Informatief, was dit nog niet tegengekomen hier:
Santarus (SNTS) UBS Global Life Sciences Conference September 19, 2012 4:00 PM ET
Gerald Proehl - President and CEO
"and Ruconest, a recombinant C1 inhibitor. We expect to announce results from the Phase III study in the end of October or first half of November."
"With Ruconest, we’d need to call on a different target audience. We’d need to call on allergists and immunologists, and it’s going to require about 25 sales representatives. It’s a very specialized orphan drug type of indication."
"Ruconest is our second product. It actually will read out late October, early November. It’s a recombinant C1 inhibitor for hereditary angioedema. Two studies have already been completed. This is a third study, 75 patients. It’s a three to two design, 45 patients on active, 30 on placebo. We think this will be a best-in-class product. It’s a recombinant C1 inhibitor, two [plasma-derived] products, Cinryze and Berinert.
We think recombinant products, by virtue of being recombinant, are safer products for patients. And we think it will be the most effective product. We do have a patent on this product. It will have an orphan drug, seven years exclusivity. It will also fall underneath the biologics, with 12 years of exclusivity.
These are the two Phase III studies that were completed. The European study had 100 units per kilogram. The U.S. study, 100 units and 50. The current studies have 50 units per kilogram. You can see on the right, very highly statistically significant results.
The marketplace is evolving. Cinryze is the first product approved. They’ll do somewhere around $300 million. As more products have been approved for acute use, you’re seeing the movement over in that direction. Also, you’re seeing more patients on steroids move over into acute treatment. We expect that will continue to happen.
We also expect more patients will actually seek treatment, and they’ll treat more of their attacks on an ongoing basis. Currently it’s estimated at about a $400 million marketplace. We expect it will be about a $600 million to $800 million market."