IHS Global Insight Perspective | |
Significance | Japan's MHLW has given its approval to four drugs from Lilly, GSK, Novartis and Janssen respectively. |
Implications | The accelerated review status for everolimus in Japan may soon see the drug join the U.S. market, achieving Novartis's expectation of next blockbuster. |
Outlook | With the Japanese regulator prioritising oncology drug development and approval, Novartis is likely to gain momentum with its ever-expanding portfolio of anti-cancer treatments. |
Japan's Ministry of Health, Labour and Welfare (MHLW) has granted its approval to new drugs including U.S. drug major Eli Lilly's Strattera (atomoxetine) for the treatment of attention deficit hyperactivity disorder (ADHD) in paediatric patients, GlaxoSmithKline's (GSK, U.K.) Allermist nasal spray (fluticasone furoate) for allergic rhinitis treatment, Swiss major Novartis's Clozaril (clozapine) for treatment-resistant schizophrenia and Janssen's (U.S.) Doxil (doxorubicin) for the treatment of recurrent ovarian cancer. According to Pharma Japan, MHLW also granted fast-track review status to Novartis's everolimus in the treatment of unresectable or metastatic renal cell carcinoma (RCC).
Novartis's Treatments Gain Momentum
Earlier this year, IHS Global Insight reported that the MHLW approved 15 new drugs in Japan, four of which were from Novartis, namely leukaemia treatment Tasigna (nilotinib), hypertension drug Co-Diovan (valsartan + hydrochlorothiazide), asthma treatment Xolair (omalizumab) and wet age-related macular degeneration (AMD) therapy Lucentis (ranibizumab) (see Japan: 21 January 2009: MHLW Green Lights Takeda, Novartis, Astellas, Ono, Dainippon Drugs in Japan). During the latest round of new drug approvals, Novartis snatched one more regulatory green light for its antipsychotic drug Clozaril although on the condition of using a rigorous monitoring system. Nevertheless, similar monitoring systems were also applied in the United States, United Kingdom, Canada and Australia out of the nearly 100 countries in which it has been approved.
On the other hand, the fast-track review status for its RCC treatment everolimus also projected a promising outlook for the drug's profile and potential approval in Japan. Recently approved in the U.S. market under the brand name of Afinitor, Novartis is expecting everolimus to become the next blockbuster (see Switzerland: 31 March 2009: Novartis Expects Blockbuster Sales as FDA Approves Afinitor for Advanced RCC).
Outlook and Implications
On top of the four new drugs approved in Japan earlier this year, the approval of Clozaril and accelerated review of everolimus will largely expand Novartis's product portfolio in the world's second-largest market, especially in the field of oncology treatments. In line with the Japanese regulator's prioritisation of oncology drugs, Novartis is likely to gain momentum in Japan's cancer drug market. Everolimus may soon join the U.S. market in the realisation of its blockbuster expectation.
For Lilly, the approval of Strattera will help to boost the drug's sales, which increased by 7% year-on-year to US$158.9 million in the first quarter of 2009 (see United States: 21 April 2009: Eli Lilly Reports 5% Rise in Q1 Sales on Higher Volume and Prices). In terms of Janssen, the regulatory approval of Doxil's additional indication will strengthen the company's oncology focus in Japan and encourage the expansion of the drug's indication for breast cancer treatment (see United States - Japan: 24 November 2008: Janssen Enhances Strength in Oncology in Japan).