About Supernus Pharmaceuticals

Supernus Pharmaceuticals, Inc. operates as a biopharmaceutical company. The company focuses on developing and commercializing products for the treatment of central nervous system (CNS) diseases. The company's diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, attention-deficit hyperactivity disorder (ADHD), hypomobility in Parkinson's Disease (PD), cervical dystonia, chronic sialorrhea, dyskinesia in PD patients receiving levodopa-based therapy, and drug-induced extrapyramidal reactions in adult patients. The company is developing a broad range of novel CNS product candidates, including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders. Strategy The key elements of the company's strategy are to advance product candidates toward commercialization; continue to grow its pipeline; and target strategic business development opportunities. Commercial Products The company's commercial products, including those sold by or through its subsidiaries, include: Qelbree Qelbree (viloxazine extended-release capsules) is a novel non-stimulant product indicated for the treatment of ADHD in adults and pediatric patients 6 years and older. On April 2, 2021, the FDA approved Qelbree for the treatment of ADHD in pediatric patients 6 to 17 years of age. In 2021, the company launched Qelbree for pediatric patients in the U.S. In 2022, the FDA approved Qelbree for the treatment of ADHD in adult patients. The company launched Qelbree for adult patients in 2022. GOCOVRI GOCOVRI (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with PD receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with PD experiencing off episodes. GOCOVRI was approved by the FDA in 2017 for the treatment of dyskinesia and in February 2021 as an adjunctive treatment for off episodes. The February 2021 update to the label indication makes GOCOVRI the only medicine clinically proven and approved to reduce both off episodes and dyskinesia in PD patients taking a levodopa-based medication, resulting in a clinically meaningful increase in good on time without the need for a trade-off when managing these motor complications. GOCOVRI has been granted orphan drug exclusivity until August 24, 2024 for the treatment of dyskinesia in patients with PD receiving levodopa-based therapy with or without concomitant dopaminergic medications. Oxtellar XR Oxtellar XR is indicated for the treatment of partial-onset seizure in adults and children 6 years of age and older. Oxtellar XR is the first once-daily extended-release oxcarbazepine product indicated for the treatment of epilepsy in the U.S. market. In 2013, the company launched Oxtellar XR for adjunctive therapy in the treatment of partial-onset seizures in adults and children 6 to 17 years of age. In January 2019, the company launched Oxtellar XR for monotherapy treatment of partial onset epilepsy seizures in adults and children 6 to 17 years of age. The company has entered into settlement and license agreements with third parties permitting the sale of a generic version of Oxtellar XR beginning in 2024, or sooner under certain conditions, and entitling the company to receive royalties on those sales. Trokendi XR Trokendi XR is indicated for epilepsy: initial monotherapy for the treatment of partial-onset and primary generalized tonic-clonic (PGTC) seizure in patients 6 years of age and older (1.1); adjunctive therapy for the treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome in patients 6 years of age and older (1.2); and for preventive treatment of migraine in patients 12 years of age and older. Trokendi XR is the first once-daily extended-release topiramate product indicated for the treatment of epilepsy and the prophylaxis of migraine headaches in adults and adolescents in the U.S. market. APOKYN APOKYN (apomorphine hydrochloride injection) is a product indicated for the acute, intermittent treatment of hypomobility or off episodes (end-of-dose wearing off" and unpredictable on-off episodes) in patients with advanced PD. APOKYN's adjustable dose subcutaneous injection pen is designed to quickly and reliably reverse the effects of oral levodopa wearing off in patients with inadequately controlled PD. XADAGO XADAGO (safinamide) is a once-daily product indicated as adjunctive treatment to levodopa/carbidopa in patients with PD who are experiencing off episodes. XADAGO is a monoamine oxidase B (MAO-B) inhibitor that works by blocking the catabolism of dopamine, which is believed to result in an increase in dopamine levels, and therefore a subsequent increase in dopaminergic activity in the brain. XADAGO was approved by the FDA in March 2017. MYOBLOC MYOBLOC (rimabotulinumtoxinB) is a product 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 treatment of chronic sialorrhea in adults. MYOBLOC is the only Type B toxin available on the market. MYOBLOC injections must be administered by a physician. MYOBLOC was approved by the FDA in 2019 for the treatment of chronic sialorrhea in adults and in 2000 for the treatment of adults with cervical dystonia. Osmolex ER Osmolex ER (amantadine) extended-release tablets is for the treatment of PD and drug-induced extrapyramidal reactions in adult patients. Osmolex ER was approved by the FDA in 2018. In December 2023, the company submitted to the FDA a notification of discontinuance to withdraw Osmolex ER from distribution, stating that manufacturing has been discontinued and distribution of the product will cease by April 1, 2024. Research and Development The company's research and development expenses included $91.6 million in 2023. The company is committed to the development of innovative product candidates in neurology and psychiatry. The company also engages in a variety of additional research and development efforts, including development of a pipeline of novel CNS product candidates for the treatment of various CNS conditions. The company has devoted and continue to devote significant resources to research and development activities. SPN-830 (apomorphine infusion device) SPN-830 is a late-stage drug/device combination product candidate for the continuous treatment of motor fluctuations (off episodes) in PD patients that are not adequately controlled with oral levodopa and one or more adjunct PD medications. If approved, it would be the only continuous infusion of apomorphine available in the U.S. and an important step for PD patients that would have otherwise been candidates for potentially invasive surgical procedures, such as deep brain stimulation. Continuous slow infusion may also limit some of the side effects of a bolus injection of apomorphine. In 2021, the company resubmitted the NDA to the FDA. In 2022, the company received a notice from the FDA that the resubmission of the NDA for SPN-830 was considered as a Standard Review and was assigned a PDUFA target action date in early October 2022. In 2022, the FDA issued a Complete Response Letter (CRL) regarding the NDA for SPN-830. In February 2023, the FDA granted the company a Type C meeting request to discuss the CRL with the meeting scheduled in April 2023. In October 2023, the company resubmitted the NDA for SPN-830. In November 2023, the FDA accepted the resubmission of the NDA for SPN-830. SPN-820 (NV-5138) SPN-820 is a first-in-class, orally active small molecule that activates the brain mechanistic target of rapamycin complex 1 (mTORC1), a gatekeeper of cellular metabolism and renewal. SPN-820 binds to and modulates sestrin, which senses amino acid availability in the brain, a potent natural activator of mTORC1. The mTORC1 activity governs the pace and ability of the cell to synthesize protein and other cellular components. This complex may be suppressed in people suffering from depression. In other disease states such as severe depression, inadequate mTORC1 activity contributes to disease pathology by limiting energy utilization and protein synthesis, leading to impaired function. Multiple preclinical studies have shown that mTORC1 activation is required for the efficacy of many rapid-acting antidepressant compounds, including but not limited to modulators of the N-methyl-D-aspartic-acid (NMDA)-mediated signaling pathway like ketamine. The company initiated a Phase II multi-center, randomized double-blind placebo-controlled parallel design study of SPN-820 in adults with treatment resistant depression. The study will examine the efficacy and safety of SPN-820 over a course of five weeks of treatment in approximately 270 patients. The company initiated a Phase II multi-center open label study in 40 subjects with Major Depressive Disorder (MDD) in the fourth quarter of 2023. The study will evaluate the efficacy of SPN-820 in MDD, with the change from baseline in the Hamilton Depression Rating scale-6 (HAM-D6) total score as the primary efficacy assessment. SPN-817 (huperzine A) SPN-817 represents a novel MOA for an anticonvulsant. SPN-817 is a novel synthetic form of huperzine A, whose MOA includes potent acetylcholinesterase inhibition, with pharmacological activities in CNS conditions, such as epilepsy. The development will initially focus on the drug's anticonvulsant activity, which has been shown in preclinical models to be effective for the treatment of partial seizures and Dravet Syndrome. SPN-817 has received Orphan Drug designation for both Dravet Syndrome and Lennox-Gastaut Syndrome from the FDA. The company focuses on completing and optimizing the synthesis process of the synthetic drug, as well as developing a novel dosage form. Given the potency of SPN-817 (huperzine A), a novel extended-release oral dosage form is critical to the success of this program because initial studies with the immediate-release formulations of non-synthetic SPN-817 (huperzine A) have shown serious dose-limiting, side effects. The company has commenced an open-label Phase IIa clinical study of SPN-817 in patients with treatment-resistant seizures. SPN-443 - Novel stimulant for the treatment of ADHD/CNS The company plans to initiate a Phase 1 single dose study in healthy adults in 2024 following submission of an Investigational New Drug Application. Sales and Marketing The company markets its products through its own sales forces in the U.S. and seek strategic collaborations with other pharmaceutical companies to commercialize its products outside of the U.S. The company has a commercial sales and marketing organization in the U.S. to support sales of its commercial products. With the launches of Qelbree for both pediatric and adult patients, the company expanded its sales efforts to market the commercial product to the relevant physician audience of psychiatrists, pediatricians, primary care physicians and allied health professionals. The company's sales representatives who previously supported Trokendi XR and Oxtellar XR now devote their full efforts to the promotion of Qelbree. Customers The majority of the company's product sales are to pharmaceutical wholesalers, specialty pharmacies, and distributors who, in turn, sell its products to pharmacies, hospitals, and other customers, including federal and state entities. The majority of sales of Oxtellar XR, Trokendi XR, Qelbree, and XADAGO are made to wholesalers and distributors. In addition, MYOBLOC is available for direct purchase by physicians and hospitals. The majority of sales of APOKYN, GOCOVRI, and Osmolex ER are made to specialty pharmacies. Each of the company's three major customers, Cencora, Inc., Cardinal Health, Inc., and McKesson Corporation, individually accounted for more than 20% of its total product revenue in 2023 and collectively accounted for more than 75% of its total product revenue in 2023. Manufacturing The company has agreements with CMOs headquartered in North America, including: Patheon Pharmaceuticals, Inc. (a subsidiary of Thermo Fisher Scientific Inc.), Packaging Coordinators, Inc., Aphena Pharma Solutions, and Catalent Pharma Solutions, Europe, and Asia for the manufacturing and packaging of some of its commercial products, including those of its subsidiaries, as well as for its pipeline product candidates. For Qelbree, Trokendi XR, GOCOVRI, and Oxtellar XR it relies on third-party CMOs for the manufacturing and packaging of final commercial products. The company relies on third-party CMOs in Asia for the manufacturing of bulk drug substance for Trokendi XR and Oxtellar XR and rely on a third-party CMO in Europe for the raw materials and manufacturing of Qelbree and GOCOVRI. With respect to GOCOVRI, the company has an additional manufacturer of bulk drug substance. The company purchases APOKYN, MYOBLOC, XADAGO, and Osmolex ER as finished goods. APOKYN is manufactured and packaged in Europe for the U.S. market and is supplied to it by its licensing partner, Britannia. Britannia (a subsidiary of Stada Arzneimittel AG) also supplies injectable apomorphine to the European market under the brand name Apo-go. MYOBLOC is manufactured and packaged in Europe by Merz GmbH & Co. KGaA (Merz). XADAGO is manufactured and packaged in Europe by Zambon S.p.A. (Zambon). Osmolex ER is manufactured and packaged in the U.S. by Osmotica Pharmaceutical US LLC (Osmotica), which is the sole manufacturer of Osmolex ER and a subsidiary of Osmotica Pharmaceuticals plc. Proprietary Technology Platforms The company's key proprietary technology platforms include: Microtrol, Solutrol, and EnSoTrol. These technologies have been utilized to create novel, customized product profiles designed to enhance efficacy, reduce the frequency of dosing to improve patient adherence and improve tolerability. The company's technologies have been used to create ten commercial products, including its products: Qelbree, Trokendi XR and Oxtellar XR; Adderall XR (developed for Shire); Intuniv (developed for Shire); Mydayis (developed for Shire); Orenitram (developed for United Therapeutics Corporation); and Namzaric (developed for Allergan plc). The company also engages in generating and assessing New Chemical Entities (NCEs). These NCEs are generated by leveraging the company's expertise in structure function relationships in active molecules. The company's NCEs are being assessed in preclinical pharmacology models for CNS activity and are advancing towards Investigational New Drug application (IND) enabling toxicology studies to support potential future clinical investigation. Intellectual Property and Exclusivity Patent Portfolio The company's commercial products, including those of its subsidiaries, covered by active patents include Trokendi XR, Oxtellar XR, Qelbree, GOCOVRI, Osmolex ER and XADAGO. The company, or ots subsidiaries, own all the issued patents for Trokendi XR, Oxtellar XR, Qelbree, GOCOVRI, Osmolex ER, as well as the pending U.S. patent applications for Oxtellar XR, Qelbree, and GOCOVRI. The company has a license from Zambon for the U.S. patents that cover XADAGO. The company has ongoing litigations concerning Trokendi XR, Oxtellar XR and XADAGO. Qelbree The company has three families of pending U.S. non-provisional and foreign counterpart patent applications for Qelbree. Patents, if issued, could expire from 2029 to 2033. The company has patents issued in the U.S., Canada, and certain countries in Europe covering a method of treating ADHD using viloxazine hydrochloride. In a second family, covering the novel synthesis process of the active ingredient, the company has patents issued in the U.S. as well as in certain foreign countries. In a third family, the company has four patents issued in the U.S. covering modified release formulations of viloxazine hydrochloride, three of which cover Qelbree. The company also has patents issued in certain foreign countries. The company owns all the issued patents and the pending patent applications. Trokendi XR The company has 10 U.S. patents that cover Trokendi XR. The company owns all the issued patents. The company also owns additional foreign patents for extended-release topiramate. The ten issued U.S. patents covering Trokendi XR will expire no earlier than 2027. The company has entered into settlement agreements with third parties, permitting the sale of a generic version of Trokendi XR beginning in January 2023 and entitling the company to receive royalties on those sales. Oxtellar XR The company's extended-release oxcarbazepine patent portfolio includes 14 U.S. patents, 11 of which cover Oxtellar XR. The 11 issued U.S. patents covering Oxtellar XR will expire no earlier than 2027. The company owns all of the issued patents and the pending U.S. patent applications. The company also owns additional foreign patents for extended-release oxcarbazepine. The company has entered into settlement and license agreements with a third parties permitting the sale of a generic version of Oxtellar XR beginning in September 2024, or sooner under certain conditions, and entitling the company to receive royalties on those sales. XADAGO The patent portfolio covering XADAGO has three U.S. patents licensed from Zambon. These patents will expire from 2027 to 2031. The company has entered into settlement agreements with third parties, permitting the sale of a generic version of XADAGO beginning in December 2027, or earlier under certain circumstances. GOCOVRI The patent portfolio covering GOCOVRI includes 18 U.S. patents. The company has additional pending applications containing method and composition claims relating to the pharmacokinetic profile and dosing, and formulations of amantadine extended release. The issued patents expire through 2038. These patents and patent applications are owned by Adamas Operations and, as of the first quarter of 2022 are licensed to Supernus Pharmaceuticals, Inc. The company, through its subsidiary Adamas Operations, own additional foreign patents and patent applications covering amantadine extended release. Osmolex ER Osmolex ER is covered for its FDA-approved indications by 18 issued U.S. patents and additional applications containing method and composition claims relating to the pharmacokinetic profile and dosing, and formulations of amantadine extended release. These issued patents expire through 2038. These patents are wholly owned by Adamas Operations and, as of the first quarter of 2022 are licensed to Supernus Pharmaceuticals, Inc. Adamas Operations also owns additional foreign patents covering Osmolex ER. SPN-830 (apomorphine infusion device) The company's SPN-830 development program is potentially eligible to receive the Orphan Drug Designation in the U.S. The company plans to file for such designation with the FDA in 2024. If such designation is granted by the FDA, SPN-830 would receive 7 years of U.S. exclusivity from the time of approval by the FDA. SPN-817 (huperzine A) The company has one patent issued in the U.S., and in China and certain other countries relating to extended-release formulations of huperzine. The company additionally has pending patent applications in the U.S. and certain foreign countries. SPN-817 has received Orphan Drug designation for both Dravet Syndrome and Lennox-Gastaut Syndrome from the FDA. SPN-820 (NV-5138) Under the terms of the April 2020 Development Agreement with Navitor, the company has an exclusive option to license or acquire NV-5138 in all world territories, prior to initiation of the Phase III clinical program. Other Intellectual Property Rights The company, including its subsidiaries, have filed for trademark protection for several marks, which are used in connection with its pharmaceutical research and development collaborations as well as with its products and those of its subsidiaries. The company or its subsidiaries are the owner/licensee of various U.S. federal trademark registrations and registration applications, including Supernus, Microtrol, Solutrol, Trokendi XR, Oxtellar XR, Qelbree, XADAGO, MYOBLOC, APOKYN, GOCOVRI, Osmolex ER, Namzaric, and the registered Supernus Pharmaceuticals logo. Collaborations and Licensing Arrangements APOKYN and SPN-830 (apomorphine infusion device) The company has an Amended and Restated Distribution, Development, Commercialization, and Supply Agreement with Britannia that grants it certain intellectual property and product rights in relation to APOKYN, including the right to use and market APOKYN in the United States (Territory). Additionally, under the agreement, Britannia retains certain intellectual property and product rights in relation to APOKYN, including the right to use and market APOKYN in the rest of the world, excluding the United States. Under the Agreement, Britannia has an obligation to supply the company with APOKYN for its marketing and sale of the product. XADAGO The company has a License and Distribution Agreement and a Supply Agreement with Zambon. Under the License and Distribution Agreement, the company is the exclusive distributor of XADAGO in the U.S. Under the Supply Agreement, the company must purchase from Zambon and Zambon must provide to it all XADAGO finished products for the U.S. market. MYOBLOC The company has a contract manufacturing agreement with Merz Pharma GmbH & Co. KGaA (Merz) for the manufacture and supply of MYOBLOC and NerBloc (Merz Agreement). Pursuant to the Merz Agreement, Merz is required to provide a dedicated manufacturing facility including a stand-alone building, dedicated clean room suites, dedicated manufacturing and purification equipment, and filling and packaging production lines (collectively, the manufacturing facility) to manufacture finished products. The Merz Agreement will expire in July 2027, unless the Company and Merz mutually agree to extend the term. SPN-820 (NV-5138) In 2020, the company entered into a Development and Option Agreement with Navitor to collaborate on a clinical development program for NV-5138 (SPN-820), Navitor's mTORC1 activator. Under the terms of the agreement, the company and Navitor will jointly conduct a Phase II clinical program in TRD. Namzaric Namzaric (memantine hydrochloride extended release and donepezil hydrochloride) capsules for the treatment of moderate to severe dementia of an Alzheimer's type is marketed by Allergan plc under an exclusive license agreement between Adamas Pharmaceuticals and Forest Laboratories Holdings Limited (Forest), an indirect, wholly-owned subsidiary of Allergan plc (collectively, Allergan) in the United States. Adamas Pharmaceuticals receives royalties on net sales of Namzaric from May 2020. Allergan is responsible for all manufacturing related to Namzaric. In November 2012, Allergan was granted an exclusive license, with right to sublicense, certain of Adamas Pharmaceuticals' intellectual property rights relating to human therapeutics containing memantine in the United States. In connection with these rights, Allergan markets and sells Namzaric (memantine and donepezil hydrochlorides) extended-release capsules and NAMENDA XR (memantine hydrochloride) extended-release capsules for the treatment of moderate to severe dementia related to Alzheimer's disease. License Agreements with Other Third Parties The company has granted other companies, including United Therapeutics Corporation and Takeda Pharmaceuticals Company Ltd., rights to utilize certain of its proprietary technologies in the development of certain of their products. These technologies were used by these companies to develop certain other products, including Orenitram (treprostinil) and Mydayis. The company receives royalties under these arrangements based on net product sales of certain products developed using the licensed technologies. The company has also entered into settlement and licensing agreements with generic companies to settle patent litigation and to grant non-exclusive licenses to market generic versions of Trokendi XR and Oxtellar XR in the U.S. Under certain licensing arrangements, the company is eligible to receive royalties based on net product sales as defined in the and the number of generic equivalent products on the market in the U.S. The company receives royalties from third parties related to certain agreements for Trokendi XR. Government Regulation The U.S. Foreign Corrupt Practices Act (FCPA), to which it is subject, prohibits corporations and individuals from engaging in certain activities to obtain or retain business or influence a person working in an official capacity. In order to be eligible to have the company's products paid for with federal funds under the Medicaid and Medicare Part B programs and purchased by certain federal agencies and grantees, the company must comply with the Veterans Health Care Act of 1992 (VHCA). History Supernus Pharmaceuticals, Inc. was founded in 2005. The company was incorporated in Delaware in 2005.