UPDATE : Tuesday, January 22, 2019
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US law expected to benefit Korean drugmakers
  • By So Jae-hyeon
  • Published 2018.06.04 16:02
  • Updated 2018.06.04 16:02
  • comments 0

Korean developers of anticancer treatments and orphan drugs have welcomed a new U.S. law, which allows terminally ill patients to try experimental drugs.

President Donald Trump recently signed the so-called “Right-to-Try” bill into law. The legislation gives patients access to treatments that remain within the Food and Drug Administration’s (FDA) approval process after the completion of the phase-1 trial, but that did not obtain the nod under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.

The law applies to patients with life-threatening diseases or conditions, patients who have used all of the approved treatment options and are not able to participate in clinical trials, and those who have provided written consent to use the drug to their physician.

Analysts said Korean pharmaceutical firms testing anticancer and orphan drugs in the U.S. would benefit from the new legislature. Among such Korean companies are Yuhan Corp., Hanmi Pharmaceutical, SillaJen, and Theragen Etex.

Yuhan is developing YH25448, a treatment for non-small cell lung cancer (NSCLC), with Ostech.

Also targeting NSCLC, Hanmi Pharm is conducting trials on Poziotinib, which the company licensed out to U.S. firm Spectrum.

The Right-to-Try law is likely to make it easier for Yuhan and Hanmi to recruit patients for their clinical studies.

SillaJen’s Pexavec is also drawing attention as it targets to treat end-stage cancer patients with kidney cancer, liver cancer, and solid cancer.

Medpacto, a subsidiary of Theragen Etex, is experimenting with anticancer immunotherapy TEW-7197.

Since 2014, Medpacto has been testing the therapy in end-stage solid cancer patients who have no therapeutic effect with conventional anticancer treatments or who do not have appropriate remedies.

The latest U.S. legislation will help Medpacto, which has a relatively small number of patient groups but needs to secure meaningful clinical data.

“Unlike chronic disease drug suppliers, developers of orphan drugs or end-stage cancer treatments often struggle to recruit clinical patients in large scale. Their clinical tests usually take a long time, too,” a pharmaceutical source said.

Although the U.S. law won’t allow drugmakers to get full access to the results of the patient’s use of investigational drugs, Korean firms will enjoy benefits from the law in any form, the source added.


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