Fast Forward 2017- What’s in store for lifesciences?
Find out what the top companies from Asia Pacific have lined up for the year
How was 2016 for Novotech?
It was another record year for Novotech along a number of dimensions. Our revenues increased over 30 per cent, and our pipeline increased by over 50 per cent. Our book: bill ratio is one of the highest in the industry giving us enormous confidence about medium-term growth and our ability to invest across the region. Our clinical operations department has made significant progress, and we have seen improvements in start-up times and recruitment rates in our facilities across countries. We have seen improvements in levels of staff engagement across the company.
Business plans for 2017?
We will continue to invest in Asia platform, where we now have an unparalleled ability to serve the complex needs of Western biotechs undertaking clinical trials in Asia Pacific. We have a very rigorous three-year planning process at Novotech (which we refresh every year), and have around 60 projects running at any point of time to ensure continued improvement in the business. To capture a few highlights for the year ahead, we have many important service expansion, systems and learning and development initiatives underway. In terms of new services, we will continue to grow the safety service that we launched in 2016 as we have been very happy with the substantial investment that we made in Oracle Argus. We have soft launched a central lab service in conjunction with one of the largest laboratory services in the world, and we are very excited about the efficiencies and real-time access to data that this will be able to provide our clients as we expand this service in 2017. We will continue our investments in a range of systems including major upgrades of our Oracle CTMS system and eTMF systems. Finally, we will be launching many training programmes for our leadership and clinical operations teams.
How will the lifesciences sector perform this year?
While the biotech sector has come off its 2015 peak, there is still an enormous pool of capital available to be invested and this will be a positive for the sector. Most of our clients are US and European biotechs and so we are very interested in the increasing number of biosimilar approvals in the US as well as the more liberal approach that the US FDA has recently taken to orphan and ultraorphan approvals. The impact that president-elect Trump will have on the sector is a little unclear, but investors clearly feel that there will be net-positives, with the biotech sector outperforming the market since the US federal election. A few policies driving this are the commitments made to infrastructure investment, as well as potential incentives to encourage multi-national pharmaceutical companies to repatriate offshore cash to the US.
In our own part of the world, the regulatory environment is rapidly evolving and we are seeing many positive initiatives that will improve timelines in Thailand, the Philippines, China and India. There are also proposals in Korea that may materially reduce the cost of clinical trials.
Emerging trends in bioscience/medtech/drug discovery/technology
Technology trends take a long time to play out, and short-term trends are often driven by regulatory changes or trial failure. To this extent, we will see increasing interest in biosimilars in the US driven by regulatory behaviour, and recent big-pharma trial failures will see
many companies re-examining their pipelines in immunotherapies and Alzheimer’s.
New technologies and trends the company is focusing on
We are investing in many areas that will improve clinical trial performance for our clients, including Cloud-based clinical trial management platforms. We are also investing in new systems to measure the performance of sites and investigators in our region. In relation to longer term trends, we are particularly interested in advances in adaptive trial design and the significant impact this can have on our client’s return on investment.
How was 2016 for JHL Biotech?
It was a pivotal year for JHL Biotech. We received UK MHRA approval to conduct human clinical trials of our rituximab biosimilar. We opened the world’s largest modular, single-use cell culture facility in Wuhan, China. We made great progress on our internal pipeline programmes and plan to file an investigational new drug (IND) in China before the end of this year. We announced a strategic partnership with Sanofi that includes a US$100 million capital injection.
Business plan for 2017?
In 2017, we plan to start European trials of our rituximab biosimilar and also have a rich pipeline for INDs. Due to competitive reasons, we cannot divulge too much.
How will the Biosimilars sector perform in 2017?
We believe 2017 will be an important year for biosimilars. Coherus is challenging ABBVIE in the US and we will see some results from their patent challenge. Later in 2017, we will see how Remicade sells in developed markets, and likewise, Samsung has restarted trials of its rituximab biosimilar. Additionally, we believe we will see more biosimilars firms targeting niches—specialty therapeutic biosimilars and orphan products.
Emerging trends in bioscience/medtech/drug discovery/technology? Asian countries that will flourish in biosimilar space in 2017? New technologies and trends that company is focusing on?
We believe a major trend in the biologics world is the shift towards development of bispecifics, ADCs, and combination therapies. We are very keen on the development of these therapies, as we feel they will drive demand for our biosimilars. Likewise, analytics and manufacturing technologies are changing the face of the industry. In 2016, we opened the world’s largest modular cell-culture bioprocessing facility in China, and we believe modular and single-use technologies will become more and more prevalent. Additionally, we believe another major trend is the further growth of the Greater China biologics community. Very good work is being done in China and Taiwan on next-generation discovery platforms and we believe next year will see new great partnerships announced and new therapies commercialised.
How was 2016 for Bionomics?
2016 was an incredibly exciting year for Bionomics as we made significant progress across our broad and diverse clinical portfolio. In September, we announced positive results from our Phase 2 trial of BNC210 in Generalised Anxiety Disorder (GAD). The single centre, double-blinded, placebo and lorazepam-controlled, 4-way cross-over Phase 2 clinical trial was conducted in 24 patients with untreated GAD. The objective of the study was to evaluate the capacity of BNC210 to engage brain systems relevant to anxiety while resting and in response to anxiety-related tasks. The co-primary endpoints were change in cerebral perfusion measured by arterial spin labelling and change in taskrelated brain activity, specifically in the amygdala as measured by functional Magnetic Resonance Imaging (FMRI) during the Emotional Faces Task (EFT). Results from the study showed that BNC210 induced statistically significant changes in cerebral perfusion (300mg BNC210, p<0.05) and also significantly reduced amygdala activation in response to fearful faces during the EFT (300mg BNC210, p<0.05). In comparison, lorazepam exerted a modest suppressive effect on amygdala activation during performance of the
EFT (1.5mg lorazepam, p=0.069). Earlier this year, we initiated a Phase 2 clinical trial of BNC210 for the treatment of Post-Traumatic Stress Disorder (PTSD) and from our oncology programme, we initiated a Phase 1 study of BNC101 for the treatment of metastatic colorectal cancer in March.
Business plan for 2017?
We intend to build on the incredible momentum we’ve built over the last year as we head into 2017. Importantly, we anticipate topline results from our Phase 1 clinical trial of BNC101 for the treatment of metastatic colorectal cancer in mid-2017. This is an open label, multi-centre clinical trial aimed to demonstrate the safety and tolerability of BNC101 and its ability to delay disease relapse in treated patients. It is being conducted at specialist centres across Australia and will run in two parts, firstly with BNC101 alone and then in combination with standard of care chemotherapy. Each part has two phases, an escalation to find the optimal dose level and then an expansion of the study at that dose level.
In tandem, we will continue to advance BNC210 with our Phase 2 trial in Post-Traumatic Stress Disorder (PTSD). The study’s primary objective is to determine whether BNC210 causes a decrease in symptoms of PTSD as measured by the globally-accepted Clinician Administered PTSD Scale (CAPS5). Secondary objectives include the determination of the effects of BNC210 on anxiety, depression, quality of life, and safety. The trial is recruiting 160 subjects with PTSD at 8-10 clinical research centres throughout Australia and New Zealand. The study is a randomised, double-blind, placebo-controlled design with subjects to be treated over 12 weeks with BNC210 or placebo. We look forward to reporting topline results from this study in 2018.
How will the life sciences sector perform in 2017?
Based on current market performance, we are expecting 2017 to be an excellent year for the life sciences sector. With the political uncertainty of the US presidential election behind us, we expect the sector to offer key growth opportunities in 2017.
Emerging trends in bioscience/medtech/drug discovery/technology?
Our development work intersects two of the most important areas of great unmet medical need: cancer and CNS disorders. We are excited to be bringing forth very promising therapies in both areas and believe that we can make a meaningful difference in patients’ lives.
New technologies and trends that company is focusing on?
Bionomics is a fully integrated biotechnology company that has created proprietary technology platforms, which include IONX, MULTICORE and CSCRx, for each step in the drug discovery and development process. IONX is an integrated platform of genomics discoveries and technologies that serves as the foundation for our CNS drug discovery and development activities. IONX includes systems for high throughput electrophysiology for early, high content evaluation of drug hits. Our technology involves a suite of integrated synthetic methods that gives access to complex druglike molecules. Many marketed drugs and naturally occurring bioactive molecules have complex ring structures. While the importance of this type of structure is recognised, these complex molecules are often too difficult to synthesise for drug discovery purposes. Bionomics’ CSC Rx Discovery platform is a validated method for discovering highly active, functional therapeutic antibodies and small molecule candidates that target cancer stem cells at the root of cancer. Each of these advanced technologies is a source of competitive advantage offering the company the opportunity to identify and progress unique new pharmaceutical products, such as our cognition and pain programs with Merck & Co. which combines the platform expertise from IONX and MULTICORE.
How was the year for Avesthagen?
It was the year for cleaning up and finalising the strategy for the next five years.
Business plan for 2017?
We will convert our patents and products into viable business step by step and fund raise for each project.
How will the pharma sector perform in 2017?
Pharma will do well except that they will feel the rumble of new drugs in the international markets as generics will give way to precision medicine.
Emerging trends in bioscience/medtech/drug discovery/technology
A combination of Crisper Cas, pluripotent cells, robotics and bio markers. Healthcare industry will gear itself for the new era Microbiome led immune Therapy.
New Technologies and Trends that company is focusing on
Avesthagen Limited will be the holding company that will invest in research development. The R&D focus will be on Avestagenome Project where the focus will be on building expertise in the new technology platforms of Crispr-Cas, Microbiome, Stem Cells for Cancers, Metabolic disorders, and auto immune conditions. We will work towards a pipeline of novel bio markers and new drugs for these conditions. The R&D of the past 15 years will be commercialised through partnering by spinning three commercial companies Avesta Nordic Nutrition, Ava Seeds, and Amgen Pharma.
2016 for Sproxil?
The year has been challenging for SNG. The declining Nigerian economy was plunged into recession at the end of second quarter. The government has devalued the currency and the gap between the official and parallel market has widened as a result of the inability of the government to meet demand for foreign exchange required for imports. Nigeria being an import dependent economy implies that the volume of business has reduced due to limited access to foreign exchange. Overall, the economy is hit by reduction in aggregate demand, spiralling inflation and lull in the business environment. - Chinedum Chijikoe - Sproxil West Africa
We have reinvented ourselves in the 2016. Earlier we were mainly deployed though our mobile authentication-based Counterfeiting Solution in Pharma Sector, we now have expanded our solution to cover all sectors that are impacted by Counterfeiting.
Business plan for 2017?
We are focusing on specific sectors where we see opportunities for growth, leveraging product innovation to enable us achieve our overarching objectives. We are also streamlining our operations and rethinking our operating model with a view to ensuring we remain efficient and nimble to respond to market changes and clients demands.
In 2017, we would expand to new geographies in Asia-Pac & Middle East as well as add new vertical sectors to our business. We have been focused mainly on India and Pakistan till 2015. In 2016 we started to explore other South Asia & Middle Eastern countries by establishing relationships. We would deploy in some of these places in 2017.
Corporate clients have always been keen to avoid mentioning the issue of counterfeiting that is faced by their products. This is especially true in pharmaceuticals where alternative brands are available. It is feared that the end customer may choose to not opt for any brand that discloses that it had counterfeiting problems even if that brand is actually taking measures to counter this while other brands might just be ignoring the issue. We have now deployed a solution that not just confirms that the product is genuine but also rewards the consumer for the participation in multiple ways. -
How will the lifesciences sector perform in 2017?
In 2017 we see an optimistic outlook towards lifesciences sector in 2017 in West Africa, South Asia & Middle East.
New technologies and trends that company is focusing on.
We have upgraded our technology platforms and built in higher levels of security, robustness besides making it more flexible to the requirements of specific corporate. We have been working on ways by which we can increase ROI for our corporate clients. We have lined up and deployed a few new solutions that enable corporate using our solutions engage more holistically with the end customers. Now customers can refer other like minded / interested customers to our clients or even engage in a discussion with the product manufacturers. Our clients in turn are able to provide relevant advice to the consumers.
John Moller, coo Asia, novotech, Australia
Deborah rathjen, ceo and Managing Director, bionomics, Australia
Jhl Biotech, Taiwan
Dr Villoo Morawala Patel, cMD, Avesthagen, India
Anand C Mehta Managing Director Sproxil South Asia & Middle east
Chinedum Chijikoe Managing Director Sproxil West Africa