Dec 13 Eli Lilly and Co said it will
stop one of three late-stage trials of its rheumatoid arthritis
drug tabalumab after an analysis showed that the trial was
unlikely to be successful.
The trial was testing the drug in patients with
moderate-to-severe rheumatoid arthritis who were not responding
adequately to methotrexate therapy, which is a standard
rheumatoid arthritis treatment.
The decision was not based on safety concerns, and patients
currently enrolled in other tabalumab rheumatoid arthritis
studies will continue treatment, Lilly said.
However, the company said it would suspend enrolment of new
patients in the rheumatoid arthritis program until additional
analysis from other ongoing rheumatoid arthritis studies is
completed in early 2013.
"The results of this study were unexpected given the data
generated in earlier Phase II clinical studies of tabalumab,"
Lilly's vice president of autoimmune product development, Eiry
The discontinuation of the study is expected to result in an
after-tax charge of about 2 cents per share in the fourth
Late-stage trials testing the drug in lupus, an autoimmune
disorder, will continue to enrol new patients, the company said.
ISI Group analyst Mark Schoenebaum said the drug's sales
were estimated at around $250 million in 2018, noting that
rheumatoid arthritis was a competitive market and expectations
for the lupus market were low as well.
"If we wipe out all (tabalumab) sales from our model, our
discounted cash flow drops about 50 cents, so the impact is
small," Schoenebaum added.
The company's shares, which have gained more than 25 percent
in the past twelve months, were down 1 percent at $48.50 in
afternoon trade on the New York Stock Exchange.
Lilly is working on another rheumatoid arthritis drug called
baricitinib, which is being far more closely watched by the
industry given its potential. The drug is also getting tested
for psoriasis and diabetic nephropathy.
Baricitinib, currently in late-stage development, belongs to
a new class of oral medicines called Jak inhibitors that aim to
compete with the injected rheumatoid arthritis drugs that
currently dominate the market with billions in sales.
Rheumatoid arthritis is an autoimmune disorder that leads to
inflammation of the joints and surrounding tissues. Jak
inhibitors block enzymes believed to be involved in the
Pfizer Inc was the first company to bring one of
these new drugs to market with the U.S. approval of tofacitinib,
which will be sold under the brand name Xeljanz. It was launched
Another autoimmune disorder drug in Lilly's pipeline is
ixekizumab - being tested for psoriasis and psoriatic arthritis.