Print（PDF/156KB） Apr. 06, 2023 Licensing

JCR and Sumitomo Pharma Enter into Co-Promotion Agreement in Japan for IZCARGO I.V. Infusion 10 mg, a Recombinant Therapeutic for Mucopolysaccharidosis Type II

JCR Pharmaceuticals Co., Ltd. (Head Office: Ashiya, Hyogo, Japan; Chairman and President: Shin Ashida; hereinafter, “JCR”) and Sumitomo Pharma Co., Ltd. (Head Office: Osaka, Japan; Representative Director, President and CEO: Hiroshi Nomura; hereinafter, “Sumitomo Pharma”) announced today that they have concluded a co-promotion agreement (hereinafter, “the Agreement”) for IZCARGO® I.V. Infusion 10 mg (hereinafter, “the Product”) in Japan. This is a recombinant therapeutic for mucopolysaccharidosis type II currently sold by JCR.

From April 24, 2023, JCR and Sumitomo Pharma will jointly engage in information dissemination activities for the Product to healthcare professionals. JCR will continue to manufacture and sell the Product.

Sumitomo Pharma will make an upfront payment to JCR upon execution of the Agreement. Sumitomo Pharma will record the consideration for promotion received from JCR as revenue.

The Product is a treatment for mucopolysaccharidosis type II (Hunter syndrome), a type of lysosomal storage disease, developed by JCR. It is the world’s first I.V. infusion to cross the blood-brain barrier (BBB) and act directly on brain parenchyma cells, through the use of J-Brain Cargo®, JCR’s BBB penetration technology. The Product can be expected to improve or control not only systemic symptoms but also central nervous system manifestations. JCR has marketed the Product since May 2021. Cumulative sales for the third quarter of the fiscal year ending March 31, 2023 were approximately 3.4 billion yen.

Sumitomo Pharma has positioned rare diseases as focus areas for business in Japan and has years of sales experience in Fabry disease, a type of lysosomal storage disease. Sumitomo Pharma has been strengthening its partnership with JCR in this area through a marketing alliance signed in March 2022 for Agalsidase Beta BS I.V. Infusion [JCR], a recombinant therapeutic for Fabry disease.

Sumitomo Pharma and JCR will contribute further to the treatment of patients with mucopolysaccharidosis type II (Hunter syndrome) through the co-promotion of the Product.

Reference

About lysosomal storage diseases

Lysosomal storage diseases are a group of disorders caused by genetic abnormalities that lead to loss or decreased expression of enzymes processing unwanted substances and proteins transporting them across biological membranes, resulting in the excessive accumulation of substances that would normally be metabolized in cellular organelles called lysosomes. This aberrant buildup damages cells and tissues. Symptoms vary depending on the types of accumulated substances. Central nervous system manifestations are associated with most of these disorders.

About mucopolysaccharidosis type II (Hunter syndrome)

Mucopolysaccharidosis type II (Hunter syndrome) is a type of lysosomal storage disease designated as an intractable disease and a specific pediatric chronic disease by Japan's Ministry of Health, Labor, and Welfare. Hunter syndrome is an X-linked recessive disease caused by a deficiency of iduronate-2-sulfatase, an enzyme that breaks down complex carbohydrates called glycosaminoglycans (GAGs, also known as mucopolysaccharides) in the body.

The incidence of mucopolysaccharidosis in Japan is reported to be 1.53 per 100,000 live births, and that of mucopolysaccharidosis type II is 0.84 per 100,000 live births (one in 119,000)^*. Hunter syndrome gives rise to a wide range of somatic and neurological symptoms. Central nervous system symptoms related to Hunter syndrome have been unmet medical needs so far.

* Khan SA. et al. Mol Genet Metab, 121(3): 227-240, 2017.

About JCR Pharmaceuticals Co., Ltd.

JCR Pharmaceuticals Co., Ltd. (TSE 4552) is a global specialty pharmaceuticals company that is redefining expectations and expanding possibilities for people with rare and genetic diseases worldwide. JCR continues to build upon our 48-year legacy in Japan while expanding our global footprint into the US, Europe, and Latin America. JCR improves patients’ lives by applying our scientific expertise and unique technologies to research, develop, and deliver next-generation therapies. JCR strives to expand the possibilities for patients while accelerating medical advancement at a global level. JCR’s core values – reliability, confidence, and persistence – benefit all our stakeholders, including employees, partners, and patients. Together we soar.

For more information, please visit https://www.jcrpharm.co.jp/en/site/en/.

About Sumitomo Pharma Co., Ltd.

Sumitomo Pharma Co., Ltd. defines its corporate mission as “To contribute broadly to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide.” By channeling its efforts into the research and development of new drugs, Sumitomo Pharma aims to realize its mission and provide innovative and effective pharmaceutical solutions to people in Japan and but also around the world.

Sumitomo Pharma has positioned Psychiatry & Neurology, Diabetes, and Rare Diseases areas as focus areas for business in Japan.

For more information, please visit https://www.sumitomo-pharma.com.