CORPORATE OVERVIEW
MANAGEMENT TEAM
BOARD OF DIRECTORS
SCIENTIFIC ADVISORY BOARD

Business Strategy

To lead in the discovery, development and commercialization of innovative and targeted radiotherapeutics and molecular imaging pharmaceuticals that improve disease detection, management and overall patient care. Our strategy is to build our product portfolio in each of these areas through our internal research efforts, use of our proprietary technologies and by acquiring or in-licensing complementary products and technologies.

We plan to take the following steps to implement our strategy:

  • Seek regulatory approval for Azedra, Onalta and Zemiva in the United States, and selectively in other countries. We have received Orphan Drug and Fast Track designation from the FDA for Azedra and are currently conducting a Phase 1 clinical trial and designing the Phase 1/2 trial protocols for Azedra. Onalta is a designated Orphan Drug that has previously completed Phase 2 trials and has been used in more than 300 patients. We are working with the FDA to develop a clinical development plan for Onalta. We have a Phase 2 clinical trial to develop our own Normals database for Zemiva underway that will be used as part of our pivotal registration trials and in the commercialization of Zemiva, if approved by the FDA and other regulatory bodies. Upon validation of our Normals database against the completed Phase 2 trial results, we plan to begin a U.S. multi-center pivotal registration clinical trial with Zemiva. If we achieve FDA approval, we would expect to license our products outside of the United States and may seek regulatory approval outside of the United States to support our licensing capabilities.

  • Develop our own specialty sales and marketing teams to market Azedra, Onalta and Zemiva in the United States. We intend to develop our own specialty sales and marketing team to market Azedra, Onalta and Zemiva in the United States. We plan to use our own sales and marketing team to market Azedra and Onalta outside of the United States and plan to establish one or more strategic collaborations to market Zemiva for non-U.S. markets.

  • Expand the indications for which Azedra and Onalta may be used, beginning with indications earlier in the treatment regimen and in additional neuroendocrine indications. We believe that Azedra and Onalta may offer significant therapeutic benefits in the treatment of metastatic neuroendocrine cancer. We plan to explore the use of these products earlier in the treatment regimen and in additional NET positive or somatostatin positive tumors such as breast, small cell lung, VIPomas, medullary thyroid, gastrinoma and glucagonoma tumors. We also plan to explore the use of Azedra and Onalta in combination with each other, various chemotherapy agents and anti-angiogenesis compounds, or compounds that work to prevent the formation or development of new blood vessels.

  • Expand the indications for which Zemiva may be used, beginning with indications in the non-acute settings. We believe that Zemiva may offer significant benefits over the current standard of care in the non-acute setting for the diagnosis of coronary disease. Our plan is to initiate a U.S. Phase 2 clinical trial for Zemiva in non-acute settings in the future in order to demonstrate significant throughput advantages of dual-isotope imaging with Zemiva. Following Phase 2 and Phase 3 clinical trials in the non-acute setting, we plan to file a supplemental new drug application, or sNDA, to include the use of Zemiva in the non-acute setting as an additional approved indication in the Zemiva NDA. We are also exploring the use of Zemiva in other indications such as the detection and monitoring of diabetes-related cardiac disease, microvascular cardiac disease in women, chronic kidney disease, heart failure and cardiomyopathy.

  • Advance the development of our preclinical product candidates. We have several early stage development programs which will expand our activity in molecular cardiology, oncology and neurology. These programs focus on novel approaches in target selection and the use of our technology platforms to provide innovative new product candidates.

  • Expand our product pipeline through our proprietary platform technologies, acquisitions and strategic licensing arrangements. We intend to leverage our proprietary platform technologies to grow our portfolio of product candidates for oncology, cardiology, neurology and other areas of unmet medical need. In addition, we intend to continue to in-license and acquire products, product candidates and technologies that are consistent with our research and development and business focus and strategies.

The documents contained in (or directly accessible from) this website include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about business strategy and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions. There are a number of important factors that could cause Molecular Insight Pharmaceuticals, Inc.'s actual results to differ materially from those indicated by such forward-looking statements, including the risk factors identified in the company's Registration Statement on Form S-1, as amended, and any subsequent annual or periodic reports filed with the SEC. The company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date such statement was first made.