Accu-Break Pharmaceuticals, Inc. Enters into a Product Development and License Agreement with Alembic Pharmaceuticals Limited
Geoff Green, 954-236-7351Vice President, Business Development & Clinical Affairs
Accu-Break Pharmaceuticals, Inc. (“ABP”) announced today that it has entered into a development and license agreement with Alembic Pharmaceuticals Limited of Gujarat, India to develop new brand products that will use ABP’s innovative Accu-Break™ tablet technologies. ABP’s patented Accu-Break tablets can be split easily by hand into exact smaller doses to provide maximum flexibility, and to make it easier and safer for patients and caregivers to adjust their dosage. The first product that ABP will seek Food and Drug Administration marketing approval for is an Accu-Break-formatted version of the popular anticoagulant medication warfarin (Coumadin®).
“We are delighted to be working with a leading pharmaceutical company in India that is vertically integrated and has the ability and expertise to develop and manufacture pharmaceutical products for the U.S. market,” stated Elliot F. Hahn, Ph.D., Executive Chairman of Accu-Break Pharmaceuticals, Inc. “Together, we are looking forward to filing the first of what we anticipate will be many 505(b)(2) New Drug Applications for products utilizing our patented Accu-Break technologies in combination with Alembic’s broad base of active pharmaceutical ingredients and formulations.”
Based in Plantation, Florida, 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. Behind the strength of its innovative inventions and broad patent portfolio, the company is currently developing its first product, and is licensing the Accu-Break technologies to other parties for product development. ABP currently has 48 patents issued and 22 patents pending worldwide. For more information please visit .
Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities all over the world including the US FDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a field force of over 3000 sales representatives, are well recognized by doctors and patients. More information about the company can be found at ; (reuters:ALEM.NS)(bloomberg:ALPM)(nse:APLLTD)(bse:533573)
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. 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 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.