Roche MS Drug's Good Test Results Boost Pipeline's Prospects
20 October 2011 - 9:08PM
Dow Jones News
Roche Holding AG (ROG.VX) Thursday gave investors fresh evidence
its drug universe is expanding beyond the core cancer franchise,
after the Swiss giant said long-term data showed multiple-sclerosis
medicine ocrelizumab helped patients keep the disease in check.
Roche said the drug, which already achieved solid results in a
24-week trial, had a lasting effect after 96 weeks in patients with
relapsing-remitting multiple sclerosis, the most common form of
this autoimmune disease that affects the central nervous system.
Side effects were similar to those registered in the original
trial, Roche said.
"This demonstration of long-term efficacy of ocrelizumab
confirms the compelling benefit demonstrated in the first 24-week
treatment period", said Roche's Chief medical officer Hal Barron.
"These results indicate a high likelihood of success of the ongoing
[late stage] program," he said.
Analysts expect a potential market launch in 2014 but some
cautioned the drug may not immediately develop into a blockbuster
medicine with more than $1 billion in annual sales, due to tough
competition in the $10 billion-plus multiple-sclerosis market. This
is because newer treatments such as Novartis AG's (NVS) Gilenya,
which within a year since its launch has attracted some 20,000
patients worldwide, are administered orally, while Roche's
ocrelizumab is administered intravenously, making it less
convenient for patients.
"The data are promising," said Karl-Heinz Koch of brokerage
Helvea, noting that ocrelizumab compares well to current treatments
such as Biogen Idec Inc's (BIIB) and Elan Corp Plc's (ELN.DB)
Tysabri. "But in spite of the strong efficacy and safety data,
ocrelizumab is rather late to the game and hence for the time being
we forecast limited peak sales of CHF500 million," he said.
Other analysts said Roche's attempt to test the drug as a
therapy for primary progressive multiple sclerosis, for which there
is no treatment, could, if successful, help the medicine generate
more revenue.
Roche, which will present the data at the European Committee for
Treatment and Research in Multiple Sclerosis on Thursday, said the
trial showed no patient who received a 600 milligram dose developed
a new or enlarging brain lesion and that the annualized relapse
rate was less than 0.2 attacks per patient per year.
It added the data also showed that, of the patients who
completed the study, two thirds in the 600 milligram group were
free of any disease activity. Also, the rate of infections, a
common side effect, remained stable after 96 weeks.
Analysts said the strong data increases the likelihood that the
drug may pass regulatory hurdles.
A potential launch will broaden Roche's drug portfolio, which is
currently biased towards cancer drugs, which make up a substantial
part of the company's $50 billion in annual sales.
Recent attempts to broaden its franchise, such as the takeover
of U.S. based hepatitis drug maker Anadys Pharmaceuticals Inc
(ANDS) and strong results from an Alzheimer's trial, bode well for
Roche's prospects, which last year were hit by a series of setbacks
that prompted a major restructuring.
The strong trial results and hopes that Roche may
sooner-than-expected broaden its franchise helped the company's
shares Thursday. The stock, which lost more than 20% last year,
outperformed the Swiss stock market and at 0850 GMT were 0.9%
higher at CHF143.6 in a lower overall market.
-By Goran Mijuk, Dow Jones Newswires, +41 43 443 80 47;
goran.mijuk@dowjones.com
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