Date: 2016-06-16
Type of information: Licensing agreement
Compound: relugolix (TAK-385), RVT-602 (TAK-448)
Company: Takeda Pharmaceutical (Japan) Roivant Sciences (Switzerland) Myovant Sciences (USA - CA)
Therapeutic area: Cancer - Oncology - Women health
Type agreement: establishment of a new company licensing
Action mechanism: GnRH receptor antagonist/peptide. Relugolix is an oral, once-daily, potential best-in-class gonadotropin-releasing hormone (GnRH) receptor antagonist for uterine fibroids, endometriosis and prostate cancer. By inhibiting GnRH receptors in the pituitary gland, relugolix rapidly reduces circulating sex hormone levels leading to suppression of estrogen and testosterone. Suppression of these sex hormones improves the symptoms of women with uterine fibroids and endometriosis, and decreases prostate-specific antigen (PSA) levels in men with prostate cancer. Two phase 3 registration studies in women with uterine fibroids are underway in Japan (NCT02655237, NCT02655224).
RVT-602 (TAK-448) is a kisspeptin analog that acts to stimulate the physiologic release of GnRH and downstream hormones important in fertility such as luteinizing hormone. Recent evidence from trials performed in women undergoing In-vitro Fertilization (IVF) revealed that the native kisspeptin peptide has the potential to act as an alternative to human chorionic gonadotropin (hCG) or GnRH agonists in triggering egg maturation, an essential step in every IVF cycle.
Disease: uterine fibroids, endometriosis, prostate cancer
Details: * On June 6, 2016, Takeda Pharmaceutical and Roivant Sciences announced the formation of Myovant Sciences, a biopharmaceutical company focused on delivering innovative women's health and prostate cancer solutions. In addition, Lynn Seely, MD, an endocrinologist who led the development of Xtandi® (enzalutamide) for the treatment of prostate cancer as the Chief Medical Officer of Medivation from 2005 to 2015, was named the President & Chief Executive Officer of Myovant Sciences. Takeda has also granted Myovant an exclusive, worldwide license to RVT-602 (TAK-448), a novel, oligopeptide kisspeptin receptor agonist as a product candidate for the treatment of infertility in females.
Takeda has granted Myovant an exclusive, worldwide license (excluding Japan and certain other Asian countries) to relugolix (TAK-385), a phase 3 drug candidate that has been evaluated in over 1,300 patients to date. Relugolix is being developed as an oral, once-daily, potential best-in-class gonadotropin-releasing hormone (GnRH) receptor antagonist for uterine fibroids, endometriosis and prostate cancer. Takeda will retain commercial rights for relugolix in Asian countries, including Japan, where Takeda is actively conducting two phase 3 registration studies for the treatment of uterine fibroids.
Financial terms: Financial terms of the partnership were not disclosed.
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