On December 10, 2019 Solasia Pharma K.K. (TSE: 4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter "Solasia") reported that it has entered into an exclusive license agreement with Maruho Co., Ltd. (Headquarters: Osaka, Japan, President & CEO: Koichi Takagi, hereinafter "Maruho") for commercialization of Solasia’s product SP-04 (PledOx, hereinafter "product"), a therapeutic agent for chemotherapy induced peripheral neuropathy (currently undergoing Phase III clinical trials; active ingredient name: calmangafodipir) in Japan (Press release, Solasia, DEC 10, 2019, View Source [SID1234552204]).

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Under the license agreement, Maruho will commercialize the product exclusively in Japan after Solasia completes development of the product. Based on the license agreement, Solasia will supply the product exclusively to Maruho, and Maruho will pay Solasia an upfront payment of 1.0 billion yen and milestone payments based on progress in development and marketing up to a total of 18.0 billion yen.

In addition to the above license agreement, Solasia and Maruho have entered into a capital alliance agreement whereby Maruho acquires Solasia shares by a third-party allotment with a view to maintain a close business relationship going forward.

Capital alliance format:

Acquisition of newly issued Solasia shares by Maruho in third-party allotment

Pay-in date:

December 26, 2019

Number of shares issued:

11,324,000 Solasia common stock

Issue price per share:

151 yen (closing price on December 9, 2019)

Total issue amount:

1,709,924,000 yen

Shareholding ratio after issue:

Maruho will hold 9.70% of outstanding shares in Solasia

Lock-up agreement:

Maruho must obtain prior consent from Solasia if transferring its shareholding before the day following the date of the initial announcement of the clinical trial results and others by Solasia after completion of the two Phase III trials of the product currently under way.

Solasia’s top shareholder, ITOCHU Corporation must obtain prior consent from Solasia if transferring its shareholding within one year of the pay-in date stated above.

Use of proceeds:

For in-licensing and development of new pipeline product SP-05.

Maruho specializes in dermatology and has contributed to improving the quality of life (QOL) of patients suffering from skin disorders caused by cancer treatment. This time, in order to further contribute to cancer patients and their families, Maruho decided to obtain the rights to commercialize the product. Solasia specializes in oncology in Asia, and 3 of their 4 existing and development products include drugs that treat the side effects of anticancer drugs. Solasia is yet to establish an in-house sales force in Japan. Therefore, in light of the steady progress of the phase III clinical trial for the product, Solasia decided to derive the commercialization rights to Maruho who share the common philosophy of the importance of improving patient QOL.

Koichi Takagi, President and CEO of Maruho, commented as follows:
"Solasia is a specialty pharmaceutical company in oncology. The company supports patients undergoing cancer treatment and their families by developing not only anticancer drugs, but also cancer supportive care products to improve patient QOL. In collaboration with Solasia, we will continue to do our best to help cancer patients and their families further by combining Solasia’s extensive knowledge in oncology with the experience we have gained in improving patient QOL."

Yoshihiro Arai, President and CEO of Solasia, commented as follows:
"Maruho is a leading company in Japan in the dermatology area that has gained from many years’ experience with cancer and other patients the insight that improving patient QOL is as important as treating the underlying disease. We are confident that Maruho, with its wealth of knowledge and experience in patient QOL, is the best partner for Solasia, as we can broadly share the expectations and importance of our development product SP-04 in the treatment of chemotherapy-induced peripheral neuropathy and work together to improve patient QOL.".