ScinoPharm and Foresee Pharmaceuticals have signed an agreement to form a joint venture for developing a series of peptide injectable drugs with the first being a new oncological Leuprolide injectable drug used for treating prostate cancer.
The JV will formulate Leuprolide in a proprietary controlled-release drug delivery platform technology, developed by Foresee.
Under the JV, ScinoPharm will act as the exclusive provider of Leuprolide active pharmaceutical ingredient (API).
ScinoPharm, which has invested $3.6m for a minority ownership in the new company, said it will further work with Foresee to develop additional new peptide drugs utilizing Foresee's drug delivery system.
ScinoPharm president and CEO Jo Shen said, "We are expanding our capabilities into the formulation sector providing our existing clients with one-stop service for oncological and peptide APIs and drug products, capitalizing on our expertise and leadership in their development and manufacturing."
The JV said the pivotal Phase III clinical trial of Leuprolide is planned for late 2013, and the regulatory submission of the new drug application will be via Provisions of CFR 505(b)(2) in the US.
The product, which is pending a successful filing and NDA approval, is expected to be introduced in the US in 2016-2017 with international filings to follow.
