ScinoPharm (TWSE: 1789) and Foresee Pharmaceuticals, Inc. (Foresee) jointly announced today that an investment agreement to form a joint venture has been signed. This venture looks to develop a series of peptide injectable drugs with the first being a new oncological Leuprolide injectable drug product, where Leuprolide will be formulated in a proprietary controlled-release drug delivery system originally developed by Foresee and transferred to the joint venture. ScinoPharm commits to invest USD3.6 million for a minority ownership in the new company.
This peptide injectable drug is for treatment of prostate cancer and will be the first new drug investment made by ScinoPharm. The pivotal Phase III clinical trial 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. Pending a successful filing and NDA approval, the product is expected to be launched in the US in 2016-2017 with international filings to follow.
ScinoPharm will be the exclusive provider of Leuprolide active pharmaceutical ingredient ("API") for the joint venture and will further work with Foresee to develop additional new peptide drugs utilizing Foresee's proprietary controlled-release drug delivery platform technology and ScinoPharm's manufacturing capability to capitalize on the peptide injectable market. According to the 2011 market statistics, the global market for Leuprolide products was roughly USD2.6 billion and expecting strong growth in the near future.