Avecho Completes Phase III Sleeplessness Study, Awaits Interim Results
Avecho has completed the treatment of all 244 participants in its phase III sleeplessness study. The company is now awaiting the release of interim results in June. These results will provide the first indication of the efficacy of its synthetic cannabinoid (CBD) based candidate and may inform the final trial size, which is expected to be around 520 patients.
The company’s management hopes that the interim analysis will support ongoing licensing discussions. One unique aspect of Avecho’s approach is its pursuit of the local over-the-counter (OTC) route, allowing patients to access approved cannabis-based medications without a prescription. This became possible due to a 2020 regulatory change for low-dose, non-THC cannabis therapies. However, the Therapeutic Goods Administration has yet to approve any OTC drug, as it must meet high-quality standards.
Avecho has already partnered with Sandoz Group, the world’s largest drugmaker, which obtained the Australian rights to its product. In return, Avecho received an upfront payment of US$3 million ($4.1m), with potential development milestones of US$16m and sales royalties of 14-19%.
Dr Paul Gavin, CEO of Avecho, mentioned that as far as he knows, the trial is the only phase III effort globally testing CBD for insomnia. He is scheduled to host an investor webinar on Monday morning.
AFT Pharmaceuticals Achieves Strong Financial Growth
New Zealand’s largest local pharmaceutical company, AFT Pharmaceuticals (ASX:AFP), has set a target of NZ$300 million in revenue for the current year, having delivered NZ$254.7 million for the year ending March 2025. The company also achieved an operating profit of NZ$24.4 million, which is 38% higher than the guided range of NZ$20-24m.
AFT Pharmaceuticals has been expanding its reach into over-the-counter brands by focusing on indications overlooked by Big Pharma. Its best-selling products include Maxigesic, a paracetamol and ibuprofen combination, and Hylo eye drops.
The company’s full-year turnover consisted mainly of product sales and royalties of NZ$251.6 million, representing a 21% increase. The fledgling international arm grew turnover by 66%, reaching NZ$28.5m. Australasia remained AFT’s cornerstone, with revenue of NZ$210.5 million, up 19%.
AFT also plans to increase operating profit by 14%, reaching NZ$32m for the current year. Co-founder and managing director Dr Hartley Atkinson stated that this result demonstrates continued execution against their strategy.
Expanding R&D and International Reach
AFT Pharmaceuticals spent NZ$18 million on R&D in the past year, a 20% increase, with plans to invest NZ$25 million this year. This includes the cost of a large, 1366-patient clinical trial for a new injectable iron product.
The company has also formed partnerships with Stablepharma UK to develop room-temperature versions of several fridge-stored injectables. In the US, AFT will distribute its Maxigesic (Combogesic Rapid) analgesic via Mark Cuban’s Cost Plus pharmacies. In the UK, Boots and Super Drug chains handle the distribution.
Earlier, AFT launched a proprietary antiseptic cream in mainland China, the world’s second-largest pharma market after the US. The company declared a dividend of 2.5 cents per share, a 38% increase.
Truscreen Raises Funds for Cervical Cancer Diagnosis Technology
Truscreen Group (ASX:TRU) has launched a NZ$2.9 million capital raise, consisting of a placement with options and a rights issue. The company has developed the portable Truscreen assay for diagnosing cervical cancer, particularly in regions without established laboratory infrastructure.
The raising includes a NZ$1 million placement at NZ1.4 cents per share, with attached options on a one-for-two basis. The options are exercisable at the same price within two years. The company also aims to raise approximately NZ$1.943m via a rights offer on a one-for-five basis.
Truscreen reported sales growth of NZ$2.4 million in the year to March, a 42% increase year-on-year. This included first sales in India, where there are 468 million screening-age women, and in Indonesia, with 95 million screenable women.
Despite reporting a March-end cash balance of NZ$1.5 million and a full-year loss of NZ$2.2 million, Truscreen is seeking additional funding.
Saluda Medical Gains Attention in Spinal Cord Stimulator Market
Bell Potter has assigned a $2 a share valuation to Saluda Medical (ASX:SLD), more than four times its current worth. While some analysts remain skeptical, the firm believes that even at $2, the shares would still be undervalued compared to their listing price of $2.65 a share in early December last year.
Saluda has commercialized its Evoke closed-loop spinal cord stimulator (SCS), an implantable device used to treat chronic back and leg pain. The closed-loop system measures spinal cord activation levels after each electrical pulse and adjusts the stimulus accordingly.
The company has recorded revenue growth of 9%, 17%, and 34% over the last three quarters, outpacing the broader SCS market. Saluda competes with three medtech giants, including Medtronic, but Bell Potter views its offering as superior.
Island Pharmaceuticals Appoints Raymond Taylor for Ebola Research
Island Pharmaceuticals (ASX:ILA) has appointed Raymond Taylor to drive the development of its anti-viral Galidesivir. Taylor, who spent 19 years at Biocryst Pharmaceuticals, was involved in securing US$490 million in US government biodefence funding and a further US$125m in public stockpiling contracts.
Island is preparing to study the Marburg virus under the US Food and Drug Administration’s Animal Rule, which allows registration using non-human studies. The company is positioned to contribute to the fight against viral outbreaks like Ebola.
