Nippon Shinyaku Co., Ltd. announced today that Nippon Shinyaku and Capricor Therapeutics (Headquarters: California, USA, CEO: Linda Marbán, NASDAQ: CAPR) have entered into an exclusive distribution agreement for CAP-1002 for the treatment* of Duchenne muscular dystrophy (DMD) in the territory of US.
KYOTO, Japan, Jan. 25, 2022 /PRNewswire/ -- *NS Pharma Note: CAP-1002 is an investigational therapy and not approved in the US. This press release is being provided for a US audience as a reference. The original news release was issued by Nippon Shinyaku Co., Ltd., the parent company of NS Pharma on January 25, 2022 (Japan standard time). Please click here (https://www.nippon-shinyaku.co.jp/english/index.php). The text contains content related to U.S. unapproved drugs and unapproved indications. Nippon Shinyaku Co., Ltd. (Headquarters: Kyoto, Japan, President: Toru Nakai) announced today that Nippon Shinyaku and Capricor Therapeutics (Headquarters: California, USA, CEO: Linda Marbán, NASDAQ: CAPR) have entered into an exclusive distribution agreement for CAP-1002 for the treatment* of Duchenne muscular dystrophy (DMD) in the territory of US. DMD is a progressive muscular dystrophy caused by a deficiency of the dystrophin protein leading to weakness of skeletal, cardiac, and pulmonary muscles. DMD has a variety of genotypic variants, and therapeutic agents have been developed for patients with DMD caused by specific genetic mutations, thus contributing to the fulfillment of unmet medical needs. However, treatment for DMD patients due to the other type of genetic mutations and treatment for relatively older, non-ambulant DMD patients is still unsatisfactory, and effective therapies are required to be developed. CAP-1002 is comprised of human allogeneic cardiosphere-derived cells. Exosomes (extracellular vesicles) secreted by CAP-1002 are thought to be the mechanism of action of CAP-1002 and have been shown to reduce oxidative stress, inflammation, fibrosis, and increase myocyte generation, as well as improve motor and cardiac function. CAP-1002 is expected to be effective in a wide range of DMD patients, regardless of the type of genetic mutation, and a Phase II clinical trial (HOPE-2 study) suggested improved upper limb function and improved cardiac function in non-ambulatory DMD patients. CAP-1002 has received orphan drug designation and RMAT designation from the U.S. Food and Drug Administration (FDA) and Capricor is currently ready to initiate a Phase III clinical trial (HOPE-3 study) at several US health institutions. After the BLA approval in US, CAP-1002 will be marketed by our wholly owned subsidiary NS Pharma, Inc. (New Jersey, USA, President: Tsugio Tanaka). Nippon Shinyaku is focusing on the field of intractable, rare disorders, and have commercialized our in-house developed DMD treatment, Viltepso® (an antisense exon skipping agent) in the US. Executing this agreement with Capricor, Nippon Shinyaku aims to contribute further to the treatment for patients suffering from DMD. About exosomes About Orphan Drug Designation About RMAT designation About Nippon Shinyaku About Capricor Therapeutics Contact About VILTEPSO® (viltolarsen) injection Indication Important Safety Information Common side effects include upper respiratory tract infection, injection site reaction, For more information about VILTEPSO, see full Prescribing Information. SOURCE NS Pharma | ||
Company Codes: NASDAQ-SMALL:CAPR |