NPSP
ASBMR 2003
PaTH Data Increases Probability of Success in Phase III Study
Twelve-month results from the PaTH study testing Preos head-to-head vs.
Fosamax (ALN) and vs. the combination were presented at the American Society
of Bone and Mineral Research (ASBMR). The data suggested that Preos alone
resulted in a significant increase in bone building vs. the other two arms. The
same results were concurrently released in the New England Journal of Medicine
and will be highlighted during a conference call at 9:45 AM this morning.
While the trial did not support combination use of Preos and ALN, which was also
suggested in several prior studies of parathyroid hormone (PTH) and ALN, it
reinforced Phase II Preos results and suggested an increased probability of success
for the phase III Preos study expected to be released in March 2004.
In addition, concurrently released data of PTH + ALN in men supported the notion
that one year may be too short a period of time to assess the full anabolic effects
and benefits of PTH therapy. Several other studies, including the phase III Forteo
results and the concurrently published Finkelstein results of PTH in men, suggest
that many benefits of PTH on bone are not seen until at least 12-18 months of
therapy.
In two small studies, Cinacalcet decreased serum calcium in patients with primary
hyperparathyroidism that were hypercalcemic. In one study, it was shown to
reduce serum calcium levels into the normal range for up to three years. In
addition, the drug appeared safe and well tolerated in both trials.
Important near-term catalysts include phase III data for Cinacalcet in SHPT in
Nov. at ASN, phase II data for ALX-0600 in Short Bowel Syndrome in 2H03, data
from the Preos rat carcinogenicity study in Nov., phase III Preos results in March
2004 and a BLA filing for Preos in mid-2004.
Thus, based on the positive PaTH data, very encouraging sales trends for Forteo
(currently on a $90 MM yearly run rate despite a heavily constrained label and
marketing), further proof of Cinacalcet’s benefits on hypercalcemia &
hyperparathyroidism and multiple upcoming catalysts, we reiterate our BUY
rating for NPS (NPSP, C-1-9, $32.82).
Eric J. Ende, M.D.
Comment available. |
