By Louis Garguilo, Chief Editor, Outsourced Pharma
Why do we never get an answer, When we're knocking at the door
With a thousand million questions, About hate and death and war?
-- lyrics from The Moody Blues
Where exactly are your drugs developed and manufactured?
People want to know. Today it’s potentially injurious not to.
If your current efforts are ultimately successful, where will your therapeutics or vaccines to treat or prevent COVID-19 in the U.S. be manufactured?
Will you utilize CDMOs, build out or dedicate existing internal capacity to the requisite processing, manufacturing, and fill and finish activities?
The coronavirus pandemic has tossed together your supply chains with a worldwide health and health-care challenge, national security concerns, and international and domestic politics.
Questions of you have been elevated to a level of global consciousness.
Take this component of the coronavirus trauma as a positive. Use it as a strong catalyst to deeply reconsider geographic and other supply-chain risks; to enhance decisions for maintaining the most reliable source of drugs and vaccines for patients; to openly answer more questions.
From what I’ve learned the past few days, you are doing just that.
Questions Of Geography
A Novartis executive with knowledge of the supply chain informed my directly on March 22nd the company will manufacture hydroxychloroquine here in the U.S., at Novartis facilities.
On March 20th the company put out a public statement committing to “donate up to 130 million doses of hydroxychloroquine to support the global COVID-19 pandemic response.”
Hydroxychloroquine and a related drug, chloroquine, are under evaluation in clinical trials for the treatment of COVID-19. The company commented: “Novartis Sandoz division will pursue appropriate regulatory authorizations and, upon approval, will work with stakeholders to determine how best to get this medicine to the patients who need it.”
Public acknowledgement of intent; clear indication of location of manufacture. Much appreciated.
Likewise with Regeneron.
New York-based Regeneron “has rapidly initiated multiple efforts to help address COVID-19,” including a research program using “VelociSuite technologies for discovering a new potential antibody therapeutic for use as prophylaxis or treatment against COVID-19, as well as a global clinical trial program with Sanofi to investigate KEVZARA (sarilumab) as a treatment for patients with severe COVID-19.”
In reply to my questions on manufacturing location, the company quickly responded to me:
“All Regeneron clinical and commercial products are manufactured at our Industrial Operations and Product Supply facilities in the United States and Ireland. Any new product would be made at one of these sites (as Kevzara currently is).”
Regarding the potential use of CDMO/CMO, I was told:
“Regeneron and Sanofi have robust, in-house scale-up and manufacturing facilities. While we believe these existing in-house resources are more than adequate at this time, we will continue to assess whether additional support from contractors is needed. Core to all of our manufacturing decisions is ensuring the quality, sterility and safety of our medicines.”
Again … transparency appreciated.
On the vaccine (and smaller scale organization) side, I contacted GeoVax Labs, Inc. (OTCQB: GOVX) of Atlanta, Georgia, one of many organizations publically announcing efforts to create a vaccine effective against COVID-19.
CEO David A. Dodd responded immediately. In a wide-ranging phone call, he provided enlightening analysis of the current situation, more of which I’ll detail in a separate editorial.
Dodd did no dodging: Although still quite a ways to go before developing a vaccine, he insists his intentions are to manufacture in the U.S. any approved vaccine that would be distributed here.
He added GeoVax – a company he founded decades ago and that has done extensive work on HIV and other diseases – relies fully on outsourcing, and working with external development and manufacturing partners.
When asked if he is confident he can find partners in the U.S. for large-scale vaccine manufacture, he said he is, and given the choice, he always prefers to keep operations at U.S.-based CDMOs.
I contacted Gilead about plans for the ramp up of remdesivir.
The company immediately responded it was committed to doing everything possible “to support the global health community in responding to the novel coronavirus (COVID-19) outbreak,” and added:
“As you might imagine, we are receiving many inquiries every day related to our efforts to provide our antiviral expertise and resources to address the COVID-19 outbreak. As such, we appreciate your patience while we review your inquiry.”
And we all appreciate Gilead’s efforts.
As widely reported, there are high hopes for remdesivir, an experimental antiviral originally developed by Gilead for use against Ebola.
Remdesivir has received orphan drug designation from the FDA, and clinical trials are underway in the U.S., China, and soon other Asian countries.
(Unfortunately, on March 22nd the company said it was temporarily putting new “emergency access” to remdesivir on hold because of the “exponential increase in compassionate-use requests.”)
Gilead said publically it had originally built up clinical supplies of remdesivir as part of its testing the drug for Ebola; initial COVID-19 clinical studies in China are being supplied from that source.
It has also said publically it is expanding its “network of manufacturing partners and has started internal production of remdesivir in preparation of getting coronavirus data.”
"We're investing heavily in our supply chain and manufacturing such that, should it work, we can respond immediately," said CEO Daniel O’Day.
We know historically Gilead has been made extensive use of external suppliers.
Back in 2015, CFO Robin Washington publically described the firm’s strategy as an “operationally leveraged model,” referring to its heavy use of CMOs.
While Gilead has its own facilities in California, Canada and Ireland, it has utilized external sources for the majority of its active pharmaceutical ingredients (APIs) and solid dose products, including bestseller HCV drug Sovaldi, according to a recent article in Biopharma Drive.
Let’s Call It A New Clarity
A number of other biopharma companies very much in the COVID-19 news for their efforts on developing medicines and vaccines have yet to respond. If and when they do, I’ll report on them for all readers.
For now, in terms of increasing transparency – particularly on the geographic location of production – we should all be encouraged.
Novartis, Regeneron, GeoVac, and Gilead should set the example for all Outsourced Pharma readers as we move – hopefully much sooner than later – into a post-Wuhan coronavirus world.