Ovid Therapeutics and Angelini Pharma have signed a cooperation agreement to use OV101 to treat angel syndrome in Europe.

Guide: Ovid Therapeutics and Angelini Pharma have signed an exclusive licensing agreement for development, production and commercialization to use OV101 to treat angel syndrome in Europe!----(New York and Rome) July 13, 2020 - Ovid Therapeutics Inc., a biopharmaceutical company dedicated to developing drugs to improve the lives of patients with rare neurological conditions (NASDAQ: OVID, "Ovid") with an Italian family that has a long history of focusing on mental health, rare diseases and consumer health and working to help patients The pharmaceutical company Angelini Pharma S.p.A("Angelini Pharma") announced the signing of the agreement to develop, manufacture and commercialize the OV101 (gaboxadol) as a potential treatment for Angel syndrome in the European Union and other European Economic Area countries, as well as in Switzerland, Turkey, the United Kingdom and RussiaAngelini Pharma will enforce this Agreement through its newly established subsidiary Angelini Pharma Rare Diseases AGOV101 is considered to be the only delta (s) selective GABAA receptor agonist in development and is currently being evaluated in the critical Phase III NEPTUNE trial for angel syndrome and is expected to obtain the results of the top-line trial in the fourth quarter of 2020under the terms of the agreement, Ovid will receive an up-front payment of $20 million and up to $212.5 million for development, manufacturing, and sales of the first indications (angel syndrome), while if OV101 is successfully commercialized, it will receive a royalty equivalent to a double-digit percentage of net salesOvid will retain all commercial rights to OV101 in the United States and other parts of the world"Sour with Angelini Pharma to introduce OV101 into the european field of angel syndrome treatment as soon as it is approvedAngelini Pharma is an ideal partner for Europe, with deep regional knowledge, proven infrastructure and product success, and a commitment to improving the quality of life of the vast range of patients they serve" said Jeremy LevinDphil, chairman and chief executive of Ovid Therapeutics, MB, BChir"Finding the right partner to bring OV101 into the treatment of angel syndrome as soon as possible is a core part of our global strategywe believe that this partnership with Angelini will help maximize the potential commercial value of OV101 and achieve our strategic objectives in this important region"
" "Today is the day we will remember."Working with Ovid Therapeutics, we have laid the foundation for the development of innovative medical solutions for rare diseases based on Angelini Pharma's new strategy," said Pierluigi Antonelli, Ceo of Angelini Pharma"Angelini Pharma Rare Diseases AG, a new business unit, will strive to achieve the commercialization of OV101 in Europe once it is approved, the extremely promising drug of Ovid Therapeutics is being evaluated in Phase III clinical trials for the treatment of angel syndrome there is no effective treatment for this rare genetic disorder, which manifests itself in childhood with severe mental health disorders we are proud to fulfil this commitment, both from a scientific and social impact perspective "As shareholders and executives of Angelini Holding, we continue to invest in the pharmaceutical sector," said the " Executive Vice President Thea Paola Angelini and CEO Sergio Marullo di Condojanni half of our group's revenues currently come from this area " "Our global development and internationalization strategy focuses on business areas with high growth potential specifically, we are carefully studying all the opportunities that can be realized, not only in health care, but also in the consumer and machinery industries "Rothschild and Co are consultants for this cooperation agreement." Angel syndrome is a rare genetic disease that can exhibit a variety of signs and symptoms the disease is characterized by stunting, intellectual disability, severe language disorders, mobility and balance problems, seizures, sleep disorders, and anxiety The most common cause of angel syndrome is the loss of the function of the ubiquitin-protein-linked asesomeE E3A (UBE3A) coding gene, which plays a key role in nerve cell communication, resulting in impaired stress inhibition people with angel syndrome usually live normally, but cannot live independently , these patients need ongoing support from specialists and caregivers the global incidence of angel syndrome is about one in 12,000 to one in 20,000 the U.S Food and Drug Administration (FDA), the European Medicines Agency and the rest of the world have not approved any angel syndrome drugs, and current treatments include behavioral interventions and symptom control angel syndrome is associated with decreased stress suppression progressive inhibition is a function of the delta(sic) selective GABAA receptor, allowing the brain to correctly decipher excitatory and inhibitory nerve signals without overloading if tension inhibition weakens, the brain floods the brain with a flood of signals and loses the ability to separate background noise from critical information ov101 (gaboxadol) OV101 is considered to be the only delta (s) selective GABAA receptor agonist currently under development and the first research drug specifically targeted at the suppression of destructive stress stress suppression is a central physiological process in the brain that is disrupted and is thought to be a potential cause of certain neurodevelopmental disorders OV101 exhibits the ability to selectively activate the gamma-based GABAA receptor in laboratory studies and animal models the receptor is located in the synaptic outer gap (outside the synapse), thus regulating tension inhibition to affect nerve activity Ovid is developing OV101 to treat angel syndrome and brittle X syndrome, possibly to address the severe core symptoms of the condition through the recovery of stress suppression the underlying pathology of both syndromes involves the destruction of tension inhibition semen regulated by the gamma-based GABAA receptor preclinical studies have found that OV101 can improve the symptoms of angel syndrome and brittle X syndrome the compound has previously been tested in more than 4,000 patients (more than 1,000 years of exposure) and is considered to have good safety and bioavailability characteristics Ovid is conducting a critical Phase III (NEPUNE) clinical trial for needle-angel syndrome and has completed a Phase II Signal Search (ROCKET) clinical trial for brittle X syndrome OV101 has been approved by the FDA for research on rare pediatric diseases with angel syndrome FDA also approved OV101 user angel syndrome and brittle X syndrome for orphan drugs and fast-track eligibility In addition , the European Union Commission (EC) has approved OV101 for the treatment of angel syndrome orphans drug eligibility the U.S Patent and Trademark Office has granted Ovid a patent for the treatment of angel syndrome and brittle X syndrome using OV101 Patents granted by will expire in 2035 without regulatory extensions Ovid Therapeutics Ovid Therapeutics Inc., a New York-based biopharmaceutical company, uses its BoldMedicine ® method to develop drugs that improve the lives of patients with rare neurological disorders Ovid's drug development pipeline includes a number of promising new drugs the company's most advanced experimental drug, OV101 (gaboxadol), is currently in the clinical development phase for angel syndrome and brittle X syndrome Ovid has also partnered with Takeda Pharmaceuticals to develop OV935 (soticlestat) as a potential drug for the treatment of rare developmental and epileptic encephalopathy (DEE) to learn more about Ovid, visit About Angelini Pharma, owned by Angelini Holding, is a pharmaceutical company dedicated to providing patients with long-term and widespread attention to mental health, including pain, rare diseases and consumer health Angelini Pharma has a wide range of approved research and development projects, "world-class" production plants, and international commercialization of active raw materials and market-leading drugs for more information , please visit about Angelini Holding, the parent company of an international group that does business in the pharmaceutical and consumer goods sectors Founded in Italy in 1919, the Angelini Group today operates in 17 countries, employs 5,600 people and generates revenues of 17 billion euros in addition to the pharmaceutical sector, the , the Angelini Group also engages in the personal and home care products business through Fater, a joint venture with Procter and Gamble, through the mechanical industry business through another joint venture with The Company, the Fameccanica Group, which is involved in automation and robotics in the consumer goods industry, the perfume and skin care business through Angelini Beauty, and through Bertani Domains Angelini Holding recently entered the baby food market through a joint venture with the Hero Group, Madre Natura, which provides 100% organic baby food Ovid Therapeutics Forward-Looking Statements This press release contains certain disclosures that contain "forward-looking statements", including but not limited to statements regarding the advancement and commercialization of OV101, the potential efficacy and value of OV101, the expected reporting arrangements for OV101 clinical data, and the benefits and results of this partnership you may identify the words "will," "show," "think" and "anticipate" contained in forward-looking statements forward-looking statements are based on Ovid's current expectations and assumptions As forward-looking statements relate to the future, they may be subject to inherent uncertainties, risks and changes in circumstances that differ materially from those considered by the forward-looking statements, which are neither statements of historical fact nor guarantees or warranties for future performance important factors that could cause actual results to differ materially from the forward-looking statements include uncertainty in the development and regulatory approval process, preliminary data for clinical trials may not be indicative or warranty for the final outcome of clinical trials, and are subject to the risk that one or more clinical outcomes may change significantly as patient registrationcontinues and/or obtains additional patient data other risks that could cause actual results to differ materially from those described in the forward-looking statements are listed in the "Risk Factors" section of Ovid's filings with the Securities and Exchange Commission these risks may be exacerbated by the outbreak of new crown pneumonia and its potential impact on Ovid's business and the global economy Ovid is not responsible for updating any forward-looking statements contained herein to reflect any expected changes, even if new information is available .