Here is a message from Cole:
I believe he was referring to Peter Edwards, who left the company in the spring to become the GC at the BAX spinco Baxalta…Terry has been with MNK as GC ever since…
They said they still were still reviewing the data and they plan to have a more clear picture of what is next step by the end of this year.
I asked them through email and they said they didn't want to release the data before the annual meeting.( This is some kind of meeting policy)
BACKGROUND: Infantile spasms (IS) typically occur within the
first year of life. Children with IS frequently experience spasms,
hypsarrhythmia and psychomotor retardation. H.P. Acthar Gel® is an
adrenocorticotropic hormone (ACTH) analogue that is FDA approved
for the treatment of IS. Evidence-based guidelines recommend the use
of ACTH as first-line therapy for IS. Long-term prognosis of IS patients,
specifically neurodevelopmental outcomes, is relatively poor. Initiating
ACTH therapy soon after diagnosis may improve favorable outcomes
and may decrease the risk of mental retardation. Prompt diagnosis and
treatment may prevent developmental delays and may also reduce
healthcare utilization and costs.
OBJECTIVE: We compared the economic consequences of initiating
ACTH early (within 30 days of IS diagnosis) with that of late ACTH
treatment ( 30 days after diagnosis).
METHODS: All patients 30
days of the index date). Patients with continuous health plan enrollment
for 3-months prior and 12-months post index date were included in
this retrospective analysis. We estimated and compared the healthcare
resource use and costs (inpatient, outpatient, and pharmacy) separately
for patients in the two groups. Multivariate regression models were
constructed to adjust for gender and prior hospitalizations.
RESULTS: We identified a total of 259 IS patients who met our study
eligibility criteria. 197 (76%) patients used ACTH early and 62 (24%)
patients were late users of ACTH. Over the one-year follow-up from IS
diagnosis, early users had 16% fewer outpatient visits (95% CI: -13% to
-19%) and 15% less overall healthcare resource utilization (95% CI: -13%
to -18%) when compared to late ACTH users. Unadjusted 12-month
total outpatient costs (excluding the costs of administering ACTH)
for early users were 30% lower ($23,200 for early users as compared
to $33,500 for late users; 95% CI: -10% to -50%) as were the total
medication costs excluding cost of ACTH (50% reduction; 95% CI: -20%
to -70%). After adjusting for gender and prior hospitalizations, the
relative rate ratio of outpatient visits (0.89; 95% CI: 0.85 to 0.92), overall
healthcare resource utilization (0.91; 95% CI: 0.88 to 0.94) and total
medication costs (excluding ACTH costs) (0.5; 95% CI: 0.3 to 0.8) were
statistically significantly lower in early ACTH users than late users.
CONCLUSION: In this analysis, we found that the economic
consequences of treating patients with ACTH within 30 days of IS
diagnosis may be associated with decreases in overall healthcare
resource use, outpatient visits and total medication costs.