Building Pharmaceutical Supply-Chain Resilience

Antheia is the next-generation pharmaceutical ingredient producer with a mission to end drug shortages. Using advanced biosynthesis and fermentation technology, Antheia’s biomanufacturing platform enables rapid, efficient, agile, and on-demand production of key starting materials (KSMs) and active pharmaceutical ingredients (APIs) that are critical to public health. The firm believes its flexible approach supports the needs of a growing society and improves global access to essential medicines.

Founded in 2015, Antheia has grown into a commercial-stage company with its first product to market, an active customer pipeline, and near-term product launches. Dr. Christina Smolke, the company's co-founder and CEO, details her company's value proposition with Carol Massar and Tim Stenovec on Bloomberg Businessweek Daily.

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Episode Transcript

Speaker 1 (00:02):
Bloomberg Audio Studios, Podcasts, Radio News.

Speaker 2 (00:07):
You're listening to Bloomberg Business Week with Carol Masser and
Tim Stenoveek on Bloomberg Radio. Thinking about leverage and trade
negotiations between the US and China. We often talk about
China's large domestic market and it's rarests, but not that often, Carol,
we talk about medicine.

Speaker 1 (00:24):
No, we don't, but we are going to talk about
it now.

Speaker 2 (00:27):
We're going to a Bloomberg piece from last week, actually
ahead of this week's meeting between the President and Chinese President.
Hijin Pang notes that China's power arrests on its grip
over the global supply of active pharmaceutical ingredients or APIs,
which are core components of commercial drugs. Beijing's broad sway
extends upstream to the raw chemicals, the solvents, the reagents
known as key starting materials needed to make the APIs themselves.

(00:51):
Doctor Christina Smolke thinks a lot about this. She's the
co founder and CEO of Anthea. It's a pharmaceutical ingredient producer.
Their goal is to end at drug shortage. As she
joins us from Memlo Park, California, doctor Smolkie. Great to
have you on the program. A pharmaceutical ingredient producer. We
think about this, I don't. I don't often think about
you know, when I take a pill, what actually goes

(01:11):
into the manufacturer of these pills. What I do know
is that oftentimes it comes from outside of the United States.
Oftentimes the supply chain spans the globe. Is that a
national security risk?

Speaker 3 (01:24):
Yeah? Thanks for that question. Is it is increasingly being
viewed as a national security risk. And the reason is
that is based upon the United States reliance on foreign
sources for these materials and also the increasing frequency and
duration of disruptions we are experiencing in critical life saving medicines.

Speaker 1 (01:45):
So tell us a little bit about what you guys
are doing specifically. I agree with Tim. I think we
just like get our prescriptions, we take them, and not
until there's a problem do we like, wait, what's in
this stuff? So talk to us about what you are
doing or trying to do.

Speaker 3 (02:02):
Yes, Anthea has developed a new way to produce these
critical life saving pharmaceutical ingredients, and it's leveraging a technology
that allows us to do so in a way that
is more resilient, more predictable, and addresses a lot of
the pain points we see in the current in the
current industry. In particular, what Anthea's technology allows us to

(02:25):
do is to shift from producing these medicines overseas in
very long as I said, very basically vulnerable multi step
processes to a process that looks closer to brewing beer.
So we're able to take yeast and we basically modify
those yeast so that they can basically, instead of producing beer,

(02:48):
can produce these critical life saving pharmaceutical ingredients. And one
of the key advantages of that is then allows us
to move those production processes more locally into the United States.

Speaker 2 (02:59):
So at what point the processes does that does that happen?
I mean, are you are you? Are you taking it
from the perspective of okay, you're you understand what goes
into a given medication and you can create the ingredients
from the yeast then, or or do you sort of
reverse engineer it? You take the final product and you say, okay,
this is what we need to produce and here's how

(03:20):
we can do it. Like, how does that work? Scientifically?

Speaker 3 (03:23):
Great? Yes, great question, so scientifically it will it works?
As us saying this is the molecule that we want
to produce. This is the medicine that we want to produce,
So we know the endpoint, we know the structure, and
then we basically will modify program the yeast and really
teach them through making modifications to their genome to be

(03:47):
able to then synthesize those those pharmaceutical ingredients from sugar.
So essentially what the process will look like at the scales,
we throw the yeast into a large vat, we feed
them sugar, and they're basically working as miniature medicine factories
to convert that sugar directly to the pharmaceutical ingredient that

(04:07):
then ultimately will be formulated into the medicine that patients take.

Speaker 1 (04:13):
So how could this help me understand? How is this
being done already?

Speaker 3 (04:20):
Yes, it is being done already. So Anthea launched We
launched our first product commercially now about a year ago
and you know, basically seen tremendous response from the marketing
from our customers again really responding to the solutions that
this brings in terms of shoring up their supply chains

(04:40):
and their ability to have very stable, very consistent supply
of these medicines. So it's now a technology that's fully
commercial and you know, one of the I think very
powerful things about this technology is it a true platform
we've built out While we've launched our first product commercially,
we've built out a very large pipeline of pharmaceutical ingredients

(05:03):
that we are applying the strategy to and now queued
up to basically launch our second and third products.

Speaker 2 (05:09):
Shortly, how do you characterize the makeup of the medications
or the ingredients that since they're produced from yeast, how
are they classified? Like? Are they synthetic? Are they naturally occurring?
Like are they basically yes, Yeah, I don't understand that question.
Great question.

Speaker 3 (05:29):
So one of the things to really highlight here is
that we already leverage fermentation to produce medicines in our
pharmaceutical supply chain. Insulin is an example of that. You know,
we used to extract insulin from animals and now it's
all produced via fermentation process. So within the industry, we

(05:49):
follow very standard procedures for how the molecules that we
produce are characterized. We ensure that they basically are exactly
the same as what has already been used in these
meta and meet all of the quality requirements. That are
needed to ensure patients not just have access to these
life say even to medicines, but that they are safe

(06:11):
and consistent for them as well.

Speaker 1 (06:12):
Christina, what's the FDA oversight of all of this?

Speaker 3 (06:16):
Yes, it's it's These are basically tracked and approved by
the FDA. And so again, because the idea of fermenting
or using biosynthesis to produce medicines is not novel within
the industry, there are regulatory basically steps in terms of

(06:37):
how they are approved, and they has already gone through
those approval processes. Everything is produced within the quality that
the FDA requires.

Speaker 2 (06:46):
So what so if a pharmaceutic pharmaceutical company, like, what
what is your relationship with a pharmaceutical company? If pharmaceutical
company were to come to you and say we want
you to manufacture this, is that how it works?

Speaker 3 (06:59):
Yeah, at this Dame age, the medicines that we're bringing
to market are are again there were focused on the
medicines that played the most critical role in public health,
but really transforming and rebuilding those supply chains so that
drug shortages you know, do not infect patients you know,
going forward, and so we're able to basically sell the ingredient.

(07:21):
Two pharmaceutical companies globally, you know, and and there are
pharmaceutical customers basically will take that ingredient and then formulate
it into the drug product that the patient actually takes.

Speaker 2 (07:35):
You know, I ran into an issue a couple of
years ago. I've talked about this on air before, but
it was with a max of syllin.

Speaker 1 (07:40):
Yeah, I remember this.

Speaker 2 (07:41):
My Yeah, my son had this terrible ear infection, like
just screaming, and the doctor couldn't find a pharmacy that
had a max oficillin coming off the pen it was
coming off the pandemic. And it was interesting because a
few months before that, we had had a I think
it was a big take story that talked about the
profit margins are so all on some of these generics

(08:02):
that it's hard to find producers to actually make these drugs. Ultimately,
we did find a pharmacy that had it, thank god.
And you know, you take that medication and within hours
that you're infection is better. But is that the type
of thing, doctor, that you're trying to solve or is
it more advanced drugs more complicated to us than that.

Speaker 3 (08:19):
No, it's exactly the type of it's first and foremost
is exactly the type of thing that you just highlighted, right,
and you're not alone. I've experienced the same thing, whether
it's you know, basic antibiotics, cold medicines, you know, things
that are required for surgery. It's you know, we don't
expect these to be in shortage because they're not the
most advanced kind of latest drugs, but they are. And

(08:41):
that's the type of thing that we are that we're
bringing to market you know, today right now and solving
those issues. And one of the things I would just highlight,
you know, coming back to by leveraging this technology, it
solves not just being able to synthesize it domestically so
that we have greater control and transparency over these supply chain.
It does so at a fraction of the cost, because

(09:03):
it's really leveraging a novel technology to make sure that
we can synthesize them in more efficient and cost effective ways.
So it addresses some of that some of that issue
that you just described. I mean, now the same technology
can also be applied to new medicines, you know, and
advanced medicines as well, and that's really a longer term
trajectory that in THEYA is looking at. But right now,

(09:25):
what we're bringing to market are the ones that are
most critical for public health.

Speaker 1 (09:29):
So when you're doing biologics or biosynthesis, Christina, I mean
my understanding. You know, you're using a living organism and
engineered systems or living organisms raised a lot of questions
when it comes to biosafety or you know, unintended by products,
how to regulate them. So I'm just curious. That makes

(09:52):
it difficult, right and also providing consistency, so that is
one of the things that is is a risk.

Speaker 3 (10:02):
It's a great question. And let me highlight a couple
things about the technology itself. At the end of the day,
the product that we sell and the product that goes
to patients, it is a chemical we are not it's
you know, the living organism isn't actually not going into
the patients. I guess we use a yeast sale to
make the product, but ultimately we purify that chemical down

(10:26):
to greater than ninety nine you know, percent purity and
meet all of the existing requirements. So it's very well characterized.
So that carryover of sort of an uncontrolled you know,
living organism into a patient that doesn't happen with this technology.
The other thing I will just highlight, and what we
have been able to show with this platform is that
we can program the synthesis so precisely that we actually

(10:51):
are able to provide products that have fewer byproducts than
what we see through other manufacturing approaches.

Speaker 1 (10:58):
Hey, just lastly, twenty and I know you guys did
a Series C about fifty six million dollars. When is
it commercially viable? And forgive me, it's just twenty seconds here.

Speaker 2 (11:10):
No.

Speaker 3 (11:10):
Absolutely, As I mentioned, Anthea is commercial at this stage
and we'rek And now what we're doing is we're leveraging
that funding, leveraging the support from the investors to really
grow and ramp basically how we bring our products to market,
what markets we can enter and ensure that this is
truly disruptive.

Speaker 1 (11:30):
Come back and keep us informed. Christina Smolkey, co founder
CEO of Anthea joining us