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Tuesday, January 09, 2024

Ginkgo Announces New Advisory Board!

 January 8, 2024

Today we’re thrilled to announce the formation of our new Biopharma Advisory Board!

This council of experts from across the biopharmaceutical industry will provide critical insight into the development of Ginkgo’s core platform service offerings across target discovery, drug discovery, optimization, and manufacturing. The group, which will conduct regular meetings at Ginkgo and with its partners, includes (in alphabetical order) —

    How many of these CEO's have signed deals with Ginkgo Bioworks to provide Ginkgo with revenue rather than Ginkgo providing the CEO's with income? 

“We try never to forget that medicine is for the people. It is not for the profits.”

– George Merck

I would like to focus on one of the members of the new committee. Previously I have talked about one of the new members of Ginkgos Advisory Board.

  • John Maraganore, PhD, served as the founding Chief Executive Officer and a Director of Alnylam from 2002 to 2021. Under his leadership, Alnylam helped lead the interventional RNA revolution by launching the first RNAi therapeutic medicine, ONPATTRO®, in 2018, followed by four more RNAi therapeutics through mid-2022. Dr. Maraganore was the chair of the Biotechnology Innovation Organization (BIO) from 2017 to 2019 and is an active mentor to leaders across the biotechnology industry. John is the principal of JMM Innovation, and also serves as a Venture Partner for Arch Ventures and Atlas Ventures, an executive partner for RTW Investments, a senior advisor for Blackstone Life Sciences, and as an advisor for M28.

A quick search of ONPATTRO: 

Wikipedia

Onpattro is a medication used for the treatment of polyneuropathy in peop[le with hereditary transthyretin-mediated amyloidosis, a fatal rare disease that is estimated to affect 50,000 people worldwide.

The per-patient cost is between US $451,430 and $677,145, depending on the number of vials needed. As of 2020, there were 1050 people globally receiving parisian, generating $65.5M in net revenues. 

The FDA

Alnylams Pharmaceuticals push for parisian to be expanded to a much larger pool of patients...

In a briefing document released ahead of the Sept. 13 meeting of the FDA's Cardiovascular and Renal Drugs Advisory Committee, the agency called into question the efficacy of the drug in treating that pool of patients.

Remember, medicine is for the people, not the profits. 

Patisiran was already approved by the FDA in 2018 for the treatment of hereditary ATTR amyloidosis polyneuropathy, which made it the first-ever RNA interference therapeutic approved by the regulator.

Nevertheless, vutrisan - sold under the brand name Amvuttra - still represents the company's most lucrative product. In its second-quarter 2023 financial update, net revenues for the drug were $132 million, versus $91 million for Onpattro. In the fourth quarter Onprattro sales were down to $79M.

For the full-year 2023 net product revenues of $1.24B were reported. The revenues come from sales of its four marketed products Onpattro, Amvuttra, Givlaari and Oxlumo.

Onpattro: $355M

Ambuttra: $558M

4060 patients worldwide were receiving commercial Onpattro and Amvuttra as of year-end 2023.

Givlaari: $219M

Oxlumo: $110M

650 patients were receiving Givlaari as of year-end 2023

430 patients were receiving Oxlumo as of year-end 2023

So roughly 5140 patients are generating $1.24B. 

Yahoo Finance

In October 2023, Alnylam experienced a massive setback after the FDA issued a Complete Response Letter (CRL) in response to the company's supplemental new drug application (sNDA) for the label expansion of Onpattro to treat the cardiomyopathy of transtheyretin-mediated (ATTR) amyloidosis. 

However, following this development, the company shifted its focus to the phase III HELIOS-B label-expanding study of Amvuttra in the treatment of cardiomyopathy of ATTR amyloidosis. 

CCS

John Maraganore has long struggled to get dubious RNAi drug products on the market. From the perspective of the market, he has succeeded. But then again, so did the Covid vaccine. Safety and efficacy can be dealt with best under emergency conditions. John Maraganore has succeeded. He is a hard working man. Long listed here as a Cargo Cult Scientist he has created over $25B in market capitalization. 

Alas, only 5,140 patients are receiving treatment. Those patients are already very sick people. They get results only a professional statistician working in the Cargo Cults can detect. We have to wonder what it is like for the patients receiving the RNAi drug product. Do they feel a difference? Are they less sick?

In the Cargo Cults the natives still look to the skies. They believe what they are doing will one day provide results. Ginkgo Bioworks has said that John Maraganore has produced results and he will now advise them on how they too can see the massive returns on their investments. Although the expertise of John Maraganore was in RNAi drugs, he seems to have now moved on to biotechnology capital. He is an investment strategist. He advises on money. Ginkgo does not do RNAi drugs. Nonetheless, they have found an ally. A man who knows that medicine can make great profits even if the people don't need them. 

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