Strategy

ITI is a specialty pharmaceutical company that integrates life science expertise across 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 patients and health care professionals, we prioritize our portfolio objectives, strategic direction and positioning for each product. We continue to combine market research and development 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.

 

Formulation Science

Our lead product programs focusing on nasally-delivered medication to treat specific diseases and medical conditions. Much of our early research has been conducted in collaboration with the University of Kentucky, a leading U.S. nasal research institution.

Our lead products are in unit dose nasal sprays which offer patients ease of use in a convenient dosage form. These products have pending US and internation patents covering the formulations.

 

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 proven commercialized unit dose devices from a leading delivery device supplier. This represents a low risk option since one wants to decouple the risk of drug development with device development.

The unit dose embodiment is ideally suited to the patient needs of the therapy since it can be quickly and easily administered by a patient or caregiver.

 

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.

 

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 late phase clinical and registration stability and commerical supply. A leading CRO has been qualified for use.

 

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. Typically, these take advantage of existing clinical and regulatory experience with known off-patent molecules to reduce development timelines, cost and risk.

Partner-Marketed Products

Products may be developed through Phase II clinical trials and out-licensed or partnered 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.