Strategy

ITI is a fully integrated specialty pharmaceutical company with expertise spanning the entire product development cycle. Our business strategy is designed to combine our technology and expertise to develop new and differentiated products that fit unmet medical needs in the marketplace:

A Fully Integrated Specialty Pharmaceutical Company

Product Concept and Identification

Based on extensive market research, including interviews with health care professionals, we have prioritized our portfolio, strategic direction and positioning for each product. We will continue to combine market research and nasal formulation expertise to identify and prioritize development candidates. In addition to working with off-patent drugs, we will partner with other pharmaceutical and biotechnology companies to develop alternative delivery systems for existing patented drugs and potentially new chemical entities.

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Formulation Science

We are focusing on aseptic, patent-protected nasally-delivered medication to treat diseases and medical conditions. Much of our research has been conducted in collaboration with the University of Kentucky, a leading U.S. nasal research institution. Our products do not contain preservatives, which can affect a drug’s shelf-life, toxicity and stability and cause side effects such as irritation and allergic reactions. The trend in the global pharmaceutical industry is to discourage, or ban, preservatives in nasal products.

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Delivery Systems

We will utilize a variety of proprietary and commercially available delivery systems to design, customize and match nasal spray systems and formulae to develop products which will result in superior therapeutic outcomes. Initially, we have chosen to use unit and bi-dose devices from a leading delivery device supplier with whom we have a market exclusivity agreement. In addition, ITI has exclusive worldwide rights to a multiple unit dose nasal spray device designed by the University of Kentucky.

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Clinical and Regulatory Development

Our in-house clinical and regulatory research staff manages the spectrum of clinical and regulatory requirements in consultation with key medical opinion leaders and contract research organizations.

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Manufacturing

ITI is capable of supplying clinical trial materials for early studies and will then utilize a contract manufacturing organization, or partner companies facilities for registrational and commerical batches.

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Commercialization

Direct-Marketed Products

Direct-marketed products are developed through New Drug Application (NDA) filings and approval by the Food and Drug Administration (FDA), and then taken directly to market with our own sales force.

Partner-Marketed Products

Internal products will be developed through Phase II clinical trials and out-licensed for late stage clinical development and marketing. Partner-funded products are partners’ drugs in R&D programs to which we will apply our formulation technology, clinical development and manufacturing capabilities.

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