UPDATE: Novartis MS Pill Faces Key FDA Panel Vote, Rivals Watch
08 Juin 2010 - 4:06PM
Dow Jones News
Rivals vying to get the first multiple sclerosis pill to market
face a key decision Thursday when U.S. experts vote on whether
Novartis AG's (NVS) candidate Gilenia should be recommended for
approval.
Gilenia is so far seen as leading the race to get an oral MS
treatment approved. But it could lose that edge if safety issues
prompt the U.S. Food & Drug Administration's Peripheral and
Central Nervous System Drugs Advisory Committee to not recommend it
at a meeting Thursday.
The drug has been linked in clinical trials to a number of
potentially serious side effects, including heart problems and skin
cancer.
A memo released Tuesday by the FDA in advance of Thursday's
meeting said Gilenia was effective but carried "a number of safety
issues."
The panel will be asked to vote on a series of questions
including whether studies of a lower dose of the product should be
conducted prior to approval. If the FDA were to endorse such an
option, it would significantly delay approval of Gilenia.
Novartis hopes that won't happen and rather that the promise of
Gilenia benefits will outweigh concerns over potential health
risks.
"Novartis has been working to reduce the risk of disappointment
by limiting its requested indication to treating
relapsing-remitting multiple sclerosis with 0.5 milligrams of
Gilenia once-daily, which appears to have a cleaner safety profile
than 1.25 milligram daily dosing," said Mike Ward of Ambrian, who
has a hold recommendation on the Swiss company.
Investors will be watching the FDA panel decision closely. So,
too, will Merck KGaA (MRK.XE) of Germany, Sanofi-Aventis (SAN.FR)
of France and Israel-based Teva Pharmaceutical Industries Ltd
(TEVA) which are fielding rival treatments.
All raise the possibility for the first time that oral
treatments might become available alongside the more cumbersome
injections and infusions currently used to treat multiple
sclerosis, a disease in which the body's immune system attacks
nerve cells in the brain. People with the most common form of the
disease--relapsing-remitting MS--experience attacks, or relapses,
followed by periods of remission.
Merck KGaA Tuesday said it has just resubmitted its request for
U.S. regulatory approval for its experimental oral MS product
Mylinax, or cladribine, after having its initial submission kicked
back by the FDA last November.
Sanofi last week said new data from a phase II study of its
rival multiple sclerosis drug teriflunomide showed "improvement in
outcomes" for patients suffering from relapsing multiple sclerosis.
Teva's candidate laquinimod is licensed from NASDAQ-listed Active
Biotech.
The FDA panel decision on Gilenia--licensed from Mitsubishi
Tanabe Pharma of Japan and also known as fingolimod--is viewed by
analysts as a key news event for Novartis, not least due to its
potential to the Swiss group offset revenue lost due to expiring
drug patents.
Analysts say Novartis' oral MS drug has a clear advantage in
being easier to take than injectables from Elan Corp. PLC (ELN),
Biogen Idec Inc (BIIB), Bayer AG (BAY.XE), Merck KGaA and Teva
Pharmaceutical Industries Ltd, as well as not causing the flu-like
symptoms seen with some of these products.
Jefferies, which has a buy rating on Novartis, said in a recent
note: "We see this as a clear commercial advantage in this market,
as is the lack of troublesome flu-like symptoms common with the
interferons, hence our peak sales expectation for Gilenia now sits
well above consensus, or circa $1.6 billion at $3.5 billion."
Stockbrokers Goodbody Tuesday said the FDA panel decision will
have significant implications for companies offering MS treatments,
including Ireland-based Elan, which markets controversial multiple
sclerosis treatment Tysabri along with U.S. partner Biogen Idec
Inc.
"If the committee recommends approval, it will have a negative
impact on companies with existing MS treatments, including Elan ...
Any question marks over the new drug will, conversely, be seen as
positive for Elan," Goodbody said in a note to clients.
-By Sten Stovall, Dow Jones Newswires; +44 207 842 9292;
sten.stovall@dowjones.com
(Jennifer Corbett Dooren contributed to this article.)