Proprietary products are central to TransForm’s value creation strategy. TransForm has already begun to leverage its novel technologies to market products with significant commercial potential with our “Platforms to Products” (P2P) effort. Our P2P opportunities have come from, and will continue to come from, several different sources:
| Building TPI’s Product Pipeline
|
|||
| 2002 2003 2004 2005 | |||
| Improved marketed products | |||
| Products from internal capabilities | |||
| In-licensing/M&A | |||
| “Bricks” from pharma pipelines | |||
| Proprietary enhancement of marketed compounds, through identification of new forms/formulations that potentially either fix known problems with the drug, or may enable new indications, dosing schedules, delivery systems or combination therapies | |
| Salvaging product candidates belonging to our pharma partners, and thought to be “undevelopable” due to their poor solubility (“bricks”) | |
| In-licensing product candidates with “development issues,” to the extent that we believe our technologies will uniquely enable us to overcome them | |
| Products emerging from partnered platform development projects (such as our partnership with ALZA, under which we have the right to leverage our high-throughput transdermal formulations platform to explore and develop our own proprietary transdermal products) |
We are actively working on the first set of product opportunities, and have identified eight major, marketed products that appear attractive. Of this first set of opportunities, we have advanced 4 candidates with proprietary, improved forms/formulations into animal trials, with promising results. Our goal is to file our 1st IND in early 2004 and to continue to build a broad pipeline of new product opportunities. We intend to pursue some of these proprietary enhancements on our own, and some in conjunction with the original innovators.
Improving Marketed Products:
We have had great initial success with our P2P effort. We have already demonstrated that there are meaningful opportunities to improve marketed products that have deficiencies or could benefit greatly by optimizing their form and/or formulation. Below are some examples of work we have done on several major marketed products:
| Therapeutic Area | Goal | TransForm Impact |
| Oncology* | Better IV formulation | Replaced undesirable excipient |
| CNS* | Better form for new indication | 100X solubility; faster onset |
| Surgical* | Replace IV emulsion | Replaced emulsion; lower COGS |
| Anti- infective |
Better form/formulation | Form: 50X solubility Formulation: 3X solubility |
| Pain management* | Better form/formulation | Faster onset & 2X better bioavailability |
*Additional indication possible
Our goal is to put two compounds into human clinical trials by the end of 2004. Building a robust pipeline normally requires a significant investment. However, because our initial efforts will start with marketed products, the timing, cost, risk and regulatory complexity of developing our proprietary products are all considerably lower than would be the case for a new chemical entity. We are also able to evaluate new product opportunities rapidly, through internal feasibility work that can often be completed in a matter of weeks at a low cost. This approach lends great flexibility and lower risk to our product development efforts.