Coqui RadioPharmaceuticals: Working to Supply Moly-99 to the US

Last month, Moly Investing News (MIN) delved into the topic of molybdenum-99, highlighting the fact that the supply situation for the isotope is very precarious. Indeed, just five reactors around the world manufacture it, and they’re all past their prime. 

That’s a problem as moly-99′s decay product, technetium-99m, is a key component in nuclear medicine. As the World Nuclear Association explains, that branch of medicine uses radiation to glean information about a person’s organs, generally to diagnose illness — essentially, not having technetium-99m leaves doctors unable to figure out what’s wrong with their patients.

Given how essential technetium-99m — and by extension, moly-99 — is, it would be reasonable to assume that numerous companies are working to replace the existing reactors. And some are — Northwest Medical Isotopes, Eden Radioisotopes, SHINE Medical Technologies and NorthStar Medical Technologies are a few mentioned in last month’s article.

However, they’re being slowed down by the fact that in recent years, concerns have arisen about the way moly-99 is made. Specifically, most moly-99 is produced via processes that require highly enriched uranium (HEU), which is associated with nuclear weapons creation. That means companies looking to start providing moly-99 are having to figure out how to do so without using HEU.

To find out more about what it’s like to operate within such tight parameters, MIN spoke with Carmen Bigles, CEO of Coqui RadioPharmaceuticals. Her company, which is in the process of going public, is looking to supply moly-99 to the United States, and in the interview below she provides some great insight into what exactly that will take.

MIN: Can you start by telling me a little about your background? How did you come to start Coqui RadioPharmaceuticals?

CB: My husband is a radiation oncologist and we own a radiation oncology center. In early 2009, we realized that there was something going on with our patients — we were getting calls saying they couldn’t get their exams done, couldn’t get their diagnostics.

Around the same time, in April 2009, the American Association of Physicians in Medicine held their annual meeting in Anaheim, California. Our medical assistant went to the meeting and when he came back, he said, “Carmen, there’s this crisis, you have to get involved.”

I said, “I can’t get involved, we have the clinic, we’re working on all this other stuff, I have two children and a husband. Forget it.” But he talked to my husband, and my husband convinced me. He gave the example of a child who almost drowned. With technetium you can see how the brain is functioning and help the child — without that you don’t know what the child’s future could be.

So I told our medical assistant I needed meetings with Dr. Crowley from the National Academy of Sciences, who did a book in 2004 on how to make moly-99 without using HEU, as well as with the director of the National Nuclear Security Administration. I also needed a meeting with INVAP and the resident commissioner.

He got all the meetings set up, and in September 2009, we founded Coqui RadioPharmaceuticals.

MIN: So the company has been around for about five years — what’s happening now?

CB: We are building two twin research reactors in Alachua, Florida. The location will be official on August 19. Basically we’ll be using low-enriched uranium (LEU) technology instead of HEU, and they’ll be research reactors, meaning they won’t be power producers. They’re also waterproof, so they don’t go supercritical. It will be a facility dedicated to radioisotopes, moly-99.

We have the same engineers from INVAP who worked on the OPAL reactor in Australia. The moly-99 produced by OPAL is already approved by the US Food & Drug Administration and is distributed in the US. However, we’re not one of the US Department of Energy’s (DOE) partners. We’re not one of the companies they gave money to because we’re not using an emerging technology.

Companies like NorthStar and SHINE use what’s called emerging technology, non-proven technology. If you look at their technology, you’re only going to see models, you’re never going to see a real picture of the technology because it hasn’t been built and it hasn’t been proven. Our technology is proven.

MIN: And I believe your company is in the process of going public?

CB: Last year we purchased a public company, a shell company. It actually trades on the OTCBB. What we’re working on is a reverse merger, which should be complete by the end of the year. Once that’s complete, the company will be called Coqui Pharma.

MIN: What made you want to take the company public?

CB: The potential for investment. At the beginning, people were asking, “why is the DOE giving money to emerging technologies and not to you?” But we’re seeing more people now who understand the crisis and are knowledgeable in how the process works. That has made it a lot easier — they can look at the other technologies and say, “okay, this is not going anywhere.”

That said, the DOE did introduce us to our technology, and has invited us to partake in all of their meetings at the White House.

MIN: What are your other plans going forward?

CB: We are currently doing boring samples, all of the environmental reports. Classification and characterization of the site, basically.

We are expecting to submit our SAR, or safety analysis report, along with our environmental report, to the Nuclear Regulatory Commission (NRC) in mid-2015. The reason we’re submitting them together is that there have been problems with other companies that have submitted them separately. So that’s where we’re at with respect to the NRC.

With respect to construction, we are working with local engineers as well as starting to get together all the construction documents that need to be submitted to local authorities so that we can begin construction.

Because it’s a proven technology it makes it a lot easier. The NRC has an existing set of regulations and guidance to license this facility.

MIN: Best-case scenario, when are you looking at having everything up and running?

CB: I’d rather be very conservative, and that would be 2020. The crisis will get stronger in 2016 because both the NRU reactor in Canada and HFR out of the Netherlands will shut down. [Editor’s note: NRG, which operates the HFR, will in fact keep operating the reactor until the commissioning of its successor, the PALLAS reactor].

MIN: Obviously moly-99 supply is a concern for the US, but it’s a worldwide issue as well. Are other companies in other countries doing much work in that arena?

CB: I was in Vienna in November signing a pledge for the CTBTO, which is basically for the xenon emissions we will liberate into the atmosphere when the plant is operational. In Vienna it wasn’t just US stakeholders. I saw Iranians, Indians, companies from around the world.

MIN: It sounds like Coqui is off to a good start. Is there anything you’d like to add?

CB: We’re very passionate about helping people. Without diagnostics you can’t treat disease — we have to make a change and get it done.

Securities Disclosure: I, Charlotte McLeod, hold no direct investment interest in any company mentioned in this article. 

Editorial Disclosure: Interviews conducted by the Investing News Network are edited for clarity. The Investing News Network does not guarantee the accuracy or thoroughness of the information reported. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.