Corporate Strategies Fact File: Coronavirus Pipeline And Corporate Updates

Executive Summary confirmed cases of COVID-19, the newly named The coronavirus outbreak is at a tipping point, disease caused by the coronavirus outbreak that after which its development into a global originated in Wuhan, China, at the end of 2019. pandemic may be unstoppable. Companies large According to the World Health Organization, there and small have mobilized in the fight against the have been more than 3,190 deaths from the virus disease bringing new and repurposed treatment and there are now cases recorded in 76 countries. options into development and preparing their business for the unsteady months ahead. While more than 80,000 of the coronavirus infections are in China, substantial outbreaks have occurred in South Korea, Italy and Iran (see exhibit 1a & 1b). As of March 4, 2020, there were more than 93,000

Exhibit 1a: The Five Worst Hit Countries

Data correct as of 4 March 2020 Source: WHO Data

2 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) Exhibit 1b: Virus Spread Outside Of China

Data correct as of 4 March 2020 Source: WHO Data

R&D Progress have been launched in China to determine Research efforts are now underway to investigate the safety and efficacy of two existing antiviral a range of novel and established drug platforms, therapies: AbbVie Inc.’s HIV combination Kaletra including repurposed medicines, prophylactic (lopinavir and ritonavir) and vaccines and therapeutic treatments against the Inc.’s nucleotide analogue remdesivir, which was virus, known as SARS-CoV-2 (see Exhibit 2). already under development for Ebola.

The World Health Organization is leading the According to data from Pharmaprojects there charge by working with Chinese researchers to are 35 vaccines and therapies in development conduct rapid clinical trials of existing antiviral against COVID-19, though the majority of recent treatments to treat patients infected with SARS- R&D efforts have been directed towards vaccine CoV-2. It announced on 20 February that trials approaches.

3 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) Exhibit 2: COVID-19 Development Pipeline In March 2020

Data correct as of 4 March 2020 Source: Pharmaprojects | Informa Pharma Intelligence

4 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) A vaccine from US biotech firm Inc. their programs for SARS-CoV-2. US biotech Inovio for COVID-19 has been readied for a Phase I Pharmaceuticals Inc. has said it is preparing its trial, moving from the lab to ready for testing vaccine INO-4700 for clinical studies as early as in humans in a remarkable 42 days. It uses this summer. The Nasdaq-listed firm recently messenger RNA (mRNA) technology. The partnered with Beijing Advaccine for tests on Cambridge, MA-based company shipped its patients with COVID-19 disease in China. mRNA-1273 vaccine to the National Institute of Allergy and Infectious Diseases (NIAID) on UK-based GlaxoSmithKline PLC is also partnering 24 February for use in a US Phase I study. It with Chinese firm Clover Corp. Ltd. to develop a targets a pre-fusion stabilized form of the Spike novel protein-based COVID-19 S-Trimer vaccine, protein, selected by the firm in collaboration with developed by Clover. GSK will provide the investigators at the NIAID’s Vaccine Research company with its pandemic adjuvant system to Center. (Also see “Moderna Marches First evaluate the candidate in preclinical studies, and Coronavirus Vaccine To US Test “ - Scrip, 25 Feb, Clover is readying its cGMP facilities in China for 2020.) scale-up and mass production.

To date, Moderna has produced and released Johnson & Johnson and Pasteur meanwhile more than 100 batches of the vaccine candidate are partnering with the US Department of Health from its Norwood manufacturing site for human and Human Services to develop vaccines against clinical trials. the outbreak. Sanofi Pasteur, the vaccines division of Paris-based Sanofi, has confirmed a new Messenger RNA is increasingly becoming a research effort being funded by the US agency leading technology in fighting virus outbreaks and BARDA, which will focus on bringing a new vaccine Moderna is developing six vaccines: a respiratory into in vitro testing within six months and into syncytial virus (RSV) vaccine for older adults, initial clinical trials within 12-18 months. an RSV vaccine for young children, a meta- pneumovirus vaccine, influenza H7N9 vaccine and Despite the rapidity of the response from vaccine the COVID-19 vaccine. companies, these 12-18 month timelines will not see the vaccines distributed on a mass scale, Meanwhile, on 4 March, Vir Biotechnology Inc. which could take at least another 12 months. and Alnylam Pharmaceuticals Inc. announced By this time, the coronavirus threat may have that they would move forward with one or more receded or, alternatively, grown. Experts say the RNAi (RNA interference) therapeutics targeting profile of the disease – less frequently deadly SARS-CoV-2. The companies are expanding on a than the SARS outbreak of 2002-03, but more 2017 alliance to utilize Alnylam’s recent advances easily transmitted – suggests it could become a in lung delivery of novel conjugates of siRNA – permanent background threat similar to seasonal the molecules that mediate RNAi – together with influenza. Vir’s infectious disease expertise. They expect to progress one or more siRNAs to treat SARS-CoV-2 Biopharma Market Worries and potentially other coronaviruses as well. Vir Major events worldwide, such as Facebook’s will lead all development and commercialization annual F8 Conference in San Jose, CA, and the of any selected candidates. World Indoor Championships in Nanjing, China, have been cancelled – with rumors that the Multiple other vaccine developers are accelerating Olympics games, due to begin on July 24 in Tokyo,

5 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) could also be postponed. In the biopharma Anxiety about the continuing spread of sector, two conferences scheduled to take place in coronavirus is also evidenced by companies Amsterdam in March – the Medicines for Europe cutting back on appearances at investor conference on biosimilars and the World Pharma conferences and advising employees to eliminate Pricing Congress – have been postponed until unnecessary travel. September.

Global Reach Of Coronavirus

For the moment, Vertex and Seattle Genetics The global outbreak and its disruption of travel represent the most cautious response, as many and business has had an immediate impact on the other companies carried on plans for the Cowen economic outlook: $1.7tn was wiped off US stock conference – including Merck & Co. Inc. and market values last week, with pharma majors Alnylam Pharmaceuticals Inc.. such as Inc. and Merck & Co. Inc. as badly affected as any another blue chip company.

6 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.) Medtech Ups And Downs Investor fears are at an all-time high over the And market leader Medtronic PLC has also impact of coronavirus and companies are having reported that it will be impacted financially by the to act now on decision-making to protect overall reduction in elective surgeries in China related performances in 2020. The outbreak has been to the outbreak. The country accounts for 7% of likened to the SARS epidemic in 2002-03, but the company’s global business, generating about China’s economy is seven times larger now $2.14bn for Medtronic in 2019. China is also the that it was then, making up 16% of global GDP, location of Medtronic’s largest manufacturing and compared with 4% in 2003. research facilities outside of the US.

In the medtech sector, supply chain disruption But it is not all doom and gloom for every and a decrease in elective surgeries are having medtech company. Manufacturers of syringes the biggest impact on the industry. Medtech and sets for blood collection could be one of multinationals with manufacturing plants the biggest financial winners in the outbreak, so clustered in China are expecting disruption to Becton Dickinson & Co. could see a financial boost supply chains due to travel bans and quarantine from the crisis. measures. Boston Scientific Corp. management announced that it expects the outbreak to lead The pandemic has also increased demand for to a $10-40m loss in first-quarter sales with lower respiratory masks and protective gear. The share procedures volumes and disrupted supply chains price for conglomerate 3M Co. has risen since in China. Travel limitations are also expected to the outbreak as a result of an increase in sales of hinder exports from China to the US and Europe the company’s face masks. 3M announced it had for finishing product assembly. increased production to meet demand.

The virus has caused uncertainty for Smith & Medtech companies in the race to produce a Nephew PLC’s 2020 outlook. China accounts for diagnostic test for COVID-19 may also begin first 7% of the orthopedics company’s revenues and sales this month. French company Novacyt SA has been a key growth driver to its business. The announced it has signed its first major agreement company’s annual results showed that emerging with a distributor to supply a COVID-19 test to two markets, including China, helped boost revenues Asian territories outside mainland China. Initial in 2019 with sales in the region up 16.6% in the sales, which are subject to local emergency-use fourth quarter. During its 20 February sales and approval, are anticipated to be £2.1m during the earnings call, Smith & Nephew executives said first six months of the agreement. It is anticipated the company expects a considerable impact that the first sales under this agreement will take on business in February as a result of a lack of place in March 2020. elective surgeries taking place in China. Utah-based diagnostics company Co-Diagnostics Philips Healthcare echoed those concerns in its has also announced a CE mark for its Logix Smart 2019 annual results call, saying overall demand in Coronavirus COVID-19 Test to be sold as an in China had suffered. vitro diagnostic.

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7 / March 2020 © Informa UK Ltd 2020 (Unauthorized photocopying prohibited.)