Onyx Pharmaceuticals Inc. (ONXX) and marketing partner Bayer AG
(BAYRY) hope to continue expanding sales of kidney and liver cancer
treatment Nexavar into a broadly used treatment. Sales growth has
been steady since its 2005 U.S. approval and the drug continues to
launch in new countries.
THE DRUG: Nexavar is a pill that is usually taken twice a day.
It works by blocking multiple signals within cancer cells to
discourage the diseased cells from proliferating. It also inhibits
blood-vessel growth, which is necessary for tumor growth.
THE DISEASE: Onyx estimates that liver cancer is the biggest
growth opportunity for Nexavar because more than 600,000 people
worldwide are diagnosed with the disease every year. More than half
of those cases occur in China, where Nexavar was approved last
summer.
The American Cancer Society estimates that about 23,000 people
in the U.S. will get liver cancer in 2009.
The group estimates that about 58,000 Americans will be
diagnosed with kidney cancer this year.
THE COMPETITION: Nexavar stands alone as the only targeted
therapy to treat advanced liver cancer and Robert Baird & Co
recently projected that competition wouldn't emerge for two years
at the soonest.
Conversely, kidney cancer is a more crowded market, including
Pfizer Inc's (PFE) Sutent and Wyeth's (WYE) Torisel. Newer entrants
include Roche Holding AG's (RHHBY) Avastin and Novartis AG's (NVS)
Afinitor.
THE SALES: Nexavar had global sales of $678 million in 2008 and
profits are split by Onyx and Bayer. Onyx projects 2009 sales
rising to a range of $850 million to $875 million.
Nexavar costs about $100 per tablet, which comes to about $6,000
for a month of therapy. Like other drug makers, Onyx offers help to
those who cannot pay for treatment and about 70% of commercial
patients pay $50 or less a month for the drug.
THE OPPORTUNITY: In July, the companies reported positive
results from a mid-stage study of Nexavar in advanced breast cancer
when used with a chemotherapy regimen. The full data will be
released in coming months, but the news increased hope of success
in other cancer types and the possibility of off-label usage.
Nexavar is likely protected from generic competition in the U.S.
for quite a while, with patent protection until at least 2020. The
drug is currently involved in more than 300 clinical trials,
according to clinicaltrials.gov.
THE CHALLENGE: Although Nexavar is broadly studied, cancer
trials carry a significant amount of risk even when early data is
promising. The drug has failed in late-stage trials in both
advanced melanoma and small-cell lung cancer.
In May, the Nexavar partnership showed the first signs of strain
after Onyx sued Bayer, alleging the German company secretly
developed a successor to Nexavar that may be more effective and
dosed less frequently.
WHAT ONYX SAYS: "As we look at the vision of Nexavar, we are
looking for all the places in which Nexavar might add benefit,
whether in monotherapy or in combination with other therapies."
-Laura Brege, executive vice president and chief operating
officer, August 12.
WHAT WALL STREET SAYS: "We are encouraged by the apparent strong
signal from a Phase II trial in breast cancer and believe this
could potentially add a future growth opportunity. However, the
competitive landscape remains unclear."
-Howard Liang, Leerink Swann analyst on Aug. 5
WHAT'S NEXT: Investors will be watching to see the details of
the breast cancer data, to be presented at a medical meeting in
coming months, in order to gauge its effectiveness and market
opportunity compared to competition.
Results from a second mid-stage trial in breast cancer, showing
its use in newly diagnosed patients, are expected before
year-end.
(This column is a periodic snapshot of the market performance of
selected drugs and vaccines.)
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com