Allergan Earnings Call Nuggets: DARPin and RESTASIS
Allergan, Inc. (NYSE:AGN) recently reported its fourth quarter earnings and discussed the following topics in its earnings conference call.
Gregg Gilbert – Bank of America / Merrill Lynch: I have a question on DARPin. I was hoping you could tell us when you will get DARPin in-house and if we hear from any of you that you’ve decided to move into Phase III before we see the final dated AAL. What can we assume that you specifically achieved in Phase II?
Scott M. Whitcup, M.D. – EVP, Research and Development, Chief Scientific Officer: It is Scott. We have a fairly robust Phase II program. So, what we will know is safety of that compound and dosing frequency. And clearly to make the decision to move to Phase III given the investment we would need to make we need to see product differentiation versus Lucentis which is the comparator. Our prediction based on PK work is that the dosing administration will be less frequent. We might be, in addition, lucky to see differences in efficacy, but those are the two things that we would be looking at. We will have data roughly mid-year. You know what we have said all along is that you will likely see the data second half most likely conference will be AAL which is in the fall. I think we have stated that prior to using the date at AAL we would announce if we’ve made the decision to move to Phase III that you’d hear that on an earnings call.
Shibani Malhotra – RBC Capital: Just questions for Scott and David, I guess, on the ophthalmology franchise, in particular, RESTASIS. What are your current thoughts on generics for the product and potential to follow on for RESTASIS as well?
Scott M. Whitcup, M.D. – EVP, Research and Development, Chief Scientific Officer: In terms of generics, Shibani, what we have stated before is that given FDA regulation there would need to be a fairly large study showing non-inferiority of a generic to RESTASIS, but also beating vehicle control because of the non-inferiority margins this would be a very large study with a fairly big risk that you wouldn’t actually achieve the goal and to our knowledge no one would go this route and no one has been going this route. We are looking at a follow on to RESTASIS, it is so call RESTASIS X, we don’t comment on it. Probably the first thing you will hear will be just watching clintrial.gov to get an idea of what that might be.