Capricor sues partner Nippon Shinyaku in DMD therapy spat
Capricor Therapeutics has fallen out with its commercial partner for Duchenne muscular dystrophy (DMD) cell therapy deramiocel, Nippon Shinyaku, and is taking its complaint to the courts.
The San Diego biotech has filed a lawsuit against the Japanese drugmaker and its US subsidiary, NS Pharma, claiming that the terms of their distribution contract for deramiocel are flawed and could hinder DMD patients from getting access to the therapy if it gets approved by the FDA.
According to Capricor, the distribution agreement with NS Pharma contains a "fundamental pricing flaw" that its partner has refused to address, and it has accused the company of failing to "adequately prepare" for the commercial launch.
Deramiocel was turned down by the FDA last year as a treatment for cardiomyopathy associated with DMD, but has since been refiled as a treatment for skeletal and cardiac manifestations of the muscle-wasting disease, and the US regulator is due to deliver a verdict on that second attempt by 22nd August after a priority review.
The lawsuit is seeking to set aside the agreement altogether, arguing that NS Pharma's actions mean that the deramiocel launch will be "delayed and disrupted" due to a previous pricing structure, described as a "mutual mistake," that it claims "renders commercialisation nonviable."
While Capricor has tried to modify the agreement with a new pricing structure, correcting what it describes as a disconnect between the proposed pricing and the Medicare reimbursement framework that would affect both federal and private reimbursement. However, it contends that NS Pharma has refused to cooperate and effectively has tried to "seize control" of the deramiocel.
"I have spent nearly two decades building Capricor with one goal in mind: making deramiocel available to treat these boys," said Dr Linda Marbán, Capricor's chief executive.
"I know what every additional month of delay costs them, because I know what is happening inside their muscles when they cannot be treated," she added. "There is no version of this case in which I am willing to watch NS Pharma's inaction take that away from them."
The lawsuit is asking for the distribution agreement to be rescinded and an injunction imposed to prevent NS Pharma from "interfering with Capricor's efforts to distribute deramiocel […] in the US."
Deramiocel consists of donor cardiosphere-derived cells (CDCs), given by intravenous infusion once every three months, that are thought to modulate the immune system and regenerate skeletal and cardiac muscle cells.
Capricor entered into the distribution agreement with Nippon Shinyaku and NS Pharma in 2022, receiving an upfront payment of $30 million and the promise of up to $705 million in milestone payments.
Under the terms of the deal, Capricor would sell supplies of the therapy to NS Pharma for distribution and receive a share of product revenue.
