things! Sincerely, Mathieu Simon, Chairman of the Board Letter to Shareholders from the CEO (as published in Idorsia's 2020 Business Report on February 4, 2021) Dear Shareholders, I want to begin by recognizing that, while Idorsia has had a very successful year, 2020 was extremely difficult for many people. No doubt some of you will have been seriously affected by the COVID-19 pandemic, and to you I extend my sincere sympathy. This year, the public has gained a new appreciation of the efforts of all frontline healthcare workers, and also of the mission that drives everyone in the pharma world -- finding medicines to prevent or treat illness. Let us hope that the vaccines developed in record time can help the world return to some semblance of normality. I myself am very proud to be a member of this industry, and to see how our efforts in research are helping patients. In spite of the pandemic, the company has made great strides this year. Our employees achieved every one of the ambitious key goals set for 2020 -- and much else besides. Their performance was simply phenomenal. In the development of new medicines, hard work does not always guarantee good results, which makes it all the more rewarding when our efforts are crowned with success. Revolutionizing the field of insomnia Our review of the progress made in 2020 must start with the outstanding results achieved with daridorexant. The Phase 3 registration program demonstrated statistically significant and clinically meaningful improvements in sleep maintenance, sleep onset, total sleep time and daytime functioning, which were sustained over time. Daridorexant was well tolerated, with a favorable safety profile in adult and elderly patients. Particularly important, as well as efficacy during the night, are the effects seen during the day. While a negative impact on daytime functioning is part of the definition of insomnia, not one of the treatments currently available have rigorously assessed their effect on this key aspect of the condition. Here, in fact, most therapies have a negative impact -- especially first thing in the morning, when patients may feel hangover effects of their medication. For the millions of people suffering from insomnia, daridorexant is an absolute gamechanger, whose excellent benefit and safety profile will encourage patients to seek treatment. It is important to recognize that these gratifying results were no accident. They are a direct result of our efforts to design a dual orexin receptor antagonist (DORA) with the properties required to deliver all the benefits of a good night's sleep. For more details, I invite you to read the interview with Martine Clozel on page 30 of the Business Report. The team responsible worked tirelessly to evaluate the huge amount of data generated and to present the results appropriately for regulatory agencies. A new drug application was submitted to the FDA in January 2021, and the submission to the European authorities will follow shortly. In anticipation of regulatory approval, the commercial team is now working flat out to prepare for the launch. Perseverance finally paying off Our efforts to design the perfect DORA began in our labs as long ago as 1998, but our work with clazosentan goes back even further. This year, the Japanese studies of clazosentan for patients suffering cerebral vasospasm following aneurysmal subarachnoid hemorrhage also demonstrated excellent efficacy results, without any unexpected safety findings (for more information on clazosentan, see pages 52 to 57 of the Business Report). I am truly delighted to finally have the evidence that clazosentan can improve outcomes for these patients -- often young adults with so much life left to live. These results give the commercial team even more to get their teeth into. The impressive data has renewed the enthusiasm of the whole REACT team to complete the global study of clazosentan as soon as possible, so that patients around the world can benefit. More to come from the pipeline Thanks to the development group's speedy response to the COVID-19 pandemic, our ongoing late-stage studies were able to continue, and risk mitigation procedures were agreed with global health authorities. Recruitment for both the CARE study (cenerimod) and the MODIFY study (lucerastat) was affected, but following some adjustments, in consultation with health authorities, patient enrollment was adapted. Accordingly, we should see the results of CARE and be able to plan for Phase 3 development of cenerimod by the end of 2021, and the results of MODIFY -- the Phase 3 registration study for lucerastat -- should also be available in the second half of 2021. In addition, again despite the impact of the pandemic, recruitment for the PRECISION (aprocitentan) study accelerated, with randomization now expected to be completed by mid 2021. As well as the conclusion of studies, 2021 will also see the initiation of a very exciting study. Under a Special Protocol Assessment (SPA) agreed with the FDA in 2020, a 14,000 patient Phase 3 study will be commenced with selatogrel -- a drug-device product for patients with suspected heart attack. The investigation of selatogrel has been designated as a "fast-track" development program, indicating the FDA's interest in this innovative approach. Patients themselves will play a crucial role in the preparations for this study, as they need to be trained to identify symptoms and self-administer treatment. The potential implications for future heart attack patients are enormous, and I look forward to sharing more details in due course. Taking our innovation to the patient Work on building our commercial capabilities began in 2019, and we continued to fill key strategic roles on the global team in 2020. We also established our US commercial organization, securing premises and -- most importantly -- a leadership team. This is a very exciting development for Idorsia, and I am proud to have such an experienced and talented group of professionals on board. Following the positive results achieved with daridorexant, a tremendous amount of work has been done to prepare for the US launch of this product in 2022 -- not least, engaging Syneos Health as the ideal partner to reach the large US primary care market. In addition, after the excellent results with clazosentan, the Japanese team is also gearing up for our first product launch in Japan. With two product launches in preparation, we have also been building our global supply chain function, to ensure consistent supplies of our innovative medicines to patients. More information on our preparations can be found in the interview with Chief Commercial Officer Simon Jose on page 22 of the Business Report. Ongoing innovation We have always had a long-term focus for Idorsia, setting ourselves the goal of becoming a fully-fledged biopharmaceutical company, innovating from bench to bedside. As our late stage pipeline starts to bear fruit, it is essential that we keep the pipeline supplied with fresh innovation for sustainable success. As our Chairman emphasized, work in our laboratories continued unabated in 2020, and there is much to show for it. Progress was made with our early-stage clinical pipeline, and we advanced a new CNS compound into clinical pharmacology studies. On the preclinical front, four compounds were selected as preclinical candidates. These advances in our discovery efforts made during lockdown are a testament to our researchers' commitment and dedication. Financing our future Through a series of financing activities in 2020, we have secured additional funding of more than CHF 865 million. Our strengthened balance sheet with CHF 1.2 billion liquidity will take us through to the next inflection points -- namely, key clinical data from late-stage assets and the launch of our first product, daridorexant. As you may be aware, Martine and I have participated in each of the capital increases, believing more than ever in Idorsia and in the value that can be created for patients, employees and shareholders alike. I am very proud of all that has been accomplished at Idorsia in 2020. 2021 will be an extremely exciting year for our growing company, and I look forward to keeping you updated on our progress throughout the year. I would also like to thank you for your confidence in Idorsia. Warmest regards, Jean-Paul Clozel, Chief Executive Officer About Idorsia Idorsia Ltd is reaching out for more -- We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we will develop Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland -- a European biotech-hub -- Idorsia is specialized in the discovery, development and commercialization of small molecules to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team of professionals covering all disciplines from bench to bedside, state-of-the-art facilities, and a strong balance sheet -- the ideal constellation to translate R&D efforts into business success. Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 900 highly qualified specialists dedicated to realizing our ambitious targets. For further information, please contact Andrew C. Weiss Senior Vice President, Head of Investor Relations & Corporate Communications Idorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil +41 58 844 10 10 www.idorsia.com The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes",
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