More MS news articles for Jan 2002

Are new multiple sclerosis treatments about to rock the market?

http://www.datamonitor.com/~07681e9baebf474a88e2c36afe9338cd~/healthcare/news/product.asp?pid=A5C7E95B-95DD-4EBC-AF4D-76337366966E

25 Jan 2002

Multiple sclerosis is a chronic and unpredictable disorder, with debilitating physical and mental symptoms. However, there are few approved treatments - and most of the ones that do exist are largely confined to speeding recovery from acute attacks of the disorder or to managing symptoms. Will new pipeline MS drugs steal the market leaders' hold?

Competition between the major multiple sclerosis (MS) players is fierce, as the market is not yet mature, and the effects of what drugs there are overlap. Manufacturers have therefore strived to exploit any advantage of their drug over rival compounds to the full.

"Efforts to extend product lifecycles include obtaining new indications for subtypes of MS and producing novel formulations," says Datamonitor healthcare analyst Anna Strudwick. "There have also been recent regulatory changes affecting the market, adding up to an upcoming therapeutic area."

The MS market is currently dominated by MS-specific treatments: Betaseron, Avonex, Rebif and Copaxone. But none of these treatments actually offer a cure for the disease, despite these opportunities for manufacturers wishing to enter the market the R&D pipeline is still inactive.

Biogen's Avonex is currently the MS market leader, with sales of $761 million in 2000. However, two recent head-to-head clinical trials have found that Avonex is less effective than either Serono's Rebif or Berlex (part of Schering-Plough) and Chiron's Betaseron. Ms Strudwick believes these results will "limit Avonex's continued ascendancy."

Checking out the EVIDENCE

In the EVIDENCE study, which compared Avonex with Rebif and Betaseron, Rebif was found to be significantly more effective than Avonex in terms of all clinical outcome measures. Patients on Rebif had a lower rate of MS exacerbations, and a higher proportion remained exacerbation-free than patients on Avonex.

At the same time, Rebif reduced the number of active lesions by a third compered with Avonex, and the proportion of patients with no active lesions at the end of the study was significantly greater in the Rebif group.

Injection site reactions were more common in the Rebif group, largely because the drug needs to be administered more frequently. However, there was no difference regarding serious adverse events, which were infrequent in both groups.

Unsurprisingly, Biogen has put up considerable opposition to the EVIDENCE study. The company claims that the study was misleading and lacked scientific vigor. Biogen has contended that the results were statistically manipulated to present Rebif in a more positive light, and that the trial was too short in duration.

Biogen fights to stay ahead

Biogen's challenge has been partly successful: in June 2001, a Swiss court injunction was issued forbidding Serono to continue claiming that those treated with Rebif in the study had a 90% greater chance of remaining relapse-free, as the statistical basis of this claim was misleading. However, the fact that the presentation went ahead at the World Congress of Neurology anyway suggests that the study may still have some influence.

In the US, where Rebif is unavailable due to Avonex's orphan drug exclusivity, Serono has submitted the EVIDENCE results to the FDA. According to Ms Strudwick, "this evidence is likely to be successful in allowing Rebif's launch in the US in 2002 before Avonex's orphan drug status runs out in 2003. Rebif's case will be boosted by its position as the leading RRMS treatment outside the US."

However, EVIDENCE isn't all bad news for Biogen. The trial showed that both drugs can delay the progression of the disease, and as a result Ms Strudwick expects that "the EVIDENCE findings will have a positive impact of 5-10% on sales of these drugs as they will effectively extend the MS treatment window."

Meanwhile, back at the lab...

In the long term, the biggest threat to Avonex will come from drugs further back in the pipeline. Copaxone is leading the competition in terms of new drug formulations. However, disappointing results from a Phase III trial of oral Copaxone suggest that it will not be launched until 2007.

Meanwhile in the UK, the cost-effectiveness and consequent revenue potential of the MS specific treatments has been put in doubt by proposed NICE guidelines. However, Ms Strudwick believes "the initiation of extensive UK clinical trials will counteract this factor to some extent, resulting in only a modest negative impact of around 0.1% on the global market."

"The predominant factor influencing the MS market will be the continued uptake of MS specific drugs in interferon naive patients. This immaturity will drive the market's growth through to 2008," she adds.

However, the launch of several novel drug classes from 2006 onwards is unlikely to have an impact on the overall market size, as the main uptake of these drugs will be as a replacement for the currently marketed products.

Old favorites fare well

In the meantime, Ms Strudwick believes that "the marketed drugs will dominate the MS market. The aggressive measures pursued by all of the manufacturers of these drugs to extend their lifecycles, such as efforts to gain new indications, will ensure that sales continue to be strong."

Only the recently launched Novantrone is expected to have any impact on the market standards' sales figures, but even that is unlikely to have any substantial effect, as Novantrone is indicated for secondary progressive MS whereas the predominant usage of the marketed drugs is currently for relapse/remitting MS. As well as this, Novantrone is hindered by its side effect profile, which is considerably worse than the marketed drugs.

For now at least

However, the launches of several new drug classes in 2006 and 2007 will make a significant impact on the currently marketed products, resulting in a reduction in their sales.

According to Ms Strudwick "these drugs will affect interferons sales more than Copaxone, as the expected launch of the oral formulation of Copaxone in 2007 will counteract the negative impact to a certain extent. Until then Avonex looks set to rule the roost."