Novartis Presents Positive Data - Analyst Blog

Novartis (NVS) presented encouraging data on one of its investigational candidates, Gilenia at the annual meeting of the American Academy of Neurology (AAN). The drug is meant to treat relapsing forms of multiple sclerosis (MS) orally. 

Novartis conducted two pivotal phase III clinical trials – TRANSFORMS and FREEDOMS. The two-year FREEDOMS study showed that Gilenia (dosage of 0.5 mcg) reduced annual relapse rates (ARR) by 62% in treatment naïve patients compared to placebo. Additionally, ARR came down by 44% for patients undergoing treatment. 

The TRANSFORMS study, conducted for over a period of one year, was aimed at evaluating Gilenia’s efficacy in two dosage forms (0.5 mg and 1.25 mg ) compared to Biogen Idec’s (BIIB) Avonex (injectable). It was observed that Gilenia (0.5 mg) reduced relapse rates by 52% compared to Avonex while the improvement in the higher dose version was less at 38%.
 
This study was extended for one year in which 1027 (89% of the 1153 patients of the original study) patients participated. It was observed that patients taking Gilenia (0.5 mg dosage) for two years experienced lower ARR. We also note that for those patients who were on Avonex in year one and Gilenia (0.5 mg dosage) in year two, the ARR in the second year was lower by 31%. 

Novartis has already submitted the application for regulatory approval of Gilenia (in 0.5 mg dosage) to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in December 2009. The FDA granted priority review status to the drug in February 2010, which reduces the standard 10-month review period to six months (June 2010). 

However, the FDA has asked for an advisory committee meeting to evaluate the risk/benefit profile of Gilenia since it involves a new active ingredient. The meeting, scheduled for Jun 10, 2010 can extend the review process beyond the six month period. 

MS is an inflammatory and neurodegenerative condition that affects almost 2.5 million people globally. However, the market is highly competitive with the presence of products such as Biogen’s Avonex ($2.3 billion in revenues in 2009) and Tysabri ($1.1 billion), Teva’s (TEVA) Copaxone ($2.8 billion) and Merck KGaA’s Rebif (€1.5 billion).
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