- Optimer Pharma presented 9/7 at the Robert W Baird Healthcare Conference - get the full schedule of biotech webcasts and links to my notes here.
- More detailed info on OPTR pipeline, etc can be found here.
- See below for my notes from the webcast:
- We are now in the second month of Dificid launch and everything is going according to plan
- Dificid (fidaxomycin) was the first product approved for C. difficile associated diarrhea (CDAD) in 25 years
- CDAD has passed MRSA as most common cause of hospital-acquired infections
- Once you have a recurrence, you are 40% more likely to recur again. If recur twice, 60% more likely for a 3rd
- CDC: $3.8b annual cost in US, $1.6b in hospitals, $2.2b in communtiy/nursing homes. Similar cost in EU
- CBST deal allows us to reach 1800 hosptials vs 1100 alone. They represent increasing access from 70% to 90% of CDAD cases
- EU milestones: 10m Euro ($14m) on launch in any Astellas territory, additional 40m euro ($56m) for launch in first 2 of the 5 major EU countries- or 6 months after approval in EU
- Our cash plus milestones will be enough to sustain launch and potentially get to cash flow positive position [Last time I listened to them the "potentially" wasn't inserted...]
- Budget - R&D support functions have increased this year. Due to medical affairs, health economics research, pharmacovigilence teams added this year
- Sales and marketing costs will continue to increase. This figure was $7m in q2, but we hired 100 sales reps over the course of May-July, so costs not in for full quarter. Also CBST service fee of $3.75m per quarter also not in 2q number
- We expect EU CHMP opinon 2h11, EU approval no later than 1q12
Qualitative description of launch so far? How does this compare to your market research? It is a little early to tell. One oncology hopstial has universally accepted Dificid as first line therapy for CDAD (very expensive and high risk patients). High risk have 1/3 not 1/4 chance of recurrence on vancomycin, the doctors there see it as suboptimal
In hospitals, there is significant use of vancomycin IV formulation made into slurry - significantly less expensive- $200-400 compared to oral Vancocin up to $2800
Script trends - in our database looking pretty good vs street expectations... solid rx $400k dollars and share pushing 4%?...I won't speak directly to 3rd party data.
CBST 180 sales reps plus 100 from OPTR for Dificid vs Cubicin which had national sales launch w/ much fewer
OPTR Q3 results will be released in the 1st week of November. We will look for an opportunity to provide color on launch before that.
Our first priority is to make Dificid a sucesss...US launch, new geography, new indications, phase IV trials to enhance label
Our platform drug discovery technology is computer aided, evaluates carbohydrate-containing compounds
CEM101 drug candidate licensed to Cempra - in phase 2 for community acquired pneumonia (Click here for my info on Cempra website)
We look to in-license additional hospital-based products for this salesforce
Data on formulary acceptance? I'm not prepared to speak on this today. Our market research indicated that 98% of hospitals said they would put Dificid on formulary. 1/3 would be open access. 2/3 restricted - most common restriction was ID consult.
Distribution? - We ship from 3rd party logistics coordinator warehouse to distributers who then ship to retail and hopstial pharmacies on 24 hour notice. We are still working on revenue recognition model - sell to vs sell thru wholesaler.