- Here are my notes from the OPTR conference call this morning 5/31/11 to discuss the FDA approval of Dificid (fidaxomicin):
- Superiority in sustained clinical response over vancocin recognized in label (lower rate of proven or suspected recurrence)
- C. difficile associated diarrhea (CDAD) associated w/ increased length of hospital stay and increased healthcare costs
- avg CDAD episode can cost up to $17,000 or more...cost $3.8b per year in US healthcare system
- Cubicin price $900-1800, up to $8000 for bacteremia
- Zyvox $2800 for bacteremia, up to $5600 for BRE infection
- vancocin $1000-1500, about 50% receive higher dose or longer duration = higher drug costs
- OPTR has set the Dificid WAC at $2800 for 10 day course
- nearly all payers/ plans surveyed said they would put on tier 3 or better at this price
- With Cubist $CBST, will launch Dificid early in 3q11 - about 6 weeks from now. OPTR will have hired the majority of planned 100 reps by then
- q&a session:
- Do you expect first line use? Will be positioned for first line therapy, especially in high risk pts- economic and patient benefits far superior to current options
- 450k annual cases of CDAD reported in hospitals. Estimate that there are an additional 250k afflicted, some estmates as high as 3m per year.
- Believe high risk portion of mkt is 70% of patients
- post marketing trials and surveillance? Will do studies in pediatric indication and looking at multiple recurrences. Also will have a surveillance programs...Still in discussions on details of these-have tieline of when to submit protocols for the studies to the FDA
- OPTR does not believe it makes sense to do trial comparing to flagyl. metronidazole is not an approved drug for this indication and has serious deficiencies in cure rate. >20% fail and an additional 27-30% fail in recurrence. This product is consistently losing sales to vancomycin.
- Do you expect near term use in prophylaxis? In process of doing retrospective studies to determine incidence of CDI in an appropriate pt population- need this info to design trial. For example, pts w/ hospital pneumonia and have broad spectrum abx (3x different), mostly in ICU. This represents 20% of total CDI pts. Could tx with Dificid initially during 14 days of pneumonia tx and the continue for some period of time afterwards. But need better idea of incidence in this pop (estimates range from 7-24%)
- Discrepancy between the two phase 3 trials? one trial noninferior. one trial clearly superiority to vanc. in subpopulation with BI strain. OPTR don't have explanation except that trial not powered to detect differences in any such sub-populations.
- It is not feasible to screen Cdif strain before tx. Strains also change over time. It is not clear when or if there will ever be clinical practice based on the given strain a pt has.
- Won't disclose COGS at this time. "pharmaceutical margins" Don't see much difference in margins between yr 1 to yr 2
- With $2800 WAC, could end up with net sales 15-25% lower that than per pt after rebates, etc
- Method of use patent thru 2027 (OPTR says this is strongest protection they have). Isomer patent to be issued in relative short term. Other polyform A patents in place thru 2025, 2026
- There is an option by both parties to extend CBST deal
- All market research surveys asked question re if vancocin goes generic- won't impact Dificid market. 80% of vancomycin use is already in form of generic slurry. No motivation on part of payers to remove dificid from tier 3
- Not doen w/ studies to determine pricing in europe, but antibiotic prices in Europe are significantly lower than US
- No financial guidance until company sees rate of launch
Your support is greatly appreciated