A Competition Blowout?
One positive marker for the future of Gilenya is that the competition is feeling the heat. On September 22, 2010, Biogen Idec—maker
of Avonex—released a press statement that read, "The long-term safety profile of Gilenya has yet to be established ... We
agree with the FDA that there is a need for safety monitoring for Gilenya through a comprehensive Risk Evaluation and Mitigation
Strategy (REMS)." Thus, the sensitivity of Novartis to potential side-effects issues is not misplaced, as it appears this
will be a key tactic of manufacturers of alternative medicines to maintain their patient base. After all, it's up to Novartis
to make the proposition to switch.
Nevertheless, competitors are resigned to sharing more sales with the newcomer, which will benefit from Novartis' size, scale,
and marketing muscle. Biogen CEO George Scangos recently told Reuters he was sure that Gilenya would take some market share, but that it was "still too soon" to predict how much. Such fear may
indeed be warranted, if analysts are to be believed. According to Bloomberg, analysts are predicting that on average, Gilenya will produce $1.8 billion of annual revenue for Novartis by 2014.
Such predictions of success seem to be the general consensus. "We expect that because of the less invasive method of administration
and high efficacy, the orals will eventually usurp the injectible formulations to become the leading therapies in MS. Moreover,
we believe Gilenya will become the leading therapy in MS," Datamonitor's Trung Huynh told Pharm Exec. "The introduction of new pipeline drugs will cause the market to peak at $9.7 billion in 2014 across the seven major [country]
One leap for Gilenya that may help forecasts like these come true is the potential for the drug to expand from approval of
the more common relapsing-remitting form of MS to the less common but more severe primary-progressive MS (PPMS). While RRMS
is characterized by symptom flareups followed by periods of complete or partial recovery (remission) that may last days, weeks,
months, or years, PPMS is a more steady onset and progression of disabling symptoms, without the fluctuation of relapses and
Gilenya is currently being studied in PPMS in the three-year, Phase III INFORMS (INvestigating Fingolimod ORal in primary
progressive Multiple Sclerosis) study, which is on track to deliver results in 2014. The primary endpoint of INFORMS is to
evaluate the effect of Gilenya relative to placebo on delaying the time to sustained disability progression for patients treated
for at least 36 months. The company says it is still too early to discuss potential filing timelines or results.
Making the Switch
With forecasts like these, and such positive safety and efficacy profiles, will patients rush en masse to abandon their current
treatments in favor of Gilenya? "People have been on these other drugs for a long time and they seem to be doing quite well,"
says Dr. Burks. "And the fact is, [with Gilenya], you're changing the mechanism of action. And any time you're changing mechanism
of action for any treatment—since we don't know the mechanism of MS—I think we have to be cautious. You must remember, neurologists
are conservative by nature; we're not therapeutic nihilists, but we are very careful about giving our patients drugs that
we don't have the full data on."
Stachowiak also weighs in on the importance of mechanism of action. "As much as I hate injecting, I don't think it is a reason
to switch from something that is working for you."
That said, Burks is cautiously optimistic that Gilenya may be the right option for many people, but one that needs to be considered
on a case-by-case basis. "If you get a shot every day for 10 years—that's 3,650 shots—I can understand why people would say,
'Okay, enough is enough.' The key is that if we follow the precautions that make sense, then I feel comfortable giving this
to patients who I feel will truly benefit from the drug."
The Winning Formula
So what did Novartis do right to earn designation as owner of Brand of the Year? It's an old story that is often neglected
in all the studies and reports that call for a "new business model" in R&D. From rescuing a not-so-promising transplant compound
to its commercialization as a drug that Datamonitor predicts "will become the leading therapy in MS," the simple persistence
of clinicians at the bench was the driving factor in success. "One of the paradigms that we work hard to set up at Novartis
is that when we have a new therapy, we try to not be locked in to our assumptions as to where it's going to work; we explore
quite broadly in smaller and earlier studies," says Mundel. "We let the compound prove or disprove itself in a wide range
of areas ... effectively letting the data drive where a drug ends up."