Pharming Group (PHARM)

[plumo]

Santarus, Inc. (SNTS) Lazard Capital Markets 8th Annual Healthcare Conference Call November 15, 2011 1:00 PM ET

http://seekingalpha.com/article/311504-santarus-ceo-discusses-at-lazard-capital-markets-8th-annual-healthcare-conference-call-transcript

RHUCIN is our next Phase III study product. It’s currently enrolling patients in the third Phase III. Two pivotal studies have already been completed. The first was actually completed in -- I’ll show you the data, was completed in Europe, that’s in the bottom here. The second study was completed in North America. The European study was done at 100 units per kilogram dose, and then in U.S. study we use 100 kilograms, but also did a 50 kilogram dose.

What was obvious is that 50 kilogram dose was also very effective. When we met with the FDA, the FDA asked that we do an additional study of the 50 units per kilograms. So we are currently enrolling 75 patients in that particular study expect to finish it somewhere in the third quarter of 2012 and then we’ll go ahead and submit the VRA it would be for treatment of acute attacks of Hereditary Angioedema.

If you look at the marketplace there are number of products currently on the market, on the right it would be Cinryze of prophylactic treatment, this patients will be taking the product twice a week every week, typically it’s going to be patients that are getting attacks probably multiple kinds a week, the costs of treatment over a 12 months period is about $400,000 and some of those patients will still have very few attacks.

On the left side is the patients that typically have been treated with anabolic steroids and these patients have been treated for many years with anabolic steroids, many doctors are starting to reduce the dose of steroids and starting to move to these other treatments.

And then the middle what we think is going to be the biggest piece of the market are going to be acute treatment. These are patients that might be getting one attack a month. They are going to be treated either with a HC1 inhibitor, currently Berinert is on the market, it’s a plasma-derived C1 inhibitor as it Cinryze oral product like Kalbitor and Firazyr.

We will be the first combatant C1 inhibitor on the marketplace. We think it offer some safety advantages over plasma-derived products, and we also think that the doctors will see disputed onsite of process is very significant. So we are looking forward to entering this particular marketplace.