Supernus Acquires Apokyn and Xadago from US WorldMeds

acquisition news

Supernus Pharmaceuticals’ acquisition of US WorldMeds’ portfolio of central nervous system (CNS) disease treatments adds two established Parkinson’s disease (PD) therapies and a leading investigative product to its neurology portfolio.

The deal calls for a $300 million upfront cash outlay, plus $230 million in milestone payments for the Parkinson’s treatments Apokyn (apomorphine) and Xadago (safinamide).

Supernus also acquired the company’s Apomorphine Infusion Pump, which, if approved by the U.S. Food and Drug Administration (FDA), would allow for a continuous subcutaneous (under the skin) apomorphine infusion.

“This acquisition aligns extremely well with our strategy of expanding and enhancing our commercial and late-stage assets and is a significant step in strengthening our leadership position in CNS,” Jack Khattar, Supernus’ president and CEO, said in a press release.

It also “brings new research and development platforms to Supernus in biologics and medical devices. We look forward to building on the success that US WorldMeds had in establishing this portfolio of unique products.”

Apokyn is given by injection between doses of the levodopa to treat a loss of body movement control in patients with advanced Parkinson’s. It has the same effect as dopamine, a naturally occurring chemical messenger in the brain that is gradually lost in the disease.

Several years after starting levodopa — a gold standard in care — most patients begin experiencing motor symptom fluctuations caused by a faster wearing off of the treatment’s effects. These “off” episodes can happen at any time of the day, and most patients experience more than one episode daily. In a Michael J. Fox Foundation survey of 3,000 patients, more than 90 percent reported having at least one “off” episode daily, and nearly 65 percent experienced such episodes for at least two hours.

Apokyn does not prevent off episodes, but it does help to improve symptoms when an episode has begun.

Xadago is an oral once-daily add-on therapy developed to improve motor function in Parkinson’s patients experiencing off periods. It works through the selective and reversible inhibition of the enzyme monoamine oxidase B, which increases functional dopamine levels. It also blocks voltage-dependent sodium channels, which regulate the release of abnormal glutamate, a neurotransmitter in the brain involved in nerve cell communication. The treatment is available in several countries, including the United States.

If approved by the FDA, the Apomorphine Infusion Pump would offer Parkinson’s patients a less-invasive and more convenient way to administer Apokyn. The device would provide a continuous subcutaneous infusion of the medication.

Supernus is expected to submit an application to the FDA requesting approval this year, likely supported by findings in a Phase 3 trial of the pump’s use (NCT02339064) in patients. If approved, the product could launch in the second half of 2021.

“The core values of Supernus align very well with US WorldMeds,” said Paul Breckinridge Jones Sr., CEO of US WorldMeds. “We expect a seamless transition with even more patients benefiting from these products under Supernus’ stewardship. This transaction will allow US WorldMeds to focus on growing our other exciting business units.”

This CNS portfolio, which includes the cervical dystonia therapy Myobloc (rimabotulinumtoxinB), had net sales last year of about $150 million. Under the agreement, Supernus will also gain a sales team with expertise in serving movement disorder specialists in the U.S.

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FDA Approves Myobloc, Injection Treatment for Chronic Drooling

Myobloc approved

Myobloc (rimabotulinumtoxinB) injections are approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic sialorrhea, or drooling, a condition often experienced by Parkinson’s patients.

Myobloc, marketed by US WorldMeds, is the first botulinum toxin type B approved for use in sialorrhea. Injections are given by healthcare professionals directly into two of the major glands producing saliva, the parotid and submandibular glands

According to US WorldMeds, a single dose can significantly reduce drooling within one week of treatment and and remain effective for up to three months.

Sialorrhea, or drooling, refers to saliva in such excess that it spills from the mouth. This is a common and bothersome symptom of neurological disorders like amyotrophic lateral sclerosis (ALS), cerebral palsy, and stroke, and it affects up to 75% of all Parkinson’s patients.

“Sialorrhea can be highly distressing for patients and their caregivers and can have a significant, negative impact on quality of life. If left untreated, pooling of saliva can lead to irritation of the skin around the mouth, oral hygiene complications, speech difficulties, and sleep interruption,” Stuart Isaacson, MD, director of the Parkinson’s Disease and Movement Disorder Center of Boca Raton Regional Hospital, said in a news release.

“These impacts can leave patients with compromised physical wellbeing, as well as feeling embarrassed by their condition, causing a lack of confidence and isolation,” Isaacson added.

Myobloc works by blocking the transmission of certain nerve signals to muscles and salivary glands. Specifically, it inhibits the release of the neurotransmitter acetylcholine, a chemical substance involved in the activation of the sweat and salivary glands.

Myobloc has already been approved, as intramuscular injections, to treat the abnormal head position and neck pain that occurs in adults with cervical dystonia.

Its approval for chronic sialorrhea came under a supplemental Biologics License Application (sBLA) that was supported by clinical trials, including a multicenter Phase 3 efficacy and safety study (NCT01994109) in 54 Parkinson’s patients with sialorrhea.

The trial met its primary efficacy goals.  There was a significant reduction in saliva production and attenuation of symptoms, in a dose-dependent manner, four weeks after a single Myobloc’s injection compared to placebo.

An open-label phase of the study also demonstrated safety and effectiveness over time, with the injection treatment given for about one year. Some adverse events, specifically gastrointestinal ones, were more common in patients using Myobloc than placebo (31% vs. 7%). The most frequent side effect reported was dry mouth.

No serious adverse events were attributed to the medicine, and no patients discontinued its use due to treatment side effects.

“We are committed to helping patients who struggle with confidence due to their sialorrhea. This new indication for Myobloc offers a fast-acting and proven treatment,” said P. Breckinridge Jones, CEO of US WorldMeds.

“We are proud to support health care providers with an option that can have such a positive impact on the lives of patients and their caregivers,” he added.

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h-Patch Device for Slow Apomorphine Infusion May Ease Off Periods in Advanced Parkinson’s, Valeritas Says

apomorphine treatment

Under-the-skin infusions of low-dose apomorphine using a wearable device called h-Patch may help in avoiding off periods and improving motor function in Parkinson’s patients, Valeritas, the technology’s developer, reports.

A preclinical study found that apomorphine delivered using h-Patch could be detected in the blood within two hours, with a gradual decline upon completing the 24-hour subcutaneous infusion. Valeritas is planning to present these results at an upcoming medical conference.

Apomorphine is a derivative of morphine with effects similar to dopamine, the neurotransmitter released by specialized neurons that are progressively lost in Parkinson patients. In patients with advanced disease, apomorphine is the only approved option for the acute treatment of off episodes, or periods when the medication wears off and before a new dose can be taken. Off periods are characterized by the resurgence of motor and non-motor symptoms.

It is available in the U.S. as an under-the-skin injection (Apokyn, by US WorldMeds), but has been associated with pain and injection-site reactions.

In prior clinical trials, single-dose, subcutaneous infusions of apomorphine have shown efficacy in suppressing off periods, reducing dyskinesia — involuntary, jerky movements — and improving motor scores of Parkinson’s patients. They also enabled significantly lesser use of levodopa, which has been associated with reduced effectiveness and with impulsive and compulsive behaviors when used for a number of years.

Infusion pumps in current use can be bulky, “requiring delivery of relatively large volumes of therapeutics [to] remain a barrier” to both patients and caregivers, Valeritas states a press release.

“This study highlights a new subcutaneous delivery of an old drug (apomorphine) which is commonly used in Parkinson’s,” said Santosh Kesari, chair and professor of Translational Neurosciences and Neurotherapeutics at the John Wayne Cancer Institute and Pacific Neuroscience Institute, both in California.

The h-Patch approach, Kesari added, “may offer a more consistent dose throughout the day” relative to oral dosing of apomorphine, and help improve functionality and quality of life. “Drug delivery for CNS disorders is still a significant barrier for optimizing new and old drugs,” he said.

Valeritas’ V-Go Wearable Insulin Delivery device for people with type 2 diabetes, which also uses the h-Patch technology, is marketed in the U.S. with the approval of the U.S. Food and Drug Administration.

“Valeritas continues to demonstrate the versatility of, and opportunities for its h-Patch technology beyond insulin delivery,” said John Timberlake, the company’s president and CEO.

“The h-Patch is a demonstrated patient-friendly, cost-effective, and powerful delivery method for a variety of therapeutics which we believe is ideal for subcutaneous delivery of apomorphine,” he added.

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