1. Yes this “repatenting" strategy has been used before - a good example of this is CPX-351 (Vyxeos) which is just two old generic drugs (doxorubicin and ara-c) in a liposome. This was sold to Jazz for around US$2 billion.
2. Yes this is correct and is one of the major reasons we continue to spend resources on developing and patenting new IP around manufacturing, formulation and use. Of course it is possible that someone will work around our patents, but in someways this is self defeating. As a pharma company you want exclusivity, not a price war. What can prevent this from even being considered as an option is orphan drug designation.
3. Orphan drug designation provides 7 years post approval (i.e. after you start selling) exclusivity (even if you have no patent what so ever) in the USA and 10 years in the EU. By pursuing a rapid path to approval in an orphan indication (AML) we can head off anyone even attempting to try and work around our patents as they would be locked out of selling the drug for 7 to 10 years. If you couldn’t sell a drug for 10 years why would you expend money and effort on trying to make Bisantrene?
Ultimately I see the competition coming from completely new FTO inhibitors. The real value of Bisantrene is the huge amount of clinical data (and manufacturing) we have that gives us a jump on all the new FTO inhibitors that will be developed. Just like was seen with Keytruda, being first can give you a really strong market position even when faced with lots of competition (there are now 7 different anti-PD-1/PD-L1 drugs on the market). Keyruda doesn’t sell $10s of billion a year because it is the only choice, but because clinicians are familiar with it.
RAC Price at posting:
$3.87 Sentiment: Buy Disclosure: Held
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