ScinoPharm, Foresee Pharmaceuticals to Partner on Oncological Drug Development
ScinoPharm 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.
"This collaboration with Foresee signifies ScinoPharm's strategic move into the new drug development field with focus on applying new drug delivery technologies involving oncological APIs. 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," said Dr. Jo Shen , President and CEO of ScinoPharm. She also expressed ScinoPharm's admiration and respect for the technical competence and professionalism of the Foresee management team in addressing pharmaceutical business challenges and opportunities.
Dr. Ben Chien , CEO of Foresee Pharmaceuticals, stated, "The strategic partnership between ScinoPharm and Foresee will enable Foresee to expedite the development of sustained release drug products to benefit patients. Foresee has long established relationships with several well-known preclinical and clinical development CROs. ScinoPharm's expertise and leadership in active pharmaceutical ingredient manufacturing and drug product development will play a critical role for the Joint Venture to successfully develop the Leuprolide injectable drug product. We are all excited about the opportunity to work with the ScinoPharm team to bring high quality and better therapeutics to patients."
ScinoPharm Taiwan, Ltd. is a leading process R&D and API manufacturing service provider to the global pharmaceutical industry. With research and manufacturing facilities in both Taiwan and Mainland China, ScinoPharm offers a wide portfolio of services ranging from custom synthesis for early phase pharmaceutical activities to brand companies as well as APIs for the generic industry. The Company also provides a vertically integrated, one-stop-shopping service by expanding into the field of oncological injectable formulation.
About Foresee Pharmaceuticals
Foresee Pharmaceuticals, Inc. (Foresee) is a specialty pharmaceutical company focused on the development and commercialization of pharmaceutical products based on its proprietary controlled release delivery platform technologies to treat chronic debilitating diseases and enable biotechnology products. Foresee's technologies enable development of tailor-made controlled release drug delivery over longer dosing intervals, in easier and more convenient forms, and in a wider range of molecular classes than most competing technologies. In the development of new therapies, a significant advantage of Foresee's delivery technology is its easy reference to the innovator's safety data since it reformulates the existing molecule for a better differentiating product. Thus, it reduces significantly the development cost and risk. In addition, Foresee is also developing a novel oral, highly potent and selective non-hydroxamate class of matrix metalloproteinase-12 (MMP-12) inhibitors for the treatment of asthma and chronic obstructive pulmonary disease (COPD).
Source: ScinoPharm Taiwan Ltd. via PR Newswire