Theramex SpA

NYON, Switzerland, Oct. 20, 2022 /PRNewswire/ -- Today, on World Osteoporosis Day, the International Osteoporosis Foundation (IOF) calls on people of all ages to be proactive in taking steps for better bone health and osteoporosis prevention. Osteoporosis is a bone disease that affects some 500 million people worldwide and is a major cause of pain, disability and loss of independence in older adults. Worldwide, one in three women and one in five men aged over 50 will sustain an osteoporotic fracture. Most people who have osteoporosis don't know their bones are getting progressively weaker - until they experience a first broken bone following just a minor slip or fall from standing height, or sometimes even from bending over to tie a shoelace. "A spinal fracture or a broken hip can be life-changing. This is why early prevention of osteoporosis is so important. Although much of our bone density is determined by genetic factors, there are steps we can take to strengthen our bones and reduce the risk of developing osteoporosis and suffering a fracture in the future," said IOF CEO Dr Philippe Halbout. IOF recommends a five step approach to better bone health and osteoporosis prevention. Ensure a nutritious, balanced diet that includes enough calcium, protein and other important vitamins and nutrients, including vitamin D which is primarily made in the body when the skin is exposed to sunlight, and which is contained in a limited number of foods. Keep moving! Physical activity is absolutely vital to bone health. This is clear when one considers that adults who are confined to bed may lose as much bone in a week than they would otherwise lose in a year. Exercises which are weight-bearing and help to strengthen muscles are ideal. This can include anything from jogging and weight-training to lower-impact exercises like walking or using elastic resistance bands. Practicing exercises that improve balance can help reduce the risk of falling. Generally, a minimum of 30-40 minutes of physical activity, two to three times a week, is recommended. Anyone who has osteoporosis should follow a targeted exercise plan as this is a key component of treatment alongside any prescribed medication. Stop bone-damaging habits such as smoking and excessive alcohol intake. Maintain a healthy body weight. Being underweight (generally a BMI below 19 kg/m2) is a risk factor. Of special concern are young people with eating disorders, as well as older adults with reduced appetites. Finally, early awareness of any personal risk factors is critical. A broken bone after the age of 50, height loss of more than 4 cm/1½ in., and parental history of hip fracture – these are just several of the key risk factors which should prompt assessment. A DXA scan may be advised as a next step to help determine whether you have osteoporosis and whether treatment is needed. The IOF Osteoporosis Risk Check, a simple online questionnaire, alerts to potential risk factors. IOF President Professor Cyrus Cooper, added: "As osteoporotic fractures can have devastating and life-threatening consequences, we urge people of all ages to prioritise osteoporosis prevention. Discuss bone health with your doctor and don't hesitate to ask for assessment and care if you are at risk. Remember, strong bones will help you stay mobile and independent as you age." World Osteoporosis Day, marked on October 20, calls for global action to fight osteoporosis and related fractures. WOD Partners: Amgen, Sunsweet, Zuellig Pharma, Abbott, Pharmanovia, Theramex The International Osteoporosis Foundation is the world's largest NGO dedicated to osteoporosis and fracture prevention. Picture is available at AP Images () Media contact: L.Misteli, [email protected] SOURCE The International Osteoporosis Foundation (IOF)

Ad hoc announcement pursuant to Art. 53 LR of the SIX Swiss Exchange GENEVA, Switzerland – July 27, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing novel therapies for women’s health, today announced that it plans to initiate a corporate restructuring and refocus the Company’s development and commercialization strategy. ObsEva believes the changes are necessary due to the commercial landscape and potential additional capital needed to fund the completion of the linzagolix clinical development program, as the U.S. Food and Drug Administration (FDA) has notified the Company of review issues regarding deficiencies in the New Drug Application (NDA) for linzagolix for uterine fibroids. These review issues preclude discussion of labeling and post-marketing commitments at this time. While ObsEva continues to engage in communications with the FDA, including submission of documentation as well as a plan for the provision of additional data addressing the deficiencies, the Company believes that resolution of the identified review issues may not be feasible by the September 13, 2022 target action date under the Prescription Drug User Fee Act (PDUFA). The FDA’s review of the NDA is still ongoing and ObsEva has not been informed of any final decision by the agency. Based on this assessment, ObsEva’s Board of Directors has decided to undertake the following actions: Termination of the license agreement with Kissei for linzagolix;Planned corporate restructuring to resize the Company to be able to meet ObsEva’s other license obligations and assess strategic options with respect to pipeline development;Application to the Swiss court for a moratorium to facilitate the planned restructuring. In consideration of the cost of ongoing development and the competitive impact of a potential delay in approval of linzagolix for uterine fibroids by the FDA, ObsEva has decided to terminate the license agreement with Kissei for linzagolix. Termination of the linzagolix license agreement will cause ObsEva’s licensing agreement with Theramex for linzagolix to be assigned to Kissei. Linzagolix was granted marketing authorization for the management of moderate to severe symptoms of uterine fibroids in reproductive age women over 18 years old by each of the European Commission and the UK Medicines and Healthcare Products Regulatory Agency in June 2022. ObsEva intends to restructure its operations to support existing license agreements, namely its global license agreement with Organon for the development and commercialization of ebopiprant and its sublicense agreement with Yuyuan BioScience for the development and commercialization of nolasiban in the People’s Republic of China. In addition, ObsEva will assess strategic options with respect to pipeline development and the worldwide rights it holds for nolasiban, excluding China. Based on an evaluation of the Company’s current assets and liabilities and cash runway, ObsEva’s Board of Directors has decided to apply to the competent court in Geneva, Switzerland, for a court-sanctioned moratorium. If granted, the moratorium will provide the Company with temporary protection against debt-enforcement and bankruptcy proceedings in Switzerland, with a view to make it possible for the Company to undertake restructuring measures under the supervision of one or more court-appointed administrators. Consistent with ObsEva’s plans to restructure its operations, ObsEva will initiate a mass dismissal process, pursuant to Swiss law. A final decision on the extent of the restructuring will be taken following a consultation process with the Company’s employees. Ebopiprant License Agreement with Organon Under the license agreement with Organon for ebopiprant, ObsEva is entitled to receive tiered double-digit royalties on commercial sales, up to $90 million in development and regulatory milestone payments, and up to $385 million in sales-based milestone payments. Upon execution of the agreement, ObsEva received a $25 million upfront payment. Ebopiprant is an investigational, orally active, selective prostaglandin F2α receptor antagonist being evaluated as a potential treatment for preterm labor by reducing inflammation and uterine contractions. Nolasiban Sublicense Agreement with Yuyuan BioScience Under the sublicense agreement with Yuyuan BioScience for nolasiban, ObsEva is entitled to receive aggregate milestone payments of up to $17 million upon the achievement of specified development, regulatory, and first sales milestones, and aggregate milestone payments of up to $115 million upon the achievement of additional, tiered sales milestones. In addition, Yuyuan BioScience has agreed to pay tiered royalties on net sales at percentages ranging from high-single digit to low-second digits. Nolasiban is a novel, oral oxytocin receptor antagonist being developed for improving clinical pregnancy and live birth rates in women undergoing in vitro fertilization.About ObsEva ObsEva is a biopharmaceutical company developing novel therapies to improve women’s reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a clinical pipeline with development programs focused on new therapies for the treatment of preterm labor and improving clinical pregnancy and live birth rates in women undergoing in vitro fertilization. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”. For more information, please visit www.ObsEva.com Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate”, “believe”, “continue”, “could”, “estimate”, “expect”, “intend”, “may”, “might”, “ongoing”, “objective”, “plan”, “potential”, “predict”, “should”, “will”, “would”, or the negative of these and similar expressions, and are based on ObsEva’s current beliefs and expectations. These forward-looking statements include expectations regarding the potential approval of linzagolix by the FDA, and the timing of such approval, the timing or results of interactions with regulatory authorities, including addressing deficiencies in the NDA for linzagolix, plans to submit additional data for the NDA for linzagolix, and the potential timing to address or resolve such deficiencies, the need for additional capital to fund the completion of the linzagolix clinical development program, potential benefits, if any, resulting from ObsEva’s filing for a court-sanctioned moratorium and the effects of such moratorium, ObsEva’s plans for, and ability to implement successfully, the restructuring of its operations and to refocus the Company’s development and commercialization strategy, the termination of ObsEva’s license agreement with Kissei, the effects of such termination and the ability of ObsEva and Kissei to cooperate successfully on the completion of the extension studies currently underway for linzagolix, clinical development of ObsEva’s product candidates, including the timing, advancement of, and potential therapeutic benefits of such product candidates, the potential for linzagolix and other product candidates to be commercially competitive, the success of the Company’s partnerships with third parties and the amount of potential payments the Company may earn pursuant to such partnerships, including with Organon and Yuyuan BioScience, expectations regarding regulatory and development milestones and ObsEva’s ability to obtain and maintain regulatory approvals for its product candidates. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties in the outcome and potential impact of the court-sanctioned moratorium, including with respect to ObsEva’s agreements with third parties, in ObsEva’s ability to successfully restructure its operations and refocus the Company’s development and commercialization strategy, and to cooperate with Kissei or other third parties on the completion of the linzagolix extension studies, in the conduct of clinical trials and clinical development, including the risk that the results of earlier clinical trials may not be predictive of the results of later stage clinical trials, related interactions with regulators, including interactions with the FDA during the New Drug Application process for linzagolix, ObsEva’s reliance on third parties over which it may not always have full control, and the capabilities of such third parties, the impact of the ongoing novel coronavirus outbreak and other geopolitical events, and other risks and uncertainties that are described in the Risk Factors section of ObsEva’s Annual Report on Form 20-F for the year ended December 31, 2021 filed with Securities and Exchange Commission (SEC) on March 10, 2022, in the Report on Form 6-K filed with the SEC on May 17, 2022 and other filings ObsEva makes with the SEC. These documents are available on the Investors page of ObsEva’s website at www.ObsEva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and, except as required by law, ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. For further information, please contact: CEO Administrative ContactShauna Dillonshauna.dillon@obseva.ch+41 22 552 1550 Investor ContactKatja Buhrerkatja.buhrer@obseva.com+1 (917) 969-3438 Media ContactJeanene TimberlakeRooneyPartnersjtimberlake@rooneypartners.com+1 (646) 770-8858 Attachment ObsEva Corporate Updates_27Jul2022_pdf

On Wednesday, Swiss women’s health company ObsEva announced that it is dropping linzagolix, its leading candidate for uterine fibroids. The company will also undergo corporate restructuring and revisit its development and commercialization strategy in order to better support its existing license agreements. ObsEva’s restructuring comes soon after the U.S. Food and Drug Administration flagged deficiencies in the company’s New Drug Application (NDA) for linzagolix. Because of these issues, the company is unable to move forward with labeling and post-market commitments. The company is currently working with the FDA regarding linzagolix’s application. Aside from submitting additional documentation, ObsEva is planning on beefing the NDA up with more data that hopefully will satisfy the deficiencies. However, it believes that the initial target action date of September 13 may no longer be feasible. As a result, ObsEva has decided to terminate its agreement with Kissei, from whom it licensed linzagolix back in 2015. Last February, ObsEva entered into a partnership with Theramex, supposedly to support the commercialization and marketing of linzagolix. Upon ObsEva’s exit from the 2015 deal, the Theramex licensing agreement will be transferred to Kissei. News that ObsEva was dropping linzagolix hit the company hard, with its shares dropping 75% in Wednesday’s premarket trading. Also, as part of its restructuring efforts, ObsEva is eyeing a mass layoff soon, following Swiss labor regulations. Final details regarding the “mass dismissal process” will follow a consultation with its companies. In addition, ObsEva is planning to apply for a court-sanctioned moratorium in Geneva, Switzerland, in consideration of its current assets and liabilities, as well as its cash runway. The moratorium will help the company fend off debt enforcement and bankruptcy proceedings if granted. These efforts should allow ObsEva to focus its resources and expertise on ebopiprant, an oral investigational treatment for preterm labor, which was licensed by Merck spinoff company Organon. Ebopiprant is a selective prostaglandin F2α receptor antagonist that suppresses inflammation and uterine contractions. The Organon deal earned ObsEva $25 million upfront, and it remains eligible for up to $475 million in various milestone payments. After its restructuring, ObsEva can fall back on its sublicensing agreement with Chinese company Yuyuan BioScience. At the center of this deal is the oral oxytocin receptor antagonist Nolasiban, which is being developed to help improve pregnancy and birth rates after in vitro fertilization. ObsEva can expect more than $130 million in development, regulatory, and sales milestones through the sublicense from the People’s Republic of China. For a while, things were looking great for linzagolix. A month ago, the drug was granted marketing authorization by the United Kingdom’s Medicine and Healthcare Products Regulatory Agency, and in June, the European Commission gave linzagolix its nod. These approvals were based on linzagolix’s strong performance in ObsEva’s two Phase III PRIMROSE studies, which showed the drug’s potentially best-in-class efficacy profile, achieving a nearly 85% responder rate in women with hormonal add-back therapy. While its NDA stumbles undoubtedly contributed to ObsEva’s choice to drop linzagolix, strong competition may also have been a factor. In March this year, Astellas Pharma reported that its oral, nonhormonal candidate fezolinetant was safe and effective for hot flashes and night sweats, common menopause symptoms. The presence of industry giant Bayer also looms large over the women’s health space, with its series of Phase III OASIS trials assessing the efficacy of elinzanetant against menopausal vasomotor symptoms.