Two Global New Drugs, Viekirax Priced In Japan
This article was originally published in PharmAsia News
Executive Summary
The latest reimbursement price listing of drugs in Japan clears the way for the first launches worldwide of two new molecules for thrombocytopenia and diabetes, and also for the local launch of an important new hepatitis C therapy.
TOKYO - Japan has granted reimbursement prices under its national health insurance system for a batch of products that sets the stage for the first commercial launches worldwide of two new drugs, Shionogi & Co. Ltd.'s Mulpleta and MSD's (Merck & Co. Inc.) Marizev, as well as the Japanese launch of AbbVie Inc.'s hepatitis C therapy Viekirax.
Mulpleta (lusutrombopag) will become the first thrombopoietin (TPO) receptor agonist to be launched anywhere globally, and is indicated for the improvement of thrombocytopenia associated with chronic liver disease in patients undergoing an elective invasive procedure.
The drug increases increased platelet levels by inducing the formation of megakaryocytes, avoiding the need for platelet transfusions. An international Phase III program is ongoing and Shionogi envisages filings in other major markets on the back of this.
While the Japanese price listing allows a national launch, Shionogi has not yet unveiled a commercialization date for the product.
MSD's once-weekly DPP-4 inhibitor Marizev (omarigliptin) is indicated for adult type 2 diabetes, and in clinical trials has shown efficacy on a par with the company’s once-daily Januvia (sitagliptin) in patients inadequately controlled on metformin.
A US NDA is planned by the end of the year for the product, which in Japan will enter a very crowded DPP-4 sector where Takeda Pharmaceutical Co. Ltd. has already launched its once-weekly product Zafatek (trelagliptin).
Both Marizev and Mulpleta were formally approved in Japan back in September (Also see "Japan First To Approve Omarigliptin, Lusutrombopag" - Scrip, 30 Sep, 2015.).
Other Key Launches
Also included in the Nov. 26 price listing issued by the Ministry of Health, Labour and Welfare (MHLW) are a number of other products approved at the same time, including Takeda's orphan drug Copaxone (glatiramer; licensed from Teva Pharmaceutical Industries Ltd.) for multiple sclerosis, and AstraZeneca PLC's Caprelsa (vandetanib) for advanced medullary thyroid cancer.
Also in oncology, Taiho Pharmaceutical Co. Ltd.'s Yondelis (trabectedin; licensed from PharmaMar SA) was given a price for the orphan indication of soft tissue sarcoma, which the Otsuka Holdings Co. Ltd. group firm notes affects around 5,000 people in the country.
Takeda has already launched Copaxone - the development of which was requested by the MHLW in 2010 due to unmet medical need - and said that around 18,000 patients in Japan are estimated to suffer from MS.
Viekirax Pricing
Also receiving a price was AbbVie's combination product for chronic genotype 1 hepatitis C Viekirax (ombitasvir 25mg/paritaprevir 150mg/ritonavir 100mg). The once-daily, oral interferon- and ribavirin-free regimen therapy is also indicated for use in HCV patients with compensated liver cirrhosis, and was approved in Japan in September in what is a highly competitive sector (Also see "Viekirax Approval Set To Rattle Japan Hep C Market" - Scrip, 29 Sep, 2015.).
Genotype 1 accounts for 60-70% of the 1.5-2 million HCV patients in Japan, with genotype-1b in turn making up around 95% of this subgroup.
The approval of Viekerax will further shake up the already crowded HCV market in the country, where Gilead Sciences Inc.'s Harvoni (ledipasvir 90mg plus sofosbuvir 400mg) was approved in July as the first single-pill therapy for genotype 1 hepatitis C (Also see "Toujeo Set For Tresiba Face-Off After Japan Approval" - Scrip, 6 Jul, 2015.).
Viekirax is reimbursed at ¥26,801.20 per pill, well below the ¥80,171.30 per pill for Harvoni, and the ministry's Central Social Insurance Medical Council (Chuikyo) noted in its pricing calculations that Viekirax was compared on a daily cost basis with Bristol-Myers Squibb Co.'s all-oral, interferon- and ribavirin-free - but two-pill - regimen Daklinza (daclatasvir) and Sunvepra (asunaprevir).
Nov. 26 Reimbursement Price Listing In Japan
|
Product |
Company |
Formulation |
Price (¥) |
|
Caprelsa (vandetanib) |
AstraZeneca |
100mg tab |
7,836.40 |
|
Copaxone (glatiramer acetate) |
Takeda (Teva) |
20mg/mL vial |
5,617 |
|
Ecumet (vildagliptin/metformin) |
50mg/250mg 50mg/500g |
87.70 |
|
|
Effexor (venlafaxine) |
37.5g cap 75mg cap |
160.80 270.70 |
|
|
Loqua Tape (S-flurbiprofen) |
10cm x 14cm |
45.90 |
|
|
Marizev (omarigliptin) |
MSD |
12.5mg tab 25mg tab |
559.20 1,045.10 |
|
Mulpleta (lusutrombopag) |
Shionogi |
3mg tab |
16,107.60 |
|
P-TOL Chewable (sucroferric oxyhydroxide) |
250mg tab 500mg tab |
214.20 314.30 |
|
|
Spiolto Respimat (tiotropium bromide/olodaterol) |
28-dose kit |
4,256.90 |
|
|
Tracleer Pediatric (bosentan) |
32mg tab |
4,577 |
|
|
Viekirax (ombitasvir/paritaprevir/ritonavir) |
AbbVie |
25mg/150mg/ 100mg |
26,801.20 |
|
Yondelis (trabectedin) |
Taiho (Pharmamar) |
0.25mg vial 1mg vial |
49,307 197,698 |
|
Zebiax (ozenoxacin) |
2%/g |
82.20 |
Peak Sales Forecasts
Given the large number of HCV patients in Japan, Chuikyo predicts in its official price calculations that peak annual sales of Viekirax at reimbursement prices will reach ¥60.8bn ($496m) two years after launch.
However, Datamonitor
sees annual Viekirax sales peaking at a more modest $391.8m in 2017, with the drug gaining around 30% of first-line genotype 1 patients.
Other predicted big sellers in this price listing by Chuikyo’s reckoning include Marizev (¥37.2bn), Ecumet (¥32.5bn) and Effexor (¥32.0bn). Datamonitor again expects Marizev sales to be more modest, at around $73m in 2023 versus the Chuikyo forecast which equates to around $303m, given the generally high compliance with daily diabetes therapies and the likely need for co-use with other daily diabetes drugs.