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Highlights from European Stroke Organisation Conference (ESOC) Scientific Symposium

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June 2019

A scientific symposium was held on the 24th May 2019, which aimed to share the advance of stroke rehabilitation and the role of NeuroAiD in post-stroke recovery.

Clinicians from Southeast Asia, Europe, and Middle-East attended the symposium. International faculties presented their perspectives on patients’ journey through stroke recovery and the critical role of both rehabilitation and NeuroAiD to achieve functional independence.

  • Professor Christopher Chen from the National University of Singapore provided an overall perspective and moderated the entire scientific session
  • Professor Pamela Duncan from Wake Forest University of the United States of America, presented stroke recovery therapeutics and rehabilitation
  • Professor NV Ramani from Raffles Hospital Singapore, presented the effects of NeuroAiD on long-term functional outcomes after stroke
  • Professor Suwanwela NC from Chulalongkorn University Thailand, presented the effects of combination treatment with NeuroAiD and rehabilitation
  • Professor M Lazdunski from CNRS France, presented NeuroAiD’s multimodal mode of action

Professor Duncan emphasized that “we are transforming acute care”. Indeed, the mortality rate of stroke patients in the United States is decreasing, however, “we are not managing the disability” among these patients. In other words, “stroke patients are living longer, with higher chance of survival, but they are not given with optimal recovery”. It is important to note that in “rehab and recovery, there is reorganization of the brain, neurogenesis, regulation of growth factors, and all of these processes take time. Therefore the “primary endpoint of clinical trials assessing recovery should be 6 months to 1 year”, she added.

 

CHIMES-E Study

CHIMES-E, NeuroAiD’s landmark study, assessed recovery for up to 2 years following a stroke. More patients in the treatment group achieved functional independence (mRS 0-1) with significant results from month 6 to 18 compared to the placebo group. Moreover, combining NeuroAiD and rehabilitation doubled the odds of achieving functional independence as early as month-3, with effect persisting over 2 years as compared to patients who underwent rehabilitation alone.

 

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

 

Moleac holds two educational symposia on the management of Traumatic Brain Injury

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March 2019

Moleac organized two symposia in Dubai and Bangkok on new approaches for Traumatic Brain Injury (TBI) recovery.

In these symposia, the speakers emphasized on the global burden of TBI, the lack of treatment options for patients, and the scientific and clinical background supporting the role of NeuroAiD to help patients who have suffered from a TBI and other brain injuries.

Clinicians from Southeast Asia, Europe, and Middle-East attended the sessions presented by International faculties:

Professor Valery Feigin (MD, MSc, PhD, FAAN), director from the AUT National Institute for Stroke and Applied Neuroscience from New Zealand, presented the BRAINS Study assessing the safety and efficacy of NeuroAiD in TBI patients.

  • Professor Mihai Berteanu (MD, PhD), senior consultant from Elias University Hospital, Romania, discussed about the consistency of NeuroAiD’s neurorestorative properties across brain injuries.
  • Associate Professor Ihsan K. Al-Shimmery from Hawler Medical University in Iraq, presented the effect of combining rehabilitation with NeuroAiD.
  • Lee Khean Hin from Gleneagles Hospital Singapore, shared his clinical experience of using NeuroAiD in several types of brain injuries.
  • Associate Professor Ramesh Kumar (MD, MRCS, FRCS) from the National University of Malaysia (UKM), one of the primary investigators for SATURN and NeST registry in Malaysia, presented the preliminary findings for these two studies.

 

The BRAINS Study

The BRAINS Study was conducted in New Zealand and published in the European Journal of Neurology in April 2018. It investigated the clinical relevance of NeuroAiD for mild-to-moderate TBI patients who suffered from persistent cognitive deficits. Complex Attention (ability to multi-task) and Executive Functioning (planning and decision making) are the most commonly affected cognitive domains following a TBI. Both cognitive domains were significantly improved after a 6-month treatment of NeuroAiD versus placebo and over the 9-month follow-up period, with a good safety profile.

In addition to the BRAINS study, ongoing research on the potential role of NeuroAiD in Spinal Cord Injury (SCI) and case reports of Intra Cranial Hemorrhage (ICH) and TBI confirm the safety profile of NeuroAiD and its promising role in improving recovery after brain injuries.

 

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

NeuroAiD combined with rehabilitation has shown additive and sustained benefits on post-stroke recovery over 2 years after an initial 3-month treatment following stroke onset

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  • More subjects on NeuroAiD™ improved to functional independence compared to placebo among subjects receiving rehabilitation up to 3 months after an acute ischemic stroke.
  • The larger treatment effect of NeuroAiD™ was sustained over 2 years which supports the hypothesis that NeuroAiD™ and rehabilitation might have additive and sustained benefits on neuro-repair processes after stroke.
  • The results were consistent at various time points and seen on several indices, i.e. modified Rankin Scale (mRS) and Barthel Index.

Singapore, 28 September 2018 – Moleac is pleased to announce the release of the results of an analysis showing the additional effect on post-stroke recovery of NeuroAiD™ combined to rehabilitation, published online in the journal Cerebrovascular Diseases1. Positive results at 3 months of the combination of NeuroAiD™ and rehabilitation had been communicated by Prof. Christopher Chen (CHIMES-E co-principal investigator) during the European Stroke Organization Conference (ESOC 2018) in Gothenburg, May 16. These new results recently published provide convincing data showing that this additive and sustained effect of NeuroAiD™ is maintained over two years in patients having received persistent rehabilitation up to 3 months. They confirm persisting long-term benefits of NeuroAiD™ on patients’ recovery after an ischemic stroke already demonstrated on 880 patients in the CHIMES-Extension study².

This analysis conducted in 380 patients having received persistent rehabilitation up to 3 months shows that adding NeuroAiD™ increases significantly the odds of improving functional recovery and independence at 3 months and beyond after an acute ischemic stroke, compared to placebo in double-blind with well-balanced groups at baseline. The odds of recovery were increased by more than twice at 6 months and 1 year, with a success rate maintained over 2 years. This confirms the sustained additive effect of NeuroAiD™ to the one of rehabilitation supporting the brain neuro-repair processes spontaneously initiated after the occurrence of any brain lesion All these results were consistent at various time points and seen on 3 indices, i.e. mRS ordinal, mRS dichotomy 0-1, and Barthel Index.

“Stroke recovery is a multi-layered process and is complex. Hence, it is likely that a multi-modal approach may be more effective in achieving better patient outcomes, by regulating more than one endogenous neurobiological process to address the complexity of the stroke recovery process,” said Prof. Nijasri C Suwanwela, director of Chulalongkorn Comprehensive Stroke Center, Chulalongkorn University and co-investigator of the CHIMES-E study². “In this new analysis, we were able to show that NeuroAiD™ combined with rehabilitation achieved better outcome both on functional recovery and independence in activities of daily living than rehabilitation alone,” she added. “There is a need for more data on the effect of combining rehabilitation programs with post-stroke treatments,” she concluded.

These results confirm the hypothesis raised by the CHIMES-E investigators: NeuroAiD™ combined to rehabilitation have a sustained additive effect compared to rehabilitation alone for improving functional outcomes after stroke 1. Since most post -stroke patients already undergo rehabilitation, combining a medical intervention that facilitates adaptive neuroplasticity with rehabilitation may be a logical and simple strategy for such multi-modal therapy, hence suggesting to extend NeuroAiD™ treatment duration beyond the 3 initial months, while recovery process is still in progress.

About CHIMES Society

The CHIMES Society is an international academic industry collaboration with the objective to establish new stroke treatments. It is a Singaporean non-profit society founded by a group of experts in stroke and South-East Asian stroke clinicians interested to implement a research project: the NeuroAiD™ Efficacy on stroke recovery trial (CHIMES trial).

The CHIMES-E Study was supported by the CHIMES society and grants were received by CHLC from the National Medical Research Council in Singapore (NMRC) which supports the implementation of CHIMES trial in Singapore.

About Moleac

To address therapeutic gaps, Moleac has pioneered a new drug development approach, looking at sources of innovation from Natural Medicines, hence shortening considerably drug development cycle time and investment to bring medicine to sufferers’ unaddressed needs. Moleac’s neurorestorative compound NeuroAiD™ reaches patients in more than 30 countries.

  1. Suwanwela NC, et al. Effect of Combined Treatment with MLC601 (NeuroAiDTM) and Rehabilitation on Post-Stroke Recovery: The CHIMES and CHIMES-E Studies. Cerebrovasc Dis. 2018;5;46(1-2):82-88. doi: 10.1159/000492625
  2. Venketasubramanian N, et al. CHInese Medicine NeuroAiD Efficacy on Stroke Recovery – Extension Study (CHIMES-E): A Multicenter Study of Long-Term Efficacy. Cerebrovasc Dis. 2015;44 39:309–318. doi: 10.1159/000382082

For more information:

Yeonhee Pee
Email: yeonhee.pee@moleac.com
Phone: +65-62113710

Moleac Announces US FDA Approval of IND Application for Phase 1 Study of MLC1501 Programme in Post-Stroke Recovery

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SINGAPORE, March 5, 2018 /PRNewswire/ — Moleac, a biopharmaceutical company focused on research and development of new medicines for central nervous system (CNS) diseases and injuries, today announced that the U.S. Food and Drug Administration (FDA) has approved an investigational new drug (IND) application for a Phase 1 study of MLC1501, as first step of a clinical programme in post-stroke recovery treatment. Approval of this IND enables Moleac to initiate a safety study of MLC1501 in normal subjects as part of the overall clinical development plan for demonstrating that MLC1501 improves functional independence and recovery of motor, speech, cognition and other neurological dysfunctions in post-acute ischemic stroke (AIS) survivors having not recovered after acute treatments (thrombolysis, thrombectomy) or having not received them. Beyond the acute phase, there are no available treatments, other than rehabilitation measures, to relieve the disabilities suffered by stroke survivors. Proving clinical safety and efficacy of MLC1501 on long-term functional and neurological recovery in patients suffering from AIS will fill a therapeutic gap and help reduce the overall burden of stroke.

This is a clear milestone for Moleac to commence development of MLC1501 an agent that has proven successful in Asia for use in the USA as a new treatment for post-stroke recovery, an area where we need more agents to reduce the devastating burden of stroke for patients and their families,” said professor Lou Caplan of Beth Israel Deaconess Medical Center and Harvard University. “We already have learned much about the properties of the parent compound, NeuroAiD. This information will guide the clinical development of MLC 1501, and trials of its use in the USA.” Prof Caplan added.

David Picard, CEO of Moleac, added, “The US FDA’s clearance of this IND is validating our collaborative and determined approach to move into registration trials for post-stroke recovery. We are confident and eager that this Phase I study will confirm the safety of MLC1501 for starting as early as possible Phase II with international stroke centers and patients. We are grateful to all our colleagues, our partners in academia and our corporate partners without whom this step forward would not have been possible.”

About Stroke

Stroke is considered among the world’s most debilitating diseases with high mortality rate and afflicts over 17 million people worldwide each year, of which more than 80% of cases are ischemic stroke. Stroke not only endangers the lives of victims but also burdens the families of the stroke survivors with significant caretaking and financial expenses.  Despite the use of revascularization treatments in AIS, a huge number of stroke survivors will suffer from disabilities causing a substantial impact on their day-to-day life and functioning, and a heavy financial burden on society.

About MLC 1501

MLC150is a further developed formulation consisting of four of the original nine herbs that are present in two parent formulations, MLC601 and MLC901 (NeuroAiD™). Pharmacological studies have demonstrated equivalent neuroprotective and neurorestorative properties of MLC1501 in nonclinical animal and cellular models of focal ischemia. Clinical trials of MLC601/MLC901 and systematic reviews of those trials showed benefit in improving functional and neurological recovery, in patients having functional impairment after an acute ischemic stroke.

About Moleac

Moleac is a biopharmaceutical company dedicated in finding, developing and commercializing worldwide new medicines for the unmet medical needs of patients suffering of central nervous system (CNS) diseases and injuries, such as stroke, dementia and traumatic brain injuries. To address therapeutic gaps, Moleac has pioneered a new drug development approach, looking at sources of innovation from Natural Medicines, hence shortening considerably drug development cycle time and investment to bring medicine to sufferers’ unaddressed needs. Moleac’s neurorestorative natural formulation NeuroAiD™ reaches patients in more than 30 countries where it is regulated.

Contact

Clément Dif, Business Development & Marketing Department
Emailclement.dif@moleac.com
Phone: +65-62113710
Web: www.moleac.com

NeuroAiD at ASEAN Neurological Association

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Moleac will attend the 12th Biennial Convention of ASEAN Neurological Association (ASNA) & 39th Annual Convention of Philippine Neurological Association (PNA), in Manila, Philippines from 21 to 24 November.

Prof. N Venketasubramanian (Ramani) from Singapore, one of the principal investigators of NeuroAiD’s landmark study, CHIMES-E, will present the following posters:

  • Synergistic Effect of Combining MLC601 and Rehabilitation on Post-Stroke Recovery – The CHIMES Study.
  • Targeting Stroke Patients with a Higher Potential of Long-term Benefit from Treatment: Insights from the CHIMES-E Study.
  • Comparison of Long-term Spontaneous Functional Recovery and Response to Treatment with MLC601 between Cortical and Non-cortical strokes – The CHIMES-E Study.

In addition, Moleac and E*Chimes (distributor of NeuroAiD in the Philippines) will host a Twilight symposium with renowned speaker Prof. Simeon Marasigan from the Philippines to introduce the NEURITES study on 22nd November, 17:00 – 19:00:

  • NEURoaid II (MLC901) Assessment in Cognitivitely Impaired Not Demented Subjects: A Pilot Double Blind, Placebo Controlled Randomized Trial in Efficacy and Safety (NEURITES) Study (Preliminary Report).

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

NeuroAiD at Asia Pacific Stroke Conference

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Renowned clinicians and researchers will present abstracts from the latest studies conducted on NeuroAiD, including the principal investigators of NeuroAiD’s landmark study, CHIMES-E, demonstrating the long-term benefits of a 3-month course in achieving functional independence:

  • Prof. Christopher Chen from Singapore:

Abstract: Comparison of Long-term Spontaneous Functional Recovery and Response to Treatment with MLC601 between Cortical and Non-cortical strokes – The CHIMES-E Study.

  • Prof. N Venketasubramanian (Ramani) from Singapore

Abstract: Targeting Stroke Patients with a Higher Potential of Long-term Benefit from Treatment: Insights from the CHIMES-E Study.

  • Prof. Nijasri Suwanwela from Singapore

Abstract: Synergistic Effect of Combining MLC601 and Rehabilitation on Post-Stroke Recovery – The CHIMES Study.

Refer to the APSC program for more details – 26th to 28th October, Nanjing, China.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

NeuroAiD at World Congress of Neurology

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Moleac’s flagship product, NeuroAiD, will be presented at the 23rd Word Congress of Neurology during oral abstract presentations by A/Prof. Alice Theadom from New-Zealand.

    • A Randomized, Placebo-controlled Pilot Trial to Investigate the Safety and Efficacy of MLC901 (NeuroAiDIITM) in Adults Following Mild or Moderate Traumatic Brain Injury – 19th September, 11:40 – 11:50.

In addition, Moleac will be hosting a symposium on the 17th September with renowned researchers in the field of neurology, to cover the following topics:

    • Prof. Jose Navarro from the Philippines, one of the principal investigators of NeuroAiD’s landmark studies, CHIMES and CHIMES-E, will present NeuroAiD’s long-term benefits in post-stroke recovery and the latest analyses conducted on prognostic factors or poorer outcomes.
    • Prof. Marasigan from the Philippines, will introduce NEURITES, ongoing clinical trial on NeuroAiD in vascular cognitive impairments.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

NeuroAiD presentations at European Stroke Conference

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NeuroAiD, Moleac’s main product, will be presented at the 26th European Stroke Conference on 24th May during abstract presentations on the 24th and 26th May by A/Prof. Narayanaswamy Venketasubrmanian:

  • Comparison of Long-term Spontaneous Functional Recovery and Response to Treatment with MLC601 between Cortical and Non-cortical strokes – The CHIMES-E study (24th May)
  • Targeting Stroke Patients with a Higher Potential of Long-term Benefit from Treatment: Insights from the CHIMES-E Study (26th May)
  • Synergistic Effect of Combining MLC601 and Rehabilitation on Post-stroke Recovery – The CHIMES Study (26th May)

In addition, Moleac will be hosting an evening symposium on the 25th May with recognised leaders in the field of stroke and pre-clinical research, to cover the following topics:

  • Prof. Tatjana Rundek from the Unites States will present her work on long-term prognosis and outcome of patients after stroke.
  • Prof. Michel Lazdunski from France, who has conducted several important preclinical studies on NeuroAiD with his team, will present neurorestorative strategies from natural substances.
  • Prof. N Venketasubramanian (Ramani) from Singapore, one of the principal investigators of NeuroAiD’s landmark studies, will present CHIMES and CHIMES-E key outcomes NeuroAiD clinical benefit on post-stroke recovery and insights regarding patients’ selection for clinical research.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

NeuroAiD presentations at European Stroke Organisation Conference

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NeuroAiD, Moleac’s main product, will be presented at the 3rd European Stroke Organisation Conference on 16th May during the following poster presentations:

  • Synergistic Effect of Combining MLC601 and Rehabilitation on Post-stroke Recovery – The CHIMES Study
  • Targeting Stroke Patients with a Higher Potential of Long-term Benefit from Treatment: Insights from the CHIMES-E Study

NeuroAid data will also be presented during an abstract presentation on the 18th May by Prof. Christopher Chen, National University of Singapore:

  • Comparison of Long-term Spontaneous Functional Recovery and Response to Treatment with MLC601 between Cortical and Non-cortical strokes – The CHIMES-E study

In addition, Moleac will be hosting an evening symposium on the 16th May with world-class leaders in stroke research, to cover the following topics:

  • Prof. Pamela Duncan from the United States will present her extensive research on capturing outcomes after stroke.
  • Prof. Christopher Chen from Singapore, one of the principal investigators of NeuroAiD’s landmark studies CHIMES and CHIMES-E studies, will present the long term benefits of NeuroAiD on post-stroke recovery.
  • Dr. Boutarene and Dr. Bouabdallah from Algeria will present the observational study they conducted on NeuroAiD with NeST Registry.

NeuroAiD (either MLC 601 or MLC 901), as first known as a Traditional Chinese Medicine, is a natural product combining several active ingredients including nine herbal extracts in the form of capsules. NeuroAiD properties have been studied extensively in post stroke recovery and the research is widely published. Since its first commercialization in 2006, NeuroAiD™ has shown a rapid and stable growth internationally, and is available today in numerous countries of several regions (South East Asia, Europe, Middle East, and Africa). Pharmacology research has established the neuroprotective and neurorestorative activities of NeuroAiD providing possible mechanisms for neurological recovery in post-stroke survivors.

Moleac is a pharmaceutical company headquartered in Singapore and focused on developing and commercializing treatment for the patients suffering a loss of brain functions after brain injuries or neurodegenerative diseases. Moleac was founded by French entrepreneurs and scientists in 2002 and is headquartered in Singapore.

Launch of NeuroAiD in Nigeria

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Helping patients reconnect with their lives remain our focus. This February, NeuroAiD will be launched in Nigeria in association with our local distributor, Bolar Pharmaceuticals. Nigeria is one of the most populous nations in Africa, and has recently faced an increasing prevalence of stroke (>250,000 in 2015*) and other cardiovascular diseases. NeuroAiD is bringing a unique evidence-based therapeutic opportunity for the victims to recover faster and better.

*Global Burden Disease 2015 data