IHS Global Insight Perspective | |
Significance | Chuikyo has okayed the pricing of 12 drugs to be listed in the country's NHI formulary on 11 June, primarily including the products approved by the MHLW in April. However, Victoza's pricing has been approved with this round after a two-month delay following the previous disagreement in its price between Novo Nordisk and Chuikyo. |
Implications | The listing decisions will see a wave of imminent launches of new products in the Japanese markets including new molecular entities such as alogliptin, ramelteon, liraglutide and eculizumab. |
Outlook | The five drugs to be listed and launched will give Takeda's domestic portfolio a significant boost especially with Nesina's first worldwide launch. Also in the diabetes treatment market, Victoza is now the first GLP-1 treatment approved and ready for commercialisation in Japan ahead of its main competitors like Lilly's Byetta. |
Japan's Central Social Insurance Medical Council (CSIMC, Chuikyo) has granted its positive opinion to the National Health Insurance (NHI) listing of 12 drugs, including seven new molecular entities (NMEs), at a meeting held on 2 June, according to a report by Yakuji. This round of recommended listing will be officially published in the country's NHI price list on 11 June 2010, added the source.
Among the 12 drugs to be listed, Takeda's five products approved by the Ministry of Health, Labour and Welfare (MHLW) in April, namely diabetes treatments Nesina (alogliptin), Metact (pioglitazone/metformin), insomnia therapy Rozerem, oncology agent Vectibix, and fixed-dose combination hypertension treatment Unisia (candesartan/amlodipine), have all obtained the green light for price listing. The total annual sales for the five drugs in their respective peak years are estimated to reach ¥197.3 billion (US$2.1 billion). The company's new diabetes drug, dipeptidyl peptidase-4 (DPP-4) inhibitor Nesina is expected to see first-year and peak-year sales in Japan stand at ¥1.5 billion and ¥63.3 billion respectively.
Another Type 2 diabetes treatment, Danish firm Novo Nordisk's Victoza (liraglutide), has also seen its pricing approved, which makes it the first glucagon-like peptide-1 (GLP-1) product ready to be rolled out in the Japanese market. The highest estimated peak annual sales was for Japanese firm Kyowa Hakko Kirin's renal anaemia therapy Nesp (recombinant darbepoetin alpha), which is expected to rake up ¥66.4 billion during the tenth year since its launch on the basis of 185,000 patients.
In addition, Takeda's Rozerem is estimated to have the largest peak-year patient population among the 12 drugs with 1.4 million patients expected on the 10th year of its launch. By contrast, U.S. firm Alexion's Soliris (eculizumab), an orphan drug treating paroxysmal nocturnal haemoglobinuria (PNH), is only expected to see 100 and 400 patients respectively during the first and 10th year of its rollout in the Japanese market.
Japan: Selected Products in June 2010 Listing | |||||
Drug Name | Active Ingredient | Manufacturers | Indications | Unit Price (¥) | Expected Peak Annual Sales (¥) |
Rozerem | Ramelteon | Takeda (Japan) | Insomnia | 82.60/8 mg | 31.2 billion |
Lyrica | Pregabalin | Pfizer (U.S.) | Postherpetic neuralgia | 100.50 /25 mg | 8.4 billion |
Unisia | Candesartan/Amlodipine | Takeda | Hypertension | 150.30/tablet | 57.1 billion |
Nesina | Alogliptin | Takeda | Type 2 diabetes | 60.20/6.25 mg | 63.3 billion |
Metact | Pioglitazone/metformin | Takeda | Type 2 diabetes | 84.60/tablet | 8.3 billion |
Victoza | Liraglutide | Novo Nordisk (Denmark) | Type 2 diabetes | 9,960/18 mg 3 ml | 17.3 billion |
Nesp | Recombinant darbepoetin alpha | Kyowa Hakko Kirin (Japan) | Renal anaemia | 3,086/10 ug, 1 ml | 66.4 billion |
Vectibix | Panitumumab | Takeda | Unresectable, advanced or recurrent colorectal cancer with wild-type KRAS | 75,567/100 mg 5 ml | 37.4 billion |
Soliris | Eculizumab | Alexion (U.S.) | Paroxysmal nocturnal haemoglobinuria (PNH) | 577,229/300 mg 30 ml | 19.7 billion |
Cosopt | Dorzolamide/timolol | Santen (Japan)/Merck (U.S.) | Glaucoma, ocular hypertension | 668.0/ml | 15.3 billion |
DuoTrav | Timolol and travoprost | Alcon (U.S.) | Glaucoma, ocular hypertension | 1,360.0/ml | 5.6 billion |
Fentos Tape | Fentanyl citrate | Hisamitsu (Japan) | Cancer pain | 570.6/mg | 10.9 billion |
Source: Yakuji June 2010 | |||||
Outlook and Implications
The Chuikyo listing has followed the expected timeline for drugs mostly granted marketing authorisation in April and is set to see the wave of new product launches in the Japanese market shortly after next week's official listing (see Japan: 20 April 2010: Japan's MHLW Grants Wave of New Drug Approvals, Takeda Clinches Five). With five products approved and ready for commercialisation, Takeda will see its domestic portfolio bolstered by the positive developments. Its diabetes treatment Nesina is now poised for its first worldwide roll-out, which is promising for the expansion of the company's diabetes portfolio especially after the regulatory setbacks experienced in the U.S. and European markets for alogliptin. However, it still lags behind the launch of two other DPP-4 inhibitors, Merck's (U.S.) Januvia (sitagliptin) and Novartis's (Switzerland) Equa (vildagliptin).
Also in Japan's diabetes treatment market, Novo Nordisk's Victoza is set to launch as the first-in-class GLP-1 product, which will give it the benefit of market exclusivity within the same class. The listing of Victoza was postponed from the originally-expected April listing due to the failure to reach an agreement in the drug's pricing between the company and Chuikyo. Details regarding the negotiation between the two parties have not been available. One of Novo Nordisk's competitors in the diabetes treatment field, U.S. major Eli Lilly, filed a new drug application in Japan for its GLP-1 drug Byetta (exenatide) in August 2009 (see Japan: 21 August 2009: Lilly Files NDA for Diabetes Drug Byetta in Japan).