Onyx Pharmaceuticals Inc. (ONXX) (ONXX)'s
treatment for a deadly blood cancer won U.S. approval, giving
the company its first wholly owned drug to sell.
The medicine, called Kyprolis, was cleared for patients who
have received two prior therapies, the Food and Drug
Administration said today in a statement. Annual sales may be
$682.7 million in 2016, according to the average of six
analysts' estimates (ONXX) compiled by Bloomberg, more than doubling
the South San Francisco, California-based company's $447 million
revenue last year.
"We think this is just terrific for patients," Chief
Executive Officer Tony Coles said in a telephone interview
today. "We are prepared to launch, we have all the necessary
plans in place."
Hospitals and clinics will be able to order the medicine by
Aug. 1, which will then be available within 24 hours, Helen Torley, Onyx's chief commercial officer said today on a company
conference call. The therapy will cost $9,950 for a 28-day
cycle, she said. The median time patients were taking the drug
in a study was 4.4 months and Onyx estimates a cost of $40,000
for treatment.
Onyx gained (ONXX) 12 percent to $76.38 at the close in New York.
Ligand Pharmaceuticals Inc., which has an agreement to explore
an IV version of the drug, fell less than 1 percent to $17.51.
FDA advisers voted 11-0, with one abstention, in June that
the benefits of Onyx's multiple myeloma treatment, also known as
carfilzomib, outweigh its risks. Onyx had applied for
accelerated approval of the treatment based on the second of
three phases of trials typically needed for market clearance.
Attacks Tumors
The medicine shrunk tumors in 22 percent of multiple
myeloma patients. Side effects for the treatment included
cardiac arrest, chest pain, pneumonia and shortness of breath,
the FDA staff said in a report last month. More than 70 percent
of patients had lung complications with the drug, according to
the FDA report.
Kyprolis would be used to treat multiple myeloma patients
who have first tried Celgene Corp.'s (CELG) (CELG) Revlimid and Takeda
Pharmaceutical Co. Ltd.'s (4502) Velcade.
About 50,000 people in the U.S. are living with the disease
and 20,000 new cases are diagnosed each year. About 11,000
patients die of the blood cancer annually, according to the
National Cancer Institute.
"This is great news for patients, great news for Onyx,
they really did a bang-up job with this drug," Michael King, an
analyst with Rodman Renshaw in New York, said in an e-mail.
Onyx, founded in 1992, focuses on developing cancer
treatments. The company's only other approved product is
Nexavar, a kidney-and-liver-cancer drug it markets in
collaboration with Bayer AG. (BAYN) Globally, Nexavar sales reached $1
billion last year, with Onyx recording $287 million in revenue
from the medicine, according to a filing.
To contact the reporter on this story:
Ryan Flinn in San Francisco at
rflinn@bloomberg.net
To contact the editor responsible for this story:
Reg Gale at
rgale5@bloomberg.net
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