Poredeen Appoints ICB as Exclusive Named Patient Program Manager for HMTM# in Hong Kong and Macau
- Written by Media Outreach
Poredeen Appoints ICB as Exclusive Named Patient Program Manager for HMTM# in Hong Kong and Macau
Poredeen grants ICB the exclusive rights to manage the importation and logistics for the HMTM# tablets under the NPP such that qualified prescribing doctors in the Territories can request HMTM# on behalf of eligible patients. HMTM# is currently undergoing clinical evaluation for its potential use in managing Mild Cognitive Impairment ("MCI"), Alzheimer's Disease ("AD") and behavioural-variant Fronto Temporal Dementia ("bvFTD"). It is not registered for commercial sale in the Territories. This NPP marks a significant milestone in the parties' joint mission to combat some of the world's most challenging and prevalent neurodegenerative diseases in the Territories.Promising results are observed in LUCIDITY, TauRx's third and latest global Phase 3 clinical trial of HMTM#, offering hope to many patients and their families. LUCIDITY comprised a 12-month double-blind controlled Phase 3 clinical trial followed by a 12-month period in which all participants received HMTM# at 16 mg/day as a monotherapy. The trial investigated changes in various clinical and biomarker outcomes comparing HMTM# 16 mg/day with methylthioninium chloride ("MTC") given 4 mg twice weekly as a control over the first 12 months.
The safety profile seen in LUCIDITY remains positive and consistent with earlier published HMTM# trials data. There were no treatment-related serious adverse events or evidence of amyloid-related imaging abnormalities ("ARIA") in LUCIDITY. The LUCIDITY trial is now complete and TauRx is preparing peer-reviewed publications to report the full 24-month data.
Alzheimer's Disease is one of the leading causes of death throughout the world and one of the most important public health issues to be addressed globally. TauRx will contribute to addressing this unmet need with data from LUCIDITY. In the United Kingdom, TauRx is actively pursuing approval from the Medicines and Healthcare products Regulatory Agency ("MHRA UK") through the Innovative Licensing and Access Pathway ("ILAP"). TauRx was granted an Innovation Passport in May 2022, marking the first stage of the approval process, indicating MHRA UK's recognition of the potential importance of this medication for Alzheimer's Disease.
TauRx is also submitting the HMTM# results from LUCIDITY and earlier trials for regulatory approval in the USA. TauRx and Poredeen will be meeting and submitting data packages to other drug regulators in more territories, including the People's Republic of China ("China"), soon.
"This appointment reflects our unwavering dedication to improving the lives of those impacted by AD," stated TauRx's Managing Director, Dr SENG Shay Way, "We are delighted to appoint ICB as NPP Manager so that doctors may request this groundbreaking product for their eligible patients in need. Through this appointment, we aim to make a substantial and positive difference in the fight against AD thereby enhancing the quality of life for the patients, their families and caregivers."
"We focus on upholding the highest quality standards and compliance with regulatory guidelines," Poredeen's Executive Director, Dr LOH Yin Sze echoed, "where patient safety and well-being are of paramount importance, and our dedicated team will collaborate closely with ICB to provide ongoing support and education regarding this groundbreaking drug."
Securing this appointment not only expands Immuno Cure's position as a leading player in the biotech sector into pharmaceutical services but also showcases ICB's commitment to addressing critical unmet medical needs of AD patients through the launching of the NPP for prescribing doctors' immediate access to TauRx's HMTM#.
"We are delighted to be appointed the exclusive NPP Manager by Poredeen. Through our close relationship with healthcare institutions and practitioners, ICB will ensure the efficient and timely accessibility of HMTM# to the prescribing doctors and their patients," ICB's Chairman, Dr Percy Cheng said. "ICB will work closely with healthcare institutions, professionals, patient advocacy groups, and regulatory authorities to ensure the swift, safe and responsible availability of this groundbreaking treatment to eligible patients in need in Hong Kong and Macau."
TauRx, Poredeen and ICB are strategically aligned and committed to propel forward in their mission to transform the landscape of neurodegenerative disease treatment and make a profound improvement to the lives of those affected by MCI, AD and bvFTD and their families.
HMTM# is an investigational drug which has not received approval for any indications in the Territories, and its efficacy and safety have not yet been evaluated for registration purposes.
Disclaimer: This press release contains commercial information. It does not constitute any medical advice, and should not be treated as such. Any questions about any medical matter should be directed to medical practitioners or other professional healthcare provider.
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