Opportunities at Noven

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Transdermal drug delivery is a compelling product line-extension or life-extension strategy.
It also has a highly favorable risk-reward profile.

Product-Line and Product-Life Extension
Actual time-to-market can be as short as three years, with development costs of $10-$15 million. The U.S. clinical development program may follow the 505(b)(2) NDA filing route, or a similar route overseas, that permits accelerated development for drugs with an already established safety and efficacy profile. The following diagram maps the path, costs and timeline for accelerated development.

Accelerated Transdermal Drug Development Program

Financial Return
Transdermal drug delivery can be highly rewarding with a favorable risk/return profile. The graph below illustrates the relationship between expected peak annual sales performance and estimated rates of return for a hypothetical transdermal product based on the following assumptions:

•	Four years to market from start of pre-clinical feasibility;
•	70-80% probability of success;
•	$10-$15 million cost of development;
•	Peak annual sales in the fourth year after launch;
•	50% pre-tax profit margin;
•	Ten years of sales (no residual value); and
•	IRR is calculated before profit sharing with partners.

As illustrated, the internal rate of return (IRR) on investment (after adjustment for success probability) is estimated to range from 139% to 155% if the product achieves peak annual sales of $500 million, and an estimated IRR range of 49% to 59% if the product achieves peak annual sales of $50 million.

For additional information, contact Noven Business Development.