Capricor & Nippon Shinyaku Team Up To Bring Duchenne Muscular Dystrophy Treatment To Europe

Capricor Therapeutics, a Biotech firm developing cell and exosome based treatments for rare diseases, has made a binding term sheet with a Japanese pharmaceutical company Nippon Shinyaku Co.Ltd. The agreement is focused on the distribution and commercialization of Deramiocel, in Europe. Deramiocel is the lead asset of Caprior, used for treatment of DMD (Duchenne Muscular Disorder), for which fewer treatments are available. The bind showcases the potential for broader global reach of the product. Besides, Nippon has agreed to purchase approximately $15million of Capricor common stock at 20% premium to the 60-day volume weighted average price.

According to the terms of the binding sheet, which is anticipated to be finalized in the fourth quarter of the following year to a Definitive Agreement. The development, manufacturing of Deramiocel for possible approval across all countries in E.U, U.K and other regional markets will be controlled by Capricor while the sales and distribution in those areas will be handled by Nippon. In addition upon signing the Definitive Agreement, Capricor is willing to receive an upfront payment of $20million, and upto $715million revenue based on performance in sales and development. 

Linda Marbán, Ph.D., Capricor’s Chief Executive Officer said,“Our expanded partnership with Nippon Shinyaku into the European region marks a pivotal moment for Capricor as we work together to bring deramiocel to DMD patients worldwide.” Dr. Linda Marban also added  “With the addition of the upfront payment and equity investment, we will be able to extend our runway into 2026 and be well positioned to advance toward potential approval of deramiocel in the United States and beyond. Furthermore, these funds will provide necessary capital for commercial launch preparations, manufacturing scale-up and product development for Europe, as we envision high global demand for deramiocel.”

Dr. Marban further said, “As previously reported, we held a successful pre-BLA meeting with the U.S. Food and Drug Administration (FDA) in August. Since that meeting, we have now had several additional informal meetings with the agency to continue to refine our approval pathway for deramiocel in the United States and we plan to provide further updates as they become available.”

President of Nippon Shinyaku, Toru Nakai commented, “We look forward to building deramiocel’s commercial footprint around the world and this partnership would allow us to continue to invest in Nippon Shinyaku’s DMD franchise and to potentially advance life-changing therapies for patients in need.”

Along with the term sheet Nippon Shinyaku has accepted to buy 2,798,507 shares of common stock at $5.36 per share, which reflects a 20% premium over the 60-day volume-weighted average price (VWAP) of Capricor’s common stock, resulting to $15million. Moreover, the anticipated date for clouser for the offer is September 20,2024. Capricor expects to utilize the revenue primarily for general administration, support product development and corporate purpose.

The offer and sale have not been registered under the Securities Act of 1933 or relevant state securities laws and are being conducted as a private transaction. As it does not contain an effective registration statement these securities cannot be reoffered or resold in the United States. As part of the terms, Capricor agreed to file a registration statement with the Securities and Exchange Commission in order to register the resale of common stock purchased by investors.