Emisphere Reports Results of Study Comparing its Oral Heparin Formulation to Traditional Injectable Heparin
Friday March 31, 8:30 am ET
Results Show that Heparin Delivered Orally Using Emisphere's eligen(R) Technology is Identical to Heparin Delivered by Injection Based on all Analytical Methods Utilized
TARRYTOWN, N.Y., March 31 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - News) today announced results of a clinical study designed to compare heparin administered in the Company's proprietary oral formulation to heparin administered by the two standard methods of injection. The purpose of the study was to demonstrate that heparin's molecular configuration when delivered by the oral route using the Emisphere's eligen® technology is unaltered as compared to heparin when administered by either the subcutaneous or intravenous routes of administration. The results show that heparin delivered orally utilizing Emisphere's eligen® drug delivery technology, is chemically identical to heparin delivered by injection. The study was conducted as a result of discussions with the U.S. Food and Drug Administration ("FDA") regarding potential expedited registration pathways for oral heparin.
Previous studies have repeatedly demonstrated that Emisphere's oral heparin formulation can elevate the key parameters of anticoagulation (aptt, anti-Factor Xa, Anti-Factor IIa and TFPI) similar to injectable heparin. The data from the recently completed study is expected to support a claim that heparin is unchanged by the oral route of administration using Emisphere's eligen® technology.
"Our data confirms that the eligen® technology makes it possible to deliver heparin to the blood stream in an oral formulation," commented Robert J. Linhardt, Ph.D., Professor of Chemistry and Chemical Biology at the Rensselaer Polytechnic Institute. "The data show that heparin delivered to the blood in an oral formulation has the same molecular properties as native heparin (naturally occurring heparin) and heparin delivered by injection. We look forward to submitting these results to peer reviewed publications with additional data in the near term."
Professor Shaker A. Mousa, PhD and Chairman of Pharmaceutical Research Institute Albany College of Pharmacy who conducted the pharmacodynamic component of the study, commented, "the fact that oral heparin delivers the full range of heparin molecules is important, not only because it faithfully reproduces the injectable heparin, but also because it provides an oral agent that can take full advantage of the pleiotropic properties of heparin, many of which reside exclusively on the higher molecular weight fractions of unfractionated heparin."
Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere, stated, "We are very excited by these results and quite impressed with the capabilities of Professors Linhardt and Mousa. We will be submitting their report to the FDA in the near future, at which time we will discuss ways to utilize the findings of the study to expedite the registration process for oral heparin. The detailed results of this study will be made available thru publication and presentation at scientific meetings."
About Oral Heparin
Emisphere's lead product candidate is oral heparin, an antithrombotic/anticoagulant used to prevent deep vein thrombosis following surgery. Deep vein thrombosis (DVT) is a condition in which a blood clot (thrombus) develops in deep veins of the body, most often in the deep veins of the legs, either above the knee or below it. While this condition itself is not life- threatening, the blood clot can break free and become lodged in the blood vessels of the lung causing a pulmonary embolism (PE).
Thromboembolic events are responsible for more deaths in the U.S. than AIDS, breast cancer, and highway fatalities combined. Every year, approximately 2 million Americans are affected by deep vein thrombosis, and approximately 600,000 experience pulmonary embolisms. For up to 200,000 of those with PE, the blood clot in the lung proves fatal. Approximately 600,000 people with DVT are hospitalized and about 60,000 die each year in the U.S. as a result of thromboembolic events.
There are approximately 350,000 patients who undergo total hip replacement surgery in the U.S. each year. In addition, anticoagulant therapy is prescribed for total knee replacement (estimates are U.S. 350,000 patients), DVT treatment (estimates are U.S. 600,000 patients), atrial fibrillation (estimates are U.S. 1.5 million patients), and a number of other indications. The prevalence of DVT and PE in knee and hip replacement patients has been well documented. Patients who undergo total hip replacement are at a high risk of developing VTE which includes DVT and PE.
About Emisphere Technologies, Inc.
Emisphere Technologies, Inc. is a biopharmaceutical company pioneering the oral delivery of otherwise injectable drugs. Emisphere's business strategy is to develop oral forms of injectable drugs, either alone or with corporate partners, by applying its proprietary eligen® technology to those drugs or licensing its eligen® technology to partners who typically apply it directly to their marketed drugs. Emisphere's eligen® technology has enabled the oral delivery of proteins, peptides, macromolecules and charged organics. Emisphere and its partners have advanced oral formulations or prototypes of salmon calcitonin, heparin, insulin, parathyroid hormone, human growth hormone and cromolyn sodium into clinical trials. Emisphere has strategic alliances with world-leading pharmaceutical companies. For further information, please visit emisphere.com. |
