CytoDyn Inc (OTCMKTS:CYDY), a Vancouver-based biotech developing its flagship leronlimab (PRO 140) candidate for multiple indications, said Tuesday that it is executing a strategic agreement with Samsung BioLogics Co Ltd to manufacture leronlimab.
The manufacturing agreement will support potential revenue of approximately $1 billion for CytoDyn, based on leronlimab costing nearly $120,000 per patient, per year.
Investors cheered the news and sent shares of CytoDyn up by nearly 5.7% to $0.51.
The agreement starts immediately and entails the technology transfer of the fully validated commercial process and regulatory support during the pre- and post-approval process with the US Food and Drug Administration (FDA) and other global regulatory bodies.
READ: CytoDyn submits first part of biologics license application to FDA for flagship HIV drug leronlimab
In the last four years, Samsung BioLogics has secured eight biologics drugs approvals from the FDA and 22 overall, when considering approvals from other regulatory agencies around the world.
CytoDyn’s financial obligations to Samsung will be met predominantly from sales from existing inventory of commercial grade leronlimab and non-dilutive financing, said the company.
The initial contract period starts on April 1, 2019 and extends to December 31, 2027, encompassing the multitude of potential indications for leronlimab for which CytoDyn anticipates pursuing regulatory approvals.
“We are elated at the distinction of partnering with the world’s preeminent biologics manufacturer for our franchise-defining drug,” CytoDyn CEO Dr Nader Pourhassan said in a statement. “In the last four years, Samsung BioLogics has been among the most successful, consistent and highest quality biologics manufacturers in the world. We are thrilled beyond measure that Samsung chose to partner with us.”
"Fast Track" designation
The US FDA has granted a “Fast Track” designation to leronlimab as a combination therapy with HAART for HIV-infected patients. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that appears to play multiple roles with implications in HIV infection, tumor metastases and immune signaling.
Leronlimab has successfully completed nine Phase 1/2/3 clinical trials in over 700 people, including a successful pivotal Phase 3 trial in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients.
CytoDyn is conducting additional research with leronlimab in the cancer setting and plans to initiate additional Phase 2 human clinical trials, in addition to triple-negative breast cancer.
CytoDyn plans to seek FDA approval for leronlimab in combination therapy and has filed the non-clinical portion of a Biologics License Application for its flagship leronlimab as a combination therapy for HIV using the FDA’s rolling review process.
Biologics license application
Pourhassan said the company is working to complete the clinical and chemistry, manufacturing, and controls (CMC) information portion of the biologics license application.
The biologics license application is a request for permission to introduce a biologic product for interstate commerce.
The non-clinical portion constitutes the first of three sections of the BLA submission for leronlimab as a combination therapy with HAART for HIV-infected patients.
“The validation of Samsung is particularly important as we rapidly advance towards completing the rolling BLA,” said Pourhassan. “We are also currently evaluating several potential licensing deals for leronlimab to commercialization companies. We are getting closer to have such agreements in place which will provide CytoDyn non-dilutive funds to execute on our vision.”
The CEO earlier said CytoDyn continued to execute on the submission of its BLA and was “well positioned for potential revenue in 2020,” subject to final approval.
—(Upadtes with share price rise)—
Contact Uttara Choudhury at [email protected]