Onyx Pharmaceuticals, Inc.
) received a huge boost recently with the US Food and Drug
Administration (FDA) approving the company's multiple myeloma (MM)
candidate, Kyprolis (carfilzomib). Kyprolis has been approved for
use in treatment-experienced multiple myeloma patients (who have
received at least two prior therapies, including Takeda/
Johnson & Johnson's
) Velcade (bortezomib) and an immunomodulatory agent) and whose
disease has progressed on or within 60 days of completion of the
last therapy. Onyx Pharma's shares were up more than 11.5% on the
Approval was based on results from a phase IIb study (003-A1).
The indication for Kyprolis is based on response rate. We note that
currently no data demonstrating an improvement in progression free
survival or overall survival is available on Kyprolis.
Kyprolis' approval, which came a few days before the target date
of July 27, did not come as a huge surprise as, last month, the
FDA's Oncologic Drugs Advisory Committee had issued an opinion in
favor of Kyprolis. While reviewing the application, the panel voted
overwhelmingly (11-0) in favor of clearing Kyprolis. One panel
member abstained from voting.
Immense Commercial Potential
Onyx Pharma has priced Kyprolis at $1,658 per vial, at a premium
to Velcade. The price per 28-day cycle is $9,950 based on the
dosing schedule in the label and assuming a 78 kilogram individual.
The mean duration of treatment was 4.4 months in study 003-A1,
which means treatment cost could reach $44,000.
According to the American Cancer Society, about 21,700 people in
the US could be diagnosed with multiple myeloma in 2012 with 10,710
people expected to die from the disease. Onyx Pharma estimates that
Kyprolis-eligible patients could be about 10,000 - 15,000 annually
in the US. This represents significant commercial potential for the
The company has a dedicated 100 person oncology sales force in
place for the launch. The Kyprolis sales force will call on about
2,000 physician offices and hospitals where a major part of
Kyprolis-eligible patients are treated. The company expects the
product to be available to order by August 1. As far as
reimbursement and formulary coverage is concerned, Onyx Pharma
expects coverage for about 80% of the indicated population.
While a miscellaneous J-code will be used for the time being, a
Kyprolis specific Medicare J-code is expected in January 2014.
Kyprolis is currently in a phase III study (ASPIRE), which is
being conducted to assess the clinical benefit of Kyprolis. The
study is being conducted under the FDA's Special Protocol
Assessment (SPA) program.
The speedy approval of Kyprolis is a major positive for Onyx
Pharma. Kyprolis' approval should remove concerns about the
company's dependence on Nexavar for growth.
We currently have a Neutral recommendation on Onyx Pharma, which
carries a Zacks #3 Rank (short-term Hold rating).
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ONYX PHARMA INC (ONXX): Free Stock Analysis
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