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Accu-Break Pharmaceuticals, Inc. Issued First Two Patents for Its Accu-Breakô Technologies


Thursday, February 14, 2008

Pharmaceutical Tablets Utilizing Accu-Break Technologies Are Made to Be Broken for Easy and Accurate Dose Adjustment

Plantation, FL -- Accu-Break Pharmaceuticals, Inc. ("ABP"), a company with a suite of pharmaceutical tablet technologies for creating divisible dosage forms, announced today the recent issuance of two patents covering its Accu-Break technologies. Tablets made in the Accu-Break format contain a drug-free layer that may be used as a break zone should the dose need to be adjusted. The technologies are intended to create pharmaceutical tablets that can be easily divided into precise doses to facilitate titration, dose adjustment and individualized dosing.

The first patent (U.S. 7,318,935) claims a layered immediate-release (IR) tablet having at least two different active ingredients segregated from each other by a drug-free layer. The innovative tablet design may be used to combine medications in a way that allows them to be administered together in a single tablet, as in traditional fixed-dose combination tablets, but also enables the two medications to be accurately separated if medically indicated simply by splitting the tablet through the drug-free layer. The invention also allows for the combination of active ingredients within a single tablet that are incompatible, providing a potential solution for useful combinations containing formulations that may be difficult to combine in a single tablet due to incompatibility reasons, among others.

The second patent (U.S. 7,329,418) also claims divisible tablets, but involves the creation of tablets that contain a half dose of the same active (or combination of the same actives) on each end of the tablet, separated by a drug-free break layer. Division of these tablets through the drug-free break layer would provide an accurate partial dose of the active(s), useful for titration and dose adjustment.

ABP’s CEO, Allan S. Kaplan, Ph.D. (co-inventor of the patented technologies together with Lawrence Solomon, M.D.), stated, "The Company views the issuance of these patents as key to both our own product development and the worldwide licensing of our innovative tablet technologies. The granting of these patents should bode well for additional pending applications that cover, among other things, new and complimentary tablet technologies."

Dr. Kaplan continued, "Together with our recently announced strategic alliance agreement with Azopharma Development Group, we now offer patented technologies and a center of excellence to pharmaceutical companies wishing to develop their products utilizing the Accu-Break technologies."

ABP has additional patent applications currently under review or awaiting review by the United States Patent and Trademark Office. These additional applications include claims of varying scope, such as those containing from two to five (or more) layers, novel score patterns, and controlled-release embodiments.

About Accu-Break Pharmaceuticals, Inc.

ABP is developing Accu-Break technologies for pharmaceutical tablets. The Company believes that these technologies may allow physicians to better customize treatment for their patients and that tablets utilizing Accu-Break technologies will represent improved dosage forms for many types of medications. ABP is located at 1000 S. Pine Island Road, Suite 230, Plantation, FL 33324. The corporate website address is www.accubreak.com.

ABP Disclosure Notice

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. For this purpose, any statements contained herein or which are otherwise made by or on behalf of the Company that are not statements of historical facts may be deemed forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "should," "would," "estimate," or "continue," or the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. Shareholders are cautioned that all forward-looking statements involve risk and uncertainties which may cause results to differ materially from those set forth in the statements. Such risks and uncertainties include, but are not limited to the following: the success of research and development activities and the speed with which regulatory authorizations and product launches may be achieved; government regulation generally; competitive developments; the ability to successfully market products domestically and internationally; difficulties or delays in manufacturing or issues relating to manufacturing capacity; commercial obstacles to the successful introduction of brand products generally; legal defense costs, insurance expenses, settlement costs, and the risk of an adverse decision or settlement relating to product liability, patent protection, governmental investigations, and other legal proceedings; the Company’s ability to acquire and protect patents and other intellectual property both domestically and internationally; the absence of certainty regarding the receipt of required regulatory approval or the timing or terms of such approvals; any changes in business, political and economic conditions; business interruption due to hurricanes or other events outside of the Company’s control. No ACCU-BREAK tablets have been marketed.

Readers are cautioned not to place reliance on these forward-looking statements, which are valid only as of the date they were made. The Company undertakes no obligation to update or revise any forward-looking statements to reflect new information or the occurrence of unanticipated events or otherwise, except as expressly required by law.



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