July 12, 2005

Napo pharmaceuticals bucks the trend bringing drugs to the third world

Napo pharmaceuticals is going a very different route to hopefully making first-world drug profits from the third-world. Their new approach means skipping the first-world entirely and going straight for those in the third-world that need it most.

The company has created a drug called Crofelemer which is used to treat chronic diarrhea. Crofelemer is unique in how it was created, and how it works. Born out of the research of Shaman Pharmaceuticals, a company which went bankrupt in 2001, Crofelemer has its roots in a South American tree called croton lechleri. Natives used an extract made from the tree to treat diarrhea. The extract itself can cause sickness if it is given in doses that are too high, but Shaman researchers isolated a compound that could be given in higher doses.

Crofelemer is unique in how it works because traditional anti-diarrhea medications like Lomotil and Loperamide decrease bowel motility, and are absorbed by the bloodstream. Crofelemer works locally, only in the gut, to stop the flow of “excess” water. (I use the term “excess” loosely because the water often lost in diarrhea cannot afford to be lost, and isn’t actually “excess” in the traditional sense of the word.)

This different mechanism of action is fantastic news for children whose immune systems haven’t fully developed, and AIDS patients whose immune systems are compromised: traditional anti-motility drugs can’t be used by either population because of their decreased immune response: allowing pathogens to linger longer in the GI tract can allow them to grow and infect the gut more than simply excreting them out. Crofelemer is unique because it doesn’t prevent bowel movements, it simply prevents diarrhea.

This drug discovered in the third world also has the greatest potential there: millions of children die every year from chronic diarrhea, and diarrhea can weaken those patients already dealing with AIDS, leading to quicker, higher mortality rates for that disease as well.

Aside from their drug being unique, Napo’s approach to making profits on Crofelemer is unique as well. The traditional model for creating profitable drugs is based on a first-world clientele: create a drug, and keep its prices high until the patent(s) expire to make up for the cost of bringing the drug to market. (Which can often reach and exceed half a billion dollars.) Napo, however, is skipping the first world and going right for the third world where the largest need and potential customer base is.

Napo, in a way, is the Henry Ford of pharmaceutical companies: they’re marketing to the huge masses of the third world, a drug that fills a very basic need, banking on moving huge quantities of the drug to create decent profit margins, as opposed to creating products with sky-high prices to sell to small, rich populations like that which exists in the United States. While Napo plans to bring Crofelemer to the US at some point, it is not its primary focus.

Should Crofelemer become profitable (and I see no great reason it shouldn’t be), I would expect some of the huge pharmaceutical companies in the US to take notice, and perhaps change their game. If drugs that fill basic needs should prove to be as profitable the ever-popular (and relatively trivial) lifestyle drugs, I could see a shift in research paradigms and a sudden focus on the huge population that makes up the third world. This can only be a good thing for those too poor to afford basic life-saving medications which are currently too costly for their governments to afford.

Napo has the potential to positively affect millions of people, and perhaps even turn the pharmaceutical industry on its head. Lifestyle drugs have their place, but currently most of the research emphasis is on these drugs because this is where the greatest profit margins are. Napo has a chance to show the world that money can be made by filling basic needs, instead of just catering to those with the deepest pockets.

| 11:24 pm |

6 Comments »

  1. [...] San-Francisco based Napo Pharmaceuticals has created a novel new drug against diarrhea which is quite unique in the way it works AND in how it is to be sold : Crofelemer is unique in how it works because traditional anti-diarrhea medications like Lomotil and Loperamide decrease bowel motility, and are absorbed by the bloodstream. Crofelemer works locally, only in the gut, to stop the flow of “excess” water. (I use the term “excess” loosely because the water often lost in diarrhea cannot afford to be lost, and isn’t actually “excess” in the traditional sense of the word.) [...]

    Pingback by The Boschmans Account » Blog Archive » A Novel Way of Treating Diarrhea, Only Available In 3rd World Countries (for now) — July 17, 2005 @ 6:04 am

  2. I think that this drug and the process of filling a basic need of the third world has the potential of making the pharmaceutical companies respected again amongst consumers. It is a fresh spin on a common approach. By keeping the price for the drug at a minimum provided that it does indeed work they are opening it up to a relatively untapped market. Once the rest of the world finds out, Viola! It will be a veritable cash cow.

    Comment by Larry Harris — July 20, 2005 @ 12:30 am

  3. I am a physician from India and have had a chance to use this drug on a number of patients.

    There are 2 things that i would like to point out. Firstly most deaths from diarrhea in 3rd world countries are not due to chronic but acute form of diarrhea. There was a recent breakout of acute diarrhea in our city which lasted for a couple of months and took the lives of number of children and adults.

    Secondly this drug does not, I repeat does not work as well as lomotil or loperamide. We had a number of cases where this drug had average to minimal effect in patients with multiple ongoing watery stools. Loperamide was then used to control diarrhea.

    From our experience we found that Crofelemer worked well in patients with mild to moderate diarrhea (3-10 stools/day). For severe diarrhea combination of loperamide plus crofelemer worked as good or slightly better than loperamide alone while crofelemer alone was inadequate.

    Mild to modereate diarrhea were well controlled on loperamide alone.

    However as a physician I welcome another good drug to our arsenal for fighting diseases.

    Comment by Sudeep Bansal — August 3, 2005 @ 2:57 pm

  4. Thanks for leaving the feedback and clarifications. We likely won’t see the drug in the US for a few years at least, so there’s no chance that I’d see it in action for a while. All I can find out about it is what you read in the lay press. It hasn’t hit micromedex, yet.

    Comment by Rian — August 3, 2005 @ 4:54 pm

  5. I’m concerned that if this does work out for Napo pharmaceuticals economically, and other companies rush into 3rd world countries, that those citizens will become involuntary guinnea pigs for some of these huge companies. Several have already exhibited far below stellar moral and ethical principles. If companies do rush unproven/less proven drugs into less developed areas, which turn out to have serious side effects, what recourse will the affected people have?

    Also, knowing how corporate America feels about the almighty dollar and it’s monopolistic urges, I could easily see companies trying to sign non-competition deals with governments to bar or limit other pharmaceutical manufacturers with or without similar products, from the country.

    Finally, an affordable solution for some of these giant companies would be to bring back/reintroduce some drugs of the past that worked albeit too well for them (people got better, not strung out). With more modern production techniques and the huge volume potential combined with new market strategies such that Napo is following, making people better (not just feeling better for a time) could be quite profitable.

    Comment by John — August 17, 2005 @ 1:58 pm

  6. [...] The study suggests private-public partnerships (PPPs) to help the problem. Other companies, like Napo Pharmaceuticals, are taking a different approach to drug development banking on an inexpensive treatment with super-wide appeal to make money. Think of it as the Henry Ford way of doing business in a cash-strapped third world. Both ideas are intriguing, but I think the PPP route ultimately will have more traction. In a cash- and research-intensive field like drug discovery, adopting an unprone business models involves a bit more risk than a rich, first-world investor looking to make a buck is willing to take. It’ll be up to organizations like the Gates Foundation to pick up the slack left behind by the for-profit sector. [...]

    Pingback by Lack of economic demand for infectious disease hurting research :: OnThePharm — September 2, 2006 @ 10:02 pm

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