Emphascience, Inc.

Strategy & Innovation

Emphascience designs novel, non-infringing formulations of approved drug products and licenses them to marketing partners for commercialization.

Overview

For Emphascience, business strategy and innovation are all about making fact-based, well-informed queries into the realms of healthcare and science. The strategic process begins with defining unmet needs from the perspective of the patient, the healthcare provider, or the manufacturer of the medicine, and then moves on to understanding molecular properties and designing the environment necessary to ‘optimize’ the physical, chemical, pharmacokinetic and pharmacological ‘personalities’ of the products. We take a disciplined approach to develop our understanding and build platforms that have wider applications, making choices that create long-term value for our shareholders.

Since the drugs being redesigned by Emphascience have already been approved for marketing by the respective regulatory agencies and, in many cases, have been in use, the risks and costs of development are significantly lower than discovering a new drug. Also, due to an increasing understanding of overlapping biochemical pathways and their roles in diseases that are more interconnected than ever imagined before, newer dosage forms and increased flexibility of dosing uncover the possibility of extending the pharmacological applications of known drugs. This would mean creating new therapies with tested methods. New drugs. New medicines. But safer, well understood mechanisms.

 

Filing Strategy

In the United States, typical reformulated products as designed by Emphascience are covered under section 505(b)(2) of the Food, Drug and Cosmetic Act and may be submitted as a New Drug Application (NDA) to the Food and Drug Administration (FDA). Just as the generic equivalent of a marketed product can be approved simply on the basis of bioequivalence and appropriate controls on chemistry and manufacturing without the need for clinical evidence of effectiveness and safety, the Drug Price Competition and Patent Term Restoration Act of 1984 also allows the FDA to approve a 505(b)(2) NDA based on data that may already be available (to the Agency) but not generated by the applicant. Unlike generic products, however, the products being developed by Emphascience are designed to be different and arguably better, thereby offering brand differentiation in the market and better products to those who use them.