Exclusive Licensing Deal: Link Healthcare to Market Cefiderocol in AUS & NZ

Shionogi & Co., Ltd. is pleased to announce that it has entered into an exclusive licensing agreement with Link Medical Products Pty Ltd (hereinafter ""Link""), part of Clinigen, the global specialty pharmaceutical services group (Senior Vice President - JAPAC: Dr. Varun Sethi; hereinafter ""Clinigen"") for the development and commercialization of cefiderocol in Australia and New Zealand. The Therapeutic Goods Administration (TGA) regulatory authority in Australia accepted the market authorisation application for cefiderocol in December 2024 and the application is under evaluation1.

Under the terms of the agreement, Link will in-license cefiderocol from Shionogi and obtain exclusive rights for its development and commercialization in Australia and New Zealand. Shionogi will receive an upfront payment, milestone payments based on development progress, and royalties from Link.

Shionogi is committed to research and development of innovative treatments for infectious diseases for the benefit of patients around the world and to helping tackle urgent global health challenges such as antimicrobial resistance (AMR).

About Cefiderocol

In Europe, cefiderocol is commercially available under the brand name Fetcroja® for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options2. In the U.S., cefiderocol is available under the brand name Fetroja® and is indicated in patients 18 years of age or older for the treatment of hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia (HABP/VABP) and complicated urinary tract infections (cUTIs) caused by certain susceptible Gram-negative microorganisms3. In Japan, cefiderocol is commercially available under the brand name Fetroja® and received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare for various infections caused by strains resistant to carbapenem antibiotics among sensitive strains of Escherichia coli, Citrobacter species, Klebsiella pneumoniae, Enterobacter species, Serratia marcescens, Proteus species, Morganella morganii, Pseudomonas aeruginosa, Burkholderia species, Stenotrophomonas maltophilia, and Acinetobacter species4.

Cefiderocol is listed on the World Health Organization's Essential Medicines List5, and preparations are underway through a collaborative agreement with The Global Antibiotic Research and Development Partnership (GARDP) and Clinton Health Access Initiative (CHAI) to improve access to this antibacterial agent for patients in low- and middle-income countries 6.

About AMR

Antimicrobial resistance (AMR), the phenomenon where bacteria acquire resistance to antibiotics, is one of the most significant global public health threats facing humanity and requires urgent action. AMR has been referred to as a ""silent pandemic”, and without countermeasures, it is projected to result in over 10 million deaths annually by 20507,8

Click here to learn more about our efforts to address drug resistance.

About Link Medical Products Pty Ltd

For almost 30 years, Link Healthcare, part of the Clinigen Group, has played a vital role in the Australasian healthcare landscape as a trusted partner providing ethical and compliant pathways to both registered and unregistered medicines. With a team of 58 employees, Link Healthcare offers specialised pharmaceutical services across the product lifecycle, from clinical through to commercial, supporting pharmaceutical and biotech companies and healthcare professionals to address unmet patient needs.

For more information on Link Healthcare, a Clinigen Company visit: https://www.linkhealthcare.com.au

About Clinigen

Clinigen is a global, specialist pharmaceutical services company focused on providing ethical access to medicines. Its mission is to accelerate access to medicines for patients in every corner of the globe. The Group supports pharmaceutical and biotech companies across the medical product lifecycle, from clinical through to commercial and operates from sites in North America, Europe, Africa and the Asia Pacific. Clinigen has more than 1,100 employees across five continents in 15 countries and provides access in more than 130 countries every year.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!