12 new drugs, including seven New Molecular Entities (NMEs), are set for launch in Japan shortly, following their listing on the National Health Insurance (NHI) formulary later this week.

Japan’s Central Social Insurance Medical Council (Chuikyo) gave its formal approval for the drugs’ listings last week, and their prices will be published officially on June 11. Five products from Takeda are included among the 12 set for market roll-out, including the DPP-4 inhibitor Nesina (alogliptan) for the treatment of type 2 diabetes, whose launch in Japan will represent its first introduction worldwide. Sales of the product in its first year on the market are expected to reach 1.5 billion yen, with annual sales peaking at 63.3 billion yen, according to local news source Yakuji.

The other four Takeda products newly listed on the NHI formulary are Metact (pioglitazone/metformin), another drug for the treatment of type 2 diabetes, plus the insomnia treatment Rozerem (ramelteon), Unisia (candesartan/amlodipine) for hypertension, and Vectibix (panitumumab), which is indicated for the treatment of unresectable, advanced or recurrent colorectal cancer with wild-type KRAS.

Altogether, the five Takeda drugs are expected to see combined sales in their peak years totalling 197.3 billion yen, according to Yakuji.

The other seven newly-listed products are: Pfizer’s Lyrica (pregabalin) for postherpetic neuralgia; Novo Nordisk’s type 2 diabetes treatment Victoza (liraglutide); Kyowa Hakko Kirin’s Nesp (recombinant darbepoetin alpha) for renal anemia; Alexion’s Soliris (eculizumab) for paroxysmal nocturnal hemoglobinuria (PNH); Santen/Merck & Co’s Cosopt (dorzolamide/timolol), indicated for glaucoma and ocular hypertention; Alcon’s DuoTrav (timolol/travoprost) for glaucoma and ocular hypertension; and Hisamitsu’s Fentos Tape (fentanyl citrate) for the treatment of cancer pain.

The products with the largest annual peak sales are expected to be Nesp, with 66.4 billion yen, and Nesina, expected to earn 63.3 billion yen in its tenth year based on treating 185,000 patients, while Vectibix will peak at 37.4 billion yen, says Yakuji. Rozerem’s sales in its tenth year should reach 31.2 billion yen, with 1.4 million patients, giving it the largest patient population out of the 12 newly-listed drugs. However, annual peak sales of just 8.4 billion yen and 5.6 billion yen are expected for Lyrica and DuoTrav, respectively, while Alexion’s orphan drug Soliris is expected to be used in the treatment of just 100 patients in its first year, rising to only 400 in its peak tenth year, it adds.

Analysts at IHS Global Insight point out that the first launch of Takeda’s Nesina is a major boost for the firm’s diabetes portfolio, but it still lags behind the market entry of two other DPP-4 inhibitors, Merck & Co’s Januvia (sitagliptin) and Novartis’ Equa (vildagliptin).