Accu-Break Pharmaceuticals, Inc. Files NDA For Unique Warfarin Potassium Tablets

HOLLYWOOD, Fla.--()--Accu-Break Pharmaceuticals, Inc. (www.accubreak.com, “ABP”), a pharmaceutical company focused on the development and commercialization of innovative worldwide patented pharmaceutical tablet technologies which address the need for accurate and customized dosing, announced today that its 505(b)(2) New Drug Application (NDA) for Warfarin Potassium was accepted for filing by the U.S. Food & Drug Administration (FDA). The Company’s product is bioequivalent to Bristol-Myers Squibb’s (NYSE: BMY) Coumadin®. ABP believes its warfarin product meets FDA standards of "Guidance for Industry: Tablet Scoring; Nomenclature, Labeling, and Data for Evaluation” (http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm269921.pdf) for “functional scoring”. ABP’s 4 mg tablet splits into exact 1 mg quarter doses, while the 5 mg tablet provides half doses. Based on IMS Data, ABP believes that these two tablets address essentially all of the currently available 9 Coumadin doses. The ABP bilayer tablet technology with its backbone drug-free layer enables accurate dose adjustments of a drug that exhibits an extremely narrow therapeutic index.

Elliot F. Hahn, Ph.D., ABP’s Executive Chairman stated, "Our first NDA filing represents an important milestone in the history of the company. We recognize that patients taking the widely prescribed anticoagulant warfarin, frequently split tablets. The ABP technology makes it safer and easier for them to obtain an appropriate dose when splitting tablets.”

ABP, in conjunction with Alembic Pharmaceuticals Limited (“Alembic”) of Gujarat, India, have developed the product. Alembic will manufacture the product. Both companies are collaborating in seeking licensees in the U.S. and worldwide.

ABP’s NDA filing was granted a small business waiver of the application fee, which was submitted with the filing.

About Accu-Break Pharmaceuticals, Inc.

Based in Hollywood, 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 58 patents issued and 4 patents pending worldwide. For more information please visit www.accubreak.com.

About Alembic Pharmaceuticals Limited

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 marketing team of over 5000 are well recognized by doctors and patients.

Information about the company can be found at india.com; (reuters:ALEM.NS) (bloomberg:ALPM) (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.

Contacts

Accu-Break Pharmaceuticals, Inc.
Robert I. Goldfarb, 954-989-4150
President & General Counsel
r.goldfarb@accubreak.com

Release Summary

Accu-Break's NDA for warfarin potassium accepted for filing. Product meets FDA functional scoring guidelines. 4 and 5 mg tablets address 9 marketed Coumadin doses. Technology patented worldwide.

Contacts

Accu-Break Pharmaceuticals, Inc.
Robert I. Goldfarb, 954-989-4150
President & General Counsel
r.goldfarb@accubreak.com