Emisphere Begins Phase I Clinical Testing of Heparin Tablets
TARRYTOWN, N.Y., Mar 9, 2001 /PRNewswire via COMTEX/ -- Emisphere Technologies, Inc. (NASD: EMIS), today announced it has commenced human clinical testing in the United States of oral heparin tablets utilizing its delivery agent, Sodium N-[10-(2 hydroxybenzoyl)amino]decanoate (SNAD). SNAD is Emisphere's drug delivery agent developed for use with Emisphere's oral heparin tablets.
Emisphere intends to use SNAD as a delivery agent with formulations of both unfractionated heparin (UFH) and low molecular weight heparin (LMWH). SNAD was developed by Emisphere following a structure-activity assessment of modifications to the SNAC family of carriers. (SNAD is structurally related to Sodium N-[8-(2-hydroxybenzoyl)amino] caprylate (SNAC), which is currently in Phase III testing with heparin in an oral solution formulation.) In published preclinical evaluations (The Annals of Surgery, April 25, 2000), SNAD was shown to be significantly more potent based on carrier-to-drug ratio when compared to SNAC, with a comparable safety profile. The Phase I studies in the United States will initially study escalating dosages of SNAD in combination with UFH in a tablet formulation to determine safety profiles.
Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere Technologies, Inc., commented, "SNAD is an example of how we have the flexibility to enhance our drug delivery agents for different product candidates within the same therapeutic family. Our SNAC carrier combined with UFH in a solution dosage form will initially offer an improved route of administration with an ideal dosing regimen of 30 days to post-surgery patients for DVT prevention. The heparin solution remains an important portion of Emisphere's overall product strategy for our family of heparins since it will be an alternative for the elderly patient population, who may be unable to swallow a tablet. SNAD, alternatively, will be made available for those who can accept the solid dosage formulation, with the same benefits of an improved dosing regimen."
Robert A. Baughman, Jr., Senior Vice President, Development and Program Management of Emisphere Technologies, Inc., stated, "SNAD, which is the subject of an IND, represents the second carrier that we have advanced on our own through this important regulatory hurdle. Including the carrier being used by our partner, Novartis, for the development of oral calcitonin, we now have three different carriers in various stages of clinical testing. As is the case with oral calcitonin in the Novartis collaboration, this IND is for a tablet dosage form. We are also preparing to take additional carriers into clinical testing with a variety of drug products."
Currently, heparin therapy is limited to injection for the treatment of deep vein thrombosis (DVT) and for the prevention of blood clots due to post-surgical complications. Emisphere's initial goal in introducing an oral formulation of heparin is to extend its usage for DVT prevention from the current one to two week administration in a home setting to 30 days.
In the United States, it is estimated that there are more than three million hip, knee, and abdominal surgical procedures performed each year that put patients at risk for DVT, with more than 250,000 cases of DVT reported. Worldwide heparin sales of all heparin products are estimated to be more than $2 billion, with a projected 15% annual growth rate. The annual global market for anticoagulant therapies is estimated at approximately $6 billion.
Emisphere Technologies, Inc., is a biopharmaceutical company pioneering the oral delivery of otherwise injectable drugs. By applying its unique carrier technology, Emisphere has taken a leadership position in solving the oral delivery of proteins, peptides and other macromolecules produced by both pharmaceutical and biotechnology companies. Three Emisphere formulations are currently in human clinical trials being conducted by Emisphere and its partners. Emisphere develops pharmaceutical products for its own portfolio and has several strategic alliances and ongoing feasibility studies with many of the world's leading pharmaceutical and biotechnology companies, including Novartis Pharma AG, Eli Lilly and Company, Regeneron Pharmaceuticals, Inc. and Cubist Pharmaceuticals, Inc. |
