CytoDyn Inc (OTCQB:CYDY), a late-stage biotechnology company developing leronlimab (Vyrologix or PRO 140) for multiple therapeutic indications, has executed an exclusive supply and distribution agreement with Macleods Pharmaceuticals Ltd in India.
CytoDyn said the commercial agreement will enable Mumbai-based Macleods to sell leronlimab in India as a coronavirus (COVID-19) treatment following regulatory clearance.
“We are delighted Macleods Pharmaceuticals reached out to CytoDyn and equally excited to reach this agreement with their team so quickly,” said CytoDyn CEO Nader Pourhassan In a statement. “From the time they first contacted us about our drug, we were able to conclude this agreement within a few days. It is an honor to work with an organization so motivated to bring leronlimab to COVID-19 patients in India. Currently India has zero product approved for critically ill OVID-19 patients and we are delighted to be working toward being the first approved drug for this population."
READ: CytoDyn raises another $25M for Vyrologix development in second covertable debt offering this month
Vijay Agarwal, a business development director at Macleods, added: “We are thrilled with our recently executed exclusive supply and distribution agreement with CytoDyn. We believe there is an immediate need for leronlimab in our country, to save COVID-19 infected patients who are on ventilators. We need to bring this product to market ASAP for them!”
Meanwhile, CytoDyn said that leronlimab has been studied in 11 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
Leronlimab is a viral-entry inhibitor in HIV/AIDS. It masks CCR5, thus protecting healthy T-cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Nine clinical trials have demonstrated leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent with fewer side effects and less frequent dosing requirements than currently used daily drug therapies.
CytoDyn has successfully completed a Phase 3 pivotal trial using leronlimab combined with standard antiretroviral therapies in HIV-infected treatment-experienced patients.
The company has also been working to resubmit its Biologics License Application (BLA) for this HIV combination therapy since receiving a Refusal to File letter in July 2020 and subsequently meeting with the US Food and Drug Administration (FDA) telephonically to address the agency's written guidance concerning the submission.
CytoDyn said it expects to resubmit its BLA via a rolling submission starting in the third quarter of calendar year 2021.
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