CytoDyn intends to obtain FDA approval for leronlimab in combination therapy, and file a biologics license application (BLA) in 2019
CytoDyn and Vyera Pharmaceuticals have signed a commercialisation and license agreement (CLA), along with an associated supply agreement to commercialise leronlimab (PRO 140) in the US.
leronlimab is a viral-entry inhibitor used for treatment of HIV. It masks CCR5 to protect healthy T cells from viral infection by blocking the prevalent HIV subtype from entering those cells.
CytoDyn president and chief executive officer Nader Pourhassan said: “This agreement helps complete the strategic objective to further establish CytoDyn as a leader in efforts to enhance the lives of patients through target-specific medicine.
“Vyera’s focus on developing therapies for patients living with serious and neglected diseases make them an ideal partner for this collaboration. We are excited to work with Vyera to leverage their platforms and capabilities to potentially offer a more effective treatment option for this HIV population.”
CytoDyn will develop and seek FDA approval for leronlimab
Under the terms of the agreement, CytoDyn is responsible for the development and FDA approval of leronlimab for all HIV-related and other indications, while Vyera will hold exclusive license to market and distribute leronlimab for HIV in the US.
Vyera will pay up to $87.5m as upfront, regulatory and sales-based milestone payments, along with a royalty of 50% on net sales, in exchange for the exclusive license. It will also invest $4m in CytoDyn, in the form of registered CytoDyn common stock.
CytoDyn is conducting a Phase 3 investigative trial of leronlimab (PRO 140) as a monotherapy for the treatment of HIV-infected patients.
The company intends to obtain FDA approval for leronlimab in combination therapy, and file a biologics license application (BLA) in 2019 for the same indication. It is also planning to start a registration-directed study of leronlimab to support the label extension.
Vyera is a US-based biopharmaceutical company that develops and markets treatments for serious and rare diseases with high unmet medical needs.
Phoenixus chief executive officer Averill Powers said: “Vyera’s collaboration with CytoDyn demonstrates our commitment to address the needs of significant patient populations across our group companies generally and, in particular, a new level of our commitment to supporting patients living with HIV.”