Nippon Kayaku will carry out the marketing and distribution of taletrectinib for ROS1-positive non-small cell lung cancer in Japan. Credit: Kateryna Kon / Shutterstock.com.

AnHeart Therapeutics and Nippon Kayaku have signed an exclusive agreement for the former’s investigational therapy, taletrectinib. 

Nippon Kayaku will market and distribute taletrectinib in Japan.

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AnHeart is entitled to receive $40m in upfront payment apart from regulatory and sales-based future milestone payments and Nippon will make royalty payments based on yearly net sales of taletrectinib in Japan. 

Nippon Kayaku will seek regulatory approvals and carry out the marketing and distribution of the therapy for ROS1-positive non-small cell lung cancer (NSCLC) in the country.

The company will also hold the rights for further development of taletrectinib for additional indications in Japan. 

AnHeart will handle taletrectinib’s clinical development for ROS1-positive NSCLC and deliver the therapy to Nippon Kayaku for marketing in Japan. 

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AnHeart recently reported positive findings from two Phase II clinical trials of taletrectinib for ROS1-positive NSCLC.

Interim trial data showed that taletrectinib shrank tumours in more than 90% of tyrosine kinase inhibitor (TKI) naïve trial subjects and more than 50% of TKI pre-treated subjects. 

Durable responses were reported with taletrectinib shown to be well tolerated with a reduced occurrence of neurological adverse events.

AnHeart Therapeutics CEO Jerry Wang stated: “We are excited to partner with Nippon Kayaku and look forward to working with a leading oncology company to bring taletrectinib to people with ROS1-positive NSCLC living in Japan. 

“With the recently reported positive interim data from our global pivotal TRUST-II trial, we are well on our way to realising our vision of bringing people with ROS1-positive NSCLC a new option.”