Sunovion Presents New KYNMOBI® (apomorphine sublingual film) Study Data at the International Parkinson and Movement Disorder Society (MDS) Congress 2021

- Preliminary analyses of an ongoing long-term KYNMOBI safety study for the treatment of Parkinson’s disease OFF episodes indicate that many patients in the study were successfully titrated without concomitant antiemetics -

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) today announced the presentation of multiple posters highlighting KYNMOBI^® (apomorphine sublingual film) for the on-demand treatment of OFF episodes associated with Parkinson’s disease (PD) at the International Parkinson and Movement Disorder Society (MDS) Virtual Congress, being held September 17-22, 2021. The presentations include post-hoc findings from the pivotal study (CTH-300) and findings from an ongoing long-term safety study (CTH-301) of KYNMOBI.

The poster titled, “Apomorphine Sublingual Film for OFF Episodes in Parkinson’s Disease: Impact of Concomitant Antiemetics on Nausea and Vomiting,” (poster 394), reports a preliminary analysis from an ongoing long-term, open-label safety study (CTH-301), with up to 48 weeks of exposure to KYNMOBI, that examined rates of nausea and vomiting in U.S. patients not previously treated with KYNMOBI. The analysis found that when the use of an antiemetic was optional, most patients (88%) were able to titrate to an effective and tolerable dose of KYNMOBI without the need for antiemetics.

In a post-hoc analysis of data from the titration phase of the pivotal study, in the poster titled, “Apomorphine Sublingual Film for OFF Episodes in Parkinson’s Disease: Characterization of Acute Nausea During Dose Titration,” (poster 427) when nausea occurred with the acute administration of KYNMOBI most episodes were mild (57%) and lasted an average of 46 minutes. These episodes rarely impacted patients’ ability to continue treatment with KYNMOBI.

“These data provide a deeper understanding of the patient treatment experience and reinforce the previously-reported tolerability of KYNMOBI for the on-demand treatment of PD OFF episodes,” said William G. Ondo, MD, Professor of Neurology and Director of the Movement Disorders Clinic at Methodist Neurological Institute in Houston, Texas, and CTH-301 study investigator. “Acute nausea was more commonly reported by patients who were not taking a maintenance dopamine agonist at baseline. The experience of acute nausea in KYNMOBI trials was largely mild in nature and rarely impacted successful titration or treatment continuity, even in the absence of antiemetic treatment.”

The poster titled, “Long-Term Safety and Efficacy of Apomorphine Sublingual Film for OFF Episodes in Parkinson’s Disease: Europe vs. North America,” (poster 428) details an analysis from CTH-301, an ongoing, open-label, long-term study evaluating the efficacy, safety and tolerability of KYNMOBI. The analysis showed that the overall incidence of treatment-emergent adverse events (TEAEs) was similar in patients from Europe and North America (81% and 84%, respectively). Clinically meaningful changes in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III score were observed at 30 minutes post-dose in both regions, with greater changes observed for European vs. North American patients at 24 weeks (–28.5/–20.1), 36 weeks (–28.2/–19.6), and 48 weeks (–30.0/–20.5) and in general across other timepoints up to 90 minutes. A self-rated FULL ON within 30 minutes post-dose was achieved by more than 75% of patients through 48 weeks across both regions.

Five additional KYNMOBI posters being shared at MDS 2021 include:

• “Long-Term Safety and Efficacy of Apomorphine Sublingual Film for OFF Episodes in Parkinson’s Disease” (poster 348)
• “Apomorphine Sublingual Film for OFF Episodes in Parkinson’s Disease: Impact on Dyskinesia” (poster 407)
• “Apomorphine Sublingual Film for OFF Episodes in Parkinson’s Disease: Analysis of Baseline Factors” (poster 426)
• “Indirect Comparison of Apomorphine Sublingual Film Versus Levodopa Inhalation Powder for OFF Episodes in Parkinson’s Disease” (poster 448)
• “Apomorphine Sublingual Film for OFF Episodes in Parkinson’s Disease: Impact on Impulse Control Disorders” (poster 383)

ABOUT KYNMOBI^®

KYNMOBI (apomorphine hydrochloride) sublingual film, a novel formulation of apomorphine, a dopamine agonist, is the first and only sublingual therapy for the fast-acting, on-demand treatment of OFF episodes associated with Parkinson’s disease. KYNMOBI may be used up to five times a day.

Phase 3 clinical trial results, published in Lancet Neurology, demonstrated that patients with PD receiving KYNMOBI 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 KYNMOBI had a patient-rated full ON response within 30 minutes at week 12, compared with people receiving placebo. KYNMOBI 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.

Important Safety Information

INDICATION

KYNMOBI^® (apomorphine HCI) sublingual film is a prescription medicine used to treat short-term (acute), intermittent “off” episodes in people with Parkinson’s disease (PD).

IMPORTANT SAFETY INFORMATION AND INDICATION FOR KYNMOBI (apomorphine HCI) SUBLINGUAL FILM
Do not take KYNMOBI if you are taking certain medicines to treat nausea called 5HT3 antagonists, including ondansetron, granisetron, dolasetron, palonosetron, and alosetron. People taking ondansetron together with apomorphine, the active ingredient in KYNMOBI, have had very low blood pressure and lost consciousness or "blacked out."

Do not use KYNMOBI if you are allergic to apomorphine hydrochloride or to any of the ingredients in KYNMOBI. KYNMOBI also contains a sulfite called sodium metabisulfite. Sulfites can cause severe, life‐threatening allergic reactions in some people. An allergy to sulfites is not the same as an allergy to sulfa. People with asthma are more likely to be allergic to sulfites. Call your healthcare provider if you have hives, itching, rash, swelling of the lips, tongue and mouth, redness of your face (flushing), throat tightness, trouble breathing or swallowing.

Before starting KYNMOBI, tell your healthcare provider:
About all of your medical conditions, including if you:

• have difficulty staying awake during the daytime
• have liver problems
• have dizziness
• have kidney problems
• have fainting spells
• have heart problems
• have low blood pressure
• have had a stroke or other brain problems
• have asthma
• have a mental problem called a major psychotic disorder
• are allergic to any medicines containing sulfites
• drink alcohol
• are pregnant or plan to become pregnant. It is not known if KYNMOBI will harm your unborn baby
• are breastfeeding or plan to breastfeed. It is not known if KYNMOBI passes into your breast milk. You and your healthcare provider should decide if you will take KYNMOBI or breastfeed.

Tell your healthcare provider about all the medicines you take, including:

• prescription medicines
• over-the-counter medicines
• vitamins
• herbal supplements

KYNMOBI may affect the way other medicines work, and other medicines can affect how KYNMOBI works. Taking KYNMOBI with other medicines may cause serious side effects. If you take nitroglycerin under your tongue (sublingual) while using KYNMOBI, your blood pressure may decrease and cause dizziness. You should lie down before and after taking sublingual nitroglycerin.

KYNMOBI can cause serious side effects, including:

• nausea and vomiting. Nausea is a common side effect of KYNMOBI. Nausea and vomiting can happen with KYNMOBI. Your healthcare provider may prescribe a medicine called an antiemetic, such as trimethobenzamide to help prevent nausea and vomiting. If trimethobenzamide is prescribed, talk to your healthcare provider about how long you should remain on this medicine.
• sleepiness or falling asleep during the day. Sleepiness is a serious, and common side effect of KYNMOBI. Some people treated with KYNMOBI may get sleepy during the day or fall asleep without warning while doing everyday activities such as talking, eating, or driving a car.
• dizziness. Dizziness is a serious, and common side effect of KYNMOBI. KYNMOBI may lower blood pressure and cause dizziness. Dizziness can happen when KYNMOBI treatment is started or when the KYNMOBI dose is increased. Do not get up too fast from sitting or after lying down, especially if you have been sitting or lying down for a long period of time.
• mouth (oral) irritation. Mouth (oral) irritation is a common side effect of KYNMOBI. You should call your healthcare provider if you develop any of these signs or symptoms:
  • redness
  • mouth sores (ulceration)
  • dryness of the mouth, lips or tongue
  • swelling
  • pain
  • pain with swallowing
• falls. The changes that can happen with PD, and the effects of some PD medicines, can increase the risk of falling. KYNMOBI may also increase your risk of falling.
• hallucinations or psychotic-like behavior. KYNMOBI may cause or make psychotic-like behavior worse including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking.
• strong (intense) urges. Some people with PD have reported new or strong uncontrollable urges to gamble, increased sexual urges, increased urges to spend money (compulsive shopping), and other intense urges, while taking PD medicines, including KYNMOBI. If you or your family members notice that you have strong urges, talk to your healthcare provider. The strong urges may go away if your KYNMOBI dose is lowered or stopped.
• high fever and confusion. KYNMOBI may cause a problem that can happen in people who suddenly lower their dose, stop using, or change their dose of KYNMOBI. Symptoms include:
  • very high fever
  • confusion
  • stiff muscles
  • changes in breathing and heartbeat

Do not stop taking KYNMOBI or change your dose unless you are told to do so by your healthcare provider.

• heart problems. If you have shortness of breath, fast heartbeat, chest pain, or feel like you are going to pass out (faint) while taking KYNMOBI, call your healthcare provider or get emergency help right away.
• tissue changes (fibrotic complications). Some people have had changes in the tissues of their pelvis, lungs, and heart valves when taking medicines called nonergot derived dopamine agonists like KYNMOBI.
• prolonged painful erections (priapism). KYNMOBI may cause prolonged, painful erections in some people. If you have a prolonged and painful erection, you should call your healthcare provider or go to the nearest hospital emergency room right away.

The most common side effects of KYNMOBI include:

• nausea
• dizziness
• sleepiness
• mouth swelling, pain, or sores

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see the KYNMOBI Patient Information, full Prescribing Information, and Instructions for Use.

About Parkinson’s Disease and OFF Episodes

By 2030, it is estimated that 1.2 million people in the U.S. and an estimated 10 million people worldwide will be living with Parkinson’s disease (PD).¹ PD is a chronic, progressive neurodegenerative disease characterized by motor symptoms, including tremor at rest, rigidity and impaired movement, as well as significant non-motor symptoms, including cognitive impairment and mood disorders. It is the second most common neurodegenerative disease after Alzheimer’s disease², and the prevalence of PD is increasing as the world’s population ages.

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 illness.³

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. and 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. Connect with Sunovion on Twitter, LinkedIn, Facebook and YouTube.

About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-10 listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the U.S., China, and other Asian countries. Sumitomo Dainippon Pharma aims to create innovative pharmaceutical products in the Psychiatry & Neurology area, the Oncology area and Regenerative medicine/Cell therapy field, which have been designated as the focus therapeutic areas. Sumitomo Dainippon Pharma is based on the merger in 2005 between Dainippon Pharmaceutical Co., Ltd., and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has more than 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma is available through its corporate website at https://www.ds-pharma.com.

KYNMOBI is a registered trademark of Sunovion Pharmaceuticals, Inc.

Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co., Ltd.

^© 2021 Sunovion Pharmaceuticals Inc. All rights reserved.

For a copy of this release, visit Sunovion’s website at www.sunovion.com

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. Accessed July 2021.
² Lebouvier, T., Chaumette, T., Paillusson, S., Duyckaerts, C., des Varannes, S. B., Neunlist, M., & Derkinderen, P. (2009). The second brain and Parkinson's disease. European Journal of Neuroscience, 30(5), 735–741. Available online: https://doi.org/10.1111/j.1460-9568.2009.06873.x. Accessed July 2021.
³ 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. Accessed July 2021.

Kirsten Fallon
Associate Director, Portfolio Communications
Sunovion Pharmaceuticals Inc.
774-369-7116
kirsten.fallon@sunovion.com