Market Analysis From Decision Resources
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Multiple Sclerosis
|
Market Analysis From Decision Resources Multiple Sclerosis U.S. Market Description There were 287,800 total prevalent cases of MS in the United States in 2001 (247,500 diagnosed), which is expected to rise to 305,100 in 2006 (262,400 diagnosed) and 318,500 in 2011 (273,900 diagnosed). U.S. sales of MS therapies are expected to grow from $1.3 bil. in 2001 to $2.2 bil. in 2011. Approximately 60% of MS patients receive drug therapy. Major Treatments Multiple sclerosis is divided into relapsing-remitting or chronic progressive MS, which includes primary progressive (PP MS) and secondary progressive (SP MS). Relapses are the clinical expression of acute inflammatory focal lesions in the CNS, while progression is thought to reflect the occurrence of demyelination, axonal loss and gliosis. Disease-modifying immunosuppressant therapies, most commonly beta interferons (IFN), are used to treat MS. Several recombinant beta IFNs are available: Berlex/Chiron's Betaseron (IFN beta-1b), Biogen's Avonex (IFN beta-1a) and Serono's Rebif (IFN beta-1a). Avonex had been the first choice of most physicians because of its convenient once-weekly administration and lower association with neutralizing antibodies. However, FDA broke Avonex' orphan drug marketing exclusivity to approve Rebif because of its greater efficacy, which Serono is emphasizing to switch Rxs. Teva's Copaxone (glatiramer acetate) is generally a second-choice therapy, although it is increasingly used first-line in patients with early-stage/mild disease due to its superior tolerability. Serono's Novantrone (mitoxantrone) is an option for patients with very active RR MS, but use is limited due to cardiac risks associated with long-term use. Corticosteroids, methotrexate and azathioprine are also used to treat MS. Few treatments are available for chronic progressive MS, and sponsors have had difficulty demonstrating efficacy in this group. Trials so far have suggested that IFN beta is most effective in the minority of SP MS patients who continue to relapse. Betaseron recently was approved for use in this subpopulation. Market Needs The chief unmet medical need is for an MS therapy that can reverse neurological damage and disability by repairing injured axons and myelin. The need for therapies that prevent progression of MS is equally important. Disease-modifying drugs have shown some efficacy in slowing disease progression, but long-term benefits are controversial. Treatments for CP MS are needed. There is a desire for noninjectable therapies, especially as treatment shifts to early-stage disease. Attempts to develop inhaled and oral formulations of IFN beta and glatiramer have been disappointing. Leading Investigational Agents Drugs in the pipeline are not likely to fulfill the need for agents that can stop progression and reverse the disease. Development of IFN beta is focusing on new indications for early MS and chronic progressive MS. Like IFN beta, monoclonal antibodies are expected to be most efficacious in RR MS and SP MS patients who are actively relapsing. Biogen/Elan's Antegren (natalizumab) is in Phase III. Ilex' Campath (alemtuzumab) and Protein Design Labs' daclizumab have been evaluated in Phase II trials with mixed results. Alemtuzumab is not expected to gain approval. Altered peptide ligands, such as Corixa's AG-284 and BioMS' MBP-8298 (both in Phase II), are being studied as agents that could act on multiple immunological processes. New Product Outlook Clinical trial results have been disappointing across the pipeline. Despite the approval of new drugs, IFN beta will remain the dominant choice of therapy, representing an estimated 74% of the U.S. market in 2006 and 67% in 2011. Physicians are beginning to shift toward treatment earlier after diagnosis. Avonex was the first IFN to get an indication for early MS, in January; other IFNs are expected to gain the indication by 2006. Betaseron could regain market share with its new indication for relapsing SP MS. While the agent's total U.S. sales for MS were less than half those of Avonex in 2001 ($277 mil. vs. $710 mil.), Betaseron had higher sales for chronic progressive disease ($148 mil. vs. $109 mil.). Combination use is another potential new indication for IFN beta as the agents have a different mechanism of action than Copaxone, the most commonly used therapy after IFN beta. Although new formulations of IFN beta are highly unlikely, the market opportunity exists for more convenient formulations; Betaseron's room-temperature formulation and Copaxone's prefilled syringes could capitalize on this need. Monoclonal antibodies are also expected to drive market growth. Antegren is expected to launch in 2006 as monotherapy and as an adjunct to Avonex for RR MS; peak sales in the U.S., major European markets and Japan are projected at $250 mil.-$500 mil. Other monoclonal antibodies will have difficulties gaining market share. Decision Resources, Inc.'s report on multiple sclerosis, issued May 2002, is available through the Cognos subscription service. Each study is international in scope, covering seven major pharmaceutical markets: the U.S., France, Germany, Italy, Spain, the U.K., and Japan. For information, contact Frank Sama at 781-296-2553, or by e-mail at [email protected]. |