Multiple Sclerosis | Pharmacor | G7 | 2015

Last Updated 2 October 2015
A new era in the market for multiple sclerosis (MS) disease-modifying therapies (DMTs) has dawned: Novartis/Mitsubishi Tanabe Pharma’s fingolimod (Gilenya/Imusera) and Biogen’s dimethyl fumarate (Tecfidera) have partially fulfilled a pent-up demand for effective oral DMTs, although evolving safety experience with these drugs underscores a persistent clinical role for platform injectable therapies (e.g., interferon-βs, Teva’s glatiramer acetate [Copaxone]). In later lines of treatment, Genzyme/Sanofi’s Lemtrada (alemtuzumab) is the first of several new and potent monoclonal antibodies set to reach the market as MS thought leaders increasingly question the paradigm of escalation in MS treatment. Moreover, the first generic MS DMT—Sandoz/Momenta’s Glatopa (glatiramer acetate 20 mg/mL)—has reached the U.S. market, providing payers with long-awaited leverage to begin to rein in the high cost of therapy in the U.S. MS market. Over the next ten years, a wave of new product launches for the treatment of relapsing forms of MS, including novel products and useful follow-ons, will further shift an already complicated treatment algorithm and further fragment the market. Meanwhile, drug developers have re-sharpened their focus on developing neuroprotective or reparative treatments and therapies for progressive forms of MS—a perennially underserved population with few therapeutic options. The launch of premium-priced novel therapies, coupled with moderating U.S. price increases, will drive considerable growth in the market by 2018. Nevertheless, we expect that uptake of novel therapies will be tempered by a conservative prescriber base faced with a relative lack of long-term safety data and clinical experience with novel agents, the absence of prognostic and theranostic markers needed to help guide tough treatment decisions, and the presence of generic oral therapies on the market.