#MTFB - LSE
#MTFBF - NASDAQ
What has happened?
So the long awaited Phase 3 "REVIVE 1" results came out comparing the drug Iclaprim vs the standard of care drug Vancomycin. It proved it was non-inferior. In fact it did everything the FDA wanted and they had a major hand in designing the trial. There were also no safety concerns at all.
This has now completely derisked the entire enterprise. This was the last big "what if?" in the pathway to a new drug.
What still has to happen?
There is currently a carbon copy of REVIVE 1 running, REVIVE2. This is how the FDA wanted it. Given how good the REVIVE 1 results are the chance of success of REVIVE 2 is 95%+
They do need around $10mill further funds to complete REVIVE 2 but this will come at a big premium to the current SP mark my words.
Once REVIVE 2 is out in early Half 2 2017 then they can submit a New Drug Application to the FDA. This is a given. It will be passed. The FDA want this drug in use ASAP.
So as i type the SP is 33.5p with an MCap of £67mill
Cempra Inc. Nasdaq CEMP - got to an MCap of £700mill at the same stage Motif is now. Its had a string of bad news but still valued at £196mill!
Paratek. Nasdaq PRTK - had phase 3 read out of an antibiotic recently and is now valued at £600mill! This is probably the best comparison. Factor in a little discount for REVIVE 2 to finish but you'd still think MTFB is x5 undervalued.
How much money will Iclaprim make?
The ASSSI - skin infections market in the USA alone is around 4mill people a year. Around 25% of these people have good going kidney failure which Vancomycin is a TERRIBLE drug for. The obvious switch is to Iclapim. At $3500 a course the low hanging fruit is 3500 x 1000000 = $3.5billion revenues a year in the USA alone for ASSSI with kidney disease. Add in the rest of the world and creeping into non kidney disease patients...
Any other uses?
Yes there is! Iclaprim concentrates in the lungs and is very potent against a nasty hospital acquired chest infection, strep pneumoniae. Its about to undergo Phase 3 trials for this too and potentially double its revenue stream!
TAKE HOME MESSAGES
1) Completely derisked. Likelihood of becoming a drug now over 95%
2) To achieve parity to US peers it needs to rise 500-1000%
3) Peak year revenue for skin infections alone will be over $1billion
4) This may double with use in Hospital Acquired Pneumonia.
Target price remains norther of the FinnCap report of 125p