IHS Global Insight Perspective | |
Significance | Swiss-based pharma giant Novartis' MS pill Gilenya (fingolimod) gained European Union approval on Friday (21 January), making it the first oral multiple sclerosis (MS) drug to access the European market. |
Implications | Novartis confirmed its leading position as rival Merck KGaA faced another major blow with the rebuff of its own MS pill cladribine, rejected for the second time by the Committee for Medicinal Products for Human Use (CHMP) on cancer safety issues. |
Outlook | The future looks bright for Novartis whose first-to-market position in the MS pill market in the United States and Europe will remain uncontested for a few more months. |
Success for Gilenya in Europe
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Novartis' (Switzerland) multiple sclerosis pill Gilenya (fingolimod) for patients with highly active relapsing-remitting multiple sclerosis (MS) despite treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS. Gilenya was approved on the back of data showing a reduction of relapses by 52% at one year compared with Avonex (interferon beta-1a, Biogen, U.S.), one of the most commonly prescribed treatments for MS. The CHMP noted that the benefits with Gilenya are its ability in reducing the number of relapses in patients with relapsing-remitting multiple sclerosis. The most common side effects were influenza viral infections, headache, diarrhoea, back pain, cough and elevated liver enzyme (known as ALT).
CHMP Rebuffs Cladribine for Second Time
Novartis confirmed its leading position at a time when rival Merck KGaA faced another major blow with the rebuff of its own MS pill cladribine, rejected for the second time by the CHMP on cancer safety issues. The CHMP adopted a first negative opinion in September 2010, an opinion which was re-examined on Merck KGaA's request (see Germany: 27 September 2010: CHMP Issues Negative Opinion for Merck KGaA's MS Pill). But after re-examination of the initial opinion, the committee confirmed the refusal of the marketing authorisation on 20 January 2011. The CHMP has particular concerns about the medicine's safety as an increased number of patients with cancer were observed in clinical trials with Movectro (cladribine) compared with the control group. The committee also noted that the benefits and the most appropriate dosage for treatment had not been fully established in patients who were expected to use the medicine.
Outlook and Implications
The successful approval of Gilenya gives a leg up to Novartis which nabs a sought-after first-to-market position in Europe ahead of its German rival Merck KGaA, as was already the case in the United States (see Switzerland: 22 September 2010: Novartis Wins Final FDA Nod for Oral MS Drug). Gilenya's U.S. price which culminates at around US$4,000 per month makes it the most expensive MS drug available on the market. But Novartis pays as much as US$800 in out-of-pocket costs for non-Medicare patients who use Gilenya, reported Bloomberg. According to the source, Novartis also pays as much as US$600 per patient for testing and monitoring recommended by the U.S. FDA. This aggressive strategy is obviously aimed at convincing patients to switch from their current treatment to Gilenya despite the expensive price at which it is available. This is expected to boost Gilenya's sales performance in the United States and particularly hurt sales of Biogen's (U.S.) injectable drug Avonex (interferon beta-1a) which garnered revenues of US$2.3 billion in 2009. Novartis can expect blockbuster sales from its MS pill, especially as no real competitors are set to enter the market in the coming months in the U.S. and European markets.
Meanwhile, Merck KGaA said it remains committed to completing the ongoing clinical trials with cladribine. Setbacks faced in the United States and in Europe will prevent Merck from benefiting from first-mover advantage but will also impede it from closing the gap in sales left by patients switching from its current MS products to take the much more comfortable treatment offered by Novartis. Results from ongoing studies (due at the end of 2011 and in the first half of 2012) will therefore be determinant for the future of Merck's MS portfolio. If positive, the German company can hope to see its MS pill approved in Europe, but still not before 2012-13. However, the chances of success look thin as Merck is also facing delays in the United States where the FDA recently extended the drug review period by three months (see United States: 26 November 2010: FDA Extends Priority Review Period of Cladribine by Three Months). Merck's failure in Europe will certainly not help to convince FDA experts.