Highlights from Goldman Sachs 26th
Healthcare conference - ABGX, CYTK, GTXI,
HGSI, MEDX, VRTX
I. Abgenix (IL/N) - Panitumumab on track for potential H2 2005 BLA submission
Panitumumab, in development through a 50/50 agreement with Amgen, appears on track
for potential BLA submission in H2 2005 (assuming data are positive). Data from the ex
U.S. study will be used as the basis for filing, and the U.S study will be supplemental.
Patients in the pivotal studies have 3rd line colon cancer and will have been exposed to
5-FU, leucovorin, oxaliplatin and/or irinotecan. Enrollment in the PACCE study, which
potentially may enable Panitumumab's use as part of first line treatment with Genentech's
Avastin, is progressing well, with data possibly available in 2006. Combination studies
with Amgen's VEGF inhibitor, AMG-706, are also underway. We look for Abgenix to
make a decision on potential co-promotion of Panitumumab in 2005. In H2 2005 we look
for phase II data in the lung, renal and colorectal cancer settings. Abgenix plans to
advance ABX-PTH, for secondary hyperparathyroidism, to Phase II in 2005. Partnered
antibodies that are gaining visibility include Amgen's AMG-162 for osteoporosis, in Phase
III studies, and Pfizer's CTLA4 antibody for cancer, in Phase I. We note that in addition to
these, Amgen has an additional antibody in the clinic, Pfizer has 3, Curagen, Chiron and
Human Genome Sciences each have an antibody in the clinic. We maintain an In-Line
rating on Abgenix and Neutral coverage view. We regard progress with Panitumumab is
the primary valuation driver. Key risks include potential clinical failures and/or delays.
I, Meg Malloy, hereby certify |
