Overview

Sopherion Therapeutics, LLC is a privately held biopharmaceutical company headquartered in Princeton, New Jersey with offices in Cheshire, Connecticut, Estero, Florida and an operating subsidiary, Sopherion Therapeutics Canada, in Toronto, Canada.

Sopherion Therapeutics LLC is a specialty biopharmaceutical company with an exclusive licensing agreement with Zeneus Pharma Ltd., now Cephalon, Inc., for the commercialization of Myocet™ (a liposome-encapsulated doxorubicin-citrate complex) in the United States and Canada. Sopherion’s current business focus is the execution of a Phase III, global, randomized, registration trial for first line therapy of invasive, metastatic breast cancer and the development and commercialization of Sopherion’s lead agent, Myocet™. Myocet is being investigated in an FDA agreed upon registration trial in combination with two other drugs, Herceptin® (Trastuzumab) and Taxol (Paclitaxel) vs. Herceptin® and Taxol alone, the current standard of care for first line HER-2-overexpressing metastatic breast cancer. Myocet™, a liposome-encapsulated doxorubicin with reduced cardiotoxicity, is a nanotechnology product that localizes into tumor vasculature and in contrast to parental doxorubicin avoids homing to the heart. This 363 patient global trial in twelve countries has as of 03/06/09 been fully recruited. Unblinding is anticipated by the summer of 2010 with NDA submission for full approval following within 6 months. Myocet® is already a registered drug in Canada, where Sopherion has commercial rights and in Europe where Cephalon has commercial rights for use in first line metastatic breast cancer in combination with cyclophosphamide.; Our Phase III trial is based on a Phase II trial, supported by Roche, which gave a 96% response rate and two and a half year median progression free survival for patients with metastatic breast cancer.

A successful trial outcome could yield a new standard of care for HER-2-overexpressing metastatic breast cancer. Myocet also has potential, with clinical expansion trials, for more than a dozen other malignant diseases for which doxorubicin is already approved in the US.

Sopherion Therapeutics LLC evolved from a predecessor Company, Sopherion Therapeutics, Inc., originally formed as an R&D company employing its proprietary technology platform for drug discovery. Sopherion Therapeutics Inc. and its successor Company, SPHN Holdings, Inc. has utilized its proprietary R&D platform to create a preclinical pipeline and to explore strategic partnerships with pharmaceutical companies with interest in proprietary, peptide-based therapeutics as anti-angiogenic/anti-metastatic, targeted, anti-cancer agents. In this process, SPHN Holdings, Inc. has leveraged its Minicell Peptide Display™ screening technologies. More recently, SPHN Holdings, Inc. has decided to spin out the R&D platform to a separate entity or otherwise largely divest itself of this asset.