ITMN CC on Oritavancin Sept 20, 2001
Disclaimer: These are my notes from the CC. I have tried to get the info correct, but some of the language is mine. I have no science training and would welcome corrections if I have any of this wrong.
ITMN obtained world wide rights to Oritavancin by license from LLY bringing ITMN a big step closer to becoming one of the big 10 biotechs.
ITMN plans to file an NDA in 2003 and reach market a year later.
ITMN has 10 MD’s on staff, 4 of which are infectious disease trained.
Oritavancin is effective against gram positive infections and may work in a broad range of infections.
Oritavancin is bactericidal rather than just bacteria static, can be dosed once a day and may lead to shortened treatment periods.
Data from the 1st PIII is due 4Q01. A second PIII is due in 2H02 setting up an NDA filing by YE 2003.
Data from a PII in bacteroremia of the blood is due in 1Q02.
An alarming increase in drug resistance increases the need for Oritavancin.
Oritavancin fits with the infectious disease capability of ITMN.
The product can be marketed by a sales force of 100 in the US (similar in EU) since it is sold primarily to hospitals.
Oritavancin has sales potential of $300 to $500 million annually world wide.
Currently Vancomycin does $400 million and Zyvox + Cynercid do another $200 million. At 2nd generation pricing this is a $2 billion market. Zyvox and Cynercid each have problems, mylo suppression and venus inflamation often requiring pic line administration, respectively.
Oritavancin is more potent than Vancomycin.
Over all some $4 billion is spent annually on drug resistant disease costs suggesting that an effective, albeit more expensive drug could carve out a significant market.
The LLY deal will allow GM of 70% after COGS and royalties.
R&D expense will rise $25 million in 2002 and 2003 and a further $10 million in 2004.
Profitability of ITMN will be pushed back to mid 2004.
There will be a meeting for investors and Analysts at the Four Seasons Hotel in NY on 11/26/01.
Vancomycin is the gold standard in gram positive disease. Oritavancin is 1000 times more potent.
Over 1,000,000 patients get Vancomycin each year.
Vancomycin market is concentrated with 200 hospitals accounting for 75% of sales.
Oritavancin has a longer half life, taking longer to be distributed from the tissues that absorbed it. This can shorten treatment and increase potency. Further, this appears to be an advantage since it is combined with a good safety profile.
The market for this class of drug is US 30-35%, EU 30-35%, Japan 20% and the rest of the world 10-20%.
In 4Q the company will double the sales force.
Oritavancin MOA:
- binds to the same target as Vancomycin
- inhibits cell wall synthesis
- binds to Vancomycin resistant cells
- forms dimers when binding [strong connection?]
- inhibits enzymes
- dimers were discussed at the last ICAAC
- safety has been quite good
LLY licensed the drug because they have 10-12 late stage drugs that they wish to leverage their resources on and they believe in ITMN’s ability to move this drug forward.
ITMN believes Oritavancin will be a premium product that can be priced accordingly.
They will present data on cryptococal meningitis at ICAAC. |
