JAV notes
Did not present slides on webcast, so these notes may not be as accurate as usual.
*Plan is to retain N American and select EU territories. In partnering discussions for other territories.
*Emphasized intrinsic safety advantages of nasal administration (saturable absorption)
*Discussed management experience—again, they hired the former FDA division director of the division to which they are applying for approval for all 3 of their products
*Dyloject filed for approval in Europe, awaiting receipt of approval letter now
*In US, accrual completed in first Dyloject pivotal, second accrual has begun.
*Pursuing indications in a graded manner for ketamine product—first Department of Defense/military applications, and civilian emergency use, third and fourth cancer breakthough pain and add-on to opioids (will be pursued through sNDAs)
*Estimated $250 million/year market for Dyloject in US (estimated by subtracting peak from current sales for ketolorac).
*Use of Dyloject over current products over 1.5 days would save hospitals 50 pounds
*Also noted statistical superiority over current products because of rapid onset of efficacy; at 5 min, Dyloject but not ketolorac demonstrated statistically significant pain relief. Summary of differentiating factors: faster onset, equal duration of efficacy, ease of administration, improved side effect profile, clinically meaningful opioid sparing effect
*Ketamine—only drug that does not interfere with pooling mechanism post-trauma. Also does not depress ventilatory drive. Makes it ideal for shock trauma.
*First NDA for ketamine will be filled for acute pain in civilian emergency and military settings. Market research showed serious unmet need in civilian market. Pain relief as early as 4 min after administration. Because the active ingredient is already given in much higher doses (10-fold higher) and there is a large safety database, FDA decided no more trials needed. Currently, PK trials are being conducted. Will file mid-year 2008.
*Rylomine: discussed delivery mechanism, which leaves little residual product for abuse. Suggested that rylomine will compete in injectable market.
*Dyloject: have put in place a number of activities—hired managing director in UK, secured European ad and med ed agencies, taken first steps to establish German office. Impressive positive response from physicians and pharmacists, in terms of ease of use, speed of onset.
*Conservatively estimate G5 peak sales at $75 million.
*Conservatively estimate US sales of $175 million/year.
*Market research for ketamine in civilian emergency setting: 110 million emergency room visits per year, 60%-70% have moderate to severe pain; current standard of treatment is to give small titrated doses of morphine, however, many patients have a medical condition who cannot take morphine because of risk for AEs. Total potential for ketamine—23 million patients, 2 units per patient, works out to $275 million annually in US, does not include potential use in ambulances. Also noted that ketamine-class agents prevent progression to chronic pain.
*Bragged about management again. Which really is pretty impressive, aside from Rick Pierce.
*Noted that Dyloject is stable at room temperature for years…good news as physicians can just stick this in the Pyxis.
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