King Pharmaceuticals, Inc. Q2 2009 Earnings Call Transcript

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2009-08-07 06:08:19.0

Tags: FDA, Agency, Call Transcript, Earnings, Question, King Pharmaceuticals Inc., Federal Government, Advertising & Promotion, Government, Marketing, Seeking Alpha

Question-and-Answer Session

Operator

(Operator instructions) Our first question comes from the line of Louise Chen of Collins Stewart. Please state your question.

Louise Chen -- Collins Stewart

My question was with respect to your abuse-deterrent opioid franchise. Based on comments made by the FDA, it sounds like they do want to approve your products. So can you talk about maybe some of the conservatism that they are having or maybe some of the caution that they are taking with respect to the approvability of these products?

Brian Markison

I think each of these products are different and each of them are also in different stages of review. So really, there's no blanket answer for all three of these. I think, certainly with Embeda, the major, I would say, issue that's on the table that has held it up for awhile has been the REMS and what type of our REMS will be applied to Embeda once it gets approved. And we believe we've reached a tentative agreement with the agency on an interim REMS that we feel will not be unduly onerous for the Company to execute, and we believe that we've a very good path forward there.

With Acurox, I think you may have seen Acura put out a press release this morning. We submitted our briefing packet to the FDA and we plan to meet with them during the last month of the quarter, and we believe we'll come out of that with a pretty good path forward. And, likewise on Remoxy, we recently met with the agency. We are quite enthused at the outcome of the meeting and we believe that we’ve a strong path forward. It's all down to execution and as we mentioned earlier in earlier releases, we're planning on filing or resubmitting midyear 2010.

Operator

Our next question comes from Adam Greene of RBC Capital Markets. Please state your question.

Adam Greene -- RBC Capital Markets

A question on the Auto-injector CP. You received a response back yesterday. Just curious what your take was on the citizens' petitions, the reply by the FDA, just how that relates to EpiPen, whether you think this was positive or negative.

Brian Markison

The long and short of it is, we believe that the response is relatively positive. I think the agency agrees with King, that if these auto injectors are different, if there's different instructions, different ways of using them, then that clearly needs to be recognized and would not facilitate an AB rating. I think these are fairly complicated devices, and in the case of EpiPen, where it's life-saving, I really think the agency is going to look at these filings on a case-by-case basis. But we, in general, view it as quite positive.

 

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