Hanmi Pharm has released a complex drug by combining Evista (compound: Raloxifene), a selective estrogen receptor modulator (SERM) osteoporosis therapy, with vitamin D.

On March 31, the Ministry of Food and Drug Safety (MFDS) allowed the marketing of RaboneD developed by Hanmi Pharm, the first osteoporosis therapy in the world, which combines SERM-series with vitamin D.

Evista, a representative osteoporosis treatment made by Takeda Pharmaceuticals Korea, saw its substance patent expired in 2015, and its combination method patent expired on March 20, 2017. UBIST, a private data provider, said about 14.8 billion ($13 million) worth of the drug was prescribed last year.

Raloxifene, the primary compound of Evista, is SERM series non-hormonal substance and shows the similar effect to estrogen in a skeletal system by selectively combining with estrogen receptor. Estrogen is an important female hormone that plays a pivotal role in making and maintaining bones. RaboneD is the combination of Estrogen and vitamin D essential for patients with osteoporosis.

Hanmi Pharm said it applied its patented manufacturing technology Poly Cap to RaboneD to reduce its size and minimize its safety and interaction.

“Many osteoporosis patients separately take vitamin D supplement to prevent a decrease in the vitamin D level,” a company spokesman said. “Most of the existing vitamin D products, however, are very large because they have to combine with calcium compounds, making consumers feel uncomfortable because of decreased compliance and side effects in the stomach.”

To treat osteoporosis, people widely use hormone therapy, SERM, the bisphosphonate, and calcitonin. Most frequently used are bisphosphonate-series drugs, which prevents bone resorption by weakening the function of an osteoclast. Some common types of bisphosphonate-series drugs are alendronate, risedronate, and Ibandronate.

The problem with these drugs is the complicated way to take them. People have to take them in empty stomach with 150ml of water to prevent problems in the gastrointestinal tract and can’t lie down on a bed for 30 minutes to an hour after intake. Also, they have to take drug holiday of three to five years after taking them to prohibit side effects such as atypical femoral fracture in the case of long-term intake.

However, the official said, women can take RaboneD at the early stage of menopause for a long time and without drug holiday.

Hanmi plans to set the drug price similar to the prices of previous SERM-series medicines to reduce patients’ financial burden by allowing them to also take vitamin D at the cost of one drug. The company will try to increase its market share by stressing the new drug’s advantages, such as long-term intake without drug holiday, its smaller size despite taking vitamin D at the same time, and more economical price.

“Osteoporosis is a lifetime disease women have to control since menopausal period, which results in a long-term intake,” said Park Myung-hee, an executive director at Hanmi. “RaboneD combines Raloxifene, whose efficacy has already been verified through massive researches for several decades, with vitamin D, and will provide an alternative treatment for medical staffs and patients.”