I did some research, found out that the active ingredient used in Ceplene in combination with IL-2 for AML is just a OTC drug (aka - considered a counter irritant).............so there is no patent protection..............tis stock wont go up beyond what it is now........
Looks like someone needs a very fundamental primer on pharmaceuticals in general.
You essentially asked: 'what's the big deal, I can order this stuff up from a high school scientific supply catalog?'
So let me ask the question in a different way: What's to keep any old physician from ordering any compound he wants from a catalog and administering to a patient?
The answer to both is the same: THE LAW
In order to administer ANY drug, it must be approved. That means its dosage, its formulation, its manufacturing, its prescribing and administration protocols, etc etc etc.
And the company that identifies that compound and performs the required research and demonstrates its efficacy and safety for that particular indication, and in this case for an orphan drug, obtains market exclusivity.
Simple as that. It is the law. God forbid the day we have highschool chemistry teachers cooking up meds in their lab and selling it on the street corners. (Which is essence is what you were implying.)
The active ingredient in Ceplene is histamine dihydrochloride. The compound is not available OTC either in Europe or in the US . There are no known sources of supply of pharmaceutical-quality histamine other than ours. The compound is protected by worldwide-wide patents covering its use and certain elements of the manufacturing process. Protection is also available to the compound via its orphan drug designation both in the US and Europe , which guarantees marketing exclusivity for 7 and 10 years, respectivity, after approval.