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December 10, 2019

Stockholm, December 10, 2019. PledPharma AB (STO: PLED) today announced that its Asian partner Solasia Pharma KK (“Solasia”) has entered into an exclusive license agreement with the Japanese pharmaceutical company Maruho Co Ltd (“Maruho”) for commercialization of PledPharma’s therapeutic agent PledOx® (calmangafodipir) for the treatment of chemotherapy induced peripheral neuropathy (CIPN) in Japan.

Under the license agreement, Maruho will commercialize PledOx exclusively in Japan after Solasia and PledPharma completes development of the product in Japan. The global Phase III program in CIPN with PledOx® is ongoing and consists of two studies.

“This agreement between Solasia and Maruho is a strong validation of the potential for PledOx to address chemotherapy induced nerve damage, a large unmet medical need. Maruho will bring a strong and experienced Sales & Marketing team for commercialization of PledOx to maximize the value of the asset“, said Nicklas Westerholm, Chief Executive Officer and President, PledPharma.

Link to Solasia’s PR.

The Phase III POLAR program for PledOx comprises two double-blind, randomized, placebo-controlled trials – POLAR-A and POLAR-M.
POLAR-A, which is expected to be fully recruited before yearend 2019, includes 280 patients with colorectal cancer undergoing adjuvant chemotherapy and is conducted in Asia and Europe. The trial compares PledOx at a dose of 5 μmol/kg with a placebo.
POLAR-M includes 420 patients with metastatic colorectal cancer undergoing chemotherapy and is conducted in Europe, Asia and the US. The trial compares PledOx at doses of 2 μmol/kg and 5 μmol/kg, respectively, with a placebo. It is expected to be fully recruited in Q2 2020, and it is anticipated that PledPharma will have top line results approximately a year later.

In October 2019, PledPharma and Solasia entered a second license agreement for PledOx in Japan, China, Hong Kong, Macau, South Korea and Taiwan, covering chemotherapy induced peripheral neuropathy (CIPN) by any chemotherapy. This agreement is a comprehensive extension of the original license agreement between PledPharma and Solasia, announced in November 2017.



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