Korean pharmaceutical and biotech companies are stepping up efforts to license in promising drug candidates from outside, alongside their own new-drug research and development. The strategy is seen as a way to cut the time and uncertainty involved in drug development while expanding pipelines efficiently by drawing on existing clinical, regulatory and sales capabilities.
SK Biopharmaceuticals recently signed a deal worth up to $795 million (about 1.1 trillion won), including a $400 million upfront payment, to license the epilepsy drug candidate Opacalim from U.S.-based Biohaven, industry sources said on the 1st. Opacalim is an oral drug that suppresses seizures by selectively activating potassium channels that regulate the excitability of nerve cells.
The deal shows that in-house drug development and licensing in can work together rather than as substitutes for each other. SK Biopharmaceuticals (326030.KS) developed the epilepsy drug Xcopri on its own, won approval from the U.S. Food and Drug Administration and built a direct sales network in the country. By adding Opacalim, which is in late-stage clinical trials, the company aims to diversify its product lineup and make fuller use of the U.S. sales network it has already established.
Cases of companies acquiring drugs that match their areas of expertise and business base are increasing. Chong Kun Dang (185750.KS) recently paid $1 million to secure domestic rights to the clinical development, approval and commercialization of KIO-301, a retinal disease drug candidate from U.S.-based Kiora Pharmaceuticals. KIO-301 is designed to restore light sensitivity to retinal ganglion cells in patients who have lost their photoreceptors, and is being developed as a treatment for degenerative retinal diseases including retinitis pigmentosa.
JW Pharmaceutical (001060.KS) in April secured exclusive domestic rights to bofanglutide, an obesity and diabetes drug candidate, from China's Gan & Lee Pharmaceuticals for $81.1 million. Bofanglutide is a long-acting treatment administered once every two weeks and is in Phase 3 trials in China and Phase 2 trials in the United States. JW Pharmaceutical will handle domestic clinical trials, approval and commercialization, aiming to speed up its entry into the fast-growing obesity treatment market.
Drugmakers are turning to licensing in because discovering a single new drug and winning approval typically takes more than 10 years, with low odds of success. Bringing in a candidate that already has clinical data cuts the time needed for early research and lets companies concentrate on the clinical development, approval and commercialization stages where they hold an advantage. Licensing in a promising drug does not guarantee profitability, however. The later the stage, the larger the share of upfront payments, and losses from clinical failure can be substantial. "What is needed is not only an eye for spotting good candidates but also the capability to carry a licensed drug through clinical trials, approval, and production and sales," an industry official said. "The ability to combine in-house research and development with external innovation efficiently will become a new source of competitiveness for drugmakers."
