FAQs.

Frequently asked questions.

"Over the years, I have followed the progress of Rajiv Datar, PhD and have been impressed with his abilities to bring people and teams together to address bioproduct development and production issues and provide the necessary leadership. These skills should be particularly important as the Company develops strategies for bringing biobetter products to the market and I am very pleased to be associated with the company as a Member of its Board."

Dr. Pete Fernandes
Member of the Board,
DNX Biopharmaceuticals, Inc.

Frequently asked questions about DNX Biopharmaceuticals.

01. What is the difference between "Biobetters" and "Biosimilars"?

"Biobetters" are geared towards enhancing product safety and efficacy of innovator drugs, whereas "Biosimilars" (a.k.a. Follow-On Biologics) are essentially newly manufactured versions of formerly patent-protected biologics.

02. In what manner can biologics be modified to making them "Biobetters"? What are the potential developmental risks compared to Biosimilars?

Biobetters, which carry the same therapeutic indication and work on the same targets, are modified versions of the innovator molecule geared to enhancing efficacy and safety. These improvements can be achieved by more optimal product profiles such as, enhanced half-lives, better formulations or more convenient dosage forms, amongst several other possibilities, leading to increased market share, revenues and operating margins, along with potential patent protection.

Even though current dogma suggest that developmental risks should be lower for biosimilars, a more reasoned assessment would suggest that there could be real difficulties in demonstrating true fidelity of the biosimilar product compared to the innovator drug, and it is anticipated that in practice, Regulatory agencies will probably treat all follow-on (i.e. Biosimilar) type products as innovative medicines especially for early entrants.

03. Why are Biobetter drugs better positioned to provide enhanced revenues and higher operating margins than Biosimilar drugs?

Although it is generally believed that Biosimilars may offer a quicker path to market, since they could be approved through an abbreviated regulatory pathway, these products will necessarily end up competing with innovator drugs solely on the basis of costs. This fact alone could very well make these products less attractive especially when innovator drug companies can provide favorable reimbursement plans coupled with major discounts to reduce costs while still maintaining some level of profitability. The table below provides an illustrative example:

04. How has DNX positioned itself to creating "Better Biopharmaceuticals" for patients?

DNX Biopharmaceuticals, Inc is well positioned to develop and implement strategies to bring selected biobetters into the marketplace. Our approach is to carefully study market conditions and drug candidates, develop global strategies for market entries and work with technology companies, manufacturers and innovator companies to developing a rational approach to bring biobetter products into the marketplace. The DNX Team, with its Advisers, has more than 250 person-years of experience in biologics drug development and manufacturing, and can provide the necessary technical and business acumen to achieving success.