Over the past couple of days, companies in Japan have begun announcing the launches of a number of potentially important new drugs, following on from National Health Insurance (NHI) price approval on 12 September.
IHS Global Insight Perspective | |
Significance | A number of drugs that were approved for marketing on 1 July received National Health Insurance (NHI) price approval on 12 September, and have been launched onto Japan's market. |
Implications | The new launches include Mitsubishi Tanabe's Simponi (golimumab), Astellas' Betanis (mirabegron), Taiho's Zolinza (vorinostat) and two brands of minodronic acid: Astellas' Betanis and Ono Pharmaceutical's Recalbon. |
Outlook | Among the new launches, two products that are likely to attract particular attention are Simponi and Betanis—the former because it has already established a strong international profile, and the latter because Astellas has high global aspirations for the brand. |
The recent swathe of launches, which relates to products that received marketing authorisation on 1 July (see Japan: 4 July 2011: MHLW Approves 34 New Drugs, Indications Including Gardasil, Simponi and Onbrez), include Mitsubishi Tanabe's Simponi (golimumab), Astellas' Betanis (mirabegron), Taiho's Zolinza (vorinostat) and two brands of minodronic acid: Astellas' Bonoteo and Ono Pharmaceutical's Recalbon.
Simponi
Mitsubishi Tanabe today began co-marketing Simponi Subcutaneous Injection 50-mg Syringe with Johnson & Johnson (US)'s Janssen subsidiary, both using the same brand name. The product, which was co-developed by the two companies for the Japanese market, has been approved for the treatment of rheumatoid arthritis (including cases of articular structural damage) in cases showing inadequate response to conventional therapies. One of Simponi's main advantages over other treatments is that it is designed to be administered every four weeks, and so will reduce the frequency of hospital visits.
Betanis
Also on 16 September, Astellas began marketing Betanis, which is available in once-daily 25-mg and 50-mg tablet presentations. The product has been approved for treating urgency, urinary frequency and urge urinary incontinence associated with overactive bladder (OAB).
Astellas is already well-established in the OAB category, courtesy of Vesicare (solifenacin succinate), which was launched in Europe in 2004, the US in 2005 and Japan in 2006. The company is anticipating that Betanis' peak sales in Japan will reach JPY11.1 billion (USD114.7 million) in fiscal year (FY) 2020.
Bonoteo, Recalbon
The launch of Betanis coincides with that of another drug from Astellas, a 50-mg, once-per-four-week version of the osteoporosis treatment minodronic acid hydrate, which has been branded as Bonoteo. Minodronic acid hydrate was jointly developed with Ono Pharmaceutical, which is launching the drug under a separate brand name, Recalbon. Each product has been priced at JPY3,433.40.
A one-a-day 1-mg version of Bonoteo and Recalbon had been launched in April 2009, but clinical studies demonstrated that that the 50-mg version is equally effective and has comparably low side effects. Combined sales of all presentations of the drug by both companies are expected to reach JPY32.0 billion in FY 2015.
Zolinza
Meanwhile, Taiho announced that it launched Zolinza (100-mg capsules) on 14 September, with an indication for the treatment of cutaneous T-cell lymphoma (CTCL). The drug, which was granted orphan drug status by Japan's Ministry of Health, Labour and Welfare (MHLW) in June 2010, has benefited from an expedited approval process (see Japan: 12 June 2010: Merck Files NDA for CTCL Drug Vorinostat in Japan).
Taiho is marketing and distributing Zolinza in Japan on behalf of US company Merck's MSD division, which holds the marketing authorisation for the drug. It has been priced at JPY5,462.80 per capsule.
Outlook and Implications
In terms of sales, the most significant of the launches mentioned above are likely to be Simponi and Betanis. In the case of Simponi, the drug already has a strong international track record, and has been approved in over 40 countries, having originally been approved in the United States and Europe in 2009. That said, it suffered a setback in the US in July, when the FDA rejected an application for a new indication for Simponi in the treatment of moderate-to-severe rheumatoid arthritis.
In the case of Betanis, Astellas has aspirations to market mirabegron throughout the world, and last month submitted a New Drug Application (NDA) and a Market Authorisation Application (MAA) for the drug to the US FDA and European Medicines Agency (EMA) respectively (see United States: 31 August 2011: Astellas Applies to Market OAB Drug Mirabegron in EU and US). Meanwhile, Astellas is currently conducting a multi-regional Phase III study for mirabegron in China, India, South Korea and India. Astellas is expecting that Betanis's global sales will amount to approximately JPY50 billion in 2014.