NEW YORK & VALBY, Denmark--(BUSINESS WIRE)--H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY), a global pharmaceutical company specialized in brain diseases, and privately-held Ovid Therapeutics Inc. (Ovid), a biopharmaceutical company focused on developing therapies for rare and orphan diseases of the brain, today announced that on March 25, 2015 they entered into an exclusive worldwide license agreement for gaboxadol, the first oral medicine which holds the potential to treat patients with Angelman Syndrome and Fragile X Syndrome. Gaboxadol (OV101) is the only small molecule, highly selective extrasynaptic GABA(A) receptor agonist (SEGA) that has been tested in clinical trials.
Under the terms of the agreement, Ovid obtained exclusive worldwide development and commercialization rights for OV101. In connection with the license, Lundbeck became a minority shareholder in Ovid, and will receive certain milestone payments and royalties on sales. Ovid is responsible for all future development and commercialization for OV101. Additional financial terms were not disclosed.
Ovid plans to pursue the development of OV101 in Angelman Syndrome and Fragile X Syndrome, two orphan neurological disease indications with no available treatment options, and expects to commence a Phase 2 trial for Angelman Syndrome in 2016, followed by a Phase 2 trial in Fragile X Syndrome.
"We are delighted to secure OV101, and are proud to have Lundbeck as a stakeholder in Ovid,” stated Dr. Jeremy Levin, Chairman and Chief Executive Officer of Ovid. “This agreement comes at a time as we simultaneously experience a revolution in the understanding of the genetics and molecular basis of neurological diseases, coupled with a similar advance in understanding the molecular pharmacology of existing drugs. This nexus of new knowledge creates an important opportunity for us to match the right molecule to the right indication. OV101 is the first such molecule for Ovid. We are actively taking advantage of this approach to identify and add products to our growing pipeline."
“We are happy with this agreement allowing development of gaboxadol as a potential treatment for patients who have no medical options available today. If successful, these development programs can change the lives of these patients, and we look forward to following Ovid in their pursuit of realizing gaboxadol’s potential in these indications,” said Anders Gersel Pedersen, Executive Vice President and Head of R&D at Lundbeck.
“OV101 is the only SEGA that has been tested in clinical trials to date. By restoring tonic inhibition at low doses, it has shown promising functional improvement in models of Angelman Syndrome, Fragile X Syndrome, as well as genetic epilepsy models. It is fitting that on the 50-year anniversary of Dr. Harry Angelman’s first description of the syndrome, the development of a potential new therapeutic option is underway,” stated Dr. Matthew During, President and Chief Scientific Officer of Ovid. “There is a critical need for therapies that address rare and orphan neurological diseases such as Angelman Syndrome and Fragile X Syndrome. We look forward to working with the Food and Drug Administration, key thought leaders as well as patients, families and disease foundations, including Foundation for Angelman Syndrome Therapeutics, the Angelman Syndrome Foundation and Fragile X Foundation, to advance gaboxadol through the clinic.”
The selection of Angelman Syndrome and Fragile X Syndrome as initial indications is based upon Ovid’s expectation of a highly favorable benefit-to-risk profile for OV101. The company believes that clinical and preclinical evidence to date strongly support OV101’s anti-epileptic, motor improvement and cognitive enhancement effects. OV101 is the only drug that has been shown to correct the motor deficit, a cause of major morbidity in patients, in a mouse genetic model for Angelman Syndrome. OV101 has been shown to be well tolerated in clinical trials involving approximately 3,000 patients.
About Angelman Syndrome and Fragile X Syndrome
Angelman Syndrome is a rare genetic neurological disorder characterized by global severe developmental delay, movement and balance disorder, seizures, sleep disturbances, severe speech impairment and a happy, excitable demeanor. Approximately 1 in 15,000 live births have Angelman Syndrome, with an estimated 4,000 patients in the United States. There are no therapeutic agents approved to treat Angelman Syndrome.
Fragile X syndrome is a genetic neurological disorder that causes intellectual disability, behavioral and learning challenges and various physical characteristics. There are approximately 100,000 patients with Fragile X Syndrome in the United States. No therapeutic agents have been approved to date to treat this disease.
About Ovid Therapeutics Inc.
Ovid Therapeutics Inc. is a privately-held, New York based, biopharmaceutical company committed to transforming the lives of patients with rare and orphan diseases of the brain and few, if any, treatment options - patients who currently have no hope of cure or improvement. Ovid focuses on patients and their needs. Using the significant operational, product development and business development experience of its management team, Ovid aims to become a leading neurology company, with multiple products and a rich pipeline coupled with compelling research and development.
Geller Biopharm Inc. and Hogan Lovell US LLP represented Ovid in its negotiations.
For more information on Ovid, please visit http://www.ovidrx.com.
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are alcohol dependence, Alzheimer's disease, bipolar disorder, depression/anxiety, epilepsy, Huntington's disease, Parkinson's disease, schizophrenia and symptomatic neurogenic orthostatic hypotension (NOH).
In 2015, Lundbeck celebrates its 100th anniversary. During the past century, millions of people have been treated with our therapies. It is complex and challenging to develop improved treatments for brain disease, but we keep our focus: There is still so much we need to achieve in the next 100 years to ensure a better life for people living with brain disease.
Our approximately 6,000 employees in 57 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have research centres in China, Denmark and the United States and production facilities in China, Denmark, France and Italy. Lundbeck generated core revenue of DKK 13.5 billion in 2014 (EUR 1.8 billion; USD 2.4 billion).
For additional information, we encourage you to visit our corporate www.lundbeck.com.