There's been a little bit of buzz from the NSM about Plasmin and B+L's hopes on this being the secret weapon in the pipeline. Is Plasmin the magic bullet to be that "non-steroid steroid" and reduce inflammation while having very few adverse events? In short, probably not. Here's why:
1) B+L has licensed Plasmin technology from Bayer in January 2005 for ophthalmic use. It's now 2011 and there is still yet to be announced a successful phased trial and a market launch date.
2) Mechanism of Action: Plasmin is the protease responsible for cleaving fibrinogen and fibrin at focal contact zones. Neovascularization was shown with uPA (a type of plasmin) in rabbit corneas. The vascular response could possibly decrease the possibility of stromal ulceration. Remember home study, kids? The stroma layer is deep. That means that if this piece of junk makes it to market that they may be trying to obtain a funky indication. It doesn't mean that plasmin will replace a steroid, it's a different animal.
3) Possible indication: Epithelial defects and stromal ulceration...meaning it could work in areas where a steroid is contraindicated. Like corena ulcers or maybe somewhere else off label. The good news is you will have something novel for eye doctors. The bad news is that corneal ulcers are tricky (sterile/bacterial/viral/fungal, considered an emergency, etc.). More proven therapies are being used for this very threatening condition and plasmin may be an insignificant piece of the puzzle. B+L will need some major and unbiased white papers to prove the corneal-protective properties that plasmin can offer, assuming that is a possible indication.
4) Isn't this Zirgan territory? Well, you know how large the herpetic keratitis market is (or isn't). Doctors were stoked because B+L did something none of the big pharma companies were stupid enough to do: invest millions in a market that is so small that your drug will go off patent before you turn a profit. Think of Plasmin as trying to get a piece of this already small and pathetic marketplace. If you're a salesperson, this is not a good scenario. Zirgan is not exactly what we call a blockbuster drug.
5) Time and Cost. Figuring that Bayer patented the plasmin technology in 2003-04 and B+L is still tinkering with the molecule in 2011...approximately 8 years will have expired on the patent life leaving you somewhere with 10 years left to turn a profit. This can mean a few things in the marketplace: #1: The cost is going to be high to make up for lost time, #2) High cost will exclude this drug from many formularies, #3) The demand may be low for an unproven and novel new product that may only offer small benefits in an even smaller marketplace. The cost versus benefit for the patient may be a deciding factor for many would-be prescribers, #4) Given B+L's past push of Besi and Zirgan on the reps you can expect more unrealistic goals and even more turnover
In short, Plasmin may not be anything to herald. It may be something to fear.
1) B+L has licensed Plasmin technology from Bayer in January 2005 for ophthalmic use. It's now 2011 and there is still yet to be announced a successful phased trial and a market launch date.
2) Mechanism of Action: Plasmin is the protease responsible for cleaving fibrinogen and fibrin at focal contact zones. Neovascularization was shown with uPA (a type of plasmin) in rabbit corneas. The vascular response could possibly decrease the possibility of stromal ulceration. Remember home study, kids? The stroma layer is deep. That means that if this piece of junk makes it to market that they may be trying to obtain a funky indication. It doesn't mean that plasmin will replace a steroid, it's a different animal.
3) Possible indication: Epithelial defects and stromal ulceration...meaning it could work in areas where a steroid is contraindicated. Like corena ulcers or maybe somewhere else off label. The good news is you will have something novel for eye doctors. The bad news is that corneal ulcers are tricky (sterile/bacterial/viral/fungal, considered an emergency, etc.). More proven therapies are being used for this very threatening condition and plasmin may be an insignificant piece of the puzzle. B+L will need some major and unbiased white papers to prove the corneal-protective properties that plasmin can offer, assuming that is a possible indication.
4) Isn't this Zirgan territory? Well, you know how large the herpetic keratitis market is (or isn't). Doctors were stoked because B+L did something none of the big pharma companies were stupid enough to do: invest millions in a market that is so small that your drug will go off patent before you turn a profit. Think of Plasmin as trying to get a piece of this already small and pathetic marketplace. If you're a salesperson, this is not a good scenario. Zirgan is not exactly what we call a blockbuster drug.
5) Time and Cost. Figuring that Bayer patented the plasmin technology in 2003-04 and B+L is still tinkering with the molecule in 2011...approximately 8 years will have expired on the patent life leaving you somewhere with 10 years left to turn a profit. This can mean a few things in the marketplace: #1: The cost is going to be high to make up for lost time, #2) High cost will exclude this drug from many formularies, #3) The demand may be low for an unproven and novel new product that may only offer small benefits in an even smaller marketplace. The cost versus benefit for the patient may be a deciding factor for many would-be prescribers, #4) Given B+L's past push of Besi and Zirgan on the reps you can expect more unrealistic goals and even more turnover
In short, Plasmin may not be anything to herald. It may be something to fear.