Study # 66, 102 pages
Michelle A. Grady; Michael McGuill M.P.H.
Multiple sclerosis (MS) is the second most common cause (after trauma) of neurological disability in young and middle-aged adults. MS progresses at different rates in different patients; progression results in increasing levels of disability. Lacking a cure for the disease, physicians have long relied on disease-modifying immunosuppressant therapies. The first such therapy, interferon-beta (IFNb)-1b (Schering’s Betaferon/Berlex’s Betaseron) reached the U.S. market in 1993. Since then, several other disease-modifying therapies—IFNb-1a (Biogen’s Avonex and Ares-Serono’s Rebif) and glatiramer acetate (Teva’s Copaxone)—have been commercialized in several of the world’s seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom, and Japan).
These agents have revolutionized MS treatment because they offer unmatched efficacy in reducing the frequency and severity of relapses and, in some cases, slowing disease progression. However, most of these drugs have proved effective in only one form of the disease: relapsing-remitting MS (RR-MS). Approximately 65% of the prevalent MS population suffers from RR-MS. Developers’ efforts to establish the usefulness of these agents in other forms of the disease—secondary progressive (SP), primary progressive (PP), and progressive relapsing (PR)—have been problematic, and approval for use of some of these drugs in indications beyond RR-MS is doubtful.
Key findings of this Pharmacor study include the following:
The number of prevalent cases of multiple sclerosis in the major pharmaceutical markets totaled 590,200 in 2001. Because there is no evidence of a true increase in MS, we assumed constant age- and gender-specific prevalence to estimate 628,800 prevalent cases in 2011, the end of our study period.
Key unmet needs:
Unmet needs in MS management include disease reversal; prevention of disease progression; improved therapies for chronic progressive forms of MS; induction and maintenance of remission; more convenient formulations.
Avonex, already established as the RR-MS market leader in the United States, will lose significant U.S. market share following Rebif’s launch in March 2002. Ares-Serono submitted data from the comparator EVIDENCE trial of Rebif and Avonex to the U.S. Food and Drug Administration in order to break Avonex’s orphan drug status. These trial results show that Rebif has greater efficacy at 24 and 48 weeks; most thought leaders suggest that it does primarily owing to higher dosage: thrice weekly for Rebif versus once weekly for Avonex. Once launched in the United States, Rebif will be quickly adopted into medical practice for treatment of RR-MS, primarily at the expense of Avonex. The EVIDENCE trial results will also negatively impact Avonex’s RR-MS prescription share in Europe between 2001 and 2006, but rapid growth in the number of drug-treated MS patients in Europe will generate increased sales of this drug.
Of the therapies in development, the most promising and most advanced is Élan’s natalizumab, a monoclonal antibody now in Phase III trials. Thought leaders interviewed for this study say that natalizumab promises to reduce the number of MS relapses and may delay progression of the disease. This drug is being developed for treatment of chronic progressive MS and is being tested as an adjunct to IFNb-1a (Biogen’s Avonex). We forecast peak-year sales of natalizumab in the range of $250-500 million.
Schering, Biogen, and Ares-Serono are all vying for MS market leadership by expanding into other clinical forms of MS. Schering’s drug, IFNb-1b, has obtained approval in Europe for treatment of SP-MS. However, we do not anticipate that Schering will gain approval for this indication in the United States or Japan. Furthermore, we do not expect the Biogen or Serono products to be approved for SP-MS in the U.S., European, or Japanese markets. In light of data from clinical trials of IFNb-1b and Rebif for SP-MS, we believe that IFNb will most likely be used only for SP-MS patients who continue to experience relapses—a niche subgroup that we estimate is approximately 25-30% of the chronic progressive MS population. This regulatory trend is already apparent: at the end of 2001, Rebif obtained approval from the European Agency for the Evaluation of Medicinal Products (EMEA) to include treatment of relapsing SP-MS patients in its European labeling.
The market for agents to treat MS totaled $2.1 billion in 2001. During the course of our ten-year study period, primary factors that will influence pharmaceutical sales will include earlier initiation, worldwide, of disease-modifying therapies; the launch of Rebif in the U.S. market; and the failure of interferon beta to gain approval for the SP-MS indication. We expect that the most likely impact on the MS market will be a moderate increase in overall sales by the close of our study period.
This Pharmacor study opens with an Executive Summary, designed to highlight
key strategic issues and trends that are discussed in detail in the main
text. In accessing the Executive Summary electronically, you will find
convenient hyperlinks to pertinent sections of the main text. Also available
to those accessing this study electronically is Decision Resources’ proprietary
Interactive Forecast Tool (IFT). The IFT provides quantitative assumptions
and calculation tables to support our seven-country market forecast. Additionally,
the IFT allows clients to explore market alternatives by modifying or introducing
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