Alteogen Subsidiary, 'Ocrevus' Subcutaneous Injection Formulation International Patent Application

Alteogen's subsidiary Altos Biologics announced on the 24th that it has filed an international patent application (PCT application) under the Patent Cooperation Treaty (PCT) for a pharmaceutical composition containing the active ingredient Ocrelizumab and its uses.

Alteogen exterior view [Photo by Alteogen]

Ocrelizumab, an antibody targeting CD20 expressed on the surface of B cells, was developed by Roche and is currently marketed under the brand name 'Ocrevus' as a treatment for autoimmune diseases such as multiple sclerosis (MS). It received approval from the U.S. Food and Drug Administration (FDA) in 2017 and was authorized by the European Medicines Agency (EMA) the following year. It has not yet been approved domestically in Korea. It is used to treat relapsing-remitting multiple sclerosis, relapsing multiple sclerosis, and primary progressive multiple sclerosis. Last year, it maintained the top position in the global multiple sclerosis market with sales of 6.036 billion Swiss francs (approximately 9 trillion KRW). It is projected to capture 32% of the global multiple sclerosis treatment market with sales of about 8 billion USD (approximately 10.68 trillion KRW) by 2027.

Multiple sclerosis is a serious chronic autoimmune disease of the central nervous system in which the myelin surrounding nerve cells in the brain is damaged, ultimately leading to nerve cell loss. There is currently no cure, resulting in a very high level of unmet medical needs. Approximately 400,000 patients are reported in the U.S., about 700,000 in Europe, and it is estimated that there are more than 2.5 million patients worldwide. It is also known that 40% of these patients do not receive treatment. According to GlobalData, the multiple sclerosis treatment market is expected to grow from 20 billion USD (approximately 26.7 trillion KRW) in 2018 to 30 billion USD (approximately 40 trillion KRW) by 2028.

The company analyzes that the current MS treatment market is led by CD20 antibody drugs with high efficacy and safety, replacing existing treatments after the commercialization of Ocrevus, which administers 600 mg of Ocrelizumab intravenously (IV) every six months. However, despite its high effectiveness, the large dosage requires up to three and a half hours of infusion time, and infusion-related adverse reactions occur in about 30% of patients during the first administration, creating a demand for alternatives. To date, products developed to shorten infusion time targeting CD20 or those developed as subcutaneous (SC) formulations have not provided effective alternatives.

Altos Biologics, through this PCT application, has patented the pharmaceutical composition of SC formulation Ocrelizumab and the dosage and administration of its proprietary SC formulation that ensures equivalent efficacy and safety to the IV formulation of Ocrelizumab.

In particular, as the SC formulation conversion is gaining attention as a way to avoid drug price reduction pressure under the U.S. Inflation Reduction Act (IRA), it is expected to gain momentum in pioneering new markets. Under the IRA, the U.S. Centers for Medicare & Medicaid Services (CMS) has announced that biosimilars approved more than 11 years ago and chemical drugs approved more than 7 years ago will be subject to drug price negotiation. The first 10 high-revenue items will be announced soon. However, items applying SC formulation change technology are specified to be able to delay the timing of drug price reduction under the IRA by at least 10 years. This is recognized as technology including a different active pharmaceutical ingredient (API), allowing price preservation.

A company representative said, "Altos Biologics, which has abundant clinical development experience and pharmacokinetics (PK) experts, is conducting this development for efficient progress," adding, "This invention, which extends the dosing interval from one month to six months in a proprietary way different from the Ocrelizumab currently being developed as an SC formulation, is expected to be expandable to other CD20 antibody therapies according to future patents."

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