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Overview

Statement of Strategy

Emisphere Technologies, Inc. is a biopharmaceutical company that focuses on the commercialization of its own product candidates using its Eligen® Technology, a unique and improved delivery of therapeutic molecules.

Our core business strategy is to commercialize the Eligen Technology through the launch of Oral Eligen B12 globally, grow our delivery systems business through new and enhanced strategic alliances and reprioritize our product pipeline.

Strategic Initiatives

We will create new value for the Company and its shareholders by realizing improvements in healthcare through the following strategic initiatives:

  • launching our high-dose oral Eligen® B12 product in the United States
  • commercializing oral Eligen® B12 globally through strategic alliances
  • seeking or developing new prescription Medical Food  or NDA commercial opportunities where the Eligen® technology can improve the delivery, efficacy or treatment outcome
  • expanding upon existing delivery systems partnerships (such as Novo Nordisk’s development of an oral GLP-1 analog)
  • building new high-value development and commercial partnerships
  • seeking and promoting new uses for the Eligen® technology such as improving delivery of emerging peptides, pegylated peptides, proteins, biologics, and certain new small molecules

Product Commercialization

The Company has developed a high dose oral formulation of Eligen® B12 (1000 mcg) for use by documented B12 deficient individuals. During the fourth quarter 2010, the Company completed a clinical trial which demonstrated that both oral Eligen® B12 (1000 mcg) and injectable B12 (current standard of care) can efficiently and quickly restore normal Vitamin B12 levels in deficient individuals. The manuscript summarizing the results from that clinical trial was published in the July 2011 edition of the journal Clinical Therapeutics (Volume 22, pages 934 — 945). We also conducted market research to help assess the potential commercial opportunity for our potential Eligen® B12 (1000 mcg) product. On August 5, 2011, we received notice from the United States Patent Office that the U.S. patent application directed to the oral Eligen® B12 formulation was allowed. This new patent (US 8,022,048) provides intellectual property protection for Eligen® B12 through approximately October 2029. Currently, we are evaluating the results of our clinical trials and market research and exploring alternative development and commercialization options with the purpose of maximizing the commercial and health benefits potential of our Eligen® B12 asset.

The Company also has other product candidates in development in earlier or preclinical research phases and we continue to assess them for their compatibility with our technology and market needs. Our intent is to seek partnerships with pharmaceutical and biotechnology companies for certain of these products. We plan to expand our pipeline with product candidates that demonstrate significant opportunities for growth.


The Delivery Systems Business: Potential Application of the Eligen® Technology

The Eligen® drug delivery technology can be applied to molecules that are currently available or are under development. Such molecules are usually delivered by injection; in many cases, their benefits are limited due to poor bioavailability, slow onset of action or variable absorption. In those cases, our technology may increase the benefit of the therapy by improving bioavailability or absorption or by decreasing time to onset of action. The Eligen® Technology can be applied to the oral route of administration as well other delivery pathways, such as buccal, rectal, inhalation, intra-vaginal or transdermal. The Eligen® Technology can make it possible to deliver certain therapeutic molecules orally without altering their chemical form or biological activity. Eligen® delivery agents, or “carriers”, facilitate or enable the transport of therapeutic molecules across the mucous membranes of the gastrointestinal tract, to reach the tissues of the body where they can exert their intended pharmacological effect. Our development efforts are conducted internally or in collaboration with corporate development partners. Typically, the drugs that we target are at an advanced stage of development, or have already received regulatory approval, and are currently available on the market.

We believe that the Eligen® drug delivery technology is well suited to facilitate the safe and effective oral absorption of emerging peptides and biologics products that are typically only available as injectibles or are currently under development. We believe that these products represent tremendous promise for realizing improvements in healthcare and growth in the industry.



Company Highlights
  • Novo Nordisk A/S is continuing Phase I trials of an oral formulation of their proprietary GLP-1 analogue using Eligen® Technology for the treatment of Type 2 Diabetes. They have also begun work with Eligen® Technology on oral insulin for the treatment of Type 1 and Type 2 diabetes

  • Emisphere Technologies, Inc. conducted a clinical trial that demonstrated an oral formulation of B12 using our Eligen® Technology repleted B12 levels in deficient patients

  • Broad product pipeline from pre-clinical to commercially viable opportunities

  • Pharmaceutical and nutritional supplement programs address large target markets

Key Pipeline Products
  • Oral GLP-1 analogues for the treatment of Type 2 Diabetes

    » Development Partner: Novo Nordisk

  • Oral Insulin for the treatment of Type 2 Diabetes

    » Development Partner: Novo Nordisk

  • Oral Eligen® Vitamin B12 A clinical trial demonstrated that oral Eligen® B12 (1000 mcg) can restore normal Vitamin B12 levels in deficient individuals. The manuscripts summarizing the results have been published in the March and July 2011 issues of the journal Clinical Therapeutics (Castelli et al, Clin Thera, 33(3),358-371; Castelli et al, Clin Thera, 33(7),934-945). Emisphere is exploring alternative development and commercialization options with the purpose of maximizing the commercial and health benefits potential of the Eligen® B12 asset.


Eligen® Advantages
  • Safety demonstrated in thousands of trial participants over the last 20 years

  • Broadly applicable to diverse group of drug molecules (e.g., proteins, peptides and other poorly absorbed compounds) and nutritional supplements

  • Stand-alone delivery approach does not rely on the addition of agents that can have adverse effects on the intestinal membranes or digestion process (e.g., penetration enhancers or enzyme inhibitors)

  • Versatility of formulation, including oral solutions, tablets and capsules, as well as rectal, inhalation, intravaginal administration

  • Ease of manufacture, as the technology and manufacturing equipment required to produce the Eligen® delivery agent material in commercial quantities is readily available



For further information contact:
Michael R. Garone, CFO and Corporate Secretary
973.532.8005 or mgarone@emisphere.com



Any statements relating to matters that are not historical facts involve risks and uncertainties. For an explanation of risks and uncertainties that may affect Emisphere’s business please refer to Emisphere's periodic reports on Forms 10K, 10Q and 8K filed with the SEC.


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