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Acura Pharmaceuticals Management Discusses Q2 2012 Results - Earnings Call Transcript

Acura does not undertake to publicly update or revise any of its forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.

I'll now turn the call over to Bob Jones, President and CEO of Acura Pharmaceuticals.

Robert B. Jones

Thanks, David. Good morning, and thank you for joining us to discuss our second quarter 2012 financial results and corporate update.

Let's start with the AVERSION opioid products, which are designed to discourage some of the common methods of tampering associated with abuse and intentional misuse of the opioids. Last week, Pfizer notified us of their decision to return the 3 AVERSION opioid products in development while continuing to commercialize the product OXECTA. You will recall that our partnership with Pfizer was a result of our merger of our former partner, King Pharmaceuticals. Pfizer has had our 3 development products for 16 months following its acquisition of King. In that time, they have completed 1 bioequivalence study, held 1 FDA meeting and has not initiated any additional clinical studies.

In contrast, in the 8 months between King's announcement of the bioequivalence results on OXECTA and the submission of the NDA for that product, King completed 2 clinical studies, held an FDA meeting and completed all the other related development activities. It is against this background that we welcome our products back. We now control the timing and execution of these products, and we believe we have the resources and the expertise to execute the development plan for these products once they are formally returned by Pfizer. In the scheme of pharmaceutical development, these are not overly expensive products to develop if all goes well. We will also consider partnering these products with an alternative strategic partner for the development and commercialization of the returned products. Importantly, there is nothing we are aware of to indicate there are any clinical or regulatory barriers to developing these products.

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