2nd UPDATE: Onyx Gets Positive Myeloma Data On Lead Pipeline Drug
July 26 2010 - 1:49PM
Dow Jones News
Onyx Pharmaceuticals Inc.'s (ONXX) reported strong results from
its lead development candidate that may allow it to file for Food
and Drug Administration approval by year-end.
The experimental drug, called carfilzomib, was effective in
treating advanced multiple myeloma, a fatal blood cancer, in
patients that had no remaining treatment options. The data could be
significant for the Emeryville, Calif., biopharmaceutical company
by diversifying its business beyond cancer-drug Nexavar, which it
sells with Germany's Bayer AG (BAYRY, BAYN.XE).
"It validates our growth strategy to build out a portfolio of
oncology compounds," Onyx Chief Executive Anthony Coles said in an
interview Monday.
He projected that carfilzomib could achieve $1 billion in annual
sales from treating advanced multiple myeloma, along with earlier
stages of the disease, where studies are ongoing. He declined to
provide a timeline for that goal.
The data have provided a lift to Onyx shares, which recently
traded up 19% to $25.51 on more than six-time regular volume. As of
Friday's closing, the stock was down 27% for the year.
Cowen & Co. analyst Phil Nadeau projected that Onyx shares
don't fully reflect the data at the current price. JPMorgan analyst
Cory Kasimov said the results "rather easily exceeded expectations"
and provide confidence in the company's FDA strategy.
While the data was widely applauded, some on Wall Street raised
questions about whether the data would be enough for the FDA to
approve the drug, especially as Onyx is conducting additional
studies that may provide more insight on its effectiveness and
safety.
Carfilzomib was developed by Proteolix Inc., which Onyx acquired
in late 2009 for $276 million plus potential milestone payments,
all related to various U.S. and European approvals.
If approved, carfilzomib would diversify Oynx's product offering
and also bring in more beneficial economics than the profit-split
it has with Nexavar. Onyx plans to sell carfilzomib in the U.S. and
may also sell it in Europe; it is planning to find a partner in
Japan, and possibly in some other Asia Pacific markets.
Nexavar, on the market since 2005, is approved to treat liver
cancer and advanced kidney cancer. The drug had global sales of
$844 million in 2009, with about $250 million of that coming to
Onyx. The drug is being studied in a number of other cancers, but
had disappointing results in both breast and lung cancer in the
past year.
In the latest data, carfilzomib showed an overall response rate
of 24% and a 7.4-month median duration of response. Patients had
received multiple lines of therapy, but weren't responding to their
last treatment.
Although it comes from Phase II study with no placebo arm, Onyx
believes the data is sufficient for approval. In a prior study of
similar patients, the response to therapy was only 11% and survival
was six to 10 months.
The company is talking with the FDA and hopes to get an
accelerated approval, which allows products on the market with less
data than typically required because they treat patients with an
unmet need.
The drug was well-tolerated and "there were no new or unexpected
toxicities observed," Onyx said. The full details of the study will
be presented at a medical meeting.
Carfilzomib is an oral proteasome inhibitor, which blocks the
effect of a protein complex that helps tumor cells survive and
grow. It is similar to Velcade, a blood-cancer treatment
co-marketed by Johnson & Johnson (JNJ) and Takeda
Pharmaceutical Co. (4502.TO) that is given intravenously.
The multiple myeloma market is competitive. Along with Velcade,
Celgene Corp. (CELG) sells Revlimid and Thalomid to treat the
disease.
Despite the established competition, Onyx estimates annual sales
of multiple myeloma treatments is $4 billion to $5 billion and
projects growth 40% to 50% in the next five years.
"That kind of market growth should support a broad array of new
product entries, including carfilzomib," Onyx's Coles said.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com
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