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Phosphagenics Limited (POH.AX) Signs Development Agreement For TPM/Oxymorphone Patch In Japan

8/22/2017 10:46:42 AM

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22 August 2017, Melbourne: Australian drug delivery company, Phosphagenics Limited (ASX: POH; OTCQX: PPGNY), is pleased to announce the signing of a development agreement with Terumo Corporation, for the TPM®/Oxymorphone patch in Japan.

In January 2017 Phosphagenics and Terumo signed a non-binding term sheet detailing the proposed terms under which Phosphagenics would grant Terumo exclusive rights to develop, market and sell a TPM® enabled Oxymorphone patch in Japan. Since then, both parties have collaborated to finalise the composition of a patch specifically focused on the Japanese market, which prefers a 1-day (24-hour) patch. The success in developing this patch has allowed further progression to a new binding agreement and has also benefited Phosphagenics’ 3-day patch, which is designed around the requirements of the US market.

The agreement signed today targets progression of a 1-day TPM® enabled Oxymorphone patch into the clinic within the first 12 months followed by a formal consultation with Japanese Regulatory Authorities (PMDA) to determine the most efficient way forward to market. Phosphagenics will undertake some of the activities associated with progression of the patch and will receive up to $2M in development milestone payments through this period.

On successful completion of the first Phase 1 study and PMDA consultation, Terumo can activate an exclusive option and progress to a full license agreement. The terms for such an agreement, set forth in the previous non-binding term sheet, include Terumo accepting all Japanese development costs, providing additional development and sales milestones, and paying Phosphagenics single to double digit royalties on net sales in Japan. Entry into a license agreement and actual terms remain subject to further agreement by both Parties. Phosphagenics retains full rights to market and/or partner both the 1-day or 3-day TPM®/Oxymorphone patch in any market outside of Japan.

As part of this agreement Terumo has now formally informed Phosphagenics of its strategic decision not progress two TPM® enabled patches in parallel. The TPM® enabled Oxycodone patch is therefore free to be partnered by other companies across all territories. The signing of this agreement marks the fourth R&D partnered project between Terumo and Phosphagenics.

Mr Masahito Takahashi, General Manager of the Pharmaceutical Group, Hospital Systems Division, General Hospital Company, Terumo Corporation, said, “This agreement marks a significant milestone in a relationship that continues to get stronger. Terumo remains enthusiastic about the potential of TPM® enhanced products and continues to commit significant resources across all joint programs. This agreement is another demonstration of our growing confidence in TPM® and confidence in Phosphagenics as a partner and the potential of the TPM®/Oxymorphone patch for Japan.”

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