* FDA approves lower dose of Xeljanz, higher dose needs more
* Analyst expects $25,000-a-year cost, $2.5 bln peak annual
* Pill to compete with Humira, other blockbuster injectables
* Pfizer rises 1.5 pct after hours
By Ransdell Pierson
Nov 6 U.S. regulators on Tuesday approved Pfizer
Inc's Xeljanz treatment for rheumatoid arthritis, one of
the company's most potentially lucrative experimental drugs,
which is now poised to compete with Abbott Laboratories Inc's
The U.S. Food and Drug Administration said it had approved
Pfizer's pill for patients with moderate to severe rheumatoid
arthritis who have not benefited from or been able to tolerate
the standard oral treatment, methotrexate. Xeljanz can be used
by itself or in combination with methotrexate and certain other
Industry analysts have predicted Pfizer's drug, which works
differently from current treatments and is better known by its
chemical name tofacitinib, could eventually capture annual sales
of up to $3 billion. The revenue is sorely needed, amid plunging
sales of its Lipitor cholesterol fighter and other Pfizer
medicines facing cheaper generics.
As a twice-daily pill, Xeljanz could prove more attractive
to some patients than Abbott's $8 billion-a-year Humira, which
is given by injection every other week.
But Abbott has said Humira sales will continue growing by
leaps and bounds, despite competition from Xeljanz.
"It is understandable why (new) patients might prefer an
oral therapy versus one that requires needle-based delivery,"
Sanford Bernstein analyst Tim Anderson said in a research note.
He added that patients already benefiting from other medicines
are unlikely to switch to a new product.
The FDA approved a 5 milligram dose of Xeljanz, given twice
a day. But the agency said further safety data are needed to
assess a 10 milligram, twice-daily dose, that Pfizer had also
put before regulators.
Anderson said Xeljanz will likely cost $25,000 a year, in
line with injectable medicines. Besides Humira, the injectables
include Amgen Inc's Enbrel and Johnson & Johnson's
Remicade -- all three of which work by blocking a
protein called tumor necrosis factor.
Anderson predicted the Pfizer pill, approved two weeks
before Wall Street expected, will generate peak annual sales of
at least $2.5 billion. Sales could be considerably higher, he
said, if Xeljanz is also eventually approved for psoriasis,
inflammatory bowel disease and other inflammatory conditions.
Rheumatoid arthritis and related diseases have been one of
the most lucrative segments for drugmakers, with more than $20
billion in annual sales.
Rheumatoid arthritis is an autoimmune disease in which the
body's immune system mistakenly attacks healthy tissue, causing
inflammation and pain in the joints. It affects an estimated 1.5
million Americans, the FDA said.
An estimated 30 percent to 40 percent of patients with
rheumatoid arthritis do not respond to available drugs, meaning
there is room for other options.
Pfizer's drug works by blocking molecules called Janus
kinases which are linked to joint inflammation. The drug was
associated with an increased risk of serious infections,
tuberculosis, cancers and lymphoma. Humira, Embrel and Remicade
also make patients more prone to serious infections and other
The FDA said it approved the drug with a risk evaluation and
mitigation strategy, requiring safety information on the drug's
package insert label and a communication plan to inform
healthcare workers about its risks.
The agency is also requiring Pfizer to conduct a
postmarketing study to evaluate the drug's long terms effects on
heart disease, cancer and serious infections.
Pfizer shares rose 1.5 percent in after-hours trade to