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THE INTELLIGENCE REPORT CORPORATE JULY 2020
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PHARMACEUTICAL INDUSTRY INTELLIGENCE OVERVIEW
GLOBAL NEWS SA NEWS COMPANY NEWS COMPANY FINANCIAL RESULTS
Cell-Easy to Open Manufacturing Thousands of SA Patient Records Cipla is Set to Bring COVID-19 Ascendis Health Limited Plant to Produce Stem Cells Possibly Put at Risk Treatment to SA According to a recent update, the board French Start-up, Cell-Easy, recently Thousands of SA patient records were Recently, through a landmark agreement of directors of Ascendis Health recently partnered with the University Hospital left vulnerable to possible cyber-attacks, with Gilead Sciences Inc, Cipla was granted advised, that the company has concluded Centre in Toulouse to open a new due to SA medical data start-up, LogBox, a licence to manufacture and distribute agreements with its Lender Consortium, pharmaceutical manufacturing plant, keeping user data and patient records on a the antiviral medication, Remdesivir, in to restructure its current debt facilities. A dedicated to the production of stem cells. database vulnerable to hackers. Although 127 countries, including SA. Remdesivir mutual agreement was reached, between Cell-Easy is set to use its innovative mass- this vulnerability has been rectified, an is the first medication which has been Ascendis Health and its Lenders, to extend scale stem cells manufacturing process, to internal investigation has been undertaken approved by United States (US) authorities the repayment obligations on its debt develop regenerative medicine, through and all affected users will be contacted, as to treat COVID-19 and has been shown facility to December 2021. (8 June 2020) per government regulations. (2 July 2020) to accelerate the recovery of hospitalised therapeutic solutions. (9 June 2020) Aspen Pharmacare Holdings patients. (6 July 2020) Global Race for COVID-19 Vaccine First SA COVID-19 Vaccine Clinical Limited Trials Currently Underway According to Aspen’s most recent voluntary In reaction to the global COVID-19 Aspen to Increase Production of update for the ten months ended pandemic, pharmaceutical companies SA’s first clinical trial for a vaccine against Breakthrough Drug 30 April 2020, the Group has experienced are now racing to be the first to develop COVID-19 commenced in June 2020. The Aspen Pharmacare is set to increase the an elevated demand for some of their a vaccine. Organisations, such as Oxford vaccine, which was developed by scientists production of a generic anti-inflammatory Sterile Brands in Europe. This is due to the University and AstraZeneca, Moderna at Oxford University, aims to prevent medication, Dexamethasone, which could critical importance of these products in the and the National Institute of Allergy and infection by SARS-CoV-2, the virus that save the lives of critically ill COVID-19 clinical management of patients infected Infectious Diseases (NIAID), CanSino and causes COVID-19. (23 June 2020) patients. According to recent mass with COVID-19. In terms of financial year the Beijing Institute of Biotechnology treatment trial, led by Oxford University, API Technology Innovation Cluster (FY) 2020 outlook, the Group maintains (BIOB), as well as Sinovac, are all making Dexamethasone has proven to reduce its outlook published in its interim results to Make Health Care Affordable mortality rates by a third amongst strides in this development. (4 June 2020) released in March 2020. (15 May 2020) The Technology Innovation Agency, the ventilated patients. (19 June 2020) New Innovation Removes Vaccine Department of Science and Innovation, Cold Chain Requirements and North West University will work Ascendis CFO Set to Step Down in Pharmaceutical company, Stablepharma, in collaboration, to establish a local September 2020 has developed a method of transporting manufacturing Active Pharmaceutical Ascendis recently announced that its Chief and storing vaccines without refrigeration. Ingredient (API) Technology Innovation Financial Officer, Kieron Futter, is set to step The company’s StablevaX solution, allows Cluster. Through this partnership, the group down at the end of September 2020, after vaccines to be kept out of cold chain aims to make health care affordable, by a 5-year tenure at the company. According storage and transportation, for up to a year. strengthening the SA pharmaceutical value to the group, a suitable replacement will (13 May 2020) chain. (12 June 2020) be announced in due course. (10 June 2020) INTELLIGENCE TRENDS & MERGERS & INNOVATION & SOCIO-POLITICAL LEGISLATION OVERVIEW NEWS ACQUISITIONS TECH TRENDS FACTORS
PHARMACEUTICAL INTELLIGENCE OVERVIEW
MERGERS, INNOVATION & SOCIO-POLITICAL LEGISLATION ACQUISITIONS & TECHNOLOGY FACTORS PARTNERSHIPS TRENDS AstraZeneca Approaches Gilead Digital Medical Consultations COVID-19 and its Effect on Mental COVID-19 Database to Focus on for Potential Merger Embraced by SA Health Services the Public’s Right to Privacy As a result of the COVID-19 pandemic, Despite the easing of SA’s lockdown to New amendments have been introduced AstraZeneca, the largest pharmaceutical many patients have turned to online alert level three, the mental health of the to the laws regarding the National company in the United Kingdom (UK), platforms to consult with health care public and healthcare providers remains Department of Health’s (DOH) proposed recently approached leading United States professionals, without potentially exposing a concern. According to a recent online COVID-19 database, which is designed to (US) pharmaceutical manufacturer Gilead themselves to the virus. This has been survey, conducted by South African assist in combatting the spread of the virus. Sciences Inc, regarding a potential merger, achieved using several digital platforms, Depression and Anxiety Group (SADAG), The proposed changes to the database in what would be the largest healthcare which continue to be embraced by SA 65% of respondents felt stressed or very emphasises the obligations of parties to deal on record. Gilead has indicated that patients. (7 July 2020) stressed. (26 June 2020) process personal information lawfully and it has discussed the idea with advisers but respect the public’s privacy. (3 July 2020) no decisions on how to proceed has been Landmark OBEL RespiClear Range Key Concerns of Healthcare made. (7 June 2020) Introduced in SA Worker Unions Amidst COVID-19 Clicks Set to Appeal High Court Acdoco SA, recently launched a new Pandemic Ruling Regarding Unicorn Adcock Ingram Acquires Plush Pharmaceuticals Professional Leather Care decongestant range, OBEL RespiClear. This A key concern for healthcare workers since range features South Africa’s first steroid- the early stages of the COVID-19 pandemic Clicks will reportedly appeal the Western Adcock Ingram recently announced that all free nebs available over the counter (OTC), has been the access to appropriate Cape High Court’s ruling, that the group conditions, including regulatory approval, as well as vapour rub and drop formats, personal protective equipment (PPE). owns a drug-manufacturing facility, for the company’s acquisition of Plush also both Schedule 0 and OTC. Amongst other issues, unions are also in Unicorn Pharmaceuticals (UP), which Professional Leather Care were met in May (12 May 2020) salary disputes with government. according to the Pharmacy Act is illegal for 2020. The acquisition is now unconditional, (25 June 2020) a pharmacy owner. The group, however, and the final closing of the transaction was SA Lab Obtains First SARS-CoV-2 argued that UP does not manufacture set to take place before the end of May Isolates Pharmacy in Kwa-Zulu Natal medications, but only imports medications 2020. (15 May 2020) In April 2020, researchers obtained SA’s Admits to Overpricing of Face and repackages them as Clicks generics. first known laboratory isolate of SARS- Masks (10 June 2020) Coronavirus 2 (SARS-CoV-2). These isolates In a recent consent agreement with the were obtained through a collaborative Competition Commission, a Kwa-Zulu New Rules Regarding Lockdown effort between the University of the Natal based pharmacy has admitted to Pharmacy Prescriptions Western Cape (UWC) and Stellenbosch the excessive pricing of its face masks. As In May 2020, Minister of Health, Dr University (SU), opening the doors for SA such, the Commission found that the gross Zweli Mkhize, published a new directive researchers, who can now experiment on profit margin, in terms of the face masks excluding schedule 2, 3 and 4 substances live samples of the virus. (11 May 2020) for March 2020, was in contravention of from certain provisions of the Medicines section 8(1)(a) of the Act, read together with and Related Substances Act. This directive Regulation 4 of the Consumer Protection extends prescriptions for these substances Regulations. (8 May 2020) for several months, to make access to medicines during the lockdown easier. (5 May 2020) INTELLIGENCE TRENDS & MERGERS & INNOVATION & SOCIO-POLITICAL LEGISLATION OVERVIEW NEWS ACQUISITIONS TECH TRENDS FACTORS
GLOBAL NEWS INTELLIGENCE TRENDS & MERGERS & INNOVATION & SOCIO-POLITICAL LEGISLATION OVERVIEW NEWS ACQUISITIONS TECH TRENDS FACTORS
GLOBAL NEWS
CELL-EASY TO OPEN GLOBAL RACE FOR COVID-19 NEW INNOVATION REMOVES MANUFACTURING PLANT TO VACCINE VACCINE COLD CHAIN PRODUCE STEM CELLS REQUIREMENTS 9 June 2020 4 June 2020 13 May 2020 French Start-up, Cell-Easy, recently partnered with the In reaction to the global COVID-19 pandemic, Pharmaceutical company, Stablepharma, has developed University Hospital Centre in Toulouse to open a new pharmaceutical companies are now racing to be the first to a method of transporting and storing vaccines without pharmaceutical manufacturing plant, dedicated to develop a vaccine. Organisations, such as Oxford University refrigeration. The company’s StablevaX solution, allows the production of stem cells. Cell-Easy is set to use its and AstraZeneca, Moderna and the National Institute of vaccines to be kept out of cold chain storage and innovative mass-scale stem cells manufacturing process, Allergy and Infectious Diseases (NIAID), CanSino and the transportation, for up to a year. As such, this technology to develop regenerative medicine, through therapeutic Beijing Institute of Biotechnology (BIOB), as well as Sinovac, may play a crucial role in distributing vaccines around the solutions. are all making strides in this development. world, including any potential COVID-19 vaccines.
These regenerative medical solutions will be based on Over 100 candidate vaccines are currently in development According to the World Health Organisation (WHO), an Advanced Therapy Medicinal Products, that will allow for worldwide, with 10 of these already in clinical evaluation. estimated 50% of vaccines become ineffective due to affordable access to stem cell technologies, for millions One of the forerunners in the race to develop a COVID-19 failings in cold chain storage and delivery. However, the of patients. These solutions include the production of vaccine is Oxford University and its partner AstraZeneca. StablevaX will allow countries to confidently stockpile Mesenchymal stem cells, also known as stromal cells, Oxford University’s candidate vaccine, ChAdOx1 nCoV- vaccines, which can then be instantly used and possibly which will be sourced from qualified fat tissue, as per good 19, began phase 2-3 of human trials in May 2020. If this save patient’s lives. manufacturing practices. vaccine proves to be effective, it will be manufactured and distributed together with AstraZeneca. In particular, the StablevaX can thermally stabilise a variety According to Pierre Monsan, DG of Cell-Easy and Founder of drug classes, while maintaining vaccination protocols set of Toulouse White Biotechnology, Cell-Easy aims to Another front-runner, Moderna and the NIAID have also by the WHO. The solution makes use of a trehalose sugar industrialise their proprietary stem cell manufacturing made progress in vaccine development. Their candidate to stabilise pre-approved vaccines, delivered by drying the process. The goal is to make cell therapy accessible to vaccine, LNP-encapsulated mRNA, entered phase two of sugar inside a specialised sponge, which is then housed an increased number of patients, through increased clinical trials in May 2020. in a normal syringe. These vaccines can then be stored production, as well as cutting costs and increasing without refrigeration, regardless of the climate. capacity. Furthermore, a first clinical trial into researching In addition, CanSino and the BIOB’s Ad5-nCoV vaccine, possible treatments for Alzheimer disease is also on the which entered phase two of their clinical trials in April, was According to Stablepharma Managing Director and cards. the first candidate vaccine to do so. Founder, Nick Child, the company has investigated the current candidates for a COVID-19 vaccine and believe Moreover, Cell-Easy’s new pharmaceutical plant will allow Moreover, China-based Sinovac’s CoronaVac is currently its technology would be highly beneficial. He further the group to produce stem cell batches at a large scale, undergoing phase two of clinical trials, with discussions of stated that the company is ready to partner with vaccine as authorised by the French Medicines Agency. As such, moving into phase three underway. However, this phase is manufacturers to make their technology available in the Cell-Easy will become the only private pharmaceutical set to take place in the UK, as China does not have enough fight against COVID-19. organisation, able to manufacture stem cells on an cases to find the required number of volunteers for the industrial scale in France. tests.
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SA NEWS INTELLIGENCE TRENDS & MERGERS & INNOVATION & SOCIO-POLITICAL LEGISLATION OVERVIEW NEWS ACQUISITIONS TECH TRENDS FACTORS
SA NEWS
THOUSANDS OF SA PATIENT FIRST SA COVID-19 VACCINE API TECHNOLOGY INNOVATION RECORDS POSSIBLY PUT AT CLINICAL TRIALS CURRENTLY CLUSTER TO MAKE HEALTH RISK UNDERWAY CARE AFFORDABLE
2 July 2020 23 June 2020 12 June 2020 Thousands of SA patient records were left vulnerable SA’s first clinical trial for a vaccine against COVID-19 The Technology Innovation Agency, the Department of to possible cyber-attacks, due to SA medical data start- commenced in June 2020. The vaccine, which was Science and Innovation, and North West University will up, LogBox, keeping user data and patient records on a developed by scientists at Oxford University, aims to work in collaboration, to establish a local manufacturing database vulnerable to hackers. Although this vulnerability prevent infection by SARS-CoV-2, the virus that causes Active Pharmaceutical Ingredient (API) Technology has been rectified, an internal investigation has been COVID-19. Innovation Cluster. Through this partnership, the group undertaken and all affected users will be contacted, as per aims to make health care affordable, by strengthening the government regulations. The novel COVID-19 virus has had a substantial effect SA pharmaceutical value chain. around the globe, including SA, with 100 000 confirmed The LogBox programme assists patients in completing diagnosed cases and approximately 2 000 reported Through the API cluster, the group aims to create a medical forms, by consolidating and storing medical deaths. dynamic SA pharmaceutical manufacturing industry, information, which can then be viewed on the app or which ensures access to modern and critical medications. website. Moreover, the app has been used or trialed by The clinical trial was announced on 23 June 2020, This has become increasingly important due to the several medical institutions, including Lancet Laboratories, at a virtual press conference, that was hosted by the COVID-19 pandemic, which has had a severe impact on Netcare Waterfall City Hospital, and Wits University Donald University of the Witwatersrand (Wits). The trial will be SA’s ability to import APIs from China and India, in turn Gordon Medical Centre. led by Wits Professor of Vaccinology and South Africa affecting the provision of medications in SA. Medical Research Council Vaccines and Infectious However, one of the company’s databases, containing Diseases Analytics Research Unit director, Shabir Madhi, in Furthermore, the API cluster has received an initial access keys for thousands of patient records, was found collaboration with the University of Oxford and the Oxford R13 million investment and aims to stimulate industry to be vulnerable to potential hackers. The vulnerability of Jenner Institute, in the United Kingdom (UK). competitiveness and world-class API manufacturing in LogBox’s systems allowed access to an external database, SA. This will be achieved through leveraging existing skills, with access tokens for users, which can be used to access Moreover, the trial has received approval from the South technologies and facilities in SA, helping the country save user accounts. The vulnerability has since been rectified African Health Products Regulatory Authority and the some of the R15 billion spent annually on imported APIs. and affected users will be informed, pending an internal Human Research Ethics Committee of Wits. In addition, investigation. the Department of Agriculture, Forestry and Fisheries has Moreover, the cluster strategy will be supported by also approved the import of the investigational vaccine for readjusting the current capabilities at various higher Moreover, this breach comes shortly after the introduction use in the trial. education institutions, science councils and commercial of SA’s new data privacy law, the Protection of Personal companies, to achieve a focused API process and Information Act of 2013 (or PoPI). This act requires In addition to the SA clinical trial, studies of the vaccine will engineering programmes. This includes groups across the companies to inform the new Information Regulator and also be conducted in the UK, Brazil, and the United States. value chain, such as the Department of Trade, the national its users of any data breaches. Department of Health, the Industrial Development Corporation, Industry and Competition, as well as various industry associations.
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COMPANY NEWS INTELLIGENCE TRENDS & MERGERS & INNOVATION & SOCIO-POLITICAL LEGISLATION OVERVIEW NEWS ACQUISITIONS TECH TRENDS FACTORS
COMPANY NEWS
CIPLA IS SET TO BRING ASPEN TO INCREASE ASCENDIS CFO SET TO COVID-19 TREATMENT PRODUCTION OF STEP DOWN IN TO SA BREAKTHROUGH DRUG SEPTEMBER 2020 6 July 2020 19 June 2020 10 June 2020 Recently, through a landmark agreement with Gilead Aspen Pharmacare is set to increase the production of a Ascendis recently announced that its Chief Financial Sciences Inc, Cipla was granted a licence to manufacture generic anti-inflammatory medication, Dexamethasone, Officer, Kieron Futter, is set to step down at the end of and distribute the antiviral medication, Remdesivir, in 127 which could save the lives of critically ill COVID-19 patients. September 2020, after a 5-year tenure at the company. countries, including SA. Remdesivir is the first medication According to the group, Futter has played a pivotal role which has been approved by United States (US) authorities Dexamethasone, which has been on the market for over in assisting the company in navigating difficult financial to treat COVID-19 and has been shown to accelerate the 60 years, typically serves to reduce inflammation in the and economic challenges. A suitable replacement will be recovery of hospitalised patients. treatment of arthritis and breathing disorders. However, announced in due course. according to a recent mass treatment trial led by Oxford The Emergency Use Authorisation (EUA) for Remdesivir University, Dexamethasone has proven to reduce mortality Futter joined Ascendis in September 2015 and has over was initially issued by the United States Food and Drug rates by a third, amongst ventilated patients and was 20 years of experience in financial management across Administration (FDA) on 1 May 2020. The EUA was found to reduce fatalities by a fifth, amongst those patients various industries. His experience includes five years at issued mainly based on a study which demonstrated who receive oxygen support. GlaxoSmithKline Consumer Healthcare in the UK and the medication’s ability to shorten the recovery time of Dubai, five years at TransUnion Group Africa, and two years patients hospitalised with COVID-19. In response to this, the Health ministry in SA has stated as the Chief Executive Officer of Nando’s company-owned that it recognises the Dexamethasone trials as a significant restaurants division. Gilead, which currently holds the patent on this breakthrough in the fight against COVID-19, that would medication, granted non-exclusive manufacturing licenses be easy to implement in SA. Furthermore, the Health Currently, Ascendis is contending with a R5 billion debt to multiple generic pharmaceutical companies, including Department has recommended that the medication be pile, which far exceeds the company’s R524 million market Cipla. In particular, Cipla has reserved an initial batch of considered for use on ventilated patients and those on capitalisation. The company is also in the process of 35 000 vials for SA, which is expected to arrive in SA in the oxygen supply, which is set to ramp up demand for the seeking buyers for certain assets to meet its obligations to week of 20 July. product. lenders.
Moreover, according to Paul Miller, Cipla’s Chief Executive As such, Stravos Nicolaou, Aspen’s Senior Executive has However, the announcement of Futter’s resignation comes Officer, the company aims to ensure that everyone has indicated that Aspen is set to significantly increase the after the company announced that it had successfully access to life-saving medication. As such, the company will production of the medication, even though there is still pushed back its debt payments until the end of 2021, ensure that the price for Remdesivir will either be lower uncertainty regarding global demands for the medication. which has bought it additional time to sell off assets. As a than or similar to prices offered in other emerging markets, result, the group’s share price increased by 13.4% when the to facilitate access to this medication. Furthermore, Chief Executive Officer, Stephen Saad has announcement was made. confirmed that there should be a sufficient supply of Miller further stated that the medication will be the medication to meet local demand, as the product is manufactured at Cipla’s Goa site in India, as this site produced locally. is approved by the FDA and the SA Health Products Regulatory Authority (SAHPRA).
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COMPANY FINANCIAL RESULTS INTELLIGENCE TRENDS & MERGERS & INNOVATION & SOCIO-POLITICAL LEGISLATION OVERVIEW NEWS ACQUISITIONS TECH TRENDS FACTORS
COMPANY FINANCIAL RESULTS
ASCENDIS HEALTH ASPEN PHARMACARE LIMITED* HOLDINGS LIMITED*
8 June 2020 15 May 2020 According to a recent update, the board of directors of According to Aspen’s most recent voluntary update for Ascendis Health recently advised, that the company has the ten months ended 30 April 2020, the Group has concluded agreements with its Lender Consortium, to experienced an elevated demand for some of their Sterile restructure its current debt facilities and to provide for the Brands in Europe. This is due to the critical importance advance of new debt facilities. of these products in the clinical management of patients infected with COVID-19. A mutual agreement was reached, between Ascendis Health and its Lenders, to extend the repayment Within the Sterile Brands business, the increased demand obligations on its debt facility to December 2021, with no for anaesthetics in Europe CIS towards the latter part of payments required before that date, except any excess the ten-month period, has counterbalanced the expected cash which will be swept to the Lenders. decline in the Chinese business. This was as a result of the postponement of elective surgeries and less frequent This extension is set to provide Ascendis Health with haemodialysis treatment of patients during the first four the flexibility to continue driving growth and the value months of 2020. of its businesses, as well as optimising any sale of those businesses, to deliver full value to all stakeholders. In terms of the Regional Brands business, the stockpiling of everyday healthcare products and advanced filling of The existing debt facilities was valued at R5.1 billion as at prescriptions brought on by the COVID-19 pandemic, has 31 December 2019, comprising of Euro and Rand terms, had a positive impact on the business. However, this has as well as revolving facilities. Furthermore, a €6 million led to overstocking in the supply channels and households, facility was advanced in April 2020, to fund the payment which is expected to lead to a decrease in demand over of outstanding deferred vendor liabilities (VL Facility) the coming months. and an additional R87 million was advanced, to fund the procurement of essential medical equipment, to be sold in In terms of financial year (FY) 2020 outlook, the Group the fight against COVID-19 (Covid Facility). maintains its outlook published in its interim results released in March 2020, where it was indicated that The new debt facilities include the advance of a new super normalised HEPS from continuing operations in FY 2020 senior facility of €6.9 million. The Super Senior Facility will is expected to be higher compared to the prior year. finance the company’s general liquidity needs, as well as However, due to the current degree of uncertainty as a refinance the VL facility and the Covid Facility. result of the COVID-19 pandemic, the outlook for FY 2020 will be updated if required. As a result of the new debt facilities, the combined debt facilities will be valued at €218 million (R2.1 billion). *No recent financial results were available to report on
*No recent financial results were available to report on
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MERGERS, ACQUISITIONS & PARTNERSHIPS INTELLIGENCE TRENDS & MERGERS & INNOVATION & SOCIO-POLITICAL LEGISLATION OVERVIEW NEWS ACQUISITIONS TECH TRENDS FACTORS
MERGERS, ACQUISITIONS & PARTNERSHIPS
ASTRAZENECA APPROACHES ADCOCK INGRAM ACQUIRES GILEAD FOR POTENTIAL PLUSH PROFESSIONAL MERGER LEATHER CARE 7 June 2020 15 May 2020 AstraZeneca, the largest pharmaceutical company in the Adcock Ingram recently announced that all conditions, United Kingdom (UK), recently approached leading United including regulatory approval, for the company’s States (US) pharmaceutical manufacturer Gilead Sciences acquisition of Plush Professional Leather Care were met in Inc, regarding a potential merger, in what would be the May 2020. The acquisition is now unconditional, and the largest healthcare deal on record. final closing of the transaction was set to take place before the end of May 2020. AstraZeneca contacted Gilead in May 2020 but have not yet specified terms for any transaction. In terms of Gilead, In March 2020, Adcock announced that it had concluded the company indicated that it has discussed the idea with a share purchase agreement to acquire Plush Professional advisers but no decisions on how to proceed have been Leather Care, which is a 55-year old South African brand. made and the market players are not in formal discussions This aligns with the company’s strategy of pursuing value- yet. adding acquisitions, specifically in less regulated areas of the market. In addition, Gilead indicated that it is not interested in selling to, or merging with, another large pharmaceutical With this acquisition, Plush will operate as a separate player, preferring to focus its strategy on partnerships and company within the Adcock Ingram group. In particular, smaller acquisitions. the company will report into, and be managed within Adcock’s consumer division. In terms of value, AstraZeneca is currently valued at approximately US$141 billion and is the UK’s largest Although Plush Professional Leather Care is rooted within pharmaceutical manufacturer by market capitalisation. the shoe and leather care business, this company has Furthermore, the company has developed treatments for successfully diversified its product offering into a portfolio conditions from cancer to cardiovascular disease and is of homecare and cleaning products over the last ten years. also currently partnered with Oxford Vaccine Group, to In addition, these products currently make up the majority assist with the roll out of a vaccine against the COVID-19 of Plush Professional Leather Care’s revenue. virus, if approved. As things currently stand, Plush Professional Leather Care Gilead, which is worth approximately US$96 billion, generates sales of over R200 million and its products are created the medication which received US approval for distributed through most of the major retailers in SA. use with COVID-19 patients. However, the company is not currently working on a vaccine, and ceased to work on two potential antiviral treatments for COVID-19 in May 2020.
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INNOVATION AND TECHNOLOGY TRENDS INTELLIGENCE TRENDS & MERGERS & INNOVATION & SOCIO-POLITICAL LEGISLATION OVERVIEW NEWS ACQUISITIONS TECH TRENDS FACTORS
INNOVATION AND TECHNOLOGY TRENDS
DIGITAL MEDICAL LANDMARK OBEL SA LAB OBTAINS FIRST CONSULTATIONS EMBRACED RESPICLEAR RANGE SARS-COV-2 ISOLATES BY SA INTRODUCED IN SA 7 July 2020 12 May 2020 11 May 2020 As a result of the COVID-19 pandemic, many patients have Acdoco SA, a specialist brand-building distributor centred In April 2020, researchers obtained SA’s first known turned to online platforms to consult with health care on the health and beauty sector, recently launched a new laboratory isolate of SARS-Coronavirus 2 (SARS-CoV-2). professionals, without potentially exposing themselves decongestant range, OBEL RespiClear. This range features These isolates were obtained through a collaborative effort to the virus. This has been achieved using several digital SA’s first steroid-free nebs available over the counter (OTC), between the University of the Western Cape (UWC) and platforms which continue to be embraced by SA patients. as well as vapour rub and drop formats, also both Schedule Stellenbosch University (SU) and will open the doors for SA 0 and OTC. researchers, who can now experiment on live samples of Since the beginning of the outbreak, the frequency of the virus. doctor consultations worldwide has seen a major decline, The OBEL RespiClear range has been created in line with with approximately 70% of people completely stopping the latest advances in evidence-based medicine and is To find a cure or vaccine for the COVID-19 virus, gaining visits to the doctor, or massively reducing consultations. locally manufactured, nature-inspired, highly effective, and a better understanding of the virus is crucial. According This is no different for SA, with only 28% of people affordably priced. Additionally, the range is available in to Dr Tasnim Suliman, a post-doctoral research fellow at continuing to visit their doctors for in-person visits, three formats, including nebs, vapour rubs, and drops. UWC, much of the current data on the virus is based on irrespective of the risk. detecting the genetic materials of dead virus cells, which The OBEL RespiClear nebs are steroid-free and have do not give a full picture of the behaviours of the virus. However, both patients and medical staff have quickly antiviral and anti-bacterial properties, due to the essential adapted to this challenge, finding new consultation oils used in the product. These nebs are the only steroid- Moreover, obtaining live isolates of SARS-CoV-2 is extremely alternatives. Over a third of patients who chose to avoid free option available in SA and are designed to target the beneficial to SA researchers. These isolates will be able to in-person consultations, have started to consult medical upper respiratory tract to relieve symptoms and alleviate supply SA labs with samples for further research, as well professionals online. mucus build-up. as provide reference material for standardising diagnostic tests across multiple platforms in various laboratories. Additionally, although a variety of methods are used for Moreover, the OBEL RespiClear vapour rub is designed online consultations, phones were found to be more to relieve various symptoms associated with bronchitis, SA is, however, severely limited in its research capacity due commonly used than computers, with patients preferring flu, and colds. The product makes use of a unique 50ml to a lack of BSL-3 labs and the trained personnel necessary in-app chats, and commonly using social media and video. hygiene pump and is also petroleum, paraben, and for this research. Therefore, it is extremely advantageous for However, despite this popularity, SA patients were found turpentine-free. the UWC and SU researchers, to make this virus available to be less satisfied with online modes than other countries and guide others on how to safely handle the virus locally. sampled. Additionally, the OBEL RespiClear drops are preservative- free and include a combination of essential oils, such as Moreover, this trend is unlikely to end with the COVID-19 eucalyptus, camphor, peppermint, thyme, and menthol, pandemic. Approximately two-thirds of patients said which provide the drops antiviral, antibacterial, and anti- they would only use online, or a combination of an online inflammatory properties. and in-person consultation in the future, with only 17% adamant they will only use in-person services.
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SOCIO-POLITICAL FACTORS INTELLIGENCE TRENDS & MERGERS & INNOVATION & SOCIO-POLITICAL LEGISLATION OVERVIEW NEWS ACQUISITIONS TECH TRENDS FACTORS
SOCIO-POLITICAL FACTORS
COVID-19 AND ITS EFFECT KEY CONCERNS OF PHARMACY IN ON MENTAL HEALTH HEALTHCARE WORKER UNIONS KWA-ZULU NATAL ADMITS TO SERVICES AMIDST COVID-19 PANDEMIC OVERPRICING OF FACE MASKS
26 June 2020 25 June 2020 8 May 2020 Despite the easing of SA’s lockdown to alert level three, A key concern for healthcare workers during the COVID-19 In a recent consent agreement with the Competition the mental health of the public and mental healthcare pandemic has been the access to appropriate personal Commission, a Kwa-Zulu Natal based pharmacy has providers, remains a concern. protective equipment (PPE). However, according to admitted to the excessive pricing of its face masks. The representatives from four different trade unions, access to Commission received information regarding the Mandini According to a recent online survey conducted by South PPE is not the only pressing issue currently. Amongst other Pharmacy inflating the prices of its face masks in African Depression and Anxiety Group (SADAG), 65% of issues, unions are also in salary disputes with government. March 2020. respondents felt stressed or very stressed, even though 92% of respondents supported the lockdown. Although PPE is not the only issue, it remains the issue of According to an investigation by the Commission, the the moment. According to Rich Sicina, a Nurse and the Mandini Pharmacy ordered face masks from a supplier, In addition, some psychologists have seen a boost in General Secretary of the Young Nurses Indada Trade Union with the intention of reselling it to its customers. The consultations. For example, Harsha Maharaj, a clinical (YNITU), one cannot discuss the challenges health workers pharmacy, however, did not sell any face masks before psychologist based at MediClinic in Sandton, indicated face without discussing PPE. Furthermore, Khaya Xaba, the March 2020 but decided to source these masks to service that the number of consultations has increased since Spokesperson for the National Education Health and Allied the sudden demand and panic-buying, brought on by the the commencement of the lockdown. In addition, many Workers’ Union (NEHAWU), also highlighted concerns state of national disaster. patients have increasingly had to deal with anxiety related regarding the incorrect usage of PPE. Other issues in terms to COVID-19, on top of the medical and psychiatric issues of PPE which have been highlighted is the fact that PPE’s As such, the Commission found that the gross profit these patients present with. are being stored in storerooms and only used when the margin in terms of the face masks for March 2020 was in MEC or the minister visits the facility. contravention of section 8(1)(a) of the Act, read together Moreover, Dr Lesley Robertson, the Head of the Clinical with Regulation 4 of the Consumer Protection Regulations. Unit: Community Psychiatry at Sedibeng District health One of the other major issues is salary disputes with Services in Gauteng, has expressed her concern regarding government. In terms of this, the three-year wage Following the results of this investigation, Mandini patients staying away during the lockdown. Robertson also agreement between government and unions in 2018, Pharmacy has admitted to engaging in the conduct of expressed concern for people living with mental illnesses, came to an end in March and nurses expected a 5.4% excessive pricing. contracting COVID-19, and how those with severe mental salary increase on 1 April. However, according to Halama, In terms of the agreement with the Commission, the issues will cope with situations surrounding the disease. government failed to implement this, citing fiscal pharmacy has agreed to immediately desist from the constraints. According to Robertson, mental healthcare workers excessive pricing conduct, as well as reducing its net are currently under a lot of stress and also experience Furthermore, all unions have argued that small businesses margin on facial masks with immediate effect. In addition, significant anxiety regarding contracting the disease. and even the taxi industry, amongst many others, have the pharmacy will be donating essential goods to Child benefitted from the stimulus package announced by the and Welfare situated in Mandini, with the total value of President, but not healthcare workers. the donation obtained from the “overcharge”, for the face masks.
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LEGISLATION INTELLIGENCE TRENDS & MERGERS & INNOVATION & SOCIO-POLITICAL LEGISLATION OVERVIEW NEWS ACQUISITIONS TECH TRENDS FACTORS
LEGISLATION
COVID-19 DATABASE TO CLICKS SET TO APPEAL HIGH NEW RULES REGARDING FOCUS ON THE PUBLIC’S COURT RULING REGARDING LOCKDOWN PHARMACY RIGHT TO PRIVACY UNICORN PHARMACEUTICALS PRESCRIPTIONS 3 July 2020 10 June 2020 5 May 2020 New amendments have been introduced to the laws Clicks will reportedly appeal the Western Cape High In May 2020, Minister of Health, Dr Zweli Mkhize, published regarding the National Department of Health’s (DOH) Court’s ruling, that the group owns a drug-manufacturing a new directive excluding schedule 2, 3 and 4 substances proposed COVID-19 database, which is designed to assist in facility, Unicorn Pharmaceuticals (UP), which according from certain provisions of the Medicines and Related combatting the spread of the virus. The proposed changes to the Pharmacy Act is illegal for a pharmacy owner. The Substances Act. This directive extends prescriptions for to the database emphasises the obligations of parties to group, however, argued that UP does not manufacture these substances for several months, to make access to process personal information lawfully and respect the medications, but only imports medications and repackages medicines during the lockdown easier. public’s privacy. them as Clicks generics. According to the directive, the prescription for scheduled substances, previously valid only for three months, will now These amendments have also coincided with provisions The Clicks group have been involved in a four-year legal be valid for six months. As such, pharmacists must have the of the Protection of Personal Information Act, 2013 (PoPI), battle with the Independent Community Pharmacy requisite scheduled substances to fulfil this demand. which came into effect on 1 July 2020. Association, a group representing independent pharmacies, over Clicks’ ownership of UP. Additionally, patients need not consult with a healthcare The database has been designed to protect SA citizens by In June 2020, the Western Cape High Court ruled that practitioner during the timeframes the prescriptions gathering information to combat the spread of COVID-19. UP fits the definition of a manufacturer, as defined remain valid to obtain a new prescription. However, The information collected in the database includes by the Pharmacy Act, and thus is in contravention of consultations may continue for healthcare practitioners to a variety of personal information, geospatial hotspot the legislation. However, Clicks claims that it is not in monitor the needs of patients who may require changes in mapping data, and contact tracing. contradiction to the Pharmacy Act and is reportedly doses of medications or ceasing medications. appealing the High Court’s ruling. According to the amendments, information collected However, scheduled substances cannot be dispensed for by the DOH may only be obtained, used, or disclosed by According to Clicks, its ownership of UP does not a period longer than a year from the date of the issue of authorised persons and only if necessary, to address and contradict the Pharmacy Act as although Clicks holds a the initial prescription and prescriptions issued six months combat the spread of the virus. manufacturing licence, it allows only the import and export before the date of the notice may only be repeated for a of medicines, not the manufacturing. further six months. In addition, information collected from electronic systems Furthermore, the exemptions provided by the directive will or applications to be used on mobile devices or computers, Moreover, while Clicks claims by owning more of the only apply until November 2021 and information on the may only be collected on a voluntary and opt-in basis. supply chain the group can save customers money, others payment of the scheduled substances by medical schemes argue that Clicks’ position gives them an unfair advantage in terms of the Medical Schemes Act and the respective Furthermore, information regarding members of the over independent pharmacies. public obtained from electronic systems or applications medical schemes’ rules and managed care protocols operated by private entities may be included, however, this Should future appeals be unsuccessful, the Department remain silent. information must be collected on a voluntary and opt-in of Health will decide on what sanctions should be put in basis with the express consent of the individual to share place against Clicks, or alternatively Clicks may be required the information with the DOH. to sell UP to comply with the law.
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