Errant Gene Therapeutics (“EGT”) asks European Authorities to Re-examine the Approval Process of Zynteglo, While US Litigation Moves Forward

Sep 28, 2020 | Gene Therapy, News, Price Watch, Sickle Cell Disease, Thalassemia

Errant Gene Therapeutics (“EGT”) asks European Authorities to Re-examine the Approval Process of Zynteglo, While US Litigation Moves Forward

Picking up on the ongoing “Family Man” saga, in New York Court, EGT claims that Zynteglo, the Bluebird Bio product for Thalassemia, created Clonal Dominance. EGT alleges that Bluebird Bio assisted Memorial Sloan Kettering in orchestrating the sabotage of EGT’s product Thalagen, allowing Bluebird to fix what EGT believes was a faulty vector in a bid to gain proprietary data and eliminate EGT. EGT alleged that there was no other direct competition. In this assertion, with EGT out of the way, Bluebird subsequently raised the price of Zynteglo from $750,000 (price stated on page 43 of the 2013 JP Morgan report on Bluebird) to $1,800,000. Notably, Article 30 of the European Economic Community (EEC) Treaty states that anti-competitive behavior and violation of IP is a reason to restrict commercialization of a product in the European Member States. Does all of this apply in this particular context? Only a court could determine. The case shines a light on just how rough and tough biotech competition can become. 

TrialSite opted to learn about and report on the “Family Man” saga due to concerns involving  uncompetitive actions leading to the destruction of companies. Competition is good for patients; however, if it crosses the line into unethical, illegal or improper behavior, it must be addressed. TrialSite emphasizes here that the matter of EGT and Bluebird Bio are in the courts and that the legal system shall determine the outcome—not the press, nor any outside opinion. 

Price Unreasonable?

Bluebird is also working on LentiGlobin for Sickle Cell Disease, which EGT CEO, Patrick Girondi, claims also uses EGT technology. Girondi told TrialSite that the Zynteglo price of $1,800,000 is unrealistic and unreasonable. Zynteglo will face the same upward climb as Glybera, a gene therapy product approved in 2012, which cost $1,200,000. Subsequently, Glybera was used on one patient and abandoned. Zynteglo achieved partial approval in Europe for less severe Thalassemic patients in June of 2019, and the price was recently approved in Germany. Still, no patients have been treated that TrialSite could find. Girondi again shared with TrialSite, “There are very few Thalassemic and Sickle Cell Disease patients in Germany.”

Thalagen-treated patients never had incidents of Clonal Dominance, a precursor to cancer, as did one patient treated with the Bluebird vector according to Girondi. Although there have been no recent reports of Clonal Dominance since Zynteglo’s modifications mirroring the EGT vector, Girondi states, “Patients deserve a safe choice. One product is not a choice and it’s just not possible for insurance companies, single payers or patient families to afford this price of $1,800,000. As a consequence, very few patients will ever be treated.” 

Pending Litigation

TrialSite looked into other pending litigation associated with Bluebird Bio. Two of them involve EGT.

Pending cases include:

  • EGT vs. Memorial Sloan Kettering Cancer Center and Bluebird Bio: Supreme Court of the State of New York, case number 150856/201, trial is October 29, 2020 – November 5, 2020.
  • EGT vs. Nick Leschly and Third Rock Ventures: Massachusetts, case Number 19-1832
  • Francisco Dos Ramos Alvarado vs. Bluebird Bio and Executives, Delaware Chancery Court case # 2020-0237

Bluebird Bio

In the meantime, Bluebird Bio continues to execute to its business plan. Positioned as a gene therapy pioneer with a purpose, the Cambridge, Mass-based company develops gene therapies for severe genetic diseases and cancer, with a goal that people facing potentially fatal conditions with limited treatment options can live full lives. 

Bluebird bio mentions in investor presentations that the company seeks to positively disrupt healthcare systems, create transparency and promote education all in a bid to make gene therapy available to all who can benefit.  All sounds exactly in line with the vision and goals of TrialSite! With offices in Seattle, Durham and Zug, Switzerland, it’s a shame that companies such as these two litigants couldn’t find ways to leverage, collaborate and drive entrepreneurial transformation for the better of all in healthcare.

Just One Slice of View 

Full transparency, TrialSite has covered this story from the point of view of “Family Man” that is the small biotech vantage. Consequently, this article should not be read to be a comprehensive nor conclusive commentary but in all reality, but one vantage into what is certainly a complex, multifaceted situation. As mentioned previously, TrailSite emphasizes here that the matter of EGT and Bluebird Bio are in the courts and that the legal system shall determine the outcome—not the press, nor any outside opinion. 

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