PLANTATION, Fla.--(EON: Enhanced Online News)--Accu-Break Pharmaceuticals, Inc. and its subsidiary, Accu-Break Technologies, Inc. (“ABP” or the “Company”) announce that it has been granted its fiftieth patent relating to its innovative tablet technologies and designs that make tablets easy to split by hand into precise smaller doses. The patents, which have been granted in many countries throughout the world, including the United States, Europe and Asia, expiring no earlier than 2025.
“We are pleased that all of these countries have recognized the novelty and uniqueness of our technologies. We look forward to continuing to develop human and companion animal products utilizing these technologies as well as licensing the technologies to other companies.”
ABP, together with Alembic Pharmaceuticals Limited, is developing a number of prescription brand products via the 505(b)(2) NDA pathway utilizing the Accu-Break tablet technologies. These include a new easily and accurately divisible version of the popular anticoagulant warfarin. Accu-Break tablets are particularly useful for medications that require frequent and accurate dose adjustments such as those commonly used in cardiology, central nervous system disorders, pain management and diabetes. Additionally, ABP believes that Accu-Break tablets comply with the Food and Drug Administration’s (“FDA”) newly released Guidance for Industry Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM269921.pdf). ABP has also licensed its technologies to companies seeking to meet this newly enacted FDA Guidance.
“ABP wants to make it easier and safer for patients and caregivers to adjust doses through tablet splitting. It is important that patients obtain a consistent dose when they split their tablets. ABP’s technologies are designed to ensure this occurs with ease.” Dr. Hahn concluded, “We are pleased that all of these countries have recognized the novelty and uniqueness of our technologies. We look forward to continuing to develop human and companion animal products utilizing these technologies as well as licensing the technologies to other companies.”
About Accu-Break Pharmaceuticals, Inc.
ABP is a technology licensing and product development company. ABP has invented, developed and patented a suite of novel Accu-Break™ technologies that enable pharmaceutical tablets to be made that can be subdivided by hand into accurate partial doses with the intent of making it easier and safer for patients to adjust their dose. The Company is currently developing its first Accu-Break product, an Accu-Break-formatted anticoagulant, and is licensing the Accu-Break technologies for use in other products that are currently in development.
ABP Disclosure Notice: This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995. 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. Readers 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 obtaining 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.
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, except as expressly required by law.