrested in Los Angeles, where the company is based, according to the Department of Justice. He was charged alongside Berk Eratay of Las Vegas, and a third person, Jerry Banks of Colorado, was previously arrested for kidnapping and allegedly murdering the victim, Gregory Davis.

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Adam Russell, ARPA-H's incoming acting deputy director

NI­H's new, in­de­pen­dent break­through drug ac­cel­er­a­tor ARPA-H gets its first em­ploy­ee

Despite the controversy of housing it in NIH, HHS Secretary Xavier Becerra on Wednesday afternoon formally announced the establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the NIH, as HHS had previously stipulated that “NIH may not subject ARPA-H to NIH policies.”

Becerra also announced the appointment of ARPA-H’s inaugural employee, Adam Russell, who will serve as acting deputy director.

David Ricks, Eli Lilly CEO (David Paul Morris/Bloomberg via Getty Images)

Eli Lil­ly set to in­vest $2.1B in home state man­u­fac­tur­ing boost

Eli Lilly is looking to expand its footprint in its home Hoosier State by making a major investment in manufacturing.

The pharma is investing $2.1 billion in two new manufacturing sites at Indiana’s LEAP Lebanon Innovation and Research District in Boone County, northwest of Lilly’s headquarters in Indianapolis.

The two new facilities will expand Lilly’s manufacturing network for active ingredients and new therapeutic modalities, including genetic medicines, according to a press release.

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Pfiz­er and CD­MOs ramp up Paxlovid man­u­fac­tur­ing with Kala­ma­zoo plant ex­pan­sion lead­ing the way

As the Covid-19 pandemic continues to evolve, pharma companies and manufacturers are exploring how to step up production on antivirals.

Pfizer is planning to expand its Kalamazoo-area facility to increase manufacturing capabilities for the oral Covid-19 antiviral Paxlovid, according to a report from Michigan-based news site MLive. The expansion of the facility, which serves as Pfizer’s largest manufacturing location, is expected to create hundreds of “high-skilled” STEM jobs, MLive reported. No details about the project’s cost and timeline have been released, but according to MLive, Pfizer will announce the details of the expansion at some point in early June.

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FDA spells out the rules and re­stric­tions for states seek­ing to im­port drugs from Cana­da

The FDA is offering more of an explanation of the guardrails around its program that may soon allow states to import prescription drugs in some select circumstances from Canada, but only if such imports will result in significant cost reductions for consumers.

While the agency has yet to sign off on any of the 5 state plans in the works so far, and PhRMA’s suit to block the Trump-era rule allowing such imports is stalled, the new Q&A guidance spells out the various restrictions that states will have to abide by, potentially signaling that a state approval is coming.

ProFound Therapeutics founding team

Flag­ship's lat­est biotech could turn some of the thou­sands of new pro­teins it dis­cov­ered in­to ther­a­pies — and it has $75M to start

Flagship Pioneering, the incubator of Moderna and dozens of other biotechs, says it has landed upon tens of thousands of previously undiscovered human proteins. The VC shop wants to potentially turn them into therapeutics.

Like other drug developers that have turned proteins into therapeutics (think insulin for diabetes), Flagship’s latest creation, ProFound Therapeutics, wants to tap into this new trove of proteins as part of its mission to treat indications ranging from rare diseases to cancer to immunological diseases.

Richard Silverman, Akava Therapeutics founder and Northwestern professor

This time around, Lyri­ca's in­ven­tor is de­vel­op­ing his North­west­ern dis­cov­er­ies at his own biotech

Richard Silverman was left in the dark for the last five years of clinical development of the drug he discovered. The Northwestern University professor found out about the first approval of Lyrica, in the last few days of 2004, like most other people: in the newspaper.

What became one of Pfizer’s top-selling meds, at $5 billion in 2017 global sales before losing patent protection in 2019, started slipping out of his hands when Northwestern licensed it out to Parke-Davis, one of two biotechs that showed interest in developing the drug in the pre-email days, when the university’s two-person tech transfer team had to ship out letters to garner industry appetite.

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Pfizer CEO Albert Bourla at the World Economic Forum (Gian Ehrenzeller/Keystone via AP Images)

All about ac­cess: Pfiz­er moves to a non-prof­it mod­el for drug sales in 45 low­er-in­come coun­tries

Leading the way to increase access to cheaper drugs worldwide, Pfizer said Wednesday it will provide all current and future patent-protected medicines and vaccines available in the US or EU on a not-for-profit basis to about 1.2 billion people in 45 lower-income countries.

Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to sign on to this accord, which will also seek to blaze new paths for quick and efficient regulatory and procurement processes to reduce the usual delays in making new medicines and vaccines available in these countries.