Takeda (NYSE:TAK) signed a licensing settlement with Hutchmed (China) (NASDAQ:HCM) to develop and commercialize oral cancer drug fruquintinib exterior of mainland China, Hong Kong and Macau.
Under the settlement, Takeda can pay $400M upfront, up to $730M in extra potential funds in regulatory, improvement and business milestones, plus royalties on internet gross sales.
The Japanese drugmaker will get an unique worldwide license to develop and commercialize fruquintinib in all indications and territories exterior of mainland China, Hong Kong and Macau.
Hutchmed famous that fruquintinib was authorised in China in 2018 and is an inhibitor of vascular endothelial progress issue receptors (VEGFR) -1, 2 and three. Fruquintinib is orally administered and has the potential to be used throughout subtypes of refractory metastatic colorectal cancer (CRC), no matter biomarker standing.
Fruquintinib is marketed as Elunate by Hutchmed with Eli Lilly (LLY) as a therapy for sure sufferers with metastatic CRC. The drug is just not authorised for use exterior of China.
In August 2022, fruquintinib met the principle aim of total survival in sufferers with superior, refractory metastatic colorectal cancer (CRC) in a section 3 trial known as FRESCO-2.
However in November 2022, the drug met one primary aim however didn’t attain statistical significance in one other aim of a late stage examine, dubbed FRUTIGA, in Chinese sufferers with superior gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The transaction is topic to closing situations, together with antitrust evaluations.
Hutchmed added that in December 2022, it began a rolling submission of a brand new drug utility (NDA) for fruquintinib with the U.S. FDA, which is anticipated to be accomplished in H1 2023. Filing are additionally deliberate within the EU and Japan.
HCM +3.35% to $17.90 premarket Jan. 23