Solasia, PledPharma partnership trigger milestone payment as first patient enters Phase 3 program testing PledOx in Japan

Solasia Pharma and PledPharma, have reached an important milestone, triggering €4,78 million payment from Solasia to PledPharma, in Phase III program for drug candidate PledOx in Japan, as the first human has been included in trial.

The Phase III program is conducted in Europe, Asia and the United States, and will include a total of 700 colorectal cancer patients undergoing chemotherapy treatment. The first patient included in the program was in the USA in November 2018, and the top line results are expected in the second half of 2020. PledOx (calmangafodipir) is a first-in-class drug candidate, the first of its kind designed to prevent nerve damage associated with chemotherapy, without adversely affecting the anti-cancer effect.

PledPharma entered a license agreement in November 2017 pertaining to the clinical development and commercialization of PledOx in Japan, China, Hong Kong, Macau, South Korea and Taiwan.

The total deal value amounts to milestones-linked approximately $83 million (700MSEK, €72M).

PledPharma noted in the press release that Solasia will also pay royalties on potential future sales of PledOx, and will fully finance the Asian part of the POLAR studies.

“The partnership with Solasia Pharma is an important component of PledPharma’s strategy to realize the global commercial potential of PledOx, and it is with great satisfaction that we now see that the POLAR studies also are initiated in Asia,” says PledPharma AB’s CEO, Nicklas Westerholm.

President & CEO, Solasia Pharma K.K.’s., Yoshihiro Arai, said: “We are extremely thrilled that Asia is part of the global Phase III program, and it was our joint collaborative effort with PledPharma that led us to achieve this huge milestone in such short time.”

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