Onyx Modifies Carfilzomib EU Trial - Analyst Blog
March 30 2011 - 4:30AM
Zacks
Onyx Pharmaceuticals Inc. (ONXX) recently said
that it plans to expand its phase III (FOCUS) trial, which is being
conducted to support the European filing of carfilzomib as a
treatment for relapsed and refractory myeloma. The company is
conducting the FOCUS trial to evaluate the efficacy and
tolerability of carfilzomib in patients with relapsed and
refractory myeloma.
Onyx Pharma plans to change the primary endpoint of the trial to
overall survival from progression-free survival. The company
intends to enroll 300 patients instead of 84.
In February, the US Food and Drug Administration (FDA) granted
fast track status to carfilzomib for the treatment for patients
with relapsed and refractory multiple myeloma.
Earlier, in December last year, Onyx Pharma reported positive
results on the candidate from a phase IIb trial (003-A1). The
results showed that patients experienced an overall response rate
of 24.1%, while the clinical benefit rate was higher at 34.2%. The
duration of response was 8.3 months, while the median overall
survival was 15.5 months. The patients, who enrolled in the study,
had already received a median of five prior lines of therapy and
their disease was refractory to their last therapeutic regimen.
On the basis of these results, Onyx Pharma initiated the
submission of a rolling New Drug Application (NDA) for gaining
accelerated approval of carfilzomib for relapsed and refractory
multiple myeloma. The company expects to complete the submission by
mid-2011.
Onyx Pharma has an agreement with a Japanese company, Ono
Pharmaceutical Co. Ltd., for the development and commercialization
of carfilzomib and ONX 0912, in Japan. ONX 0912, the follow-on
version of carfilzomib, is currently in phase I testing. The
company plans to initiate a mid-stage trial of the candidate in
2011.
We believe that the approval of carfilzomib would be a major
positive for Onyx Pharma, which currently has just one marketed
product, Nexavar (cancer), in its portfolio.
Global Nexavar sales, recorded by partner Bayer
AG (BAYRY), amounted to $934.0 million and $257.4 million
for the full year and fourth quarter 2010, respectively, reflecting
an increase of 11% and 9%.
During the fourth quarter, Onyx Pharma saw an improvement in
Nexavar sales in the Asia-Pacific region, led primarily by Japan
and China. Additionally, the company was granted reimbursement for
Nexavar for the treatment of liver cancer in South Korea. The
company also expects to receive reimbursement for Nexavar in Taiwan
by year end.
The improvement in Nexavar’s performance is encouraging as the
drug had performed below expectations in the first nine months of
2010.
Further, Onyx Pharma expects Nexavar sales to amount to $975
million to $1.025 billion in 2011, reflecting a year-over-year
increase of 5% to 10%. Moreover, Nexavar sales are anticipated to
experience double-digit growth in the Asia-Pacific region.
Our Take
We currently have a Neutral recommendation on Onyx Pharma, which
is supported by a Zacks #3 Rank (short-term Hold rating). Going
forward, we expect investor focus to remain on the approval status
of carfilzomib.
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