BIAL Announces Exclusive Licensing Agreement with Sunovion for Commercialization of Apomorphine Sublingual Film in Europe

Porto, September 2, 2021 - BIAL today announced that it has entered into an agreement with Sunovion Pharmaceuticals Inc. (Sunovion) whereby BIAL received exclusive commercial license rights to commercialize apomorphine sublingual film in the European Union (EU), the European Economic Area (EEA) and the United Kingdom.

Apomorphine sublingual film (APL-130277) is a novel thin film formulation of apomorphine that dissolves under the tongue for the acute, intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD).

APL-130277 is currently in Phase 3 clinical development in Europe. Under the terms of the agreement, BIAL will be responsible for regulatory approvals and submissions, including interactions with the European Medicines Agency (EMA). BIAL expects to submit a European marketing authorization application for apomorphine sublingual film by the end of 2021.

As part of the agreement, Sunovion will receive an upfront payment and is entitled to receive certain milestone payments. Sunovion will supply apomorphine sublingual film in all approved dose strengths to BIAL.

António Portela, Chief Executive Officer of BIAL, said, “We are pleased to be the partner of choice for Sunovion in Europe. BIAL has an ongoing commitment to Parkinson’s disease patients. This partnership reflects our commitment to the Parkinson’s community and is also an important step in our development strategy to expand BIAL’s footprint in Europe. We look forward to making this treatment option available and thus helping patients with Parkinson’s disease to cope with OFF episodes which are difficult and disabling to their lives.”

Apomorphine sublingual film is approved as KYNMOBI^® in the U.S. and Canada. Sunovion continues to hold the exclusive commercial rights to KYNMOBI in North America and all other regions of the world outside of the EU, EEA and the United Kingdom. KYNMOBI is the first and only sublingual (under the tongue) therapy available for the on-demand treatment of PD OFF episodes in the U.S. and Canada.

“As Parkinson’s disease progresses an individual’s response to levodopa/carbidopa becomes less consistent and as a result they may spend hours a day navigating debilitating OFF episodes,” said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. “Apomorphine sublingual film offers healthcare providers and patients a novel treatment option to reliably treat OFF episodes when they occur. We look forward to working with our partner BIAL to help expand access to this important on-demand treatment option for people with Parkinson’s disease across Europe.”

Parkinson's disease is a chronic, progressive neurodegenerative disorder characterized by a strong reduction of the neurotransmitter dopamine, caused by the degeneration of certain neurons in the brain. By 2030, an estimated 10 million people worldwide will be living with PD¹. It is the second most common neurodegenerative disease after Alzheimer’s disease², and its prevalence is increasing as the world’s population ages.

------

About Apomorphine Sublingual Film

Apomorphine hydrochloride sublingual film is a novel formulation of apomorphine, a non-ergoline dopamine agonist for the acute, intermittent treatment of OFF episodes in patients with PD.

Phase 3 clinical trial results, published in Lancet Neurology, demonstrated that patients with PD receiving Apomorphine Sublingual Film experienced significant improvements in motor symptoms at 30 minutes after dosing at week 12, with a mean reduction of 7.6 points, compared to placebo, on the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. Separation from placebo was seen as early as 15 minutes post-dose (first time point measured) and persisted up to 90 minutes (last time point measured). Additionally, a significantly higher percentage of people treated with Apomorphine Sublingual Film had a patient-rated full ON response within 30 minutes at week 12, compared with people receiving placebo. Apomorphine Sublingual Film was generally well-tolerated. Among the most frequently reported treatment-emergent adverse events in this study (occurring in more than 5 percent of patients and at a rate greater than placebo) were nausea, oropharyngeal reactions, somnolence and dizziness.

About Parkinson's disease

Parkinson's disease is a chronic, progressive neurodegenerative disorder characterised by a strong reduction of the neurotransmitter dopamine, caused by the degeneration of certain neurons in the brain. Epidemiological evidence highlights a complex interaction between genetic vulnerability and environmental factors. The clinical manifestations usually appear after the age of 50 years (the average age of diagnosis is approximately 60 years). The European Parkinson's Disease Association (EPDA) estimates that approx. 1.2 million people suffer from this disease in Europe³. The diagnosis of Parkinson's disease is based on clinical observation and relies on three key elements: bradykinesia (slow movements), resting tremor, and rigidity (muscle stiffness). Of these, bradykinesia must be present, with at least either tremor or rigidity. Other common symptoms are postural instability, reduced facial expression and blinking, and a slouching posture.

OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. These episodes may disrupt a person’s ability to perform everyday activities, can cause anxiety and may be burdensome for patients, family, and care partners. OFF episodes are experienced by nearly 60 percent of people with PD within the first four to six years of diagnosis and may worsen in frequency and severity over the course of the illness⁴.

About BIAL

BIAL is an innovative international pharmaceutical company committed to improve human health and quality of life for people from all over the world.

Dedicated to discovering, developing and commercializing medicines, BIAL is strongly dedicated to therapeutic innovation, consistently investing more than 20% of its annual revenue in Research and Development (R&D). The core R&D areas of BIAL are neurosciences and cardiovascular.

Strengthening its international presence based in its own innovative medicines and in a consistent partnering program, BIAL is making a real difference to the lives of people all over the world inspired by its strong motivation: Keeping life in mind.

Additional information can be found on the company’s website: www.bial.com

About Sunovion Pharmaceuticals Inc. (Sunovion)

Sunovion is a global biopharmaceutical company focused on the innovative application of science and medicine to help people with serious medical conditions. Sunovion’s vision is to lead the way to a healthier world. The company’s spirit of innovation is driven by the conviction that scientific excellence paired with meaningful advocacy and relevant education can improve lives. With patients at the center of everything it does, Sunovion has charted new paths to life-transforming treatments that reflect ongoing investments in research and development and an unwavering commitment to support people with psychiatric, neurological and respiratory conditions.

Headquartered in Marlborough, Mass., Sunovion is an indirect, wholly-owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd. Sunovion Pharmaceuticals Canada Inc., based in Mississauga, Ontario, is a wholly-owned direct subsidiary of Sunovion Pharmaceuticals Inc.

Additional information can be found on the company’s websites: www.sunovion.com and www.sunovion.ca.

References:

1- Parkinson’s Disease Foundation Website: https://www.parkinson.org/about-us/Press-Room/Press-Releases/New-Study-Shows-Over-1-Million-People-in-the-United-States-Estimated-to-be-Living-with-Parkinsons-Disease-by-2030. Last accessed in August 2021

2- Parkinson’s Disease Foundation Website: https://www.parkinson.org/about-us/Press-Room/Press-Releases/New-Study-Shows-Over-1-Million-People-in-the-United-States-Estimated-to-be-Living-with-Parkinsons-Disease-by-2030. Last accessed in August 2021

3- EPDA. The European Parkinson’s disease Standards of Care Consensus Statement: https://www.epda.eu.com/media/1181/epda-consensus-statement-en.pdf. Last accessed in August 2021

4- Schrag, A. Dyskinesias and motor fluctuations in Parkinson's disease: A community-based study. Brain. November 2000, Vol. 123, Issue 11. p. 2297-2305. Available online: https://academic.oup.com/brain/article/123/11/2297/256050. Last accessed in August 2021