Tranexamic Acid

– Sales tracking in line with $300 million FY27 revenue target – Clinical trial supports the potential patient benefits of novel iron IV development project – Growth supported by an active licensing programme AFT Pharmaceuticals (NZX: AFT; ASX: AFP) today reports good progress towards its goal of $300 million in annual revenue in FY27. In Q2 FY26 the diversified pharmaceuticals company has benefited from growth across all regions, significant progress in its research and development portfolio and continued success in its programme of out-licensing its intellectual property and in-licensing new products. AFT Pharmaceuticals Managing Director Dr Hartley Atkinson said: “We are closing out the first half of the 2026 financial year pleased with the progress we have made. We continue to see broad-based growth led by our Australian and international businesses supporting our drive towards our $300 million target. “We have also made significant progress laying the foundations for future growth through our licensing operations and research and development programme. A key achievement in the current quarter is the result from the phase III clinical trial of our intravenous iron development project which is targeting an addressable market worth US$7.41 billion1. “The study has supported the potential patient benefits of the new medicine and shown better tolerability and fewer side effects than the leading IV iron medicine currently on the market. We are now preparing to launch a large-scale study to support global regulatory approval of the medicine.” AFT will provide a detailed update on its financial and operational performance when it releases its results for the six months to 30 September 2025 on 20th November 2025. An interview with AFT managing Director Hartley Atkinson discussing the Q2 FY26 performance is available from the following link: https://youtu.be/O5MqJegS-jw Sales continue to track in line with $300m FY27 revenue target. AFT continues to make good progress across all its regions with sales continuing to track in line with its goal of achieving $300 million in revenue for FY27. We are also targeting the launch of several new products in 2H26, which are expected to help drive the longer-term organic growth across the business. Our strategy to expand into international markets that share similar commercial and regulatory dynamics as our core Australasian business is advancing well. Ongoing product launches in the International markets are a key focus to drive growth. In the UK we have extended distribution of Maxigesic tablets (marketed as Combogesic) from Boots (1800 stores) and SuperDrug (750 stores) to now include independent pharmacies. The initial launches of the intravenous form of the pain relief medicine Maxigesic IV (marketed as Combogesic IV) in several London NHS hospitals is now well into the process of being bedded down. Sales momentum of this medicine is linked to the speed with which we can achieve inclusion into further NHS hospital formularies. We have launched Combogesic IV in Canada, and we have a strong Canadian pipeline of 20 additional medicines, for which we have either regulatory approval or for which we are preparing dossiers for filing. In South Africa we have secured regulatory approval for the first four products of the pipeline of 30+ products we plan to launch in the private hospital market. The first four will be launched in 2H26. AFT continues to work closely with its partners in USA and China to advance these large potential markets as well as additional new launches. Phase III study confirms iron injection patient benefits Our novel iron IV development project, which is targeted at a US$7.41 billion addressable market, has advanced its development pathway. A just completed Phase III clinical study has generated initial data to support the medicine’s patient benefits of a reduced dosing administrations profile and has also shown fewer side effects and indications of lower toxicity. While current intravenous iron therapies are effective, they often present tolerability issues, risk of side effects, and typically require multiple infusions, creating a significant treatment burden. Our new medicine offers the potential to overcome some of these challenges. In a randomized trial of 146 patients our IV product and administration were compared to an oral iron therapy and the leading iron IV therapy. The study showed that our IV product was well tolerated with an improved dosing schedule. Against the leading iron IV therapy, it showed significantly lower delivery complications (2.7% vs. 29.7%); on average precipitated no decrease in blood serum phosphate concentrations, a key safety result as hypophosphatemia is a safety concern for iron injections; and displayed lower concentrations of free iron in patient urine and blood serum, suggesting lower toxicity. Following the study we have filed an additional two patent applications covering the use of our iron product. We are now working to finalise an Investigational New Drug (IND) application with the US Food and Drug Administration ahead of commencing a large Phase III global multicentre trial of around 1,000 patients. The study is expected to take until early 2028 to complete and provided the results are consistent with the just completed study would deliver the data to support our filing for regulatory approval of the treatment across the globe. We are meanwhile advancing IND applications for our topical strawberry birthmark and antibiotic eyedrop projects. We are planning to file the antibiotic eyedrop IND application early in 2H FY26, while the pre-IND application for strawberry birthmarks has been filed and we are awaiting FDA feedback. An active out-licensing and in-licensing programme. During the quarter we struck five out-licensing agreements. We expect deal momentum to accelerate for the remainder of the year with discussions continuing over a number of our medicines. Separately we expect to file regulatory dossiers for a total of five of the injectables in the current financial year from our AFT Pharmaceuticals Sinoject project which has a significant pipeline of products. We are continuing to grow our product portfolio with an active programme of in-licensing innovative products to satisfy unmet clinical needs. An example is a ready-to-use tranexamic acid mouthwash (a medicine to help reduce or prevent excessive bleeding) which would enable patients treated with anticoagulants undergoing oral surgery to avoid the current necessity to discontinue their anticoagulant medications before oral surgery. We also continue to explore the purchase of products in some markets to further accelerate growth. For more information: Investors Dr Hartley Atkinson Managing Director AFT Pharmaceuticals Tel: +64 9488 0232 Media Richard Inder The Project Tel: +64 21 645 643 _____ Footnote: 1 https://www.biospace.com/intravenous-iron-drugs-market-size-to-worth-around-us-7-41-billion-by-2033

FDA is requiring labeling changes to strengthen the warnings that tranexamic acid injection should be administered only intravenously (into the vein). Tranexamic acid injection products are not to be administered intrathecally (into the spine) or as an epidural injection. FDA is taking this action after having identified and evaluated medication error cases of inadvertent neuraxial (intrathecal or epidural) administration of tranexamic acid. In these cases, tranexamic acid was erroneously administered neuraxially instead of the intended local anesthetic (e.g., bupivacaine, lidocaine, mepivacaine, and ropivacaine), which resulted in serious patient outcomes, including prolonged hospitalization and death. Medical practice-level and facility-level human factors (e.g., storing tranexamic acid injection close to local anesthetics and failing to verify the product before administration) contributed to the medication errors. Tranexamic acid injection is indicated for short-term use (2 to 8 days) in patients with hemophilia to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction. Health care professionals should only administer tranexamic acid injection by the intravenous route. Tranexamic acid injection is supplied in single-dose ampules and single-dose vials containing 1,000 mg tranexamic acid in 10 mL and is marketed both under the proprietary name, Cyklokapron, and as a generic drug. Tranexamic acid is also supplied in sodium chloride injection in single-dose bags containing 1,000 mg of tranexamic acid in 100 mL solution for intravenous use. FDA is requiring the following changes to the prescribing information for tranexamic acid injection: Add a Boxed Warning to communicate the risk of medication errors involving inadvertent neuraxial administration of tranexamic acid injection Add a statement to indicate that tranexamic acid injection is contraindicated as a neuraxial injection Update the Dosage and Administration section to clarify that tranexamic acid injection is only to be administered intravenously and to provide instructions for preparing and administering the diluted solution Additionally, FDA is recommending that the container labels for tranexamic acid injection prominently display the product name and intravenous route of administration. Health care professionals should consider the following steps to minimize the risk of inadvertent neuraxial administration of tranexamic acid injection: Storage Do not store tranexamic acid injection vials or ampules near local anesthetics or in kits containing local anesthetics intended for spinal or epidural anesthesia. Store medication vials in a way that makes the labels visible to avoid reliance on identifying drugs by the vial cap color. Use barcode scanning when stocking medication cabinets to ensure the correct medication is placed in the appropriate storage bin. Store tranexamic acid injection vials and ampules in separate carts outside the operating room or in locked bins that require barcode scanning to remove from the bin. Administration Use commercially available or pharmacy-prepared intravenous infusion bags of tranexamic acid, when possible, to minimize confusion with local anesthetics supplied in vials or ampules. Use barcode scanning and always check the container label to ensure the correct product is selected and administered. If withdrawing tranexamic acid injection from a vial or ampule, promptly label each syringe when it is prepared unless it is immediately administered. If using pre-packaged spinal or epidural kits, carefully inspect the container labels of medications included in the kit to verify the intended medication before use. Additional Recommendations for Health Care Facilities Add a prominent "contains tranexamic acid" auxiliary warning label to all vials and ampules that contain tranexamic acid injection. Add tranexamic acid injection to internal high-alert medication lists and develop procedures and policies to ensure safe use and minimize the risk of mix-up with other medications. FDA encourages health care professionals and patients to report adverse events, medication errors, and product quality problems experienced with the use of any medical product to MedWatch: The FDA Safety Information and Adverse Event Reporting Program : Complete and submit the report online at www.fda.gov/medwatch/report.htm ; or Download and complete the form , then submit it via fax at 1-800-FDA-0178. Content current as of: 10/21/2025 Regulated Product(s) Topic(s) Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.