Korean rare disease drug Hunterase market share surges

Overseas sales increase, worn approval in China to enter the new market

2020 H1 accumulates sales of KRW 17.6 billion, triples competitor’s sales

Product image of Hunterase

Developed with South Korean-made rare disease treating technology, Hunterase (idursulfase-β) continues to top the market.

 

The treatment’s market share gap with Elaprase (idursulfase) that used to dominate the Hunter syndrome market has tripled as Hunterase maintains market share of over 70 percent.

 

While the treatment is generating significant sales in Central America and North Africa, its commercial value is to grow even further as it prepares for the Chinese and Japanese markets.

 

A pharmaceutical market research firm IQVIA reported on Sept.

 

24, GC Pharma’s Hunterase has generated 8.8 billion won in the second quarter of the year.

 

The sales in first half of the year accumulated to 17.6 billion won, taking up 72.3 percent of the market.

 

Although the figure went down by 0.5 percent compared to 17.7 billion won last year same time, the treatment has been dominating the market with the sales still tripling the competitor’s.

 

In the same time, Sanofi Genzyme’s Elaprase has only made 6.7 billion won.

 

In 2008, GC Pharma has licensed in the technology from Samsung Medical Center Professor Jin Dong Kyu and co-developed Hunterase to treat patients with Hunter syndrome.

 

After Ministry of Food and Drug Safety (MFDS) green lighting the drug in 2012, the Korean company successfully commercialized the world’s second Hunter syndrome treatment, following after Sanofi Genzyme’s Elaprase.

 

Hunter syndrome is a rare, inherited disorder, diagnosed roughly in one out of 100,000 to 150,000.

 

Caused by deficiency of an enzyme called idursulfase, the disease has poor prognosis as patients express skeletal abnormality, cognitive impairment other unpredictable symptoms when not treated in adequate timing and have life-expectancy of around 15 years.

 

There are about 70 to 80 cases reported in South Korea.

 

Quarterly market share of two Hunter syndrome treatments in Korea (Unit: %) Source: IQVIA

Launched in 2008, Elaprase was the only prescription treatment for treating Hunter syndrome accessible in South Korea, up until Hunterase was released.

 

Although it used to generate 7 billion won per quarter, Elaprase’s quarterly sales have plunged to around 3 billion won ever since Hunterase entered the market in the third quarter of 2012.

 

The global drug has raised 3.4 billion won in the second quarter taking up the market share of 28 percent.

 

Basically, the two-thirds of the market were handed to Hunterase.

 

Hunterase’s market presence has been consistently growing since it was released.

 

According to IQVIA’s data, the sum of two Hunter syndrome treatments in last year’s second quarter marked 12.2 billion won, which has gone up by 17.1 percent from the second quarter of 2016.

 

When Elaprase’s sales were stagnating for last four years, Hunterase has been pushing the market expansion.

 

The Korean drug’s maximum price with coverage is 2,254,200 won, which is about 17.6 percent lower than Elaprase (2,651,616 won).

 

As the follow-on drug was offered with lower pricing, the Hunter syndrome treatment market has been expanded and the rare disease patients’ access to treatment was improved.

 

Currently, Hunterase is indicated to be administered 0.5 mg per kilogram of patient’s body weight once-weekly.

 

For instance, a child weighing 36 kg would need to pay 6,762,600 won to receive 18 mg per dose.

 

In a year, the number would add up to 351.66 million won.

 

Because the number of competitors is low with limited number of patients, the companies are expecting high profit for providing life-long doses of the needed enzyme.

 

Hunterase’s quarterly sales in domestic and overseas markets (Unit: KRW 100 million) Source: GC Pharma

Also, Hunterase has been performing well in the overseas markets as well.

 

GC Pharma says Hunterase’s export in the first half of the year reached 5.2 billion won, which was 35.4 percent of the overall sales.

 

The drug’s export of 20.3 billion in last year surpassed the domestic sales of 18.7 billion won for the first time.

 

At the moment, GC Pharma supplies Hunterase to markets in Central America and North Africa, and it has been improving the drug’s commercial value by lately entering other global markets.

 

Early this month, GC Pharma won an approval by China’s National Medical Products Administration (NMPA) for Hunterase.

 

Care Pharma Hong Kong, a rare disease treatment specializing offshoot of Canbridge Pharmaceuticals, licensed out the development and commercialization exclusivity in China, Taiwan, Hong Kong and Macao regions and successfully passed the Chinese pharmaceutical authority after 20 months since the partnership deal in January last year.

 

The Korean company estimates there are 3,000 Hunter syndrome patients in China.

 

The drug is expected to significantly leverage the international sales as it was approved as the first Hunter syndrome treatment in China with a sizable market.

 

Soon, the drug would be knocking on the Japanese market as well.

 

GC Pharma’s partner, Clinigen K.K.

 

has submitted a New Drug Application in last March to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for their approval review on Hunterase Intracerebroventricular (ICV).

 

Hunterase ICV is administered to the brain directly to deliver the medicine to cerebral ventricles.

 

The specific administration route can overcome the limitation of other intravenous injection that cannot improve the cognitive improvement as the medicine fails to permeate through the blood-brain barrier (BBB).

 

The global Hunter syndrome treatment market only has a handful of competitors.

 

The limited size of the rare disease patients would ultimately hinder the domestic market expansion, but Hunterase is strategizing to rather consistently grow its global market presence in new overseas markets.