Pharma companies buck the trend to outshine other sectors in Asia-Pacific region

The COVID-19 pandemic is impacting businesses worldwide, with the total market capitalisation (MCap) of the top 50 companies in the Asia-Pacific (APAC) region witnessing a substantial decline in the quarter ending March 31. However, data and analytics company GlobalData has revealed that pharmaceutical companies have bucked the trend. An analysis of GlobalData’s company profiles database revealed that in quarter one, the composite MCap of the top 50 companies in APAC declined quarter-on-quarter (QoQ) by 11.4% from US$6.6 trillion to US$5.8 trillion. The financial services and technology sectors, which account for 30 of the top 50 companies, reported 15.7% and 1.3% decline in MCap of US$1.9 trillion and US$1.8 trillion, respectively. In comparison, the pharmaceutical sector registered 16.6% growth due to growing demand from healthcare services providers. GlobalData company profiles analyst Anindya Biswas said: “The panic associated with the rapid increase in the number of patients with COVID-19 symptoms led to a rise in the spending in healthcare solutions to fight the disease. “Quarter two MCap is likely to be driven by how quickly China recovers from the pandemic, apart from how other countries rein in on the outbreak and emerge out from the ongoing lockdown measures.” Companies specifically dealing with pharmaceuticals realised a QoQ growth of 21% from US$179 billion to US$216.6 billion, and biopharmaceutical companies reported 7.6% QoQ growth from US$87 billion to US$93.7 billion. The data is based on a sector composition of top 50 APAC companies by market cap as of 31 March Paradigm Biopharmaceuticals Paradigm Biopharmaceuticals Ltd (ASX:PAR) recently completed dosing of all 10 patients with Zilosul® under the US Food and Drug Administration (FDA) Investigational New Drug Expanded Access Program (EAP) in the US. Patients have been administered the injectable pentosan polysulfate (iPPS) drug for the treatment of osteoarthritis. Paradigm expects data from the program to be available to the market during the third quarter of this calendar year. Last month the company placed $35 million in shares to leading Australian and international institutional and sophisticated investors with the proceeds to cover the costs of the second phase three clinical trial. Paradigm is fully funded through to completion of this trial with results anticipated in late 2022. Medlab Clinical Medlab Clinical Ltd (ASX:MDC) continues to make material progress in delivering clinical trials evidence with an end goal of drug registration in cancer pain management. The company completed the SAD/MAD trial at Royal North Shore Hospital and a depression trial at Queensland University of Technology during the March quarter. Record revenue for its cannabis-based medication NanaBis™ was achieved with a 26% increase and a unique first, a free online clinical service offering advice and connecting the Australian public to doctors, specialists, naturopaths, and pharmacists was launched. In the short-term, the company expects to release the depression trial results, continue preparation of the NanaBis™ phase three trial protocols for the US and Australia as well as progress an FDA IND application. The Medlab NanoCelle™ delivery system Cellmid Cellmid Limited (ASX:CDY) subsidiary Advangen manufactures an anti-ageing haircare range, marketed as the evolis®, Advangen® Jo-Ju® and Lexilis® brands. In the March quarter, the company experienced an impact from COVID-19 in US sales as Nieman Marcus, the company’s biggest customer, was closed, however original US distribution initiatives such as QVC USA and sales on several online platforms, including amazon.com, will be implemented in the near-term to combat this. In Australia, FY2020 year sales of $1.03 million have already exceeded the full-year results for FY2019 of $994,000, but the launch of the evolis® Professional product was delayed. Consumer health sales into China are back on track with the Chinese order for Lexilis® products of $685,000 (delayed from first half of FY2020), now paid and on track to be delivered in quarter four. The company is confident of achieving its Japan budgets for the full FY2020, with slightly increased export and lower domestic sales expectations. Zelira Therapeutics Zelira Therapeutics Ltd (ASX:ZLD) is in discussions with third parties to license its products in the US and secure agreements for distribution in emerging global medicinal cannabis markets, including Australia, Germany and the United Kingdom. The company concluded the March quarter with a cash position of A$4.02 million after completing a placement to raise more than A$4.64 million. These funds will be used to accelerate Zelira’s plans to launch multiple products into global markets in the second half of 2020 as well as progressing clinical programs. The company released interim results of its Insomnia Clinical Trial during the quarter, achieving a statistically significant improvement in Insomnia Severity Index scores (the gold-standard measure of insomnia severity) in patients diagnosed with chronic insomnia compared to placebo. Zelira is also undertaking a study in collaboration with St Vincent’s Hospital in Melbourne to assess the safety and effectiveness of medicinal cannabis to reduce opioid dependence and has engaged Emerald Clinics as a second site for the trial, which has now reached full enrolment and completed dosing. The company has also received its maiden revenues from Advanced Biomedics for its first licensing deal for Hope™, which is anticipated to launch later in 2020. Most common reasons patients use medicinal cannabis Pharmaxis Pharmaxis Ltd’s (ASX:PXS) US licensee Chiesi Farmaceutici SpA has filed a resubmission which addresses issues raised by the FDA in a complete response letter received in June 2019 to the Bronchitol® New Drug Application (NDA). The resubmission follows Chiesi Group’s successful completion of a supplemental human factor study in the first quarter of 2020. If Bronchitol®, which is used for the management of cystic fibrosis to improve pulmonary function, is approved by the FDA, Pharmaxis will receive a US$10 million (A$15.5 million) milestone payment. The FDA’s review of the Bronchitol NDA is expected to be completed in mid-2020. The company also plans to submit an investigational new drug (IND) application mid‐year for a six‐month safety and efficacy study in primary myelofibrosis for its anti‐cancer systemic pan‐LOX program. SUDA Pharmaceuticals Suda Pharmaceuticals Ltd (ASX:SUD) signed a new licence agreement in the March quarter with Mitsubishi Tanabe Pharma Korea for its ZolpiMist product, an oral spray of zolpidem for insomnia. ZolpiMist™ is already marketed in the USA and the company’s aim going forwards is to create additional partnerships to roll the product out globally. SUDA is waiting on regulatory approval from the Therapeutic Goods Administration to license ZolpiMist™ in Australia. Other products in the commercialisation pipeline include Sumatriptan, which is for the treatment of migraines, and Anagrelide, which could play an important role in cancer treatment. SUDA also kicked off feasibility studies with its partners Laboratorios Ordesa SL and Sanofi-Aventis Groupe during the March quarter, both of which are progressing well. The company is developing low-risk but technically complex oral sprays using its OroMist® technology Imugene Imugene Limited (ASX:IMU) received confirmation from the Independent Data Monitoring Committee (IDMC) this month of the safety and importance of its HER-Vaxx cancer immunotherapy study. The HER-Vaxx is a B-cell peptide cancer immunotherapy is designed to treat tumours of gastric, breast, ovarian, lung and pancreatic cancers. It has been shown in pre-clinical studies and in Phase I studies to stimulate a potent polyclonal antibody response to HER-2/neu, a well-known and validated cancer target. The company continues to monitor expenditure carefully in response to COVID-19 but is well-placed to implement clinical trials for HER-Vaxx as well as for its PD1-Vaxx anti PD-1 B cell immunotherapy. Both trials are anticipated to take place later in 2020. CardieX CardieX Ltd (ASX:CDX) is focused on developing the first 'uncalibrated', non-invasive and cuffless wearable sensor for monitoring blood pressure and other cardiovascular health vital signs. The global market for 24-hour ambulatory patient monitoring is huge, with 1.56 billion people estimated to have hypertension by 2025. The company’s investment partner Blumio has recently completed its first-generation sensor development kit as one of the milestones under the co-development agreement. CardieX also has a joint development agreement with Mobvoi for the development of novel and proprietary health technologies, with applications and features to be integrated into Mobvoi’s next generation of watches and smart devices. The company is developing a commercial sensor development kit (CSDK) which would allow other device makers such as Garmin, Apple, Fitbit etc, to incorporate it into their devices - given that they use the same photoplethysmography sensor technology. The next phase of the CSDK will include further advanced algorithms and features that will become commercially available in quarter two, 2021 for licence to third-party device makers. Calculated from heart pressure pulse from Mobvoi’s Finger-based PPG sensor Admedus Admedus Ltd (ASX:AHZ) has successfully implanted its aortic valve, DurAVR™  into the first patient at the University Hospitals, Leuven, in Belgium, replicating results from animal and laboratory testing. The Brisbane-based company is focused on bringing DurAVR™ to market, building on the company’s cardiovascular patches using its ADAPT® tissue technology. Fifteen patients will be enrolled in the first-in-human study and followed up for six months after receiving implantation of the ADAPT® single-piece 3D aortic valve. In heart surgery, one of the biggest issues facing patients – and surgeons – is finding a replacement valve that will last the life of the patient and the unique design of DurAVR™ makes it a more durable valve that delivers better hemodynamic performance than devices currently available on the market. With 62 million people globally suffering from aortic stenosis – a condition that narrows the valve and in severe cases requires a repair or replacement procedure - this is a major market for the company. Orthocell Orthocell Ltd (ASX:OCC) remains focused on executing its partnering strategy for CelGro® in dental bone and soft tissue repair, which includes increasing international product awareness, growing product use in centres of excellence and growing its base of brand ambassadors led by its key opinion leaders. During the March quarter, Orthocell progressed the CelGro® nerve regeneration trial and is in final stages of completing patient recruitment. The company remains focused on completing this trial and leveraging the data for regulatory submissions in the US and Australia. Orthocell was on track to complete TGA (AUS) regulatory application by end of quarter one 2020 however COVID-19 has impacted this timeline, and the company is now targeting a submission by quarter two 2020. Over the medium to long term, Orthocell intends to leverage the CE Mark to achieve AUS and US regulatory approvals and drive the introduction of the nerve and tendon indications, in parallel to the commercialisation of Ortho-ATI®. The company is also nearing completion of recruitment to the randomised controlled clinical trial of Ortho-ATI® versus corticosteroid injection. Autologous tenocytes injected using ultrasound guidance Kazia Therapeutics Kazia Therapeutics Ltd (ASX:KZA) is progressing its Paxalisib clinical trial program and completing analysis of the ongoing Phase I study of Cantrixil following a capital raising of $1.8 million via a share purchase plan and a $7.2 million institutional placement. Preliminary analysis of the Phase one Cantrixil study in ovarian cancer has provided data which supports Cantrixil as clinically active in a very late-stage patient population. The study showed the drug could shrink tumours in a proportion of patients, with an overall response rate of 15% (three out of 20 patients) which compares favourably to a figure of 10% for historical controls. Kazia will now work closely with sites and investigators to collect and validate all remaining data and expects to release final data in the second half of 2020. Phase two study data for Paxalisib, which is used to treat glioblastoma, the most aggressive form of primary brain cancer, revealed the drug may achieve meaningful extension of patient life. Kazia's potentially pivotal Phase three using the AGILE trial network is on track to start in the second half of this year. Emerald Clinics Emerald Clinics Ltd (ASX:EMD) manages an independent clinical service and data platform designed to capture, analyse and provide new insights into these real-world issues and provide valuable anonymous data on a subscription payment, or data acquisition model, to pharmaceutical companies, regulators and other health industry stakeholders. The company is on track with investments and estimates towards its data platform, having engaged Diamond Cyber to develop a best-in-class cybersecurity infrastructure and monitoring service. During the March quarter, Emerald partnered with Three Springs Technology, a leading artificial intelligence data science company, to develop automated integration, quality control and data analysis workflows to keep its clinical data assets secure. The company is also accelerating patient recruitment and dosing as part of its clinical trial research agreement with Zelira for an opioid reduction trial involving at-home pharmacokinetic measurements. An iteration of Emerald's platform has been launched to help support the growing need to monitor patients diagnosed with COVID-19 and those required to self-isolate by improving the understanding of what symptoms and clinical risk factors are most relevant to enable rapid patient triage – to help reduce unnecessary strain on the health system. Emerald’s evidence generating care model Opyl Opyl Ltd (ASX:OPL) is focused on developing a machine learning, artificial intelligence-based software interface which can predict the likelihood of a clinical trial completing each phase. To date, the clinical trial predictor tool has been progressed to the end of stage two (proof of concept) in readiness to enter stage three and finally stage four before calendar year-end. The company recently received a $200,500 R&D refund from the Australian Taxation Office which will assist continuing research and development of three unique digital health platforms powered by artificial intelligence (AI). Opyl also announced a revenue-share alliance with UK-based huumun, a digital solution provider for the global pharma sector. The collaboration will allow the two companies to provide an extended, sophisticated end-to-end sales and marketing offering across traditional and digital platforms. This is anticipated to realised revenue for Opyl, creating a valuable business development pipeline.