Supernus Acquires Apokyn and Xadago from US WorldMeds

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.