Acorda Therapeutics Stock

Acorda Therapeutics, Inc. (Acorda), a biopharmaceutical company, focuses on developing therapies that restore function and improve the lives of people with neurological disorders.

The company markets Inbrija (levodopa inhalation powder), which is approved in the United States of America (U.S.) for intermittent treatment of OFF episodes, also known as OFF periods, in people with Parkinson’s disease treated with carbidopa/levodopa. Inbrija is for as needed use and utilizes the company’s ARCUS pulmonary delivery system, a technology platform designed to deliver medication through inhalation that has potential to be used in the development of a variety of inhaled medicines. The company also markets branded Ampyra (dalfampridine) Extended Release Tablets, 10 mg to improve walking in adults with multiple sclerosis.

Products

Inbrija/Parkinson’s Disease

Inbrija is the first and only inhaled levodopa, or L-dopa, for intermittent treatment of OFF periods in people with Parkinson’s disease treated with a carbidopa/levodopa regimen. The U.S. Food and Drug Administration (FDA) approval of Inbrija is for a single dose of 84 mg (administered as two capsules), which may be taken up to five times per day. Inbrija is available in the U.S. without the need for a medical exception for approximately 92% of commercially insured lives and approximately 18% of Medicare plan lives.

Inbrija is also approved for use in the European Union (EU). The European Commission (EC)-approved Inbrija dose is 66 mg (administered as two capsules) up to five times per day (per EU convention, this reflects emitted dose and is equivalent to the 84 mg labeled dose in the U.S.). Under the EU approval, Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor. The company has entered into agreements to commercialize Inbrija in Spain, Germany, and Latin America, and it is in discussions with potential partners for commercialization of Inbrija in other jurisdictions outside of the U.S.

Inbrija utilizes the company’s ARCUS platform for inhaled therapeutics. The company continues to discuss the use of ARCUS with companies that express interest in formulating their novel molecules for pulmonary delivery, and it has performed feasibility studies for a number of these opportunities.

Ampyra/MS

Ampyra is an extended-release tablet formulation of dalfampridine approved by the FDA as a treatment to improve walking in patients with multiple sclerosis, or MS. The company has experienced a significant decline in Ampyra sales due to competition from several generic versions of Ampyra.

Ampyra is marketed as Fampyra outside the U.S. by Biogen International GmbH, or Biogen, under a license and collaboration agreement that the company entered into in June 2009. Fampyra has been approved in a number of countries across Europe, Asia and the Americas. The company’s Fampyra patents have been challenged in Germany and could be similarly challenged in other countries where Fampyra is marketed by Biogen, and these challenges could lead to generic competition with Fampyra, which could have a material adverse effect on royalty revenue from Biogen. For example, the company understands that a generic drug manufacturer that has sought to invalidate Fampyra patents in Germany through nullity proceedings has commenced a generic launch in Germany.

Strategy

The company’s long-term strategy is to grow as a fully integrated biopharmaceutical company and to become a leading neurology company dedicated to the identification, development and commercialization of therapies that restore function and improve the lives of people with neurological disorders. For 2023, the company’s strategic priorities include accelerate inbrija growth; maintain ampyra strength; and leverage ARCUS platform.

Products and ARCUS Technology

Inbrija utilizes the company’s ARCUS platform for inhaled therapeutics. ARCUS is a dry-powder pulmonary drug delivery technology that has potential to be used in the development of a variety of inhaled medicines. The ARCUS platform allows systemic delivery of medication through inhalation, by transforming molecules into a light, porous dry powder. This allows delivery of substantially higher doses of medication than can be delivered via conventional dry powder technologies. Although the company has deferred internal investment in ARCUS research programs, it continues to discuss potential collaborations with companies that express interest in formulating their novel molecules for pulmonary delivery using ARCUS, and the company has performed feasibility studies for a number of these opportunities.

Inbrija and ARCUS

Inbrija (levodopa inhalation powder) is the first and only inhaled levodopa, or L-dopa, for intermittent treatment of OFF episodes, also known as OFF periods, in people with Parkinson’s disease treated with carbidopa/levodopa regimen. The company’s New Drug Application, or NDA, for Inbrija was approved by the U.S. Food and Drug Administration, or FDA, on December 21, 2018. The approval is for a single dose of 84 mg (administered as two capsules), which may be taken up to five times per day. Inbrija became commercially available in the U.S. in February 2019. Inbrija is available in the U.S. without the need for a medical exception for approximately 92% of commercially insured lives and approximately 18% of Medicare plan lives.

In September 2019, the European Commission, or EC, approved the company’s Marketing Authorization Application, or MAA, for Inbrija. Under the MAA, Inbrija is indicated in the EU for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson’s disease treated with a levodopa/dopa-decarboxylase inhibitor. The MAA approved Inbrija for use in what were then the 27 countries of the EU, as well as Iceland, Norway and Liechtenstein. Following the exit of the U.K. from the EU, the company was granted a grandfathered Marketing Authorization (MA) by the Medicines and Healthcare Products Regulatory Agency (MHRA) in the U.K. that was approved in November 2021.

The company has entered into agreements to commercialize Inbrija in Spain, Germany, and Latin America, and it is in discussions with potential partners for commercialization of Inbrija in other jurisdictions outside of the U.S. In 2021, the company entered into exclusive distribution and supply agreements with Esteve Pharmaceuticals to commercialize Inbrija in Spain and Germany.

Also, in May 2022, the company announced that it entered into exclusive distribution and supply agreements with Pharma Consulting Group, S.A. (known as Biopas Laboratories), or Biopas, to commercialize Inbrija in nine countries within Latin America, including Brazil and Mexico. Under the terms of the Biopas agreements, the company is entitled to receive a significant double-digit, tiered percentage of the Inbrija selling price in exchange for supply of the product, and it is entitled to sales-based milestones. Biopas expects to commence sales in at least one country in early 2024.

ARCUS Platform and Product Development

Inbrija utilizes the company’s ARCUS platform for inhaled therapeutics. ARCUS is a dry-powder pulmonary drug delivery technology that has potential to be used in the development of a variety of inhaled medicines. The ARCUS platform allows systemic delivery of medication through inhalation, by transforming molecules into a light, porous dry powder. This allows delivery of substantially higher doses of medication than can be delivered via conventional dry powder technologies. The company acquired the ARCUS technology platform as part of its 2014 acquisition of Civitas Therapeutics. The company has worldwide rights to its ARCUS drug delivery technology, which is protected by extensive know-how and trade secrets and various U.S. and foreign patents, including patents that protect the Inbrija dry powder capsules beyond 2030. The company has several patents listed in the Orange Book for Inbrija, including patents expiring between 2024 and 2032. Inbrija was also entitled to three years of new product exclusivity in the U.S. that expired in December 2021. The company has patents in Europe for Inbrija expiring in 2033. One of the company’s European patents, EP 3090773B, had been opposed by an unnamed party but in 2021 was maintained as granted by the European Opposition Board. Inbrija also has market exclusivity in Europe that is set to expire in September 2029.

Ampyra

Ampyra (dalfampridine) is an oral drug approved by the FDA in January 2010 to improve walking in adults with multiple sclerosis. Ampyra can be used alone or with concurrent medications, including immunomodulatory drugs. Ampyra is an extended-release tablet formulation of dalfampridine (4-aminopyridine, 4-AP), which had previously been referred to as fampridine. Dalfampridine is a potassium channel blocker.

Ampyra became subject to competition from generic versions of Ampyra starting in late 2018 as a result of an adverse U.S. federal district court ruling that invalidated certain Ampyra Orange Book-listed patents. The company has experienced a significant decline in Ampyra sales due to competition from several generic versions of Ampyra. Additional manufacturers may market generic versions of Ampyra, and the company expects its Ampyra sales will continue to decline over time.

License and Collaboration Agreement with Biogen

Ampyra is marketed as Fampyra outside the U.S. by Biogen International GmbH, or Biogen, under a license and collaboration agreement that it entered into in June 2009. Fampyra has been approved in a number of countries across Europe, Asia and the Americas. Biogen recently initiated a commercial launch of Fampyra in China, after receiving approval from the Chinese National Medical Products Administration in 2021. The company’s Fampyra patents have been challenged in Germany and could be similarly challenged in other countries where Fampyra is marketed by Biogen.

Sales, Marketing and Market Access

Inbrija

The company markets Inbrija in the U.S. using field-based teams supported by its corporate marketing personnel. The company’s own neuro-specialty sales representatives work in combination with sales representatives provided by a contract commercial organization, and collectively they are focused on a priority list of physicians who are high volume prescribers of carbidopa/levodopa and other products indicated to treat OFF episodes. The company’s field-based teams also include reimbursement and market access specialists, who provide information to physicians and payers on its marketed products, as well as market development specialists who work collaboratively with field-sales teams and corporate personnel to assist in the execution of its strategic initiatives. The company’s Inbrija field-based and marketing activities are focused on physician awareness and market access, as well as patient awareness, education and training. Inbrija is distributed in the U.S. primarily through specialty pharmacies, including those associated with its e-prescribing program, such as AllianceRx Walgreens Prime, or Walgreens, a specialty pharmacy that delivers the medication to patients by mail; and ASD Specialty Healthcare, Inc. (an Amerisource Bergen affiliate), a specialty distributor. In 2022, the company implemented an e-prescribing program for the distribution of Inbrija in the U.S. through a specialty pharmacy that supports electronic prescriptions.

The company has established Prescription Support Services for Inbrija, sometimes referred to as the Inbrija hub, which helps patients navigate their insurance coverage and identify potential financial support alternatives, when appropriate. The Inbrija hub also includes a virtual nurse educator program to assist patients with proper usage of the Inbrija inhaler. Insurance coverage services fall into one of these categories: insurance verification, to research patient insurance benefits and confirm insurance coverage; prior authorization support, to identify prior authorization requirements; and appeals support. For patients that may need assistance paying for their medication, Prescription Support Services offers several support options, including: a program that provides no cost medication to patients who meet specific program eligibility requirements; co-pay support, which may help commercially insured (non-government funded) patients lower their out-of-pocket costs; and a bridge program for federally insured patients who experience a delay in coverage determination. The company has a no-cost sample program, available at physician offices, to enable patients and their physicians to assess the efficacy and tolerability of Inbrija before the patient incurs out-of-pocket co-pay or co-insurance costs. In addition, the company has a first dispense zero-dollar copay program for commercially insured patients (which replaced the company’s previous free trial program) to enable those patients to assess the value of Inbrija before incurring out-of-pocket co-pay or co-insurance costs, and the company has a cash pay program allowing reduced costs for eligible cash paying patients.

Ampyra

The company markets Ampyra in the U.S. using field-based teams supported by its corporate marketing personnel. The company’s own neuro-specialty sales representatives work in combination with sales representatives provided by a contract commercial organization. Ampyra is distributed in the U.S. primarily through a network of specialty pharmacies, which deliver the medication to patients by mail. The company has contracted with a third-party organization with extensive experience in coordinating patient benefits to run Ampyra Patient Support Services, or APSS, a dedicated resource that coordinates the prescription process among healthcare providers, people with multiple sclerosis, and insurance carriers.

Material and Other Collaborations and License Agreements

Alkermes (ARCUS products)

On December 27, 2010, Civitas, the company’s wholly owned subsidiary, entered into an Asset Purchase and License Agreement with Alkermes, Inc. pursuant to which Alkermes assigned, sold and transferred to Civitas certain of its rights in certain pulmonary delivery patents and patents applications, certain equipment and instruments relating to pulmonary drug delivery, copies of certain documents and reports relating to pulmonary delivery, certain pulmonary drug delivery inhalers and certain pulmonary drug delivery Investigational New Drug Applications, or INDs, filed with the FDA. Alkermes also granted to Civitas a non-exclusive sublicense to know-how for the purpose of development and commercialization of ARCUS products.

Civitas is permitted to license and sublicense the pulmonary patents, patent applications and know-how, subject to certain restrictions, as necessary for the company’s business. Without the prior written consent of Alkermes, Civitas is prohibited from assigning the intellectual property acquired from Alkermes, except to an affiliate or to a person that acquires all or substantially all of its business to which the agreement relates, whether by acquisition, sale, merger or otherwise.

Biogen (Fampyra)

In 2009, the company entered into a collaboration agreement with Biogen (the Collaboration Agreement), pursuant to which the company and Biogen have agreed to collaborate on the development and commercialization of products containing aminopyridines, including Ampyra, initially directed to the treatment of multiple sclerosis, or MS, (licensed products). Under the Collaboration Agreement, Ampyra is marketed by Biogen as Fampyra outside the U.S. Fampyra has been approved in a number of countries across Europe, Asia and the Americas.

The company has also entered into a related supply agreement with Biogen (the Supply Agreement) concurrently with the Collaboration Agreement pursuant to which it is obligated to supply Biogen with its requirements for the licensed products. Biogen Inc., the parent of Biogen, has guaranteed the performance of Biogen's obligations under the Collaboration Agreement and the Supply Agreement.

Under the Collaboration Agreement, Biogen, itself or through its affiliates, has the exclusive right to commercialize licensed products in all countries outside of the U.S., unless rights to a particular country terminate under the terms of the Collaboration Agreement, while the company retains the exclusive right to commercialize licensed products in the U.S. Under the Collaboration Agreement, the company participates in overseeing the development and commercialization of Ampyra and other licensed products in markets outside the U.S. in part through its participation in joint committees with Biogen.

Biogen is obligated to purchase all of Biogen's, its affiliates' and its sublicensees' requirements of the licensed products from the company, unless it permits alternative sourcing of supply.

In connection with the entry into the Collaboration Agreement, Biogen and Alkermes entered into a Consent Agreement with the company. Under the Consent Agreement, Alkermes consented to the company’s sublicense of rights to Biogen, and the three parties agreed to set up a committee to coordinate activities under its agreements with Alkermes with respect to the development, supply and commercialization of the licensed products for Biogen's territory. The Consent Agreement also amended the company’s agreements with Alkermes by, among other things, permitting it to allow Biogen to grant sublicenses to certain unaffiliated distributors; permitting it to allow Biogen to package the licensed products and to work directly with Alkermes with respect to certain supply-related activities; and, requiring Alkermes to facilitate the qualification of an alternate supplier of the licensed products under certain circumstances.

Alkermes (Ampyra)

In September 2003, the company entered into an amended and restated license agreement with Elan Corporation plc that replaced two prior license agreements for Ampyra in oral sustained release dosage form. Under this agreement, Elan Corporation plc granted the company exclusive worldwide rights to Ampyra for all indications, including spinal cord injury, or SCI, multiple sclerosis, or MS, and all other indications.

Alkermes was also obligated to supply the company with its commercial requirements for Ampyra in the U.S., as well as to supply Biogen under the Supply Agreement and Consent Agreement with Fampyra for Biogen’s clinical trials and for Biogen’s commercial requirements.

Manufacturing and Supply

All commercial supply of Inbrija is manufactured at Catalent’s Chelsea, Massachusetts manufacturing facility. Catalent, as the company’s Inbrija blistered capsule supplier, is responsible for all Inbrija components other than certain packaging components, the inhaler device and levodopa, or L-dopa, the active pharmaceutical ingredient, or API, in Inbrija.

Intellectual Property

The company has patent portfolios relating to: Inbrija (levodopa inhalation powder); Ampyra/aminopyridines; and the ARCUS drug delivery technology. Its intellectual property also includes copyrights, confidential and trade secret information, as well as a portfolio of trademarks.

The intellectual property relating to the company’s programs is owned directly by Acorda or indirectly through a subsidiary, including for example its Civitas subsidiary.

Inbrija and ARCUS Development Programs

The intellectual property portfolio that the company acquired with Civitas has the U.S. and foreign patents relating to Inbrija and the ARCUS drug delivery technology, including several issued U.S. patents relating to Inbrija directed to compositions of the drug product and the capsule for the drug product. The company has several patents listed in the Orange Book for Inbrija, including patents expiring between 2024 and 2032. Inbrija was also entitled to three years of new product exclusivity, but this expired in December 2021. The company has patents in Europe for Inbrija expiring in 2033. One of the company’s European patents, EP 3090773B, had been opposed by an unnamed party but in 2021 was maintained as granted by the European Opposition Board. Inbrija also has ten years of market exclusivity in Europe that will expire in September 2029.

Ampyra/aminopyridines

There are two European patents, EP 1732548 and EP 2377536, with claims directed to use of a sustained release dalfampridine composition (known under the trade name Fampyra in the European Union) to increase walking speed in a patient with multiple sclerosis. Both European patents are set to expire in 2025, absent any additional exclusivity granted based on regulatory review timelines. Fampyra had ten years of market exclusivity in the European Union that expired in 2021. Accordingly, even though the European patents were upheld by the Technical Board of Appeal of the European Patent Office, Fampyra could potentially face competition from generic drug manufacturers that may seek to challenge Fampyra’s European patents within individual European countries.

Nullity actions with respect to Fampyra have been filed in Germany against both of the German national patents derived from EP 1732548 (the ‘548 patent) and EP 2377536 (the ‘536 patent) by ratiopharm GmbH, a generic manufacturer affiliated with Teva. In November 2021, a court issued preliminary opinions in the ratiopharm case indicating that the claimed subject matter of the ‘548 patent lacked inventive step and the claimed subject matter of the ‘536 patent lacked novelty and inventive step. At oral hearings in February 2022 and April 2022, the German Patent Court dismissed ratiopharm’s action against the ‘536 patent and the ‘548 patent, respectively, as inadmissible because of ongoing formality proceedings relating to these patents in the European Patent Office. Ratiopharm has appealed the decision on the ‘536 patent but not the decision on the ‘548 patent, and could refile the nullity actions. On December 6, 2022, the German Federal Court of Justice held that ratiopharm’s ‘536 nullity action was admissible and remanded the case back to the German Federal Patent Court. On January 11, 2022, Stada Arzneimittel also filed a nullity action against the ‘536 patent, and on July 27, 2022, Teva GmbH also filed a nullity action against the ‘548 patent, both in the same court as the ratiopharm nullity actions. On January 27, 2023, the German Federal Patent Court issued a preliminary opinion in the ‘548 Teva nullity action that the claimed subject matter of the ‘548 patent lacked inventive step and scheduled a hearing for July 11, 2023. The company is working with Biogen to vigorously defend these actions and enforce its patent rights.

Trademarks

In addition to patents, the company’s intellectual property portfolio includes registered trademarks, along with pending trademark applications. The company owns several registered trademarks in the U.S. and in other countries. These registered trademarks include, in the U.S., the marks Acorda Therapeutics, the company’s stylized Acorda Therapeutics logo, Biotie Therapies, Ampyra, Inbrija, and ARCUS. The company also has trademark registrations for Fampyra and Inbrija and pending trademark applications therefore, in numerous foreign jurisdictions. In addition, the company’s trademark portfolio includes several trademark registrations and pending trademark applications for potential product names and for disease awareness activities.

Government Regulation

In the U.S., Ampyra is regulated by the U.S. Food and Drug Administration (FDA) as a drug but, Inbrija is regulated as a combination product because it has both a drug and a device component.

Any products manufactured or distributed in the U.S. by the company pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including requirements relating to record-keeping, labeling, packaging, reporting of adverse experiences and other reporting, advertising and promotion, distribution, cGMPs, and import/export, as well as any other requirements imposed by the New Drug Application (NDA) or Biologics License Application (BLA).

Drug manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMPs, which impose certain procedural and documentation requirements upon the company and its third-party manufacturers.

Sales, marketing, scientific/educational grant programs, and other Acorda interactions with healthcare professionals must comply with the anti-kickback and fraud and abuse provisions of the Social Security Act and the False Claims Act.

Under the Veterans Health Care Act of 1992, as amended (VHCA), the company is required to offer certain drugs at a reduced price to a number of federal agencies, including the Veterans Administration, the Department of Defense (DOD), the Public Health Service and certain private Public Health Service designated entities, in order to participate in other federal funding programs, including Medicare and Medicaid.

Although Inbrija includes a medical device component (the inhaler), Inbrija is a combination product that was approved by the Center for Drugs (CDER) via an NDA in consultation with the center for devices (CDRH), and these separate medical device clearance/approval requirements are not applicable to Inbrija.

Research and Development

The company’s research and development expenses were $5.8 million for the year ended December 31, 2022.

History

Acorda Therapeutics, Inc. was founded in 1995. The company was incorporated in 1995 as a Delaware corporation.