|
|
|
|
|
|
|
downstreaming Rx to over-the-counter (OTC) products: |
|
|
|
 |
|
|
|
|
In some therapeutic areas, it may be appropriate to move Rx drugs to OTC products. There are some obvious merits to this for medicines whose safety has been well established. For conditions which are well self-diagnosed by the patient, availability of the OTC product avoids unnecessary prescribing intervention by the doctor and permits quicker access to the medicine. |
|
|
|
|
|
|
|
|
plans for the post patent period: |
|
|
|
|
|
|
|
|
Exclusivity is the key factor underpinning the commercial opportunity for a drug. This may derive from a variety of patents on the drug substance itself, process patents on its manufacture, and patents on its use in particular indications and dosage forms. It may also depend on regulatory exclusivity. Commodity market dynamics rapidly follow loss of exclusivity. Decisions will be needed well before patent expiration on whether to compete in the generic market and how this will be implemented. The generic market is a very different market. Taking a Darwinian perspective, the traits that make a drug company a good discoverer, developer, and marketeer of new drugs are not the same traits as those for survival in the generic market. In recognizing this dilemma, some major companies therefore, have set up separate generic subsidiaries. |
|
|
|
|
|
|
|
|
III.
Drug Development as a Business |
|
|
|
|
|
|
|
|
Drug development is an investment at risk. The cost of development increases with each development phase. The investment should be reviewed at each key checkpoint in development and should be justified based on the data available. |
|
|
|
|
|
|
|
|
A.
Projects as Investment Opportunities. |
|
|
|
|
|
|
|
|
Drug development requires the investment of substantial money and resources over a significant time period before the launch of the product and the possibility of revenue return. The investment opportunity must be evaluated competently. |
|
|
|
|
|
|
|
|
Generic probability of success rates at each phase of development are known, and, unless there are very strong project reasons not to do so, generic probabilities should be used (teams invariably overestimate the chance of success for their project!) Financial analysis can materially help teams in selecting best strategies by providing a basic pivot of project value around which other project parameters can be rotated. |
|
|
|
|
|