Orchard’s Lenmeldy won FDA approval, with the price tag of $4.25 million, the therapy quickly took the title of most expensive drug
FDAs Peter Marks, M.D., Ph.D., receives a simple email from Commissioner Robert Califf, M.D. each time a gene therapy gets approved.
What the Hell, it’s Only $4.25 million for a single patient!
Fierce Pharma spreads the ‘exciting’ news once again:
For every million-dollar gene therapy, Peter Marks gets an email from FDA chief Robert Califf
After Orchard Therapeutics’ gene therapy for a rare genetic disease was approved in March, Peter Marks, M.D., Ph.D., received a simple email from Commissioner Robert Califf, M.D.
“Every time we approve a new gene therapy, and then the company announces the price of the gene therapy, the commissioner sends me a note and it's usually [short]—I love short emails,” Marks told the crowd at the American Society of Gene and Cell Therapy annual meeting Wednesday morning. Marks serves as director of the Center for Biologics Evaluation and Research (CBER)…
…in March, Orchard’s Lenmeldy won FDA approval to treat the rare genetic disease metachromatic leukodystrophy (MLD). With the price tag of $4.25 million, the therapy quickly took the title of most expensive drug, taking a crown previously worn by CSL Behring and uniQure’s hemophilia B gene therapy Hemgenix, which costs $3.5 million before any discounts.”
About Orchard Therapeutics
This is the Orchard Therapeutics Story
“Our Story
We’re part of gene therapy history — and its future. Orchard was founded in 2015—but our roots run deeper, going back to some of the first research and clinical development involving hematopoietic stem cell, or HSC, gene therapy. Our team has played a central role in the evolution of this technology from a promising idea to a potentially life-transforming reality. Today, we carry forward our history of visionary science to imagine new possibilities for people and families affected by genetic and other severe diseases.”
Who develops and manufacturers Orchard’s gene therapies
This Press Release explains (November 30, 2016):
Orchard Therapeutics Announces Strategic Alliance with Oxford BioMedica
“Orchard Therapeutics (“Orchard”) announces today that it has entered into a strategic alliance with Oxford BioMedica plc (“Oxford BioMedica”) (LSE: OXB), a world-leading company in gene and cell therapy.
Under the terms of the collaboration and licence agreement, Oxford BioMedica has granted an exclusive intellectual property licence to Orchard for collaboration programmes, and will provide process development services and manufacture clinical and commercial GMP-grade lentiviral vectors for Orchard. Oxford BioMedica will receive a 1.95% equity stake in Orchard and will be entitled to royalties on future sales of products covered by the collaboration. The process development arrangements include performance-related incentives, through which Oxford BioMedica could receive a further 1.95% equity stake in Orchard.
Oxford BioMedica also developed and manufatured the AstraZeneca adenovirus SARS-CoV-2 injections, that have now been with drawn from the market:
Oxford Biomedica Signs Supply Agreement with AstraZeneca to Expand Manufacturing Support of COVID-19 Vaccine Candidate, AZD1222
“Oxford, UK – 1 September, 2020: Oxford Biomedica plc (LSE:OXB) (“Oxford Biomedica” or “the Group”), a leading gene and cell therapy group, announced today that it has signed an 18 month supply agreement under a three year Master Supply and Development Agreement (“the Agreement”) with AstraZeneca UK Ltd (“AstraZeneca”) for large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222. The Parties may extend the supply period for AZD1222 by a further 18 months into 2022 and 2023 by mutual agreement.
Under the terms of the Agreement, AstraZeneca will pay Oxford Biomedica £15million upfront as a capacity reservation fee. Subject to satisfactory scale up of manufacturing capacity and continuation of the vaccine programme, Oxford Biomedica expects to receive additional revenue in excess of £35million plus certain materials costs for the manufacture of multiple large-scale batches of AZD1222 until the end of 2021.”
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Meanwhile … Where Is The Proof
( Papers, Research , Lab Studies, Etc. )
That Gain Of Function Research
Creating An Aerosolized Self- Replicating Pathogen
Has Ever Been Successfully Accomplished ?
Or Did Someone Just Tell You All That ?
And You Believed It. It’s A Serious Question.
Everytime a bell rings...