DIFICID (fidaxomycin) was launched about a year ago for C. dfficile infections by Optimer Pharma $OPTR with support from Cubist Pharma $CBST. Continue reading for the latest updates on this program from the two companies, as well as comments on CBST's additional C. difficle (CDAD) prodcut CB-315.
Cubist Pharma $CBST conference call notes/quotes:
"in Q2, we recorded the $5 million bonus revenue from Optimer with the achievement of target revenue for DIFICID for the first year sales period. The first year sales period ends on July 31, but as the second quarter closed, we had sufficient confidence that target revenues were achieved to book this performance bonus."
"We are eligible to earn additional revenues based on the agreed split of Optimer's gross profits on the net revenues of DIFICID above the prespecified 1-year revenue target. We expect to have clarity on this by the time we report Q3 results. Shifting now to our co-promote with Optimer. I want to take this opportunity to recognize all involved for executing such a successful partnership for the launch of Optimer's DIFICID. The bonus achievement we announced today is of course important and gratifying. But of equal importance is the working model we've created, with learning that both companies can leverage in the future. We look forward to continuing our support of DIFICID through mid-2013."
"Now turning to CB-315. As you know, we have been in the startup stage of our Phase III program with CB-315, a potential new therapy to treat Clostridium-associated diarrhea. As announced last week, we are pleased to report that we have now enrolled the first patient in our Phase III CDAD program."
Optimer Pharma $OPTR earnings webcast notes
- one year anniversary of DIFICID (fidaxomycin) launch was 7/18/2012 - $51.1m net sales, 20k treatments. beat goal and triggered $5m milestone plus share of gross margin above that threshold to CBST
- booked $12.6m milestone for first EU sales from Astelllas
- booked $19.9m upfront from Astellas for Japan deal
- $130.6m cash on hand at end of 2q2012
- prophylactic trial in patients undergoing bone marrow transplant (BMT) will start 4q2012 - but dont yet agree w/ FDA on what is required. expect to file NDA mid to late 2014. use half of therapeutic dose, treat 20-30 days. represents 5x increase in total market size
- study in C. difficile patients with mulple recurrences will start 2h-2013
- Canada price is in line with EU
- 900 hospitals now on formulary, have sold DIFICID to 1900
- affirm cash flow positive guidance ~3 years post-launch
- second pediatric trial would trigger milestone (first study is just safety)
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