Gedeon Richter and Myovant Sciences Enter into Exclusive License Agreement to Commercialize Relugolix Combination Tablet for Uterine Fibroids and Endometriosis in Certain Territories Outside the U.S.

Gedeon Richter and Myovant Sciences Enter into Exclusive License Agreement to Commercialize Relugolix Combination Tablet for Uterine Fibroids and Endometriosis in Certain Territories Outside the U.S.
March 31, 2020 amarone

31 March 2020

 
Budapest, Hungary and Basel, Switzerland – Myovant Sciences (NYSE:MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate cancer, and Gedeon Richter Plc., a major pharmaceutical company in Central Eastern Europe focused on women’s health, today announced that they have entered into an exclusive license agreement for Gedeon Richter to commercialize relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia, and New Zealand. Under the agreement, Myovant will receive an upfront payment of $40 million and is eligible to receive up to $40 million in regulatory milestones and $107.5 million in sales related milestones, and tiered royalties on net sales following regulatory approval. Myovant retains all rights to relugolix combination tablet in the U.S., as well as rights to relugolix in other therapeutic areas outside of women’s health.

Under the terms of the agreement, Myovant will continue to lead the global development of relugolix combination tablet. Gedeon Richter will be responsible for local clinical development, manufacturing, and all commercialization for its territories. Myovant has also granted Gedeon Richter an option to collaborate on relugolix combination tablet for future indications in women’s health other than fertility.

“Adding innovative products to our core women’s healthcare portfolio has been the focus of our strategy,” said Erik Bogsch, Chairman of Gedeon Richter. “Through this license agreement with Myovant, we have a unique opportunity to make a meaningful difference in the lives of millions of women suffering from uterine fibroids and endometriosis.”

“We are delighted to be joining forces with Gedeon Richter, a company with a leading market position in women’s health in more than 38 countries, to accelerate the potential global launch of one pill, once a day relugolix combination tablet for women with uterine fibroids and endometriosis,” said Frank Karbe, President and Chief Financial Officer of Myovant. “In addition, this agreement further strengthens Myovant’s financial position and focus as we continue to advance the development of relugolix and prepare for multiple potential upcoming launches in the U.S.”

Myovant submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for relugolix combination tablet for the treatment of women with moderate to severe symptoms associated with uterine fibroids in March 2020. The application has completed validation and is now under evaluation by the EMA. Myovant expects top-line data from the Phase III SPIRIT 2 and SPIRIT 1 studies in women with pain associated with endometriosis in April and the second quarter of 2020, respectively.

About Uterine Fibroids
Affecting over 25% of women of reproductive age, uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual’s genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth.

Although uterine fibroids are benign tumors, they can cause debilitating symptoms such as heavy menstrual bleeding (frequently resulting in anemia and fatigue), pain (including painful periods, abdominal pain, painful intercourse, backache), increased abdominal girth and bloating, urinary frequency or retention, constipation, pregnancy loss, and, in some cases, infertility. These symptoms can also lead to loss of productivity at work, limitations in normal activities of daily living, and social embarrassment.

About Endometriosis
Affecting approximately 10% of women of reproductive age, endometriosis is a disease in which tissue similar to the uterine lining is found outside the uterine cavity, commonly in the lower abdomen or pelvis, on ovaries, the bladder, and the colon. This endometrial-like tissue outside the uterus results in chronic inflammation and can cause scarring and adhesions.

The symptoms associated with endometriosis include painful periods and chronic pelvic pain, painful ovulation, pain during or after sexual intercourse, heavy bleeding, fatigue, and infertility. Endometriosis can also impact general physical, mental, and social well-being.

For pain associated with endometriosis, initial treatment options include oral contraceptives and over-the-counter pain medications. In more severe cases, GnRH agonists such as leuprolide acetate are used for short-term treatment.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol production, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone production, a hormone known to stimulate the growth of prostate cancer. Myovant is developing a relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for women with uterine fibroids and for women with endometriosis. Myovant is also developing a relugolix monotherapy tablet (120 mg once daily) for men with advanced prostate cancer.

About Myovant Sciences
Myovant Sciences aspires to be the leading healthcare company focused on innovative treatments for women’s health and prostate cancer. The company’s lead product candidate is relugolix, a once-daily, oral GnRH receptor antagonist. The company has three late-stage clinical programs for relugolix in uterine fibroids, endometriosis, and prostate cancer. The company is also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, that has completed a Phase IIa study for the treatment of female infertility as part of assisted reproduction. Takeda Pharmaceuticals International AG, a subsidiary of Takeda Pharmaceutical Company Limited, the originator of relugolix, previously granted the company a worldwide license to develop and commercialize relugolix (excluding Japan and certain other Asian countries) and an exclusive license to develop and commercialize MVT-602 in all countries worldwide. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is the majority shareholder of Myovant. For more information, please visit the company’s website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

About Gedeon Richter
Gedeon Richter Plc. (www.richter.hu), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, in China and in Latin America. Having reached a market capitalization of EUR 3.6 billion (USD 4.1 billion) by the end of 2019, Richter’s consolidated sales were approximately EUR 1.6 billion (USD 1.7 billion) during the same year. The product portfolio of Richter covers many important therapeutic areas, including Women’s Healthcare, Central Nervous System and Cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter’s original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the Women’s Healthcare field worldwide. Richter is also active in biosimilar product development.

For more information:

Richter:

Investors:
Katalin Ördög: +36 1 431 5680
Media:
Zsuzsa Beke: +36 1 431 4888

Myovant:

Investors:
Frank Karbe
President, Chief Financial Officer
Myovant Sciences, Inc.
investors@myovant.com

Media:
Albert Liao
Director, Corporate Communications
Myovant Sciences, Inc.
media@myovant.com

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