Acura Pharma says loss for first-half 2006 hits $6.8 million, will run out of cash in August

By Angela McDaniels

Seattle, July 27 - Acura Pharmaceuticals, Inc. said its net loss increased 186% to $2.6 million, or $0.01 per share, for the quarter ended June 30 from $1.4 million, or $0.06 per share, for the same period of 2005.

Included in the results for the second quarters of 2006 and 2005 are non-cash compensation charges of $1.3 million and $200,000, respectively, for stock compensation expense related to the company's issued stock options and restricted stock units, according to a company news release.

For the six months ended June 30, Acura had a net loss of $6.8 million, or $0.02 per share, compared to a net loss of $3.3 million, or $0.15 per share, in the same period of 2005.

Cash reserves update

The company estimated that its current cash reserves, including the net proceeds from its $335,000 bridge loan due Sept. 1, will fund product development and licensing activities through mid-August. To continue operating thereafter, Acura must raise additional financing or enter into collaboration agreements with third parties providing for cash payments to the company.

Acura said no assurance can be given that it will be successful in obtaining any financing or collaborative agreements or if secured, that such financing or collaborative agreements will provide enough cash for the company to continue operations.

In the absence of such financing or third-party collaborative agreements, the company said it will be required to scale back or terminate operations and/or seek protection under applicable bankruptcy laws.

More OxyADF tests needed

According to the release, the Food and Drug Administration will require additional clinical studies prior to the submission of New Drug Application for OxyADF analgesic tablets, the company's lead product candidate.

OxyADF's active analgesic ingredient is oxycodone HCl. It also contains the company's proprietary Aversion Technology active ingredient, which is designed to produce undesirable side effects including warmth or flushing, itching, sweating and/or chills, headache and a general feeling of discomfort in people who consume doses more than 10 times greater than the proposed maximum recommended daily dose of OxyADF.

Additional required clinical studies include completion of a phase 2 clinical trial currently in progress in 25 subjects with a history of opioid abuse; a placebo-controlled, pivotal phase 3 clinical trial in 300 to 400 acute pain patients and four or five phase 1 clinical studies with 25 to 50 normal subjects per study.

The company gave no estimate as to when the clinical studies will be finished or their cost. Acura said it expects to reassess its future research and development plans pending review of data received from in-progress development activities and the availability of cash.

To date, Acura has completed patient enrollment in one phase 1 clinical trial, one phase 2 clinical trial, a pivotal bioequivalence trial and a pivotal laboratory study relating to the development of OxyADF.

The first half of the phase 2 clinical trial - designed to assess the safety and tolerability of OxyADF tablets in comparison to oxycodone HCl tablets without an ingredient to discourage excess oral consumption - has been completed in 66 healthy volunteers.

Initial results indicate that OxyADF is generally well-tolerated when taken at recommended doses, the company said.

Acura Pharmaceuticals is a Palatine, Ill., pharmaceutical company specializing in products to deter abuse of opioids.

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