Takeda Pharmaceutical Co., Ltd. and is committed to developing drugs that change the fate of patients with rare diseases of the nervous system The biopharmaceutical company Ovid Therapeutics Inc. announced that Takeda has reached an exclusive agreement. According to the agreement, Takeda will obtain from Ovid the global rights to develop and commercialize the drug under development soticlestat (TAK-935/OV935) when the agreement is signed, which can be used to treat Dravet syndrome (DS) and Lennox-Gastaut syndrome. (LGS) including developmental and epileptic encephalopathy.

Soticlestat was discovered by Takeda's research center in Shonan, Japan. It is a potent, highly selective, first-in-class cholesterol 24 hydroxylase (CH24H) inhibitor. According to this new exclusivity agreement, Takeda acquires all global rights of Soticlestat from Ovid. Takeda will assume full responsibility for further global development and commercialization. According to the original cooperation agreement, Ovid will no longer assume any financial obligations to Takeda, including milestone payments or any future development and commercialization costs. Ovid will receive an upfront payment of US$196 million when the agreement is signed and is eligible to receive additional payments of up to US$660 million when development, regulatory and sales milestones are reached. In addition, if approved and commercialized, Ovid will receive tiered royalties starting from the low double digits and up to 20% of Soticlestat's sales share. The new agreement is expected to be signed before the end of March 2021, provided that the usual closing conditions are met, including the approval of the relevant regulatory authorities in accordance with the Hart-Scott-Rodino Act.

Andy Plump, MD, Ph.D., President of Takeda’s R&D Department, said: “I would like to thank Ovid for its thoughtful and fruitful cooperation. We have jointly handed over the fruitful ELEKTRA Phase 2 study data, and Sotilestat is ready to enter 2 key points. Trial. Our collaboration demonstrates the strength of Takeda’s partnership model and our commitment to delivering transformational medicines to patients with neurological diseases."

In accordance with the 2017 version of the cooperation agreement, Takeda acquired equity in Ovid and was eligible to receive payments of up to $85 million in accordance with regulatory milestones including the initiation of phase 3 clinical trials. Ovid led the global development of Soticlestat and successfully completed its proof of concept in a variety of rare epilepsy.

Jeremy Levin, DPhil, MB, BChir, Chairman and CEO of Ovid Therapeutics, said: “This new agreement is a positive result for patients, Ovid and Takeda. We have teamed up to build the platform, optimize the project and empower it to accelerate. Ovid Can benefit significantly, but there is no need to bear the huge financial obligation for Sotilstat to complete key trials in the next few years. If it succeeds, Sotilstat will enter the global market. Importantly, with the resources delivered by the agreement, Ovid will be strategic and financial in the future. We are in a favorable position. We will promote and enrich our product line and continue to build this leading company in the field of rare brain diseases. We would like to thank Takeda, who has been an outstanding partner, and we look forward to the further success of this project in the future."

Sarah Sheikh, MD, M.Sc., MRCP, Director of Takeda Neuroscience Therapeutics Department, said: "Soticlestat has become an important late-stage molecule in our product lineup, mainly for the nervous system and neuromuscular rare diseases market with huge unmet needs. We. Efforts are being made to initiate and implement Phase 3 studies of DS and LGS in children and young adults as soon as possible. Our goal is to one day provide DS and LGS patients around the world with new treatment options with better seizure control, tolerability and function. "

Promote new treatment options for patients with DS and LGS

Takeda and Ovid reported the results of the ELEKTRA Phase 2 study in August 2020, and Sotellestat reached the primary endpoint, which is to reduce the frequency of seizures in children with DS or LGS. Takeda plans to initiate a Phase 3 study of Sotilestat for DS and LGS in children and young adults in the second quarter of 2021.

About Soticlestat (TAK-935/OV935)

Soticlestat is a potent, highly selective, first-in-class cholesterol 24-hydroxylase (CH24H) inhibitor, which is expected to reduce seizure susceptibility and improve seizure control. CH24H is mainly expressed in the brain. It converts cholesterol into 24S-hydroxycholesterol (24HC) in the brain to regulate the homeostasis of brain cholesterol. 24HC is a positive allosteric modulator of NMDA receptors, which can regulate glutamatergic signaling related to epilepsy. Glutamate is one of the main neurotransmitters in the brain and has been shown to play a role in the initiation and spread of epileptic seizures. Recent literature has shown that CH24H participates in the excessive activation of glutamatergic pathways by regulating NMDA channels, and increased CH24H expression can disrupt the reuptake of glutamate by astrocytes, leading to epilepsy and neurotoxicity. After Soticlestat inhibits CH24H, the level of 24HC in neurons is reduced, which can improve the twisted excitatory/inhibitory balance in the brain.

About Dravet syndrome and Lennox-Gastaut syndrome

Dravet syndrome and Lennox-Gastaut syndrome are different types of developmental and epileptic encephalopathy (DEE). DEE is a group of heterogeneous rare epilepsy syndromes. Dravet and Lennox-Gastaut syndrome usually manifests in infancy or early childhood, and most antiepileptic drugs are ineffective.

The most common cause of Dravet syndrome is a genetic mutation in the SCN1A gene, which affects approximately 1 in 15,000 to 21,000 people in the United States. Dravet syndrome is characterized by prolonged focal seizures, which can evolve into convulsive tonic-clonic seizures. As the number of attacks increases, children with Dravet syndrome develop developmental disabilities. Other common symptoms include changes in appetite, difficulty balancing, and squatting gait while walking.

Lennox-Gastaut syndrome is estimated to affect approximately 1 in 11,000 people in the United States. Lennox-Gastaut syndrome is a heterogeneous disease characterized by several different types of seizures, the most common being weakness (falls), tonic and atypical absence seizures. Children with Lennox-Gastaut syndrome may have cognitive dysfunction, delayed achievement of developmental milestones, and behavioral problems at the same time. Lennox-Gastaut syndrome can be caused by a variety of underlying diseases, but the etiology is unknown in some cases.

Ovid conference call and webcast information

Ovid Therapeutics will start a conference call today (March 3) at 8:30 am Eastern Time. To access this live event, please visit the "Investors" page of the Ovid Therapeutics website at investors.ovidrx.com, or call (866) 830-1640 (in the United States) or (210) 874-7820 (international), and Enter the conference ID number 6343028. A replay of the conference call will be uploaded to the Ovid Therapeutics website after the conference and will be archived for 30 days.

About Takeda Pharmaceutical Co., Ltd.

Takeda Pharmaceutical Co., Ltd. is a value-oriented R&D-driven biopharmaceutical leader headquartered in Japan. Upholding our commitment to patients, employees and the planet, Takeda is committed to discovery and delivery Medicines that change destiny. Takeda's research and development efforts focus on tumors, rare genetic diseases and hematology, neuroscience and gastroenterology (GI). We also make targeted R&D investments in plasma-derived therapies and vaccines. We are committed to the development of highly innovative drugs. By advancing the forefront of new treatment options, using our enhanced collaborative research and development engine and capabilities, we are creating a powerful and diverse product line that contributes to changing people’s lives. Our employees are committed to improving the quality of life of patients and working hand in hand with partners in the medical field in nearly 80 countries. For more information, please visit https://www.takeda.com .

Important note from Takeda

This press release and any materials distributed in connection with it may contain forward-looking statements, views or opinions related to Takeda’s future business, future conditions and operating performance, including Takeda’s estimates, forecasts, goals and plans. Forward-looking statements often include but are not limited to "objectives", "plans", "believes", "hopes", "continues", "anticipates", "aims", "intends", "guarantees", "will", " Likely, "should", "will", "maybe", "anticipate", "estimate", "forecast" or similar expressions or their negative form. Such forward-looking statements are based on assumptions about a number of important factors, including the assumptions mentioned below, which may cause actual results to differ materially from those expressed or implied in the forward-looking statements: the economic situation faced by Takeda’s global business, Including the macroeconomic environment in Japan and the United States; competitive pressures and developments; changes in applicable laws and regulations, including global health care reforms; challenges inherent in the development of new products, including the uncertainty of clinical success and the decisions or actions of regulatory authorities The timing of decision-making; uncertainty about the commercial success of new and existing products; manufacturing difficulties or delays; fluctuations in interest rates and exchange rates; claims or questions about the safety or efficacy of sold products or candidate products; including the new crown epidemic The impact of the health crisis on Takeda and its customers and suppliers, including the foreign government of the country where Takeda operates, or its impact on other aspects of its business; the timing and impact of integration measures after the merger of acquired companies; the disposal of Takeda’s non-core operating assets Ability and timing; and other factors listed in Takeda’s recent Form 20-F annual report and other reports submitted to the US Securities and Exchange Commission. For details, please refer to Takeda’s website at https://www.takeda.com/investors/reports/sec-filings / Or www.sec.gov . Unless required by law or stock exchange rules, Takeda has no obligation to update any forward-looking statements in this press release or any other forward-looking statements that the company may issue. Historical performance does not represent future performance, and Takeda’s performance or statement in this press release cannot be referred to, nor is it an estimate, forecast, guarantee or speculation of Takeda’s future performance.

About Ovid Therapeutics

Ovid Therapeutics Inc. is a New York-based biopharmaceutical company that uses its BoldMedicine ® method to develop drugs that change the fate of patients with rare diseases of the nervous system. Ovid's product pipeline contains a large number of promising first-in-class drugs. These include projects for Angelman syndrome, Fragile X syndrome and rare epilepsy, as well as early projects for other single-gene disorders. Ovid's most advanced product line projects include OV935 (Soticlestat) and the delta-selective GABA A receptor agonist OV101 in cooperation with Takeda . Ovid’s emerging product line projects include small molecule GABA transaminase inhibitor OV329 for tuberous sclerosis and infantile spasm-related seizures; short hairpin RNA therapy drug OV882 for Angelman syndrome; and KIF1A-related neurological diseases The gene therapy drug OV815; and other undisclosed research targets. For more information about Ovid, please visit www.ovidrx.com .

Ovid forward-looking statements

This press release contains certain disclosures that contain "forward-looking statements," including but not limited to potential benefits related to Sotilestat and Ovid’s other projects, clinical and regulatory development and commercialization, and the relevant provisions of the 2017 Authorization and Cooperation Agreement. The completion of the "2021 Royalties, Authorization and Termination Agreement", the potential value, benefits and outcome of the cooperation with Takeda. You can identify forward-looking statements because they contain words such as "will", "seems", "believes" and "expects." Such forward-looking statements are based on Ovid's current expectations and assumptions. Since forward-looking statements are related to the future and are subject to inherent uncertainties, risks and environmental changes, they may differ materially from those anticipated by forward-looking statements. Forward-looking statements are neither statements of historical facts nor correct. A guarantee or guarantee of future performance. Important factors that may cause actual results to differ materially from forward-looking statements include the uncertainties in the development and regulatory approval process. The preliminary data of clinical trials may not have indicative facts. Therefore, the final results of clinical trials cannot be guaranteed and are subject to The following risks: As the enrollment of patients continues and/or more patient data is available, one or more clinical outcomes may undergo substantial changes, as well as the ability to commercialize Soticlestat. Ovid’s filings with the US Securities and Exchange Commission under the heading "Risk Factors" list additional risks that may cause actual results to differ materially from forward-looking statements. The COVID-19 pandemic and its potential impact on Ovid's business and the global economy may exacerbate such risks. Even if new information appears, Ovid has no obligation to update any forward-looking statements contained in this article to reflect any changes in expectations.

Disclaimer: The original version of this announcement is the officially authorized version. The translation is only for the convenience of understanding, please refer to the original text. The original text is the only legally valid version.

Contacts
Takeda Media Contact:
Japanese media
Kazumi Kobayashi
kazumi.kobayashi@takeda.com
+81 (0) 3-3278-2095

For media outside Japan
Chris Stamm
chris.stamm@takeda.com
+1 (617) 347-7726

Ovid Investors and Media:
Ovid Therapeutics Inc.
Investor Relations and Public Relations
irpr@ovidrx.com

or

Ovid investors:
Argot Partners
Maeve Conneighton/Dawn Schottlandt
212-600-1902
Ovid@argotpartners.com

Ovid Media:
Dan Budwick
1AB
dan@1abmedia.com

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