(Adds analyst comment, background on daclizumab, MS drugs,
By Ransdell Pierson
June 16 A drug approved to prevent rejection of
transplanted kidneys significantly reduced relapses of multiple
sclerosis in a late stage-trial sponsored by Biogen Idec
and AbbVie Inc, but serious infections and
potential liver toxicity continued to cloud the drug's future.
The Phase III international study of the medicine, called
daclizumab, involved more than 1,800 patients with
relapsing-remitting multiple sclerosis -- the most common form
of MS, which can lead to disability and paralysis.
The companies disclosed partial results from the new trial
The study, called DECIDE, tested monthly injections of
daclizumab against weekly injections of Biogen's blockbuster
Avonex (interferon beta-1a) treatment for MS.
Patients taking daclizumab, which is meant to tame the
immune system by blocking a protein called the CD25 receptor,
had 45 percent fewer annual relapses than those receiving
Avonex. In addition, patients taking daclizumab had 54 percent
fewer new or enlarging brain and spinal lesions at week 96 of
the study, compared to those taking Avonex; those results met a
secondary goal of the study.
The overall incidence of side effects was similar in both
patient groups. But there was a two-fold higher incidence of
serious infections among those taking daclizumab, at 4 percent,
as well as a two-fold higher incidence of elevated liver enzymes
- a potential marker for liver toxicity.
Daclizumab would be a new approach to treating MS, if it is
approved for the condition.
Alex Arfaei, an analyst with BMO Capital Markets, said the
decline in annual relapses seen with daclizumab was a bit less
impressive than the reductions of 52 percent, versus Avonex,
achieved in earlier trials by the oral medication Gilenya, which
is made by Novartis AG. Gilenya had sales of $1.9
billion last year.
"Our first impression is that these results are good enough
for (daclizumab) to be competitive" with Gilenya and other oral
treatments, Arfaei said in a research note.
He predicted the Biogen/AbbVie drug could be introduced in
2016 and conservatively generate U.S. sales of $256 million by
Biogen and AbbVie said they would discuss with health
regulators the timing for potential marketing applications for
Swiss drugmaker Roche Holding AG introduced
daclizumab in 1997 to prevent rejection of transplanted kidneys,
under the brand name Zenapax. It stopped selling the drug in
2009 due to poor sales and the availability of newer treatments.
Multiple sclerosis is believed to be caused by overactive
immune system cells, called t-cells, that attack and destroy the
protective covering of nerves.
Biogen shares were up 0.8 percent in morning trading on the
Nasdaq. AbbVie shares slipped 0.3 percent on the New York Stock
(Reporting by Ransdell Pierson; Editing by Nick Zieminski and