We are a clinical stage, specialty pharmaceutical company focused on developing drug candidates for “orphan” oncology indications that potentially address areas of high unmet medical need in the treatment of cancer. Our strategy is to acquire late-stage compounds to pursue a lower cost and accelerated development pathway. By definition, late-stage compounds on average have lower development risk and shorter development timelines compared to early-stage compounds, and thus this strategy is intended to reduce overall clinical development risks and timelines. Additional investment to develop these drug candidates can potentially lead to swifter approval and their clinical application.
We leverage our considerable industry experience, oncology therapeutics knowledge and development expertise to identify, develop and commercialize product candidates that we believe have strong market potential and that can fulfill unmet medical needs in the treatment of cancer. Our highly experienced pharmaceutical business and drug development leadership team provides a significant competitive advantage in designing highly efficient clinical programs. Our substantial intellectual property and “orphan drug designations” in the United States and Europe maximizes market exclusivity.
Our general regulatory strategy is to pursue the fastest pathway to approval of our candidate with the highest probability of success, regardless of patient population (i.e., market size). We will work closely and cooperatively with the FDA at every stage of development, and in post approval. We intend to take full advantage of the services and assistance offered through the FDA’s Office of Orphan Products Development and the FDA’s small business program.
Our drug programs are currently in development and have not been approved for marketing and patient use. In the event our drug programs ultimately receive regulatory approval, we will evaluate the economics of marketing our own products versus licensing and other third-party arrangements for marketing and distribution in the United States. In other markets, our strategy is to seek marketing and distribution partners for our products, and to share development costs. To date, we have secured marketing partners in South Korea and Israel for glufosfamide, and in China for ILC.