smith & nephew - healthpoint

Smith and Nephew recently bought Healthpoint, based in Texas for $782 million. It’s a wound healing specialist company. It has a stable of goods, mainly a wound cleaning ointment treatment, Santyl which is their main product,( $70+ tube) and Regranex which is a growth factor etc delivery ointment (about $800 a tube and aimed at the foot/lower leg ulcer wound) which has warnings about possible malignancy issues (not recommended to use more than 3 tubes) and some studies that showed little benefit, though it is claimed for every 1 patient getting complete wound closure there are 7 who will using Regranex.

They are starting phase 3 trials with an ointment that has a Fibrin base, and suspended living cells of human keratinocytes and fibroblasts. It’s a 2 spray application. Their phase 2 trials showed good results compared to a Fibrin base only control. The fibrin base is a sealer and scaffold material which other factors can be added. Its been around for 25 years.
The trial subjects were from 18 years and above, had an ulcer for minimum 6 weeks to max 24 months. Wound size 2-12cm2.
“Approximately 70% of subjects in the active treatment group receiving the optimal observed dose achieved complete wound closure at 12 weeks compared with 46% in the fibrin control group,” “These findings underscore the importance of product design and cell delivery method to achieving wound closure, while also suggesting that, statistically, the odds of healing are 2.75 times greater for the cell-treated subjects compared to those receiving the fibrin matrix alone.”
(I can’t see the 2.75 times greater than the control, but I’m not a statistician.)
Best results obtained from 1 treatment every 2 weeks.

I note that the Vitrogro trial doesn’t mention use of a control group (which I now think odd and never picked up on that before) but that the group were those that had shown no sign of improvement after 4 weeks of best care. I calculate that the 46% in the Healthpoint trial who showed full healing would have showed improvement after 4 weeks and therefor would not have been eligible in a Vitrogro trial. Subtract that group from the 70% treatment group and you get 24% complete healing compared to the Vitrogro’s 36% complete closure. Then take into account the variations in age, length of ulcer time ( general difficulty) and it makes vitrogro look even better.

I am aware the above conjecture would be pulled apart and discredited, however there is no real way of comparing the 2 trials, except along the lines I suggest?

I had been concerned that this pipeline product mentioned earlier by a blog contributor may have been a variant of Vitrogro. Not so.

The results are impressive, but comparatively maybe Vitrogro has the edge, because of the ages of trial subjects, and wound difficulty comparison. With open age factor and prior difficulty of healing factors, and perhaps ulcer size (vitrogro trial average approx 7.5cm2) then the Vitrogro trial looks far more difficult.

Also I imagine/guess that the cost of the treatment will be well over $1000 per application x 3 for 6 week course. Vitrogro should have the financial edge. (Only based upon the cost of their Regranex.)

Also it was mentioned that it may be in market by 2017.(I don’t know why so long.) That gives vitrogro space to establish itself.

Smith and Nephew announced its acquisition after the results of the trial were announced. Healthpoint only generated 190 million in 2012, but they believe that going with S&N will triple that in 3 years.

One question is why didn’t S&N show more interest in TIS after its European trials were shown to be so good and TIS was looking for a partner. Especially as S Mercer is ex S&N.

If Vitrogro is as good as we are led to believe then there should still be a very bright future after this regulatory mess is sorted.