Recce Pharmaceuticals Receives Australian Patent for RECCE® Anti-Infectives

SYDNEY, Nov. 27, 2024 – Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q), a company pioneering a new category of synthetic anti-infectives, has announced a significant milestone. The Australian Patent Office has granted Recce a third patent family for its innovative anti-infectives, with protection extending until 2037.

James Graham, CEO of Recce Pharmaceuticals, expressed his excitement about this achievement, emphasizing the substantial promise of Recce's New Class of Anti-Infectives. He highlighted that the approval of Patent Family 3 enhances their global intellectual property portfolio, safeguarding R327 and R529 in major pharmaceutical markets until 2037. Graham reiterated that this milestone reflects their dedication to tackling severe viral threats with groundbreaking treatments, ensuring that they can provide valuable solutions to patients internationally.

The Australian Patent encompasses various aspects of RECCE® 327 (R327) and RECCE® 529 (R529), including their manufacturing process and the resulting copolymer. It also covers the use of R327 or R529 in treating infections and methods of administering these compounds through oral, injection, inhalation, and transdermal applications.

This patent represents the final one within Recce’s wholly owned patents granted for the third family and the last patent to be granted in Australia. The company's intellectual property is now fully protected across all key pharmaceutical markets worldwide, listed as follows:

- Australia: Granted - 2037
- China: Granted - 2037
- USA: Granted - 2037
- Europe: Granted - 2037
- Germany: Granted - 2037
- Spain: Granted - 2037
- France: Granted - 2037
- UK: Granted - 2037
- Italy: Granted - 2037
- Sweden: Granted - 2037
- Japan: Granted - 2037
- Hong Kong: Granted - 2037

Recce Pharmaceuticals Ltd is at the forefront of developing a new class of synthetic anti-infectives aimed at addressing the critical issue of antibiotic-resistant superbugs. Their pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives:

1. RECCE® 327 (R327) is being developed as both an intravenous and topical treatment for serious, potentially life-threatening infections caused by Gram-positive and Gram-negative bacteria, including their superbug variants.
2. RECCE® 435 (R435) is an orally administered therapy targeting bacterial infections.
3. RECCE® 529 (R529) is designed to combat viral infections.

Recce’s anti-infectives are equipped with multi-layered mechanisms of action, which hold the potential to overcome the resistance strategies employed by bacteria and viruses – a significant challenge faced by current antibiotics.

The World Health Organization (WHO) has included R327, R435, and R529 in its list of antibacterial products in clinical development for priority pathogens, acknowledging Recce’s contributions to fighting antimicrobial resistance. Furthermore, the FDA has granted R327 the Qualified Infectious Disease Product designation under the Generating Antibiotic Incentives Now (GAIN) Act, offering Fast Track Designation and 10 years of market exclusivity post-approval. Additionally, R327 is listed on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate under development.

Recce retains complete ownership of its automated manufacturing capabilities, which support ongoing clinical trials. Their anti-infective pipeline is strategically designed to meet synergistic, unmet medical needs by utilizing their proprietary technologies.