ROCKVILLE, Md., April 28, 2020 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the Company entered into a definitive agreement under which Supernus will acquire the CNS portfolio of US WorldMeds, a privately-held biopharmaceutical company. With the acquisition, Supernus adds three established and marketed products in the U.S. market with a product candidate in late-stage development:

• APOKYN^® (apomorphine hydrochloride) injection is used, as needed, to provide rapid, reliable, and robust control of body movements in people with Parkinson’s disease (PD) when they experience an off episode. An off episode, also called hypomobility, may include symptoms such as muscle stiffness, slow movements, and difficulty starting movements.
• MYOBLOC^® (rimabotulinumtoxinB) injection is the first and only approved botulinum toxin Type B injectable indicated for the treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia in adults, and the treatment of chronic sialorrhea in adults.
• XADAGO^® (safinamide) tablets is a monoamine oxidase type B (MAO-B) inhibitor indicated as a daily adjunctive treatment to levodopa/carbidopa in patients with PD experiencing off episodes.
• Apomorphine Infusion Pump is a product candidate for the continuous treatment of motor fluctuations (“on‐off” episodes) in PD patients whose motor control is unsatisfactory with oral levodopa and at least one other noninvasive PD therapy. New Drug Application (NDA) submission is expected in the second half of 2020 with potential launch, if approved by the FDA, in the second half of 2021.

“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,” said Jack Khattar, President and CEO of Supernus. “We expect this transaction to provide Supernus with enhanced operating cash flow, financial flexibility to execute on our strategy, and a continued strong balance sheet. In addition, the transaction provides increased revenue scale and adds new commercial capabilities that are important for orphan drugs and specialty pharmacy products.”

Mr. Khattar added, “In addition to expanding and strengthening our commercial capabilities in CNS, this acquisition 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.”

“The core values of Supernus align very well with 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,” commented Paul Breckinridge "Breck" Jones, Sr., Chief Executive Officer of US WorldMeds.

Strategic Rationale

• The acquisition is well aligned with Supernus’ corporate development strategy of adding commercial and late-stage CNS assets. The addition of the three marketed products and product candidate diversifies Supernus’ product portfolio into PD and other movement disorders and expands Supernus’ revenue, operating cash flow base and earnings growth profile.
• US WorldMeds’ CNS portfolio consists of three marketed products with 2019 net sales of approximately $150 million. With the product portfolio comes an experienced team including a proven salesforce and a medical organization with expertise and focus on serving movement disorder specialists in the U.S.
• The acquisition expands Supernus’ commercial platform to include sales and marketing capabilities for orphan drug and specialty pharmacy products
• The potential launch of Apomorphine Infusion Pump, if approved by the FDA, significantly enhances long-term growth with estimated potential peak annual revenue of $100 - $175 million.
• The acquisition also expands Supernus’ research and development capabilities into biologics and medical devices.

Parkinson’s Disease (PD)
PD is the second most common chronic progressive neurodegenerative disorder affecting 1-2% of individuals 65 years and older¹. The number of U.S. PD patients in 2020 is estimated at 1 million with an annual growth rate of approximately 2.5%².

PD occurs when cells in the brain, which produce dopamine become impaired or die resulting in significant mobility and motor impairment with symptoms such as tremor, slowness, dystonia, balance issues, and/or stiffness. Everyday life for PD patients becomes adversely affected with many activities that we typically take for granted such as eating, writing, getting dressed, walking, and others becoming impaired. The mainstay therapy is levodopa which is very effective, particularly in the early stages. As PD advances, treatment becomes less effective resulting in what are termed “OFF” periods. According to a patient survey conducted by the MJ Fox Foundation³, up to 70-90% of PD patients have at least one “OFF” episode per day and 65% of patients were “OFF” for > 2 hours per day. In addition, more than 50% of patients who experience an “OFF” episode indicated that it causes them to avoid activities.

Currently there are several acute treatments for “OFF”, such as APOKYN (apomorphine hydrochloride) injection. Continuous treatment could offer advantages to many such patients, but current options are limited and can be complicated, significantly impairing daily activities. Some require Continuous Infusion of levodopa through a gastric tube or even surgical intervention such as Deep Brain Stimulation. The acquired Apomorphine Infusion Pump product candidate, if approved by the FDA, would offer patients a much less invasive and more convenient option in the form of a continuous subcutaneous infusion of apomorphine.

1. Saxton JM. Exercise and Chronic Disease: an Evidence-Based Approach. London, Routledge, 2011.
2. Parkinson’s Disease: Epidemiology Forecast to 2026, GlobalData, 2018.
3. Michael J Fox Foundation for Parkinson’s Research. Executive summary: survey of Parkinson’s patients and their off time experience. Available on request from researchpartnerships@michaeljfox.org

Terms and Financing
Total consideration of $530 million consists of an upfront cash payment of $300 million plus regulatory and commercial milestone cash payments up to $230 million. All cash consideration will be funded through existing balance sheet cash.

Approvals and Timing of Closing
The transaction is anticipated to close in the second quarter of 2020, subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and other customary conditions.

2020 Guidance
Supernus will provide appropriate updates to its full year 2020 financial guidance after the closing of the transaction.

Advisors
Jefferies is acting as the exclusive financial advisor to Supernus. Piper Sandler is acting as the exclusive financial advisor to US WorldMeds. Saul Ewing Arnstein & Lehr is serving as legal counsel and Grant Thornton is providing due diligence services to Supernus, and Gibson, Dunn & Crutcher is serving as legal counsel to US WorldMeds.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals, Inc. is a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The Company currently markets Trokendi XR® (extended-release topiramate) for the prophylaxis of migraine and the treatment of epilepsy, and Oxtellar XR® (extended-release oxcarbazepine) for the treatment of epilepsy. The Company is also developing several product candidates to address large market opportunities in the CNS market.

About US WorldMeds

US WorldMeds is a specialty pharmaceutical company whose products are making a difference in the lives of the patients and communities it serves. US WorldMeds takes an agile and personal approach to pharmaceuticals – pioneering research and product development in therapeutic areas that desperately need new solutions. Headquartered in Louisville, Kentucky, US WorldMeds has global presence and nearly 20 years of experience in the development, licensure, and commercialization of unique products. For more information about US WorldMeds, visit www.usworldmeds.com.