Clinical-stage biopharmaceutical company Invex Therapeutics (ASX: IXC) has signed a major long-term collaboration and manufacturing agreement with Korean-listed Peptron (KOSDAQ: 087010) in relation to its lead neurological drug Presendin.
Invex had trademarked the already approved drug Exenatide as Presendin earlier this year, repurposing the diabetes drug for neurological conditions relating to raised intracranial pressure such as idiopathic intracranial hypertension (IIH), acute stroke and traumatic brain injury.
Peptron is a biopharmaceutical company based in Daejeon, South Korea, that develops sustained-release peptide-based medicines with high technological barriers to treat life-threatening and chronic diseases.
It also established a manufacturing facility in the country three years ago for the formulation of Exenatide and has an issued patent covering the use of the drug to treat Parkinson’s disease.
Invex emerged from a trading halt on Monday morning to announce the exclusive deal, which will provide Invex with access to Peptron’s intellectual property including an extensive pre-clinical and clinical data package as well as its proprietary manufacturing expertise and Goods Manufacturing Practice (GMP) grade drug product and placebo.
In turn, Peptron will gain exclusive commercial rights for Presendin in South Korea for the treatment of IIH.
Both companies will also benefit from the data sharing of each other’s regulatory filings.
The agreement is exclusive, applies globally and provides a defined price per dose for the supply of Presendin for clinical studies and for the first 10 years following the first commercial sale.
Peptron to manufacture Presendin in Korea
Under this new deal, Presendin will be manufactured and supplied globally to Invex from Peptron’s manufacturing facility in Osong, South Korea. The facility has the capacity to produce more than 48,000 vials of Presendin per month.
Peptron chief executive officer Dr Ho-il Choi said the partnership suits the clinical and commercial supply requirements of Presendin “at this important stage of its development”.
“Our state-of-the-art GMP manufacturing facility is ideal for Presendin manufacturing with the aseptic process for the dry powder injectable other than lyophilized or liquid injectable,” he said.
Deal de-risks and fast-tracks Invex’s development plan
Invex chairman Dr Jason Loveridge described the collaboration as a “very significant step forward” for the company as it significantly de-risks the development of Presendin for treating IIH by providing access to drug product, Peptron’s critical and extensive data package and its manufacturing and technical expertise.
“As a result, Invex will no longer need to undertake additional animal tolerability and human pharmacokinetic (PK) studies for Presendin, which reduces Invex’s development costs and significantly expedites our planned phase three registration study in IIH,” he said.
In an investor presentation on Monday, Invex executive director Dr Tom Duthy said this by-passing of previously required lead-in activities would save the company about $3 million and at least 12 months in its development timeline.
Phase three trial scheduled for 2022 first-half
According to Invex, Presendin is a once weekly sub-cutaneous formulation of Exenatide that reduces the frequency of injections and provides greater convenience for patients, which typically leads to greater patient compliance.
The company believes the drug has the potential to create significant revenue for both Invex and Peptron upon marketing approval, valuing the market at more than $1.6 billion in the United States and European Union and growing at a predicted 3.4% per annum.
The first clinical batches of Presendin are expected to be received from Peptron for a phase three trial in the fourth quarter of 2021.
Invex is continuing to define its regulatory strategy for IIH and Presendin following feedback from the US Food and Drug Administration (FDA) and aims to complete this early in the fourth quarter.
It is targeting the commencement of a single phase three trial for the registration of Presendin in the first half of the 2022 calendar year.