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Biotech / Medical : Emisphere -- Ignore unavailable to you. Want to Upgrade?

To: Miljenko Zuanic who wrote (217)	6/19/2003 11:25:10 AM
From: tuck	Read Replies (1) \| Respond to of 272

>>TARRYTOWN, N.Y., June 19 /PRNewswire-FirstCall/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS - News) announced today that it has signed a cooperative research and development agreement (CRADA) with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the U.S. Department of Defense's lead laboratory for medical aspects of biological warfare defense. USAMRIID will evaluate the use of Emisphere's eligen(TM) technology to create oral vaccines against anthrax using a new recombinant protein antigen. Under the CRADA agreement, Emisphere will provide the USAMRIID's Fort Detrick site in Frederick, Maryland with oral formulations containing EMISPHERE® delivery agents and the recombinant Anthrax antigen. USAMRIID will conduct all in vivo experiments. The formulations will use Emisphere's eligen(TM) technology, a broad-based oral drug delivery technology platform that enables the transport of the therapeutic molecules across biological membranes, including the gastrointestinal tract, without altering their chemical form or biological integrity. USAMRIID has agreed to grant Emisphere an exclusive license to each U.S. patent application or issued patent as a result of the work performed under the CRADA. Should an oral Anthrax vaccine ultimately be developed, Emisphere would be eligible to receive royalties under a license agreement with the ultimate vaccine developer. Vivien Wong, Ph.D., Emisphere's Senior Director, Proof-of-Concept Studies, stated, "The initiation of oral vaccine proof-of-concept studies to defend Americans against the risk of Anthrax is a valuable addition to our proof-of-concept portfolio. For Emisphere, it broadens the application of our eligen(TM) technology to a new and important area of vaccines and infectious diseases. Furthermore, it allows us to exercise a global responsibility in the protection against bioterrorism agents. An oral dosage form will permit wider distribution and greater compliance of this important vaccine. We are pleased to be making a contribution to this program for the United States with the Medical Research Institute of the U.S. Army." About Emisphere's eligen(TM) Technology Emisphere's broad-based oral drug delivery technology platform, known as the eligen(TM) technology, is based on the use of proprietary, synthetic chemical compounds, known as EMISPHERE® delivery agents, or "carriers." These molecules enable the transport of the therapeutic macromolecules across biological membranes, such as the intestine. Emisphere's eligen(TM) technology makes it possible to orally deliver a therapeutic molecule without altering its chemical form or biological integrity. Earlier this week, Emisphere presented promising data at the June 2003 American Diabetes Association (ADA) annual meeting that came from two clinical trials evaluating a prototype of insulin using Emisphere's proprietary eligen(TM) technology. The insulin was orally administered to patients with type 2 diabetes. These were the only studies presented at the ADA this year highlighting the oral delivery of insulin enabled by a drug delivery agent that was evaluated for the potential treatment of type 2 diabetes. Results showed that the prototype developed by Emisphere for oral delivery demonstrated a therapeutic effect with a very fast onset of action. The studies highlight the effectiveness of Emisphere's eligen(TM) technology and support the prospect of an oral insulin product for use in both the early and later phases of diabetes. About Anthrax and Existing Anthrax Vaccines Anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. Anthrax most commonly occurs in wild and domestic lower vertebrates (cattle, sheep, goats, camels, antelopes, and other herbivores), but it can also occur in humans when they are exposed to infected animals or tissue from infected animals. When anthrax affects humans, it is usually due to an occupational exposure to infected animals or their products. Anthrax in wild livestock has occurred in the United States. The currently available anthrax vaccine is manufactured and distributed by BioPort, Corporation, Lansing, Michigan. The immunization consists of three subcutaneous injections given 2 weeks apart followed by three additional subcutaneous injections given at 6, 12, and 18 months. Annual booster injections of the vaccine are recommended thereafter. Mild local reactions occur in 30% of recipients and consist of slight tenderness and redness at the injection site. Severe local reactions are infrequent and consist of extensive swelling of the forearm in addition to the local reaction. Systemic reactions occur in a very small percentage of recipients. A recombinant derived vaccine would be a significant improvement in manufacturing quality and consistency.<< snip Cheers, Tuck