South Korean pharmaceutical giant Yuhan announced Monday that it had licensed out its new clinical-stage lung cancer drug to Janssen Biotech in a deal potentially valued at up to $1.25 billion.
Yuhan said it had entered a licensing and cooperation agreement with Janssen to develop a novel clinical-stage therapeutic candidate for the treatment of patients with non-small cell lung cancer, or NSCLC.
Under the terms of the agreement, Yuhan will receive an upfront payment of $50 million and is eligible to receive up to $1.205 billion in potential development and commercial milestone payments, along with tiered double-digit royalties on future net sales.
In return, Janssen will assume responsibility for development, manufacturing and commercialization with exclusive worldwide rights to Lazertinib excluding Korea, where the development rights are retained by Yuhan.
The two companies will collaborate on global clinical trials evaluating Lazertinib both in monotherapy and combination regimens. Clinical trials are anticipated to begin in 2019, they said.
“Yuhan is committed to developing Lazertinib as an effective treatment option for patients suffering from NSCLC. And Janssen, with strong scientific expertise in lung cancer and oncology, is the best strategic partner to achieve this mission,” Lee Jung-hee, president and CEO of Yuhan, said in a statement.
“We are excited to start this collaboration and dive into advancing this treatment regimen with a focus on improving the lives of people who suffer from lung cancer,” Lee said.
News of the potentially multibillion-dollar licensing agreement led shares of Kospi-traded Yuhan to soar a whopping 29.78 percent to a close of 53,000 won on Monday.
Lazertinib is a potent, mutant-selective, irreversible, brain-penetrant and orally active third-generation EGFR tyrosine-kinase inhibitor for NSCLC with various epidermal growth factor receptor mutations, with potential to become a first-line therapy.
The compound is currently undergoing phase 1 and 2 clinical trials in Korea. Interim results show Lazertinib exhibited robust disease activity in patients with NSCLC with acquired resistance to EGFR-TKIs, with or without brain metastasis and was well-tolerated with low rates of Grade 3 or higher adverse events.
These results indicate that Lazertinib may offer the possibility of a wider therapeutic index, making it a potential best-in-class candidate as a combination regimen, Yuhan said.
If successfully developed, there are high hopes that Lazertinib can become a superior treatment to AstraZeneca’s Tagrisso (osimertinib), which was approved in April by the US Food and Drug Administration as a first-line therapy for NSCLC patients with EGFR mutations.
By Sohn Ji-young (firstname.lastname@example.org