MW: If we look at cystic fibrosis, there really are great reasons to took to an online vehicle. One of the big concerns with
cystic fibrosis is cross-infection. Patients with cystic fibrosis, unfortunately, become chronically infected with pseudomonas,
which causes a loss of lung function over time and is linked to probably 80 percent or more of the mortality in CF. Hence,
the centers don't want CF patients interacting in the same room, and so we do see that there is a very vibrant online community
If you look at different online vehicles, Twitter and Facebook are great for getting information out; but if you contrast
them to blogs, which we see more in the CF world, that's a more dynamic environment. So in CF we see the blogs as an area
where there is a lot of patient activity and a lot of family activity, compared to Twitter, Facebook, etc. What we want to
do is build awareness of our brand and, more importantly, knowledge of the product. So we need to position our messages near
Of course, having said that, in the GI segment you also have some patients with EPI due to alcoholism; online isn't a good
way to interact with that group of patients.
PE: When you talk about messages, do you mean display ads? Is this something you've rolled out yet?
MW: It is something that we have rolled out, and it's something that we've gotten very good feedback on. As a matter of fact,
one of the things that we do is try to understand what would take a person to our site. Now we know that
http://CF.com/ has directed people to our site; we even know what percentage of people it has directed to our site to gain more information.
PE: Are there any ideas of partnering with them to make something like a "patients like me" CF channel?
MW: Yes. Rather than trying to invent something, we want to rely on something that the CF community is already using, and that's
why we've gone the route we have. Previously, a lot of the supplemental enzymes would be broken down before they ever reached
the site they needed to in the small intestine.
PE: How does this drug differentiate itself from the competition?
MW: Unfortunately, a lot of the previous supplemental enzymes were broken down in the acidic environment of the stomach before
they ever reached the site they needed to treat in the small intestine. Hence the advent of enteric-coated enzymes. Zenpep,
importantly, is not just an enteric-coated enzyme. Pancreatic enzyme products today contain three key enzymes: amylase to
dissolve sugars and starches; protease to break down proteins; and, importantly, lipases to break down the fats.
What happens is lipases are unstable in the stomach. They're unstable in an environment where there's a very low pH, which
is very acidic. So before there were enteric-coated enzymes, people would have to take large quantities of enzymes but, Zenpep
is an enzyme that was developed to meet an FDA guidance issued in 2004 to ensure conformity to the official product label.
Why is that guidance important? It's about the manufacturing of enzymes. Because enzymes are inherently unstable, and manufacturers
would overfill to deliver the label amount of lipase. Under the USP Guidelines the overfill was something like 165 percent
of label claim. So a product that claimed 10,000 units of lipase could have 165 percent of that amount, if the product was
new. On the flip side, if it was an old product, it could have as little as 90 percent of the label requirement: in the example
I just gave you, a 10,000 label, 9,000 units.
Thus, FDA guidance stated that for a product to remain on the market, manufacturers had to submit NDAs and develop products
that were sufficiently stable to have zero overfill. That is to say, the product had what was on the label.