CytoDyn Inc (OTCQB:CYDY), a late-stage biotechnology company, revealed Monday that it has signed an exclusive supply agreement with American Regent Inc for the distribution of its investigational new drug, leronlimab, for the treatment of coronavirus (COVID-19) in the US.
Under the terms of the agreement, CytoDyn will supply leronlimab to American Regent, a Daiichi Sankyo Group company, which is a top-10 injectable manufacturer, and receive quarterly payments based on a profit-sharing arrangement.
“Having this distribution agreement in place ahead of the readout from CytoDyn’s COVID-19 clinical trials further emphasizes CytoDyn’s commitment to making leronlimab immediately available to patients based on the successful completion of its ongoing clinical trials,” CytoDyn CEO Nader Pourhassan said in a statement.
“We are particularly happy to be partnering with a company with the proven expertise, unparalleled commercial reach and stellar reputation of American Regent,” he added.
Vancouver, Washington-based CytoDyn is currently enrolling a Phase 2b/3 clinical trial for 390 severe and critically ill COVID-19 patients, which is a randomized, 2:1 ratio active drug to placebo-controlled trial.
CytoDyn also said it has met its 75-patient enrollment target in its Phase 2 clinical trial for COVID-19, a randomized clinical study for mild-to-moderate COVID-19 patients in the US.
“American Regent is looking forward to partnering with CytoDyn to provide COVID-19 patients rapid and efficient access to a potentially life-saving drug,” said American Regent chief Harsher Singh.
Leronlimab was previously granted Fast Track designation by the US Food and Drug Administration (FDA) for its indications as a treatment for metastatic triple-negative breast cancer and as part a combination therapy for HIV-infected patients.
The drug works by blocking CCR5, a cellular receptor that is important in HIV infection, tumor metastases and other diseases.
For COVID-19, the FDA has granted a so-called rolling review for the drug as part of CytoDyn's biologics license application submission. It has been granted more than 60 emergency Investigational New Drug authorizations by the FDA and plans to provide clinical updates for this patient population in the coming weeks.
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