ObsEva SA, a biopharmaceutical company, focuses on the development of novel therapies to improve women's reproductive health.
The company is advancing a development program for Nolasiban, an oral oxytocin receptor agonist, focused on improving clinical pregnancy and live birth rates in women undergoing in-vitro fertilization (IVF).
The company in-licensed nolasiban from Ares Trading S.A., an affiliate of Merck Serono (Merck Serono), in August 2013. It has worldwide, exclusive, commercial right...
ObsEva SA, a biopharmaceutical company, focuses on the development of novel therapies to improve women's reproductive health.
The company is advancing a development program for Nolasiban, an oral oxytocin receptor agonist, focused on improving clinical pregnancy and live birth rates in women undergoing in-vitro fertilization (IVF).
The company in-licensed nolasiban from Ares Trading S.A., an affiliate of Merck Serono (Merck Serono), in August 2013. It has worldwide, exclusive, commercial rights for nolasiban, except for the People's Republic of China, where it has been sub-licensed to Hangzhou Yuyuan BioScience Technology Co., Ltd. (Yuyuan) in January 2020. In October 2022, the company announced that Yuyuan's Investigational New Drug (IND) application for a Phase 1 clinical trial of nolasiban has been accepted by the Center for Drug Evaluation at the Chinese National Medical Products Administration. Yuyuan plans to initiate a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical trial in China to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of nolasiban in healthy adult female subjects.
In July 2022, the company initiated a corporate restructuring and refocusing of its development and commercialization strategies following the receipt of a notice from the U.S. Food and Drug Administration (FDA) of review issues regarding deficiencies in its New Drug Application (NDA) for linzagolix, a prior product candidate developed for the potential treatment of uterine fibroids. These review issues precluded discussion of labeling and post-marketing commitments. As a result, the company undertook the following actions in July 2022: gave notice of termination of its license agreement (the Kissei License Agreement) with Kissei Pharmaceutical Co., Ltd (Kissei) for the development and commercialization of linzagolix; commenced a corporate restructuring to resize the company to be able to meet its license obligations; and filed an application to the competent court in Geneva, Switzerland for a court-sanctioned moratorium to facilitate the planned restructuring.
As a result of the termination of the Kissei License Agreement, the company's licensing agreement with Theramex HQ UK Limited (Theramex) for the commercialization and further development of linzagolix across global markets outside of the U.S., Canada and Asia (the Theramex License Agreement) was automatically assigned to Kissei and the company has no further rights or obligations under the Kissei License Agreement or the Theramex License Agreement. In addition, the company assigned to Kissei substantially all of its clinical, manufacturing, and scientific contracts related to the development of linzagolix.
Strategy
The key elements of the company's strategy include to continuing to advance the development program for nolasiban for the improvement of clinical pregnancy and live birth rates in women undergoing IVF; Strategically partnering or out-licensing certain product candidates at later stages of development to focus its efforts on early to mid-stage product development; and In-licensing or acquiring complementary immunotherapeutic technologies and product candidates that are either synergistic or complementary to its capabilities to expand its pipeline.
Nolasiban in IVF
Nolasiban is an oral oxytocin receptor antagonist that is being developed to improve clinical pregnancy and live birth rates in women undergoing embryo transfer following in-vitro fertilization (IVF), including intracytoplasmic sperm injection, or ICSI. The mechanism of action of nolasiban supports its potential to improve uterine receptivity by decreasing uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation. The company in-licensed nolasiban from Merck Serono, which had previously completed preclinical studies and Phase 1 clinical trials in 103 healthy female volunteers that evaluated the safety and PK profile of nolasiban.
Nolasiban Clinical Development Program
The company previously conducted a Phase 3 clinical development program for nolasiban to evaluate its potential to improve clinical pregnancy and live birth rates for women undergoing IVF. In 2018, the company completed a Phase 3 clinical trial in Europe, which it refers to as IMPLANT 2.
In November 2018, the company initiated an additional Phase 3 trial primarily in Europe, with some additional sites in Canada and Russia, also known as the IMPLANT 4 trial. In addition, the company announced the clearance of its investigational new drug (IND) in October 2019 for the U.S. Phase 3 clinical trial of nolasiban, known as IMPLANT 3.
In January 2020, the company and Yuyuan entered into a sublicense agreement to develop and commercialize nolasiban for improving clinical pregnancy and live birth rates in women undergoing embryo transfer as part of an IVF cycle in the People's Republic of China, or PRC. Under the terms of the agreement, Yuyuan has the exclusive rights to develop and commercialize nolasiban in the PRC. They will fund all development and registration activities in the PRC, starting with the obligation to fund and conduct a Phase 1 trial and a Phase 2 proof-of-concept trial in China. The company retains all rights to the product outside of People's Republic of China (PRC), and has agreed to collaborate with Yuyuan on its global development. The company's development and commercialization partnership with Yuyuan proceeded during 2021 with steering committee meetings to define the development plan for nolasiban in China for women undergoing ET following IVF.
In October 2022, the company announced that Yuyuan IND application for a Phase 1 clinical trial of nolasiban was accepted by the Center for Drug Evaluation at the Chinese National Medical Products Administration. Yuyuan plans to initiate a single-center, randomized, double-blind, placebo-controlled Phase 1 clinical trial in China to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic characteristics of nolasiban in healthy adult female subjects.
Intellectual Property
As of December 31, 2022, the company's patent portfolio as it pertains to its nolasiban product candidate included:
Nine United States (U.S.) patents, projected to expire between 2034 and 2035, two U.S. patent applications, which, if granted, project to expire between 2034 and 2035, as well as corresponding patents and patent applications internationally, directed to nolasiban as a composition of matter and uses of nolasiban in assisted reproductive technology (ART); and
Three U.S. patent applications, which, if granted, project to expire between 2037 and 2041, as well as corresponding patents and patent applications internationally, directed to nolasiban dosing regimens, patient selection, and various other medical uses of nolasiban in the ART field.
As of December 31, 2022, the company's in-licensed patent portfolio as it pertains to its nolasiban product candidate included:
One U.S. patent, projected to expire in 2023, as well as corresponding patents and patent applications internationally, directed to nolasiban as a composition of matter.
In addition to the U.S. patents and U.S. patent applications described above, the company's patent portfolio and its in-licensed patent portfolio include issued patents and pending patent applications in various other jurisdictions. For example, it has obtained, and it licenses from third parties, issued patents in Europe that pertain to certain aspects of its nolasiban product candidate.
2013 License Agreement with Merck Serono
In August 2013, the company entered into a license agreement, or the 2013 License Agreement, with Merck Serono, pursuant to which it received a worldwide exclusive license to develop, manufacture and commercialize compounds covered by the licensed patent rights, including nolasiban, which it is developing for the treatment of conditions associated with ART.
Sublicense Agreement with Yuyuan
In January 2020, the company entered into a sublicense agreement, or the 2020 Sublicense Agreement, with Hangzhou Yuyuan BioScience Technology Co., Ltd., or Yuyuan, pursuant to which it granted to Yuyuan an exclusive sublicense under certain of its patents, trademarks and know-how to use, register, import, develop, market, promote, distribute, offer for sale and commercialize nolasiban for use in humans in the People's Republic of China, including Hong Kong and Macau. Yuyuan will be responsible for the continued development of nolasiban in China at its sole cost, and is required to use commercially reasonable efforts to develop the product in accordance with certain development milestones. Yuyuan will be responsible for commercialization of nolasiban in China at its sole cost. The company is obligated to supply Yuyuan with its clinical and commercial requirements of the product at cost. Yuyuan has agreed to not develop, market or sell any oxytocin receptor antagonist other than nolasiban during the term of the 2020 Sublicense Agreement. The development and commercialization activities for nolasiban will be governed by a joint development committee and joint commercialization committee, respectively, with each party having final decision-making authority for its territory.
Government Regulation
The company relies on contract manufacturing organizations (CMOs) to produce its product candidates in accordance with the FDA's current good manufacturing practices (cGMP) regulations for use in its clinical trials.
History
ObsEva SA was founded in 2012 under the laws of Switzerland.
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