PALATINE, Ill., Oct. 26, 2009 (GLOBE NEWSWIRE) -- Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) (the "Company" or "Acura") today reported a third quarter 2009 net loss of $4.0 million or $0.09 per share compared to net income of $3.1 million, or $0.06 per diluted share for the third quarter of 2008. For the nine months ended September 30, 2009, the Company reported a net loss of $11.8 million, or $0.26 per share compared to net income of $17.5 million, or $0.35 per diluted share for the same period in 2008. As of October 26, 2009 we had cash and cash equivalents of approximately $32.0 million with no term indebtedness.

Our financial results include revenues relating to our License, Development and Commercialization Agreement with King Pharmaceuticals Research and Development, Inc. ("King"), a wholly-owned subsidiary of King Pharmaceuticals, Inc. For the nine months ending September 30, 2009, we recognized $2.7 million in Program Fee Revenue from the amortization of the non-refundable $30.0 million upfront payment received from King in December, 2007 and $0.4 million in Collaboration Revenue from King's reimbursement to us of Acurox(R) Tablets ("Acurox(R)") development and regulatory expenses. For the same period in 2008 we recognized $23.7 million and $8.0 million of Program Fee Revenue and Collaboration Revenue, respectively. Third quarter 2009 revenues include $0.6 million and $0.2 million of Program Fee Revenue and Collaboration Revenue, respectively, compared to $1.3 million and $2.6 million of Program Fee Revenue and Collaboration Revenue, respectively, for the third quarter 2008. The Company also recognized $5.0 million in Milestone Revenue from the Acurox(R) development in the nine month period of 2008.

Our financial results include share-based compensation expense of $6.5 million and $2.4 million for the nine months ended September 30, 2009 and 2008, respectively, and $2.7 million and $1.5 million for the three months ended September 30, 2009 and 2008, respectively. Excluding the research and development share-based compensation expense, our research and development expenses decreased $7.8 million and $2.3 million for the nine and three months ended September 30, 2009, respectively, compared with the same periods in 2008. These decreases were primarily attributable to the expenses of the pivotal Phase III clinical study and additional clinical testing of the abuse deterrent features of Acurox(R) conducted in 2008.

On June 30, 2009 we received from the FDA a Complete Response Letter ("CRL") for the Acurox(R) NDA. The CRL raised issues regarding the potential abuse deterrent benefits of Acurox(R). On September 2, 2009 we and King met with the FDA and agreed that the data and evidence supporting the Acurox(R) NDA would be presented to an FDA Advisory Committee. While the FDA stated that no new clinical trials are required at this time, we and King plan to initiate an additional clinical study to further assess the abuse deterrent features of Acurox(R).