A San Diego pharmaceutical firm is now offering a new drug for a persistent and potentially deadly bacterium that affects people in hospitals and nursing homes. The story behind the development of the drug by Optimer Pharmaceuticals can give us a peek into the business of bio-technology. And the tug of war between the needs of sick people and the tremendous expense of developing new drugs...
Guest: Pam Sears, executive director of Biology and Preclinical Science, Optimer Pharmaceuticals
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CAVANAUGH: A San Diego pharmaceutical firm is now offering a new drug for persistent, and potentially deadly bacteria, that affects people in hospitals and nursing homes. The story behind the development of the drug by Optimer Pharmaceuticals can give us a peek into the business of biotechnology. And the talk of war between the needs of sick people, and the tremendous expense of developing new drugs, I'd like to introduce my guest, Pam Sears, who is executive director of biology and preclinical science at Optimer Pharmaceuticals. Pam, hello.
SEARS: Thank you, Maureen, and hello.
CAVANAUGH: Thank you for coming in. I'm sure many people don't know anything about bacteria Clostridium difficile, and how it's contracted.
SEARS: This is anaerobic, it doesn't like air to grow. It therefore grows in your colon. It's an organism, it's particularly pernicious, because it forms spores which are almost like bacteria seeds. And these can spread throughout the environment upon. So even though the organism can't grow in the air, the spores hang around. So they can be transferred through contact, through happened to hand contact, spread on the environment, on furniture surfaces and so forth and hang around for a very long time. This provides a very facile root route of infection for people.
CAVANAUGH: I hear it infects people a lot in hospitals and nursing homes. Does that mean they're doing something wrong or is it to be expected that people in those environments might develop this infection?
SEARS: To a certain extent, it's expected because this is a very difficult -- these spores are very difficult to disinfect. Things like the alcohol based hand washes don't kill them. What you actually require is hefty amounts of bleach and long contact time. It's very difficult to get rid of these.
CAVANAUGH: I've heard it's worse than MRSA, which is that scary flesh eating bacteria. Is that true?
SEARS: It has become so. The severity has been increasing, and we're seeing it in populations that previously we didn't see it in. So kids, young adults, healthy ideas individuals, which normally it was a disease more of the elderly and compromised individuals.
SEARS: And it also can be deadly; is that right?
SEARS: It can be. Actually in certain areas and in certain populations, death rates can be up to -- they have been reported like 15% mortality rates.
CAVANAUGH: And i read about 30,000 people a year die from it, estimates say.
SEARS: Probably about right, yes.
CAVANAUGH: Now, pam, before opt merintroduced the new drug, there was already a drug available that dealt with c. diff, right?
SEARS: Yes, there is one other drug in the united states, vacco micin, orally, that has a label, a package insert indication for c. Deficit, associated diarrhea.
CAVANAUGH: But your drug is being looked at as an improvement. Why is that?
SEARS: One of the biggest problems with c. difficile associated diarrhea is -- and one of our patient advocates noted it's the gift that keeps on giving. It does tend to come back repeatedly in certain individuals. And so one of the things that we wanted to look at in our trial is sustained clinical response. Okay, if this works up front, that's great. But how does the patient do for a prolonged period? What we found with fidaxomicin is that we have an improvement in sustained clinical response.
CAVANAUGH: And that's the name of the new general, deficit. Is that right?
SEARS: Deficit is the trade name. The generic name is fidaxomicin.
CAVANAUGH: Tell us a little bit about the company opt mer. When was it established?
SEARS: We were a paper company in 1998, but really, operations started in 2,001. I came onto the company in 2002, i was the first token biologist. We had a company full of chemistry individuals. So at the time, it was truly pure discovery. And about a year into that, we began developing fidaxomicin.
CAVANAUGH: How did you get to the point where you started developing this particular drug? Did you see that there was a need in the market or did it come out of pure research?
SEARS: Well, we certainly saw that there was a need. And one of the things that was interesting about fidaxomicin was that it had a lot of properties in vitro and in animal studies that suggested that it could really be an advance for C. Difficile associated diarrhea. As soon as we saw that, that offered up an opportunity to explore this in this particular niche area. And then we knew that the disease was increasing in incidents and severity. So it definitely all -- all those things together made it a good potential opportunity.
CAVANAUGH: So was this whole small company of Optimer Pharmaceuticals, was everyone pretty much workock this one drug?
SEARS: Pretty much. When i started we were about 25 people. And through phase three, we were about 30 and 40 people. So we were extremely small and focused on fidaxomicin. We more or less drafted people into the areas of need. So a lot of biology got pulled over into fidaxomicin development. I got pulled over into the clinical development. So everybody chipped in and worked on this project.
CAVANAUGH: This was a long process. You're saying it kind of started around the beginning of the two thousands, and all this time until this year -- was it approved this year?
SEARS: It was approved in may of this year. It's a fermentation product. So the initial -- and that means that you use other bacteria to make it. You make it in a big reactor. So it's a fermentation product. And improving the fermentation took from about 2,001 to 2002. Then you have to do in vitro studies before you can put it into people.
CAVANAUGH: Where did the funding come from?
SEARS: That was a challenge, actually. That was one of our biggest challenges, getting the money to keep going. We were -- we only became public in 2007. So it was really venture capital. Strategic alliances with far pharmaceuticals for for a short period of time. That was part of it. But a lot of venture capital funding, then ultimately in 2007 we went IPO, and that provided another installation of cash.
CAVANAUGH: One of the big things that came out of this new drug being offered to the public was the fact that it is quite expensive. It is i think twice as expensive than vancomycin. Why such a high price?
SEARS: Well, I'm not an expert in the commercialization side. I'm certainly more on the scientific side and the development. I know we had our commercial folks researching what was the appropriate price in terms of make a win situation for everybody. And it's my understanding it is my understanding it's not out of the realm of what new branded drugs fit.
CAVANAUGH: My understanding is the drug costs about $2,800 per treatment.
SEARS: Not not necessarily what the patient will see.
CAVANAUGH: Right.
SEARS: The patient presumably will have an insurance policy that will cover it.
CAVANAUGH: How much did it cost to develop this drug?
SEARS: You know, i haven't tallied it all up, but it's upwards of a hundred million to put this together.
CAVANAUGH: A hundred million dollars. So in a sense, Optimer wants to recoup that, and it needs to change a certain high price for this?
SEARS: Certainly in drug development, this is a need to recoup the cost of what was developed as well as there are hidden costs to all the drugs that didn't make it. Since we are being funded by investors.
CAVANAUGH: I have read that in recent years, insurance companies and hmos and so forth have become much more critical about the high price for pharmaceuticals and trying to put some sort of a cap on that. Where do you find that falling into the way Optimer looks at the drugs that it's developing going forward?
SEARS: I'll probably have to defer to the commercialization side. I'm more on the drug development side. So in terms of a commercial strategy for drug pricing, i would have to rely on our commercial folks.
CAVANAUGH: But indeed the company has to keep in business for you to keep working.
SEARS: It radio, right.
CAVANAUGH: So you must have something to do with that in a way. Which drugs is opt mer working on now?
SEARS: What we're looking for -- I'm glad you and asked. What wee focused on as a company are drugs for which there's an unmet need. Things for which there is no satisfactory treatment right now. So for example for future antibiotics, there are definitely needs in things like grand negative infection. Multiresistant grand negative infection would be an area where there's an unmet need, things of that nature where we really feel we can make a difference.
CAVANAUGH: I can't help but wish you a great deal of success with this after your very very long process in getting this on the market. I've been speaking with pam seers of Optimer Pharmaceuticals. Thanks very much for coming in and telling us about this.
SEARS: Thank you.
