Communicators

Highlights:

-          Memorandum of Understanding (MoU) with leading Indonesian biomedical company PT Etana Biotechnologies

-          MoU aims to facilitate late-stage clinical trials in Indonesia, supporting the Indonesian Government’s access to novel infectious disease medicines

-          Opportunity to access 10 ASEAN member states[1] covering a population of 670 million inhabitants

-          Patient populations readily available focussed upon significant unmet medical needs particular to the region

-          Significant bilateral initiative supported by Australian and Indonesian Government

Sydney Australia, 6 February 2024: Recce Pharmaceuticals Limited (ASX:RCE, FSE:R9Q), (the Company), the Company developing a New Class of Synthetic Anti-Infectives, is pleased to report a signed Memorandum of Understanding (MoU) with PT Etana Biotechnologies (Etana), a leading Indonesian biomedical organisation, to accelerate the clinical development of Recce’s anti-infective portfolio across Indonesia, with the aim of addressing the critical global health challenge of antimicrobial resistance (AMR).

Indonesian Minister of Health Budi Sodikin addressing Her Excellency Penny Williams and RCE CEO James Graham

Indonesian Minister of Health, Mr. Budi Sadikin stated, “The global health challenge of antimicrobial resistance is a pressing issue on the world stage. Indonesia welcomes collaborative initiatives and supports efforts to combat antimicrobial resistance, including the development of innovative therapeutics for infectious diseases.”

This is a historically significant bilateral initiative supported by the Australian and Indonesian Governments. In a meeting together with Senior Executives from Recce and Etana, Her Excellency Penny Williams PSM, the Australian Ambassador to Indonesia, the Indonesian Minister of Health, Mr. Budi Sadikin, and the Head of the National Research and Innovation Agency (BRIN), all were in full support of this initiative.

Recce Pharmaceuticals CEO James Graham (left) and Indonesian Minister of Health Budi sadiki (right)

The key objectives between Recce and Etana are as follows:

The Company will collaborate with nationally selected biotech sponsor Etana to advance Recce’s clinical program with speed, accessibility, cost-effectiveness (incl. substantial Government support), and quality. By coordinating bilateral efforts between Australia and Indonesia Governments and industry experts, this will provide Recce with market entry and penetration for international expansion in newly developed wealth of opportunities.

Chairman of BRIN (Indonesia’s National Research and Innovation Agency), Mr. Laksana Tri Handoko stated, “Health science and biomedicine is an important area in Indonesia’s research and innovation. We need to build a national capability, especially after the lesson of the recent pandemic. This collaboration is a continuation of the close relationship we have with Australia, which I see will grow moving forward. We want to build our expertise together and I look forward to the work to start with us.”

There is a significant need for new therapeutics in Indonesia, with the Government increasing its focus on addressing infectious diseases and AMR. Specifically, more than 10% of Indonesia's adult population (19.5 million) have diabetes[2], a disease that can lead to higher probabilities of foot infections, urinary tract infections, and surgical site infections[3]. Furthermore, a recent study showed that 15% of sepsis patients in Indonesian hospitals had suffered from Diabetes[4].

Chief Executive Officer of Recce Pharmaceuticals, James Graham, said, “This Bilateral Collaboration between Recce and Etana, signifies the Australian and Indonesian Governments’ shared commitment to advancing public health, fostering innovation, and addressing the global challenge of AMR in the Asia Pacific region. By combining our expertise and resources, we can make significant strides towards a healthier and more resilient future for both our nations and the global community.”

About Etana

Established in 2014, Etana is an Indonesian biopharmaceutical company that researches, manufactures and markets biological therapies for the Southeast Asian market. With a mission to serve patients by providing high quality, affordable, and innovative therapies, Etana has built state-of-the-art local production facility that meet international and Indonesian FDA standards. The facility is able to produce biological therapy with halal certification from the Indonesian Ulema Council (MUI). Etana aspires to become a leading biopharmaceutical company in the ASEAN region through aggressive expansion in production capacity and product development. Etana aims to provide innovative yet affordable therapies through local production, to support Indonesian government programs and larger market demands.

About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.

Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE® 435 as an orally administered therapy for bacterial infections; and RECCE® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.

The FDA has awarded RECCE® 327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.

Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.

This announcement has been approved for release by Recce Pharmaceuticals Board.

[1] https://asean.org/member-states/

[2] https://idf.org/our-network/regions-and-members/western-pacific/members/indonesia/

[3] https://www.verywellhealth.com/what-are-the-common-infections-with-diabetes-1087622

[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5332551/