Product Profiles: Multiple Sclerosis - Gilenya Raises Bar for New Market Entrants

14 Jul 2011 • by Natalie Aster

“Beginning with the recent approval of Gilenya (Novartis; fingolimod), MS patients are experiencing the arrival of more effective and less invasive treatment options after numerous years of limited therapeutic options. As competition intensifies, the need for less invasive modes of administration will be met and new drugs will have to compete on other factors, such as efficacy.”

The recent survey “Product Profiles: Multiple Sclerosis - Gilenya Raises Bar for New Market Entrants” by Datamonitor reveals that US neurologists prescribe Gilenya because of its strong efficacy in treatment resistant patients as well as its convenient oral mode of administration. However, long term cancer and infection risk remain the main concerns.

The multiple sclerosis market has been lucrative for drug companies over the last decade with limited competition and periodic price increases. However, as this dynamic is changing with increased competition, existing players are expanding their portfolios with new and improved therapies.

Monoclonal antibodies have demonstrated potent efficacy in Phase II trials, surpassing all existing therapies. However, excitement is tempered with safety concerns that include risk of malignancy and severe infections. Still, as seen with Tysabri, impressive efficacy may outweigh the risks for more severe multiple sclerosis patients.

Report Details:

Product Profiles: Multiple Sclerosis - Gilenya Raises Bar for New Market Entrants

Published: June 2011

Pages: 199

Price: US$ 11,400.00

Report Sample Abstract

An established safety profile and proven efficacy over the years drives uptake

Based on evidence from pivotal clinical trials and years of patient experience, it is widely accepted that Avonex is reliable in reducing future disease activity and improving quality of life for many individuals. Although there are no clear guidelines recommending how long a patient should remain on Avonex, its safety and side-effect profile is relatively benign compared to that of Gilenya, and Avonex may be used to treat patients until they no longer want treatment, it stops working (i.e. the patient is getting worse), or the patient develops another serious illness that contraindicates its use.

Avonex is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation. The lyophilized vial formulation is also contraindicated in patients with a history of hypersensitivity to albumin (human). Depression, suicidal ideation, and new or worsening other psychiatric disorders have been observed to be higher in patients using interferon compounds including Avonex. Other reported adverse reactions reported from the use of Avonex include anaphylaxis and other allergic reactions, decreased peripheral blood counts, hepatic injury, including hepatic failure, hepatitis and elevated serum hepatic enzyme levels, seizures, cardiovascular adverse events, and autoimmune disorders (Avonex prescribing information, 2011).

Development overview

Tysabri was evaluated in two randomized, double-blind, placebo-controlled trials in patients with multiple sclerosis. In study one, 942 patients were enrolled on the basis of having had at least one clinical relapse during the prior year and having not received any interferon beta or glatiramer acetate for at least the previous 6 months. In the second study, patients who experienced one or more relapses while on 30mcg of Avonex (interferon beta-1a) were recruited. Patients were randomized to a placebo and Tysabri while continuing to receive Avonex. At the end of the 2-year study, time to onset of sustained increase in disability was longer in Tysabri-treated patients than in placebo-treated patients.

More information can be found in the report “Product Profiles: Multiple Sclerosis - Gilenya Raises Bar for New Market Entrants” by Datamonitor.

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