JAV Conference Call Notes
Still waiting to buy the bulk of my position in JAV…seems like volume dried up today…finally. These are my messy notes.
1) Reviewed milestones for last quarter—completion of secondary stock offering, coverage by 6 analysts, signed commercial agreement with Baxter to act as secondary manufacturer of Dyloject.
2) Gained additional 10 y of patent protection for Dyloject in Europe. Additional patents are pending in US
3) Top-line results released for Rylomine, which met its primary end point of significantly reducing post-surgical orthopedic pain. Will be published in peer-reviewed journals.
4) Accrual completed in first of 2 US trials for Dyloject in US
5) Simultaneously started second US trial for Dyloject
6) Ketamine program: PK studies will be completed to fill out label on how to alter dose under certain conditions. These studies are on schedule.
7) Plant inspection for Dyloject by MHRA is complete. Approval will likely occur “before the end of summer.”
8) Have $53M in cash, burn $11M for SIX-month period.
9) Adam Greene (JP Morgan): asked about comparison with injectable ibuprofen product. Carr indicated that there is *no* literature on the use of IV ibuprofen for pain, in contrast to diclofenac, which has been used for years by the pain community and has “vast” literature supporting its efficacy
10) Adam Greene asked about reporting of the ketamine trials. Carr indicated that the trials will be reported before submission to the FDA. Duh.
11) Leerink-Swan asked whether they are in labeling discussions for Dyloject. The VP for Risk Management indicated that they have received and replied to labeling comments.
12) Leerink-Swan asked about preparation for the UK launch. Javelin said sales force is being hired and offer letters will be sent in “near term.” There will be 10-15 in sales force. Javelin has had extensive conversations with key opinion leaders and “are very comfortable that their marketing strategy will allow for immediate acceptance in the formulary process.” Carr reiterated that their advisory panels have included multiple specialties, including pharmacists that play a key role in formulary decisions.
13) Same guy asked “is it fair you wouldn’t have started a second phase III [for Dyloject] if you didn’t have a sense of how the first phase III went.” Carr emphasized that “Javelin does not embark on phase III trials on an exploratory basis.”
14) Top-line data from first phase III of Dyloject will be released in second half of 2007. Will be released by press release, abstract/poster at meeting, and publication.
15) R&R analyst asked about timeline of PK studies for ketamine product. Javelin said “they’re going very well.” Will complete by first half 2008 and file NDA around middle of 2008.
16) Juan Sanchez (not the coffee guy): asked a dumb question about label extension.
