Catalyst-Filled 2013 for Onyx - Analyst Blog
10 January 2013 - 1:10AM
Zacks
Onyx Pharmaceuticals, Inc. (ONXX) 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
Bayer (BAYRY), 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 breast
cancer.
Another breast cancer candidate, PD-0332991 (PD-991), which is
being developed with Pfizer (PFE), is scheduled to
enter into a phase III study this year.
Our Take
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 Valeant
Pharmaceuticals (VRX) and Ironwood
Pharmaceuticals (IRWD) carry a Zacks Rank #1 (Strong
Buy).
BAYER A G -ADR (BAYRY): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
ONYX PHARMA INC (ONXX): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
VALEANT PHARMA (VRX): Free Stock Analysis Report
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