Nagano, Japan based Kissei Pharmaceutical Co., Ltd. and ObsEva SA — headquartered in Geneva, Switzerland, have announced conclusion of an agreement granting exclusive rights to ObsEva to develop and commercialize a novel investigational drug with the development code KLH-2109, for treatment of endometriosis and other potential indications.
Under this agreement, Kissei Pharmaceutical — a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of obstetrics/gynecology, renal dialysis, urology, metabolism and ophthalmology — has granted ObsEva SA — a clinical stage biopharmaceutical company focusing on the development of a novel generation of drugs addressing serious conditions compromising pregnancy from conception to birth — exclusive worldwide rights on KLH-2109, which was discovered by Kissei, excluding some countries in Asia such as Japan. Kissei Pharmaceutical will receive an upfront payment, be eligible to receive milestone payments according to stages of development, and will supply the drug substance to ObsEva SA.
Three Phase 2a studies have been completed in endometriosis in Japan on KLH-2109, a novel orally administrable gonadotropin-releasing hormone GnRH (gonadotropin releasing hormone) antagonist that acts by antagonizing GnRH at the GnRH receptor in the pituitary and consequently suppressing the secretion of gonadotropin.
Both companies will collaborate in parallel on continued development of KLH-2109, represented in ObsEva’s pipeline as OBE2109. Financial terms of the deal are not being disclosed.
“Endometriosis is a painful, chronic disease and a leading cause of infertility, affecting more than 170 million women worldwide,” says Ernest Loumaye, CEO and Co-Founder of ObsEva in a release. “ObsEva is advancing a pipeline of clinical stage, novel compounds focused on supporting pregnancy, including indications that impact fertility as well as the overall well-being of women. This collaboration recognizes the additive nature of our expertise together with that of Kissei, and we look forward to advancing together with them this potentially best-in-class treatment option for women worldwide.”
Kissei Pharmaceutical focuses on drug discovery, research and development of new drugs, and aims at international expansion by licensing out of original products. Kissei’s Chairman and CEO: Mutsuo Kanzawa notes: “The 21st century has been referred to by many as the “century of life,” because of its promise of great strides in the diagnosis, treatment and prevention of a host of ailments. Our mission is to contribute to this progress by creating the innovative pharmaceuticals the world deserves. Our top priority is fulfilling our role as a strongly R&D-oriented corporation, producing original medicines that ease suffering and safeguard lives…. Looking ahead, we are determined to live up to our ideals of social responsibility, using our position as a manufacturer of innovative pharmaceuticals to bring smiles to the lives of everyone. to bring new ideas into reality for the benefit of everyone.”
According to The World Endometriosis Research Foundation (WERF), Endometriosis affects an estimated one in 10 women during their reproductive years, or approximately 176 million women worldwide. In Endometriosis, tissue similar to the lining inside the uterus (called the endometrium) is found outside the uterus, where it induces a chronic inflammatory reaction that may result in scar tissue. The dysfunctional growth is primarily found on the pelvic peritoneum, on the ovaries, in the rectovaginal septum, on the bladder, and in the bowel (http://www.mayoclinic.org/diseases-conditions/endometriosis/basics/definition/con-20013968). Endometriosis symptoms may include painful periods, painful ovulation, pain during or after sexual intercourse, heavy bleeding, chronic pelvic pain, fatigue and infertility, and can impact the patient’s general physical, mental, and social well-being.
The World Endometriosis Research Foundation EndoCost study (Simoens S, et al. The burden of endometriosis: costs and quality of life of women with endometriosis and treated in referral centres. Hum Reprod 2012) — the first ever prospective study of the actual cost of endometriosis — estimated the annual cost of endometriosis at EUR 70.9 billion in the US and EUR 58.8 billion in Germany, UK, France and Italy.
Kissei and Obseva say KLH-2109/OBE2109 works by preventing endogenous gonadotropin releasing hormone (GnRH) from activating its pituitary receptors which ultimately reduces estrogen production by the ovaries, noting that KLH-2109 has a potentially best-in-class profile that allows partial estrogen suppression. It maintains estradiol in the low-normal range, providing symptom reduction while avoiding significant bone loss or other adverse effects that can be associated with excessive suppression of estrogen. The companies report that Phase 2a studies in Japan indicate that KLH-2109 induces a dose-dependent reduction in serum LH and estradiol, resulting in a reduction of endometriosis-associated pain and bleeding days. A Phase 2b study of OBE2109 versus Placebo in endometriosis is scheduled to start mid-2016.
Sources
Kissei Pharmaceutical Co, Ltd.
ObsEva SA
Society for Endocrinology
The World Endometriosis Research Foundation