Business Applications

Tactically, the Company’s business strategy is focused on maximizing the economic value of its PSN technology platform in three specific ways:

  1. Reformulating marketed products. Azaya has identified several widely marketed chemotherapy drugs that it believes can be made safer and more effective with its PSN technology. The patents on these drugs are either expired or are scheduled to expire within the next 1-5 years, but when these drugs are reformulated and developed with Azaya’s technology they will be eligible for new patent protection.

    The new patent protection, improved efficacy, and reduced side effects provides an opportunity to make these reformulated drugs both economically viable products for Azaya to take to the oncology market and attractive acquisition candidates for established companies. Since these products must go through a 4+ year clinical development process to obtain FDA approval before they can be marketed and sold, the Company will also explore partnering opportunities with established biopharmaceutical companies to fund certain of the development costs associated with the FDA approval process at an appropriate time.

    Azaya’s lead product candidate ATI-1123 is a PSN-based reformulation of Taxotere (docetaxel), one of the leading chemotherapeutics with worldwide sales of $2.0+ billion per year. Taxotere, commonly used for the treatment of breast, lung, prostate, stomach and other cancers, causes side effects such as nausea, fatigue and anemia when delivered in its current form due to both the need for high dose levels and the problematic method of delivery using a toxic carrier. Taxotere comes off patent in 2010/2011.

    Azaya’s initial preclinical studies involving human tumor xenografts in mice have demonstrated that ATI-1123 enables delivery of docetaxel at almost twice the maximum tolerated dose of the FDA approved formulation of docetaxel and with substantially improved anti-tumor activity in some models. The PK study demonstrated a significantly enhanced profile for ATI-1123, compared to docetaxel, which provides a sound rationale for the demonstrated improved anti-tumor activity.

    The Company intends to advance this lead candidate formulation through Phase I clinical trials, and then will explore raising additional capital or seeking a co-development partner to complete the clinical development and bring it to market.

    Going forward the Company will continue to screen for other marketed chemotherapy products that it believes can be made safer and more effective with its PSN technology.

  2. Developing new chemotherapy products. The Company has identified several compounds with significant anti-tumor activity, which have not been developed due to their high toxicity and/or their water insolubility. As funds become available, Azaya intends to encapsulate these compounds utilizing its PSN technology for development as novel chemotherapy agents.
  3. Licensing the technology. The Company intends to develop a strategic licensing relationship with a drug delivery company(s) to enable the use of its PSN technology by licensing it to third party biopharmaceutical companies. Azaya has identified multiple companies with drug compounds who are licensing candidates for its PSN technology platform. Azaya anticipates that Azaya and its prospective licensing partner will work together with these companies to reformulate and/or encapsulate their products into nanoparticle sized liposomes and complete the necessary preclinical studies to establish proof of principle. If successful, then Azaya will license its technology to the company that owns the compounds. Such licensing agreements would be restricted to the single compound and could bring revenue to Azaya in a shorter timeline than Azaya reformulating or developing its own products.