A New Year For Novo Nordisk's Wegovy Supply Challenges
By Louis Garguilo, Chief Editor, Outsourced Pharma
Those who follow this kind of news – and some who normally don’t – jumped on Novo Nordisk for what is in fact a significant supply-chain challenge that came to light at the turn of the New Year.
Now, a year later, we, too, will take this up, but from a different perspective than presented previously in the media.
Are there any positives we can wring out of this year-long challenge of market-demand forecasting initially, that then materialized due to outsourcing circumstances.
Novo Nordisk’s CEO Lars Fruergaard Jørgensen recently told the Wall Street Journal, “We should have forecasted better, which we did not. Had we forecasted [better], we would have built a different supply chain.”
For any Outsourced Pharma reader who wonders if we can make too much in these pages of the criticality of all the aspects of outsourcing drug development and manufacturing, the Novo Nordisk situation demonstrates that concern should be put to bed.
You may recall around the New Year last year, Novo Nordisk announced supply of Wegovy, its new, FDA-approved weight-loss drug, would be running low through 2022. That has indeed come to pass.
The Big Pharma’s website currently says supply has caught up, and is “on track to make all dose strengths of Wegovy available in the U.S. towards the end of the year.” The company is also “making plans for additional production capacity to come online in 2023.”
Some of that capacity (dedicated to materials processing) is being built internally, and was already underway. But the straw that broke the back of Wegovy supply for this year was the outsourcing component of fill and finish.
To be clear, this is not a case of selecting the wrong CDMO.
Novo Nordisk outsourced its syringe-filling needs for Wegovy to Catalent, a sought-after, well-respected stalworth in our industry. Furthermore, the location for the Wegovy fills was at Catalent’s proven, flagship facility, in Brussels, Belgium.
Instead, and despite the admitted root cause of the drug shortage being assessed as inadequate forecasting – actually, because of the potential for such errors – this appears to be the result of a miscalculation in outsourcing tactics.
Namely, tactics related to the outsourcing component many of us call redundancy. You may refer to this as back-up or contingency planning, or dual sourcing … but however you name it, what’s important is you do include it as part of your overall outsourcing assessment.
In fact, what most compels me to pen this now is that coinciding with the Novo Nordisk-Catalent story resurfacing in the news, I have been finishing up an editorial based on an interview with an experienced outsourcing professional whose first attribute to look for when selecting a CDMO is that they have internal redundancies at separate locations, and the capacity to convert to that redundancy should an issue occur. (That editorial, titled, “The Best CDMOs Are Redundant,” will be published in a few weeks.)
A New Year
As can and does happen in any industry, quality and related issues spring up, despite best efforts.
Moreover, challenges can arise at unusual places – such as at the best organizations, and what we’d consider proven, state-of-the-art facilities.
That’s what happened at Catalent’s flagship. The FDA issued a Form 483, which fully halted production of Wegovy until certain violations were rectified in the eyes of the FDA.
Unfortunately, some reporting on this – from our own industry’s media – reads like Pharma bashing … for the sake of the bashing. Other media have different, legitimate purposes. The WSJ article I mention above parenthetically is informing investors of a public company whose revenues are being impacted – as well as the impact on consumers.
But instead of shooting arrows at the sponsor and/or the service-provider (the WSJ started its recent article with, “Novo Nordisk flubbed the launch of its buzzy new weight-loss drug Wegovy, missing out on hundreds of millions of dollars in sales ...”), I’d at least extend some credit to Novo Nordisk for quickly getting ahead of the regrettable narrative.
Some may consider that communication a “given,” yet how many times when we try to understand supply-chain challenges, we find it similar to gazing into a funhouse mirror. The image is distorted and unclear.
Not here, though.
While noting it had been making progress on supply, on December 17, 2021, Novo Nordisk publicly (and clearly) announced that “a contract manufacturer filling syringes for Wegovy® pens for the US market has temporarily stopped deliveries and manufacturing following issues with Good Manufacturing Practices.”
It went on to say, “As a consequence, Novo Nordisk does not expect to be able to meet demand in the US in the first half of 2022 and few new patients are expected to be able to initiate treatment. The priority for Novo Nordisk is patients who have already initiated treatment with Wegovy®. Novo Nordisk currently expects to be able to meet demand in the US in the second half of 2022 …”
From our more deliberate supply-chain angle, important here is to again note that CDMOs and all other external service providers, together with all the drug and therapy developers out there – from start-ups to Big Pharma – combine to form a single-most efficient ecosystem. At this point in our history, sponsors without external supporters are practically unimaginable.
So when established leaders in our industry experience a supply-chain challenge, we can choose to learn from it. What lessons can we draw in this case?
- Do not overlook the potential for forecasting or other supply inconsistences or challenges, and deeply consider the role of redundancy and capacity, both internally and externally.
- When unfortunate events transpire, get the word out quickly and without equivocating – to patients, investors, and the general public.
Let’s pull for Novo Nordisk and Catalent to work through their challenges quickly, and have a much better year in 2023 regarding Wegovy. Perhaps through this, it could be an improved year for others as well.