Onyx Pharmaceuticals, Inc.
) recently provided an update on its performance in 2012 and its
plans for 2013.
Kyprolis Off to a Strong Start
Oncology product Kyprolis, which was launched in late July
2012, is off to a solid start with 2012 sales expected to cross
$62 million. Strong adoption trends and rapid account penetration
should ensure continued strong ramp of Kyprolis sales. The
company estimates that about 25% of the 10-15k targeted patient
population has received Kyprolis as of October 2012.
Onyx Pharma is currently evaluating Kyprolis in other studies
including the FOCUS study which is being conducted to support the
European filing of Kyprolis as a treatment for relapsed and
refractory myeloma. Interim results should be out in the second
half of 2013. The company is also looking for partnership deals
in other countries where marketing authorization could be gained
on the basis of US approval.
Stivarga Shows Promise
Oncology product, Stivarga, which has been developed by
), could be a blockbuster. Stivarga gained FDA approval for the
treatment of metastatic colorectal cancer (mCRC) in late
September 2012, a month ahead of expectations. Bayer is also
seeking FDA approval for Stivarga for treating patients suffering
from metastatic and/or unresectable gastrointestinal stromal
tumors (GIST). Bayer is looking to expand Stivarga's label
further and is planning to initiate two phase III studies this
year - one in second-line hepatocellular carcinoma (HCC) and the
other in CRC following resection of liver metastases.
Nexavar Label Expansion Efforts
Onyx Pharma continues to work on expanding Nexavar's label.
Nexavar, which is currently approved and marketed worldwide for
the treatment of HCC or liver cancer and advanced renal cell
carcinoma (RCC) or advanced kidney cancer, recently fared well in
a late-stage study conducted in patients suffering from with
locally advanced or metastatic radioactive iodine
(RAI)-refractory differentiated thyroid cancer. A supplemental
new drug application (sNDA) for the thyroid indication could be
filed in 2013.
Another late-stage study is being conducted in patients
suffering from locally advanced or metastatic HER2-negative
Another breast cancer candidate, PD-0332991 (PD-991), which is
being developed with
), is scheduled to enter into a phase III study this year.
Onyx Pharma, which was a one-product company until a year
back, has successfully transformed into a multi-product company.
With two recent product approvals (Kyprolis and Stivarga) in its
bag and Nexavar continuing to perform well, Onyx Pharma looks all
set for growth. We expect 2013 to be a catalyst-filled year for
Onyx Pharma as the company works on expanding the labels of
currently marketed products and progresses with the development
of other candidates.
Currently, pharma companies like
) carry a Zacks Rank #1 (Strong Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis
IRONWOOD PHARMA (IRWD): Free Stock Analysis
ONYX PHARMA INC (ONXX): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
VALEANT PHARMA (VRX): Free Stock Analysis
To read this article on Zacks.com click here.