Thursday, October 4, 2012

Kyowa Hakko Kirin Subsidiary ProStrakan acquires rights to market Fareston from GTX Inc.

ProStrakan Group plc a subsidiary of Kyowa Hakko Kirin Co. Ltd has entered into an Asset Purchase Agreement with US-based biopharmaceutical company, GTx Inc., to acquire GTx‘s rights to market, distribute and sell Fareston (Toremifene) in the US.  Fareston is a selective oestrogen receptor modulator (SERM) indicated for the treatment of metastatic breast cancer in postmenopausal women with oestrogen receptor-positive(―ER+ve) or unknown tumours. Fareston is available in a once-daily 60mg oral tablet.

Orion that developed toremifene will continue to manufacture and supply Fareston for the US market under an exclusive Licence 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 plans to commercialise 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

Clinical Evidence on Fareston
Phase III studies including a total of 1869 post-menopausal women with advanced metastatic or
disseminated breast cancer. Three studies, considered as pivotal studies by the applicant, compared
toremifene 40-240 mg daily with tamoxifen 20-40 mg daily in prospective randomised trials.
In a multi-centre open randomised trial including 463 post-menopausal women with
advanced breast cancer comparing treatment with Fareston and Tamoxifen suggests that the efficacy profile of of toremifene 60 mg/day was comparable to that of tamoxifen 40 mg/day. The
benefit/risk ratio was not significantly improved by increasing the toremifene dose to 240 mg/day.

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