The treatment was launched in Europe in 1998. In March 2002 FDA approved Rebif, overriding Avonex's orphan drug status, the
first time the agency has done so based on efficacy. The head-to-head data from its comparison study with Avonex were compelling
enough that FDA decided patients needed the new option. (See "Head to Head,")
"We changed the mindset of consumers," says Paul Lammers, the US unit's chief medical officer. "They used to have the idea
that, 'Well, let's try this for a while, and if it doesn't work, let's go up a bit.' Now the concept of treating early and
with higher doses has really been established with Re-bif. For patients, this means long-term efficacy now and less disability
The franchise also includes Novantrone (mitoxantrone), indicated for reducing neurological disability in patients with worsening
MS. Pusey sums up the franchise this way: "Our overarching goal is to make a profound difference in the daily lives of people
with MS. In 2004 we made great strides toward this goal with the launch of Rebif product enhancements, including the Rebiject
II and 29-gauge needle, and the addition of MS LifeLines Nurse Educators, a program that provides education and in-home training."
The franchise is expected to continue to grow. Rebif's sales increased 49 percent in 2003, and they are projected to top $1
billion in 2004. But Serono's brightest star could also be its greatest vulnerability. Recently approved by FDA is a multiple
sclerosis product called Tysabri (natalizumab) from Biogen and Elan that could take some wind out of Rebif's sails.
MS Market Shakeup
So far the buzz for Tysabri (previously know as Antegren) is based on data from clinical trials that compare the drug with
placebo. In those studies, Tysabri reduced the rate of relapses (temporary worsening of symptoms) by 66 percent compared with
no treatment. Biogen/Elan researchers also tested the drug in combination with Avonex against placebo, and together they reduced
relapse rates by 54 percent.
What the research did not do was to test Tysabri in head-to-head studies against other products. MS experts point out that
each control group is unique and that the only way to determine a product's superiority is by direct comparison.
When asked about Tysabri, Serono's US executives are quick to note several things: 1) Biogen's Amevive (alefacept) failed
to live up to its claims, 2) Biogen and Elan only released partial data for Tysabri, and 3) prevention of relapses is not
the only measure of how well a MS drug—and its patients—are doing; a drug must also slow the progression of the disease.
"We welcome any new product for MS patients because there is still unmet medical need out there," Firouz says. "But are we
afraid of the competition? No. We entered the market here two years ago as the number-four player, and we now have nearly
20 percent of new-prescription share. We had three competitors to go after, and we're going to deal with natalizumab in the
same way—step by step, with the right resources at the right time. I am confident that we will achieve market leadership with
Rebif by 2006."
The multiple sclerosis market has been a hard-fought battle among four competitors: Serono's Rebif, Biogen's Avonex, and Schering
AG's Betaseron (all a form of recombinant interferon beta 1a) and Teva's Copaxone (glatiramer). After Rebif was approved in
Europe, it quickly gained market leadership there. Serono muscled its way into the US market in 2002 by overcoming the orphan
drug status of Avonex, and it soon partnered with Pfizer to sell Rebif in the United States. In its first year here, sales
grew 165 percent, quickly earning it a 17 percent share in the MS arena.
Putting Rebif up against Avonex—two biologics based on the same protein—was another bold move for Serono. Says Lammers: "The
company felt really confident about what we had seen so far in terms of profiles. Therefore we were willing to take this calculated
risk, and it paid off." In another confident move, Serono has head-to-head studies under way comparing Rebif with Copaxone.