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

To: nigel bates who wrote (2668)	1/24/2001 9:23:48 AM
From: Ian@SI	Read Replies (1) \| Respond to of 52153

Another IND for EMIS - Low molecular weight heparin tablets. To me, it seems that the market potential for oral versions of injectable drugs is absolutely huge. EMIS is about to start clinical trials for Oral insulin. Am I being overly optimistic? ... or is there really a diamond in the rough here? Thanks in advance, Ian. +++++++++++++++++++ Emisphere Files IND to Begin Clinical Testing of Heparin Tablets Utilizing Second Generation Oral Drug Delivery Technology TARRYTOWN, N.Y., Jan 24, 2001 /PRNewswire via COMTEX/ -- Emisphere Technologies, Inc. (Nasdaq: EMIS) today announced it has submitted an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to commence human clinical testing of oral heparin tablets utilizing its improved delivery agent, Sodium N[10-(2 hydroxybenzoyl)amino] decanote (SNAD). SNAD is currently intended to be Emisphere's drug delivery agent for solid dosage formulations of heparin and low molecular weight heparin (LMWH). SNAD is an improved version of Emisphere's delivery agent, Sodium N-[8-(2-hydroxybenzoyl)amino] caprylate (SNAC), currently in Phase III development with an oral solution formulation of heparin. In preclinical evaluations, results have indicated SNAD to be significantly more potent when compared to SNAC, with a comparable safety profile. Most recently, a study published in the April 25, 2000 issue of "The Annals of Surgery" demonstrated that SNAD facilitated the gastrointestinal absorption of LMWH. Specifically, upon comparing thrombi (blood clots) in four animal groups (control group vs. SNAD/LMWH, SNAD only, and LMWH only), investigators found the blood clots in the animals receiving the SNAD/LMWH formulation were almost completely dissolved. Michael M. Goldberg, M.D., Chairman and Chief Executive Officer of Emisphere Technologies commented, "Over the last few years, we have expanded our research and development capabilities. The results of these efforts are reflected in the development of SNAD, which represents the first time we have taken a carrier from discovery to final dosage form on our own. This achievement also exemplifies our research objective of enhancing our drug delivery agents by applying standard formulation processes and drug delivery technologies to produce more effective product candidates without comprising their safety." 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. Therapy typically consists of approximately one to two weeks of injectable LMWH, followed by 90 to 180 days of warfarin. 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 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, including a solid oral dosage formulation of heparin, 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.