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PledPharma and Solasia enter a second license agreement for the development and commercialisation of PledOx® in Asia, targeting neuropathy caused by taxanes and any other chemotherapy

October 9, 2019

Stockholm, Sweden / Tokyo, Japan, October 9, 2019 – PledPharma AB (“PledPharma”) (STO: PLED) and Solasia Pharma K.K. (“Solasia”) (TSE: 4597) today jointly announced that the companies have entered a second license agreement for PledPharma’s lead candidate PledOx® in Japan, China, Hong Kong, Macau, South Korea and Taiwan, covering chemotherapy induced peripheral neuropathy (CIPN) by any chemotherapy. The agreement includes development and regulatory milestones to PledPharma of up to approximately SEK 165 million (USD 17 million)*, as well as sales milestones and royalties.

The new agreement is a comprehensive extension of the original license agreement announced in November 2017. The extension covers the use of PledOx as prevention of CIPN by any chemotherapy in any cancer type. Most notably, this includes CIPN caused by taxanes with a high unmet medical need similar to that of CIPN caused by oxaliplatin. Taxanes have a significant use in clinical practice across several different cancer types (e.g. breast and ovarian cancer) with approximately 400,000 patients treated yearly in the US, EU5 and Japan.

According to the new agreement, PledPharma will receive development and regulatory milestones of up to approximately SEK 165 million (USD 17 million)* in Japan and China for the extension of the PledOx rights of prevention of CIPN caused by any chemotherapy. This is on top of the first agreement from November 2017, which included development and sales milestone payments of up to approximately SEK 700 million (USD 83 million)*. To date, PledPharma has received in total approximately SEK 56 million (USD 5.6 million)* from Solasia in upfront and milestone payments, and in addition, Solasia is paying for the recruitment of patients to the POLAR program in Asia.

In the new agreement, the terms for the sales milestones is altered to be based on the total sales of PledOx in Japan and China irrespective of chemotherapy. Royalty rates on sales will remain the same as in the first license agreement.

PledPharma and Solasia will share all development costs in the areas covered by the second agreement. The new agreement follows PledPharma’s initiated indication expansion program in CIPN caused by taxanes, where preclinical studies are already underway to guide further development in a clinical stage.

“There is a large unmet medical need preventing CIPN caused by taxanes, where we see a huge potential for PledOx. This is a key step in broadening PledPharma’s pipeline of development projects. We are very pleased with this important license agreement, which give us an opportunity to accelerate the development and deepen our collaboration with our partner Solasia.” said Nicklas Westerholm, Chief Executive Officer and President, PledPharma.

“We are convinced that PledOx, as a novel first in class therapy, will play an important role in fulfilling the significant unmet medical need of preventing chemotherapy induced peripheral neuropathy. Solasia is ideally equipped to support PledPharma during clinical development and local regulatory processes in Japan, and to effectively launch the product in key Asian markets,” said Yoshihiro Arai, President and Chief Executive Officer, Solasia.

* Contract based on JPY, the amount given in USD and SEK is subject to exchange rates.



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