ProStrakan Group plc ("ProStrakan") announces today that it has acquired exclusive US commercial rights to Fareston® (toremifene citrate) for the treatment of metastatic breast cancer in postmenopausal women.
Fareston is a selective estrogen receptor modulator (SERM) indicated for the treatment of metastatic breast cancer in postmenopausal women with estrogen receptor-positive (ER+) or unknown tumors. Fareston is available in a once-daily 60 mg oral tablet.
ProStrakan, which is a subsidiary of global specialty pharmaceutical company, Kyowa Hakko Kirin Co. Ltd. (KHK), has entered into an Asset Purchase Agreement with US-based biopharmaceutical company, GTx Inc. (GTx), to acquire GTx's rights to market, distribute and sell Fareston in the US. Orion Corporation (Orion), the Finnish corporation that developed toremifene, will continue to manufacture and supply Fareston for the US market under an exclusive License and Supply Agreement executed between ProStrakan and Orion. ProStrakan has paid GTx a lump sum of US$21.7m to acquire the exclusive US rights to Fareston and related assets.
ProStrakan's acquisition of Fareston for the US market is in line with a strategic focus on the therapeutic areas of oncology, nephrology and immunology shared with its parent company, KHK. ProStrakan plans to commercialize Fareston through its existing US sales force who already promote two other ProStrakan products to oncology specialists-Sancuso® (Granisetron Transdermal System), for the prevention of chemotherapy-induced nausea and vomiting, and Abstral® (fentanyl) sublingual tablets for the treatment of breakthrough cancer pain in adults with cancer who are already routinely taking other opioid pain medicines around-the-clock for cancer pain.
There are nearly 230,000 new cases of breast cancer in the US annually. Approximately 70% of those patients have ER+ tumors and may receive a combination of surgery, chemotherapy, radiotherapy and hormonal therapy. In the US, an estimated 30% of women initially diagnosed with earlier stages of breast cancer subsequently develop metastatic disease. These patients routinely receive hormonal therapy if they have ER+ tumors, the majority of which are treated with either a SERM or an aromatase inhibitor. Fareston is one of only two SERMs approved by the FDA for the treatment of metastatic breast cancer in postmenopausal women and recommended in the National Comprehensive Cancer Network guidelines.
Dr. Tom Stratford, Chief Executive of ProStrakan, said:
"Fareston fits our strategic oncology focus in the US and serves an important group of breast cancer patients and their oncologists who may be seeking an alternative option to their current hormonal therapy. Our US sales force is already calling on these oncology specialists with our anti-emetic patch, Sancuso, and Fareston will be an excellent complement to our promotional efforts."