IN 800 WORDS

Risk is “what this business story is about”

In 800 Words is a succinct, timely talk with a need-to-heed KOL.

Mark L. Baum, the head — and face — of pharmaceutical compounder Imprimis, is a former attorney turned entrepreneur on a mission: he wants to ease patients’ and physicians’ access to medicine. Two examples: he took on Turing Pharmaceuticals for its incomprehensible pricing of Daraprim by compounding the drug and undercutting Turing at a micro-fraction of the price. And, he is courting Medicare to save billions by switching to a post-cataract injection instead of drops. Mr. Baum is willing to take risk. “That’s what this business story is about.”

OM: Please describe your business.

MB: We founded Imprimis on one word: accessibility, for physicians and patients both. You can have the most innovative drug, but if people can’t afford it, it’s meaningless.

OM: How did you get involved in pharmaceuticals?

MB: In the late 1990s, I founded a pharmacy company that provided HIV medications to the HIV/AIDS community in LA. We initially focused on Spanish-speaking, gay, HIV-positive patients.

OM: Describe what you did.

MB: We went into the community and acted as advocates. We made sure patients had access to their medicines and understood what to take and when. It was through serving these folks that I better understood what “accessibility” meant to real people.

OM: How long did you do that?

MB: About 18 months. Then I started a hedge fund that happened to invest in primarily healthcare companies. In late 2011, I started Imprimis.

OM: Why a compounding pharmacy?

MB: The existing FDA approval process — from an investment perspective, the time and money required to get FDA approval — is very challenging. Importantly though, doctors do not necessarily need the FDA’s guidance when it comes to drugs they have used for years in their practices.

We now offer custom compounded medications made of well-known, FDA-approved generic drugs to patients and physicians at accessible prices.

OM: Such as?

MB: Physicians have reported that our Dropless Therapy eliminates the need for drops in better than nine of 10 cases. It also can save taxpayers lots of money. One study showed that Medicare could save $7.8 billion over 10 years.¹

But Medicare policy mandates that docs pay for Dropless for their patients. This creates an effective eye drop mandate. Why create a policy that docs pay for their patients’ meds? It’s good for the eye drop companies, but not taxpayers and patients who [post-surgery] must put in these drops, which aren’t easy for everyone to put in.

OM: Tell us about the recent partnership with Express Scripts.

MB: When we made the announcement that we would sell a compound of pyrimethamine (Daraprim, Turing) at $0.99 a pill, Express Scripts contacted us … We were contacted by all of them (other large PBMs).^* The Daraprim case isn’t much different than Dropless.

In both cases, we are offering clinically relevant and lower cost alternative compounded formulations to drugs that are really old technology and really expensive.

OM: But your drugs are not FDA-approved.

MB: The components are 100% FDA approved, we are FDA inspected, and we are registering two of our facilities with the FDA this spring. We have found that doctors are familiar with the drugs we use in our formulations, and do not need FDA instruction on moxifloxacin or triamcinolone or prednisolone use. Pharmaceutical compounding is standard, critical and integral to our drug economy.

OM: When Congress passed the FDA’s 503B regulation on compounding facilities in 2013, what effect did it have on your facilities?

MB: They outlawed office-use compounding even though some states allowed it. Patients with emergent conditions no longer had immediate access to the medicines they needed. Not smart.

The FDA has been extremely slow to move on Section 503B. I think the FDA has had a hard time thinking about how to harness the promise of safe compounding in a positive way. We are still not clear what the FDA is going to do with 503B, FDA-registered outsourcing facilities. We hope the FDA is open-minded about what can be made in outsourcing facilities. If not, this section of the law will fail.

OM: You see 503B as a friend to the compounding facility?.

MB: I have embraced the concept of FDA inspection and believe in the highest standards. The highest standards are the future of compounding.

OM: Where were you raised?

MB: I grew up in a lower-middle class area of Houston, Texas. I come from a family of dry goods merchants. Like many children then and today, hard work was demanded of me from a young age. I embraced work and everything that came from it. OM

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