- As part of my research on Optimer $OPTR following approval of Dificid (fidaxomicin), I went back to the recent UBS webcast. Click here to visit my OPTR research notes page. My notes from the webcast are below:
- C. difficile infection (CDI) is an attractive, growing market. now growing at 5-6% per year, was 10% in last decade. Driven by aging population and use of broad spectrum antibiotics
- 'sustained clinical response' is the new term instead of previously used global cure. No need for additional treatment
- CDI prevalence in US correlates w/ # of hopsital beds. Reporting is only required in 2 states currently (and in those states reported CDI rate is 2-3x higher than avg)...so think market will expand
- Current treatments are suboptimal. metronidazole efficacy is declining (was 93%, now down to 71% = 29% failure)
- vancocin (vancomycin) achieves sustained clinical reponse with 90% efficacy but 25% of pts have recurrence.
- Put these figures together, and about 35% of pts need additional treatment
- ~25% rate of recurrence (but up to 50% in elderly, high risk populations)
- Company has conducted extensive marktet research including disclosing intended price point-expect at launch to capture 20% of prescriptions in first line regardless of price (made up by taking 'lion's share' of immune compromised and elderly patients)
- In 2nd line, expect 36% market share
- Then have strategies to increase penetration after launch
- CDI is $1.6b mkt in US hospitals, plus $2.2b in nursing/longterm care facilties annually
- OPTR will announce price right after approval [conference call tuesday 5/31 8am ET). In general for competitors, EU prices about 1/2 of US prices
- Consider that branded vancomycin (most use is at 2x label dose and duration of 14 not 10 days). cost $1000-2700 per pt [So I assume OPTR will price on high end of this range at minimum...right?]
- OPTR expects universal coverage by US payers in tier 3- if new generics enter market, those generics would move to tier 2 but Dificid would remain tier 3
- OPTR expects adoption by formuarlies w/ restrictions (especially at for profit hospitals. most just will require an infectious diseases [ID] consult) --these restrictions are often removed after 6-12m experience with product
- OPTR has submitted 21 abstracts/papers related to Dificid in 2011
- Deal with Cubist $CBST- improve detailing, increase pace of prescribing and accelerate formulary approval, plus CBST reps will reach additional hospitals that OPTR force will not visit
- CBST has 180 sales reps supplemented by 18 medical affairs doctors
- Expect medicare/medicaid dual eligible pts to get Dificid w/o copay- expect high penetration in these pts
- Astellas does $2.7b sales in EU. Expect to launch 12 new products in EU in next 5 yrs including Dificid. They are ideal partner in antibiotics field and share same vision.
- expect ~10 publications/presentations about health economics. 1st is a RAND corporation study "strongly supporting" Dificid's benefits
- EU status- awaiting 180 day questions in short term, expect 4q2011 CHMP recommneation for approval. should be on mkt in EU mid-2012
- cash $180m at 3/31/11. There will be presumed EU milestones for approval and launch in key EU mkts
- Ready to launch imminently after registration. Will have CC to release price and comment on label (see link at OPTR page)
- q&a session (sorry, hard to hear on webcast):
- It is hard to measure detailing in hospital market, but have agreed with CBST that a specified % of effort will be for Dificid.
- FDA calls Dificid a macrolite. Drug is not absorbed at all - can't get to toxicity level in dogs
- MofA is unique and differentiated, have not observed any resistance
- FDA is abandoning terminoogy of broad/narrow spectrum antibiotics. But fidax is a narrow spectrum by any definition
5/29/2011 02:46:04 am
Dificid method of action is on Clostridium difficile RNA. By destroying or mutating the RNA, it disables C difficile reproduction.
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