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 With those gains, Lilly shares have leaped 26 percent for the year
to date, eclipsing a 10 percent gain for the Arca Pharmaceutical
Index of large drugmakers.
The Indianapolis drugmaker, whose sales and earnings tumbled over
the past three years due to generic competition for its biggest
products, is quickly rebuilding its pipeline of new medicines. On
Wednesday and Thursday it released favorable results from studies of
experimental treatments for rheumatoid arthritis and psoriasis.
But investors are expected to focus more intently in the next few
days on expected findings from a two-year extension of a large study
of solanezumab, an injectable treatment with the potential to become
the first approved medicine to delay progression of Alzheimer's
disease.
Limited data from an abstract of the trial, called Expedition Ext,
are expected to be released by the Alzheimer's Association
International Conference (AAIC) by Monday. The group will disclose
full results of the study at a meeting in July.
"If the drug works and is eventually approved, its annual sales
could be mind boggling, easily in excess of $10 billion," said John
Boris, an analyst with Suntrust Robinson Humphrey. An estimated 5
million Americans are believed to have the degenerative brain
disease and no drug exists to slow its progression.
In two large earlier trials that lasted 18 months each, called
Expedition and Expedition 2, solanezumab failed to improve cognition
or the ability to perform daily activities among patients with mild
to moderate Alzheimer's.
But Lilly analyzed the failed studies and discovered a ray of hope:
patients with mild disease were shown to have been helped by the
drug. It then set out to extend the trials with such patients for
another two years. Patients who previously were given placebos were
allowed to receive solanezumab, and all other patients were likewise
notified they were taking the Lilly drug.
Lilly has previously disclosed, after the initial 6 months of the
extension trial, that patients who had been in the placebo group
fared less well than those who had taken solanezumab all along. The
finding suggested that solanezumab may have slowed down the rate of
neuron death, said Dr. Eric Siemers, medical director for Lilly's
Alzheimer's team.
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The expected abstracts will describe findings over the full two
years of the extension trial.
"There will be a fair amount of interest in that two-year data, and
what you would (hope) for is a sort of maintaining over a longer
period what you saw at 6 months," Siemers said in an interview on
Thursday. "That would reinforce the conclusion that solanezumab was
disease-modifying, and that patients could never get back what they
lost by being on placebo those initial 18 months."
The Expedition Ext study will shed greater light on the safety and
effectiveness of solanezumab, but Lilly is conducting a different
trial called Expedition 3 that would be the basis for a marketing
application, perhaps by 2017, if it proves successful.
The study will only enroll patients with mild Alzheimer's disease,
and those with detectable deposits of brain plaque made of a protein
called beta amyloid, the target of solanezumab and other
experimental Alzheimer's drugs.
Biogen Idec Inc's stock jumped 6 percent on March 20 when the
company said its experimental drug, aducanumab, led to reductions in
amyloid plaque and slowed clinical impairment in patients with mild
Alzheimer's. The trial, involving only 166 people, paved the way for
a planned late-stage study.
(Reporting by Ransdell Pierson)
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