Richter secures agreement to sell Myovant drug relugolix

Deals

Healthcare company Myovant Sciences and pharmaceutical company Gedeon Richter announced that they have entered into an exclusive license agreement for 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 CIS, Latin America, Australia, and New Zealand.

According to a press release sent to the Budapest Business Journal, Myovant will receive an upfront payment of USD 40 million and is eligible to receive up to USD 40 mln in regulatory milestones and USD 107.5 mln in sales-related milestones, and tiered royalties on net sales following regulatory approval.

Myovant retains all rights to relugolix combination tablet in the United States, 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. Richter will be responsible for local clinical development, manufacturing, and all commercialization for its territories. Myovant has also granted 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," says 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."

Frank Karbe, president and chief financial officer of Myovant adds, "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."

"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 United States,” Karbe notes.

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, the press release says.

ADVERTISEMENT

Reforms to raise productivity would strengthen recovery - OE... Analysis

Reforms to raise productivity would strengthen recovery - OE...

Meeting called to address Pegasus spyware lacks quorum  Parliament

Meeting called to address Pegasus spyware lacks quorum 

Skanska commercial dev unit names new EVP of operations Hung... Appointments

Skanska commercial dev unit names new EVP of operations Hung...

Zsa Zsa Gabor's ashes buried in Budapest City

Zsa Zsa Gabor's ashes buried in Budapest

SUPPORT THE BUDAPEST BUSINESS JOURNAL

Producing journalism that is worthy of the name is a costly business. For 27 years, the publishers, editors and reporters of the Budapest Business Journal have striven to bring you business news that works, information that you can trust, that is factual, accurate and presented without fear or favor.
Newspaper organizations across the globe have struggled to find a business model that allows them to continue to excel, without compromising their ability to perform. Most recently, some have experimented with the idea of involving their most important stakeholders, their readers.
We would like to offer that same opportunity to our readers. We would like to invite you to help us deliver the quality business journalism you require. Hit our Support the BBJ button and you can choose the how much and how often you send us your contributions.