ASX Health Stocks: The US FDA will pay a visit to Cyclopharm's facility in NSW

The US FDA will come and inspect Cyclopharm’s facility in NSW
Radiopharm gets Orphan Drug Designation from the FDA
PharmAust’s research published in the Wiley peer review journal

FDA will inspect Cyclopharm’s facility

Medical equipment and radiopharmaceutical company Cyclopharm (ASX:CYC) announced the US FDA will be coming to inspect the company’s facility in Kingsgrove, New South Wales, between 24 July through 4 August.

The inspection follows last month’s confirmation by the FDA of its six-month review period for Cyclopharm’s New Drug Application of lung ventilation imaging agent, Technegas.

Technegas is an ultra-fine dispersion of radioactive labelled carbon, produced by using dried Technetium-99m in a carbon crucible, micro furnaced for a few seconds at around 2,700 degrees Celsius.

The resultant gas-like substance is inhaled by the patient (lung ventilation) via a breathing apparatus, which then allows multiple views and tomography imaging.

Historically used in the diagnosis of pulmonary embolism, Technegas is now being used in other diseases including COPD, asthma, and pulmonary hypertension.

Cyclopharm says that the FDA approval will create an initial addressable market in the USA of US$180 million per annum in the diagnosis of Pulmonary Embolism (PE).

Radiopharm gets another Orphan Drug Designation

Another radiopharmaceutical company, Radiopharm Theranostics (ASX:RAD), announced that the FDA has granted Orphan Drug Designation to its Ga68-Trivehexin (RAD 301) radiopharmaceutical technology.

Trivehexin is used to image patients with pancreatic ductal adenocarcinoma (PDAC).

The proprietary peptide-based molecule targets the αvβ6-integrin receptor, which is a cellular marker for tumour invasion and metastatic growth. This receptor is found in high density on most pancreatic carcinoma cells, making it an attractive diagnostic and therapeutic target.

Radiopharm has signed an exclusive licensing agreement with TRIMT GmbH for development and commercialisation of Trivehexin in USA, Australia, China, Hong Kong, and Japan.

“This important designation further reinforces the excitement of investigators conducting the study,” said Riccardo Canevari, CEO of Radiopharm.

“The FDA’s decision highlights the significant demand for effective imaging agents for improved and earlier diagnosis of pancreatic cancer, which has one of the highest levels of unmet needs among all cancer types.”

Radiopharm now holds two FDA Orphan Drug Designations, with the other one being the LRRC15 antibody DUNP19 for the treatment of patients with osteosarcoma.

Other ASX healthcare news today

PharmAust (ASX:PAA) says research on its lead drug monepantel at the Olivia Newton-John Cancer Research Institute and associated collaborative cancer centres has been published in the Wiley peer review journal.

That research shows that monepantel has broad anti-cancer effects across multiple cancer types (melanoma, lung, breast, brain, colorectal, prostate, and ovarian).

According to the research, monepantel’s ability to fight cancer is likely due to its effects on the cell cycle, autophagy and mTOR signalling.

EZZ Life Science (ASX:EZZ) meanwhile has entered into a major agreement with Aubay (trading as HIC) for the exclusive distribution rights of two EZZ-branded products.

The two-year agreement forecasts additional annual revenues of at least $16 million to EZZ commencing from FY24.

The deal was the culmination of several months of negotiations. EZZ says HIC’s social e-commerce model provides a unique opportunity for its products to reach consumers outside of existing distribution channels, offering significant potential for growth.