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Interview: AD is the largest unmet clinical need

Interview: AD is the largest unmet clinical need

By Priyanka Bajpai

Interview with BioSpectrum Asia and Cerecin President and CEO Charles Stacey

Alzheimer’s disease (AD) is a growing concern within the Asian community. AD is a devastating degenerative disease that causes memory loss, challenging behaviour problems, and severe functional limitations. The disease is increasing like a plague in Asia placing a huge burden on the healthcare sector. According to a recent report by Zion Market Research, the global Alzheimer’s drugs market was valued at $3.6 billion in 2017 and is expected to generate revenue of around $ 5.66 billion by end of 2024, growing at a CAGR of around 8 per cent between 2018 and 2024. AD is the 6th leading cause of death in the United States. As it stands, the disease currently affects 48.6 million patients around the world. In the Asia Pacific region, only Australia, Japan and the Republic of Korea have formulated public health policies directly targeting the burden of AD. However, it is China and India that account for a huge share of AD prevalence in the region. Recently, Dr Charles Stacey, President and CEO Cerecin, formerly Accera, Singapore, spoke to BioSpectrum Asia about his outlook on the disease, clinical trial situations in Singapore and APAC as well as the recent relocation of Accera to Singapore. Edited excerpts;

Could you please discuss Alzheimer’s Disease, available treatment and its current global prevalence?

Alzheimer’s disease (AD) is the most common form of dementia and is an age-associated, neurodegenerative disease. It is characterized by the progressive decline in memory and language, and pathologically by progressive regional declines in cerebral glucose metabolism, and later, by accumulation of amyloid plaques and neurofibrillary tangles in the brain. Despite significant advances in research and development, AD is the largest unmet clinical need, and consequently the most important, in the pharmaceutical sector. There is currently no cure for AD and just a handful of approved treatments, with the success rate for approval of new compounds the lowest of any therapeutic area and a failure rate of 99.6 per cent over the last 20 years. Despite the bleak statistics, at Cerecin our combination of a differentiated lead agent with a proven track record, global and regional expertise, strong financial position, and scientific backers put us in a strong position to make positive progress.

According to you, what is the present clinical trial landscape across APAC?

The clinical trial situation is evolving in APAC and clearly has matured most rapidly in Singapore. It is no surprise that many biopharma companies and contract research organizations have set up headquarters in Singapore. Elsewhere in Asia, clinical research is less well developed but this offers excellent opportunities for an innovative company like Cerecin that brings extensive Western expertise to the area.

The exception to this is China where we are seeing remarkable growth due to a combination of factors: easing of regulation and policy hurdles, improving infrastructure and the development of modern neuroimaging technology in the country. Recently, Shanghai Green Valley announced that their phase 3 Study of Sodium Oligomannurarate (GV-971) Capsules in mild-to-moderate Alzheimer’s disease had met its primary endpoint. Full results will be presented shortly. This highlights that China is evolving a bio-ecosystem of its own and we expect to play a key role in China from our base in Singapore

Can you share more about the decision behind the move to Singapore instead of countries like Taiwan or China?

As a small, innovative biotech company, we look for good science, good talent and capital. Singapore has all three. It has world-class science and scientific institutions that we can draw from in terms of support as well as building out our pipeline. On the talent side, Singapore is the regional centre for most of the Big Pharma companies and most of the big CROs, meaning that there is a lot of talent here to draw on. Although the majority of venture capital is in the US, there is life sciences venture capital in Singapore as well as government support in terms of grants and other forms of support. Singapore is English-speaking, very friendly towards international companies and has world-class corporate governance. Another important factor is its proximity to some of our key markets such as China, Korea and Japan, without the complexities of doing business in those countries.

In light of the new hire of Cheryl Tan, what are the commercial plans for Cerecin in the next year?

Cheryl will lead the commercial strategy for the pipeline of innovative drugs that are in development. She will also lead the commercialization of Axona in the Asia Pacific region in 2019. Axona is a medical food intended for the dietary management of the metabolic processes associated with Alzheimer’s disease. It has been on the market in the US since 2009 and we will be launching this product throughout Asia. There has already been keen interest from various potential partners and organisations in Asia-Pacific countries. This has already led to our partnership with DuChemBio, an innovative Korean company, who plans to launch Axona in Korea in 2019. We expect further partnership announcements in the coming months, now that Cheryl is building her team and actively pursuing leads.

Singapore has great talents, sciences, infrastructure, government support, policy environment – these are all important factors for biotech industry and present opportunities for companies like Cerecin. Singapore government has been very supportive for building up a vibrant biotech system. And it’s only a matter of time before VCs in Asia become more sophisticated in investing in this industry. As the Singapore life science space grows, so will we and we intend to be a major factor in its growth. We are currently building a team in our core areas of activity: clinical research, manufacturing, commercial strategy. We hope to spearhead a new generation of biotech professionals, from Singapore, who are creating this ecosystem and not merely fulfilling orders from a headquarters overseas.

What has Cerecin done to engage the local Alzheimer’s community?

On October 16, we announced the appointment of two local Senior Advisory Board members: Prof. Chua Nam-Hai and Associate Prof. Christopher Chen who will provide us with scientific advisory support. Prof. Chen’s expertise is in dementia and clinical trials, and Prof. Chua brings a wealth of knowledge on biotechnology and life science in Asia.

We have also recently engaged with the local Singapore Alzheimer’s Disease Association (ADA) to better understand first-hand the Alzheimer’s situation better here in Singapore. Moving forward, we are looking to foster greater collaboration with these local stakeholders to build up our role in finding a therapeutic for Alzheimer’s here in Singapore and in the Asian region, where the number of people with dementia in the region is estimated to increase from 23 million in 2015 to 71 million by 2050.

We are also connecting with other groups conducting research in AD in the region. Whether academic researchers or other life science companies.

What does Cerecin have in its pipeline? How do you see the growth of the company in the next 10 years?

Cerecin has a very clear positioning and strategy. The key is implementing it. We will continue the drug development and look to bring the clinical development of our lead drug compound to a pivotal study. We are also in early stages of other assets within the AD and broader neurological space.

Beside drugs, Cerecin is also looking to build up a pipeline of other solutions for brain health, especially when it’s now headquartered in Asia that has a culture of taking nutritional derived therapeutics. I personally spend a lot of time building up teams and make sure the right talents are recruited and retained. Our team will continue to grow with the business needs.

Given our combination of differentiated assets, technical know-how, experienced personnel, and can-do attitude, I am confident that Cerecin has the right ingredients to grow and be a major player in the brain health space and in Asia Pacific.

This post was first published on BioSpectrum Asia and has been reproduced with permission. Read the article on BioSpectrum Asia here: https://www.biospectrumasia.com/

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