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Monday, November 10th at 4:30 p.m. (Eastern)
Accentia Strategy Update Webcast
About Accentia Biopharmaceuticals
Accentia is a biopharmaceutical company focused on commercialization of innovative products based on revolutionary discoveries in the field of immunology.
The company uses a three-factor analysis to determine which products to develop:
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1.New Formulations for Existing Therapeutics
We focus on the development and commercialization of already approved active pharmaceutical ingredients (APIs) in new formulations or for new indications with patent protection in order to create more clinically and economically valuable products. These kinds of opportunities often can access the less costly and less time-consuming 505(b)(2) regulatory pathway, which allows sponsors to reference prior publications and approvals of the active pharmaceutical ingredient albeit in different formulations.
By focusing on these kinds of product opportunities, Accentia believes that it can expand its product offerings with less risk, less expense, and less time than required for new chemical entities (NCEs), which must use the 505(b)(1)1 regulatory pathway. SinuNase, our novel formulation of the generic antifungal, amphotericin B, is a good example of this regulatory strategy.
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2.Targeted Therapeutics
By developing targeted therapeutics, we can potentially develop therapies with increased clinical efficacy and reduced toxicities. Examples of this include technologies like our patient-specific BiovaxID vaccine, which seeks to invoke an enduring immune response against Non-Hodgkin's lymphoma in a very precise and tumor-specific manner. By contrast, classic chemotherapy agents often seek to destroy tumors by targeting all rapidly-dividing cells, leading to high systemic toxicities and high "collateral damage" of the body's natural rapidly-dividing cells.
Likewise, SinuNase (Amphotericin B) for chronic rhinosinusitis supresses the inflammatory stimulus from fungi in the nose and sinus cavities without systemic administration thereby reducing the potential for unwanted systemic toxicities. By the simple delivery as a topical formulation, SinuNase is a targeted therapeutic, with reduced risk of toxicities because its active ingredient (Amphotericin B) is known to be very poorly absorbed across mucous membranes
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3. Identifying Paradigm Shifts: Disruptive Technologies
We seek to identify breakthrough opportunities wherein a small company can drive commercial value because if its products gain regulatory approval, they have little or no competition. These opportunities often arise from paradigm shifts in clinical science. Major paradigm shifts we identified led to products like Sinunase, which eliminates the fungus suspected to be the root cause of chronic rhinosinusitis. The BiovaxID vaccine for Non-Hodgkin's lymphoma is based on the revolutionary concept of inducing a powerful antitumor immune response to kill cancer cells (which normally evade immune detection) specifically while avoiding causing "collateral" damage to normal tissues. And Revimmune is based on the rebooting of the immune system in order to delete auto-immunity.
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