In Vivo: strategic insights for life sciences decision-maker...
By Lucie Ellis 30 Sep 2020
An interactive look at recent executive-level company changes and promotions in the biopharma, medical device and diagnostics industries.
As of March 4, 2020, there were more than 93,000 confirmed cases of COVID-19, the newly named disease caused by the coronavirus outbreak that originated in Wuhan, China, at the end of 2019. According to the World Health Organization, there have been more than 3,190 deaths from the virus and there are now cases recorded in 76 countries.
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).
Research efforts are now underway to investigate a range of novel and established drug platforms, including repurposed medicines, prophylactic vaccines and therapeutic treatments against the virus, known as SARS-CoV-2 (see Exhibit 2).
The World Health Organization is leading the charge by working with Chinese researchers to conduct rapid clinical trials of existing antiviral treatments to treat patients infected with SARS-CoV-2. It announced on 20 February that trials have been launched in China to determine the safety and efficacy of two existing antiviral therapies:AbbVie Inc.’s HIV combination Kaletra (lopinavir and ritonavir) and Gilead Sciences Inc.’s nucleotide analogue remdesivir, which was already under development for Ebola.
According to data from Pharmaprojects there are 35 vaccines and therapies in development against COVID-19, though the majority of recent R&D efforts have been directed towards vaccine approaches.
A vaccine from US biotech firm Moderna Inc. for COVID-19 has been readied for a Phase I trial, moving from the lab to ready for testing in humans in a remarkable 42 days. It uses messenger RNA (mRNA) technology. The Cambridge, MA-based company shipped its mRNA-1273 vaccine to the National Institute of Allergy and Infectious Diseases (NIAID) on 24 February for use in a US Phase I study. It targets a pre-fusion stabilized form of the Spike protein, selected by the firm in collaboration with investigators at the NIAID’s Vaccine Research Center. (Also see "Moderna Marches First Coronavirus Vaccine To US Test" - Scrip, 25 Feb, 2020.)
To date, Moderna has produced and released more than 100 batches of the vaccine candidate from its Norwood manufacturing site for human clinical trials.
Messenger RNA is increasingly becoming a leading technology in fighting virus outbreaks and Moderna is developing six vaccines: a respiratory syncytial virus (RSV) vaccine for older adults, an RSV vaccine for young children, a meta-pneumovirus vaccine, influenza H7N9 vaccine and the COVID-19 vaccine.
Meanwhile, on 4 March, Vir Biotechnology Inc.and Alnylam Pharmaceuticals Inc.announced that they would move forward with one or more RNAi (RNA interference) therapeutics targeting SARS-CoV-2. The companies are expanding on a 2017 alliance to utilize Alnylam’s recent advances in lung delivery of novel conjugates of siRNA – the molecules that mediate RNAi – together with Vir’s infectious disease expertise. They expect to progress one or more siRNAs to treat SARS-CoV-2 and potentially other coronaviruses as well. Vir will lead all development and commercialization of any selected candidates.
Multiple other vaccine developers are accelerating their programs for SARS-CoV-2. US biotech Inovio Pharmaceuticals Inc.has said it is preparing its vaccine INO-4700 for clinical studies as early as this summer. The Nasdaq-listed firm recently partnered with Beijing Advaccine for tests on patients with COVID-19 disease in China.
UK-based GlaxoSmithKline PLC is also partnering with Chinese firm Clover Corp. Ltd.to develop a novel protein-based COVID-19 S-Trimer vaccine, developed by Clover. GSK will provide the company with its pandemic adjuvant system to evaluate the candidate in preclinical studies, and Clover is readying its cGMP facilities in China for scale-up and mass production.
Johnson & Johnson and Sanofi Pasteur meanwhile are partnering with the US Department of Health and Human Services to develop vaccines against the outbreak. Sanofi Pasteur, the vaccines division of Paris-based Sanofi, has confirmed a new research effort being funded by the US agency BARDA, which will focus on bringing a new vaccine intoin vitrotesting within six months and into initial clinical trials within 12-18 months.
Despite the rapidity of the response from vaccine companies, these 12-18 month timelines will not see the vaccines distributed on a mass scale, which could take at least another 12 months. By this time, the coronavirus threat may have receded or, alternatively, grown. Experts say the profile of the disease – less frequently deadly than the SARS outbreak of 2002-03, but more easily transmitted – suggests it could become a permanent background threat similar to seasonal influenza.
Major events worldwide, such as Facebook’s annual F8 Conference in San Jose, CA, and the World Indoor Championships in Nanjing, China, have been cancelled – with rumors that the Olympics games, due to begin on July 24 in Tokyo, could also be postponed. In the biopharma sector, two conferences scheduled to take place in Amsterdam in March – the Medicines for Europe conference on biosimilars and the World Pharma Pricing Congress – have been postponed until September.
Anxiety about the continuing spread of coronavirus is also evidenced by companies cutting back on appearances at investor conferences and advising employees to eliminate unnecessary travel.
For the moment, Vertex and Seattle Genetics represent the most cautious response, as many other companies carried on plans for the Cowen conference – including Merck & Co. Inc. and Alnylam Pharmaceuticals Inc..
The global outbreak and its disruption of travel and business has had an immediate impact on the economic outlook: $1.7tn was wiped off US stock market values last week, with pharma majors such as Pfizer Inc.and Merck & Co. Inc. as badly affected as any another blue chip company.
Investor fears are at an all-time high over the impact of coronavirus and companies are having to act now on decision-making to protect overall performances in 2020. The outbreak has been likened to the SARS epidemic in 2002-03, but China’s economy is seven times larger now that it was then, making up 16% of global GDP, compared with 4% in 2003.
In the medtech sector, supply chain disruption and a decrease in elective surgeries are having the biggest impact on the industry. Medtech multinationals with manufacturing plants clustered in China are expecting disruption to supply chains due to travel bans and quarantine measures.Boston Scientific Corp. management announced that it expects the outbreak to lead to a $10-40m loss in first-quarter sales with lower procedures volumes and disrupted supply chains in China. Travel limitations are also expected to hinder exports from China to the US and Europe for finishing product assembly.
The virus has caused uncertainty for Smith & Nephew PLC's 2020 outlook. China accounts for 7% of the orthopedics company’s revenues and has been a key growth driver to its business. The company's annual results showed that emerging markets, including China, helped boost revenues in 2019 with sales in the region up 16.6% in the fourth quarter. During its 20 February sales and earnings call, Smith & Nephew executives said the company expects a considerable impact on business in February as a result of a lack of elective surgeries taking place in China.
Philips Healthcareechoed those concerns in its 2019 annual results call, saying overall demand in China had suffered.
And market leader Medtronic PLC has also reported that it will be impacted financially by the reduction in elective surgeries in China related to the outbreak. The country accounts for 7% of the company’s global business, generating about $2.14bn for Medtronic in 2019. China is also the location of Medtronic’s largest manufacturing and research facilities outside of the US.
But it is not all doom and gloom for every medtech company. Manufacturers of syringes and sets for blood collection could be one of the biggest financial winners in the outbreak, so Becton Dickinson & Co. could see a financial boost from the crisis.
The pandemic has also increased demand for respiratory masks and protective gear. The share price for conglomerate 3M Co.has risen since the outbreak as a result of an increase in sales of the company’s face masks. 3M announced it had increased production to meet demand.
Medtech companies in the race to produce a diagnostic test for COVID-19 may also begin first sales this month. French company Novacyt SA announced it has signed its first major agreement with a distributor to supply a COVID-19 test to two Asian territories outside mainland China. Initial sales, which are subject to local emergency-use approval, are anticipated to be £2.1m during the first six months of the agreement. It is anticipated that the first sales under this agreement will take place in March 2020.
Utah-based diagnostics company Co-Diagnostics has also announced a CE mark for its Logix Smart Coronavirus COVID-19 Test to be sold as anin vitrodiagnostic.
Joint reporting from the Informa Pharma Intelligence Team: Scrip, Pink Sheet, Generics Bulletin and Medtech Insight
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In Vivo: strategic insights for life sciences decision-maker...
30 Sep 2020
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