In March 2017, Novo Nordisk initiated a Phase III trial to evaluate the safety of once-weekly dosing of somapacitan (NNC0195-0092) in adult growth hormone deficiency (AGHD) patients in Japan, using the company’s own daily recombinant growth hormone (rGH), Norditropin, as a comparator. The trial commenced on 3 March, and the company is planning to obtain the primary outcome measures by 28 September 2018.

With its daily rGH, Norditropin, Novo Nordisk is currently the leading company in the growth hormone market. According to Novo Nordisk’s 2016 full year financial report, Norditropin generated global sales reaching approximately $1.3bn with a 12% sales growth in the full year 2016. Based on the company’s notes, this sales growth was derived primarily from the US, reflecting a positive non-recurring adjustment to the Medicaid patient segment.

According to GlobalData’s primary research, Norditropin is also the preferred choice in Japan among the available rGHs, which include Pfizer/OPKO’s Genotropin, Eli Lilly’s Humatrope, Merck Serono’s Saizen, JCR Pharmaceuticals’ Growject, and Sandoz’s Somatropin BS CS (Omnitrope).

Growth hormones are used to treat growth hormone deficiency (GHD) in adults and children, as well as a few other related disorders that result in GHD, such as Turner syndrome, Noonan syndrome, and Prader-Willi syndrome (PWS); however, based on GlobalData’s primary research, the majority of rGHs are prescribed for GHD.

In adults, GHD manifests in physiologic impairment that can negatively impact body composition and may result in reduced quality of life. The benefit of the use of rGH in AGHD has been well documented; however, daily subcutaneous injections of the currently available rGHs can be troublesome and adherence has been a long-standing issue with these drugs.

“Somapacitan is administered with a disposable syringe, which makes it very easy to use.”

All daily rGHs have equivalent safety and efficacy profiles, but they differ in their formulation, storage and delivery device, which makes some of these products more convenient to inject over others. According to key opinion leaders (KOLs) interviewed by GlobalData, all available rGHs are prescribed in Japan in rotation; however, if patients find some of the preparations troublesome, that drug may lose its turn, and then the choice is often Norditropin.

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By GlobalData

One KOL from Japan commented: “[Norditropin] doesn’t have to be dissolved, and the syringe is disposable, which makes it easy for the patient. [Adult] GHD patients often suffer from vision impairment after surgery to the pituitary gland, and the patients tend to be elderly, so it is too much for them to have to dissolve a drug.”

The long-acting rGHs have been designed to improve patient convenience and adherence to therapy, and therefore treatment outcome. Somapacitan (NNC0195-0092, NN8640) is a once-weekly rGH drug developed by Novo Nordisk, and is currently the only long-acting rGH in the late-stage pipeline that is being investigated in Japan in AGHD.

According to results of the 26-week, randomized, active-controlled, REAL 2 Phase III trial of somapacitan, the treatment was well-tolerated and was reported to be more convenient than the once-daily Norditropin injection.

Based on KOL interviews, GlobalData believes the popularity of the long-acting rGHs in Japan, similarly to daily rGHs, will depend on their relative ease of use. Hence somapacitan may also be an obvious choice among AGHD sufferers in Japan based on the positive experience of Norditropin. One KOL from Japan pointed out: “Somapacitan is administered with a disposable syringe, which makes it very easy to use. If other drugs that need to be taken on a weekly or bi-weekly basis are a pain to dissolve, if a lot of effort needs to be put into preparation, then patients won’t be inclined to use them, even if they only need to be taken once a week or once every two weeks.”

GlobalData expects the launch of the long-acting rGHs will expand the AGHD patient population as a result of an increase in adherence to therapy. Due to Novo Nordisk’s well-established reputation in this space and somapacitan’s potential to be the first-to-market drug for AGHD in Japan, GlobalData foresees that this drug will become the most frequently prescribed rGH for AGHD in this market.