보건복지부 영문홈페이지

Daewoong Pharmaceutical Co., Ltd. joins in on successful cases of global advancement by signing an export contract worth 300 billion won

 

- The pharmaceutical company secured chances to advance into the U.S. and European markets by signing a contract worth 300 billion won including the technology fees involved in dealing with Botulinum toxin type A in high degrees of purity –

 

Nabota (tentative name), a medicine developed and produced in Korea, will advance into advanced pharmaceutical markets in the U.S. and Europe.

 

   * (scale of pharmaceutical markets) entire world 1,083 trillion, North America 398 trillion, Europe 293 trillion (resource: IMS Health Data 2012).

 

The Ministry of Health and Welfare said on September 30^th that Korean drug maker Daewoong Pharmaceutical Co., Ltd. finalized a 300-million-won contract with Evolus,* a U.S. biotech venture company, to export Nabota which includes the royalty fees.

 

   * Clinical tests and regulatory approval in the U.S. and Europe (Evolus will pay the fees for approval procedures), and will be in charge of supplying and distributing while Daewoong Pharmaceutical produces and exports the medicine.

 

This case is in line with this year’s advancements* of Korean companies, and is being interpreted as an indication that Korean companies’ are truly beginning to advance into global markets.

 

   * Beginning with Celltrion which acquired approval for their product from the European Medicines Agency (EMA) (June, 2013), JW Pharmaceutical signed an export contract for a Triple-Chamber Bag for Nutrition with Baxter (July, 2013); Boryung Pharmaceutical Company signed an export contract for the Kanarb Tab. with Central and South American countries (July, 2013); Hanmi Pharm. Co., Ltd. acquired marketing authorization for Esomezol from the U.S. Food and Drug Administration (FDA) (August, 2013); and BC World Pharm Co., Ltd. signed a contract with Japan's Koa Shoji Co., Ltd to export microsphere injections (September, 2013).

 

Natoba (tentative name), developed by Daewoong, is a Botulinum toxin type A injection that is not only used to treat migraines and muscle paralysis, but can also be used for cosmetic enhancement purposes. After recently passing clinical tests, Natoba is ready to hit the shelves in Korea by the end of this year, and is scheduled to undergo approval procedures for its advancement into the U.S. and European markets through the previously mentioned contract.

 

   * 12 billion won over a span of five years was invested in developing Nabota

 

Nabota is being assessed to have the potential to take on the U.S. and European markets, for the reasons that its strain was discovered through a unique Korean patented technology making it currently producible in Korea, that it is a product of high levels of purity compared to previous products which is in turn producing a high quality product, that it has low incidence rates of side effects, and that its price is competitive.

 

The scale of U.S. and European markets for this product was 2 trillion won in 2011, and by 2017, when Nabota is expected to enter these markets, the predicted scale is estimated to reach 3.5 trillion won (11% growth in demand every year).

 

   * The scale of the entire market in Korea is 70 billion won (as of 2012) and Meditoxin Injections by Medytox and Botox Injections by Allergan were ranked the top two products in sales, with total combined sales being roughly 17 billion won for the two companies.

 

Daewoong is an innovative pharmaceutical company and had been supported by the Ministry of Health and Welfare for an R&D project on international joint research to study innovative pharmaceutical companies.

 

   * 250 million won was subsidized to secure advanced standards and research quality on the regulatory approval of foreign countries in order to help advance Botolinum toxin injections (Nabota) into foreign markets.

 

Daewoong, the only pharmaceutical company in Korea ranking in the World Class 300 Companies, took over the Chinese pharmaceutical company Liaoning Baifeng and acquired the U.S. FDA Abbreviated New Drug Application (ANDA) (May, 2013) approval for Meropenem Injections. For their distinguished achievements, the company received an award for being an innovative pharmaceutical company from the Ministry of Health and Welfare on September 13^th this year.

 

* (World Class 300) A system that selects small- and medium-sized companies which have the will and potential to grow into a global company to provide them with a support package.

 

A ministry official said that the export contract of Nabota is meaningful for local pharmaceutical companies in that the product act has a good model for success in advancing into major pharmaceutical markets, such as the U.S. and Europe.

 

He added that the government will unsparingly support local Korean companies to help their advancement into global markets. Therefore challenging and adventurous investments in R&D, consistent innovation, and active strategic practices will be required for such successful global advancement to occur.

 

The official also stated that the idea ”we can do it” is spreading throughout the Korean pharmaceutical industry, and this year will be the first year for the industry to begin its journey to become a pharmaceutical powerhouse by the year 2020.

 

An antibiotic against super bacteria developed by Dong-A Pharmaceutical, and Zemiglo, the Korean-developed diabetes treatment from LG Life Sciences, are in the process of waiting for approval from the U.S. FDA (end of 2013 ~ first half of 2014).