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Polygenetics, Inc. |
Business Model
Access to Polygenetics’ technology usually follows two steps:
1. Enter into a development/optimization program
2. Acquire an exclusive, world-wide license
1. Development/Optimization Program
Customer and Polygenetics agree upon milestones for the various drug products, then enter into a development program designed to optimize polymer performance for each drug. If results are satisfactory at the termination of the optimization period, the customer has the option to enter into an exclusive world-wide license.
The program involves Polygenetics producing interim samples that are sent to the customer for evaluation. Samples are evaluated by the customer and results reported to Polygenetics. Through an iterative process, products with desired properties are formulated.
Polygenetics expects to complete optimization within a few months and prepare cGMP materials for preliminary clinical trials by the end of the first twelve months. It is expected that preliminary clinical studies involving a few volunteers will commence early in the second year. Polygenetics will then adjust formulations as necessary in order to assure desired blood levels are reached.
Larger clinical trials are expected to begin before the end of the second year to demonstrate efficacy of the combination product. This would be followed by completion of cGMP protocols and technology transfer to Polygenetics’ customer or designated contract manufacturer.
2. Exclusive Licensing
Following development, Polygenetics will provide an exclusive, world-wide license. The licensing terms include payment of a license fee and payment of a minimum annual royalty to maintain exclusivity for the combination products. In addition, there may be additional payments to Polygenetics based upon agreed upon milestones. All technology is transferred to licensee and the license allows customer to make, have made, use and sell products developed under program.
Time to market
Polygenetics’ goal is to prepare cGMP materials during the first year of the program, and obtain preliminary clinical results at the beginning of the second year. Following further refinement of the formulations, larger clinical trials to demonstrate efficacy are expected to be completed during the second year. Polygenetics’ goal is to have combination products ready for marketing before the end of three years following commencement of the project.
Companies interested in discussing licensing opportunities should contact Dr. James Benson directly.