UPDATED: COVID-19 PHARMA TRACKER - 19 Mar 2020

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19 Mar 2020

The latest coronavirus updates and developments impacting the global pharmaceutical supply chain…

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18 March:

• The US Food and Drug Administration issues guidance for pharma companies, investigators and institutional review boards facing challenges conducting clinical trials during the coronavirus pandemic. It recommends sponsors evaluate alternative methods for assessments such as phone contacts or virtual visits and offer additional safety monitoring for trial participants without access to investigational products or the investigational site.

• CDMO Oxford Biomedica implements a daily senior management working group to monitor current COVID-19 developments and UK government guidance to risk assess its supply chain and to direct its phased response. OXB says it “has not experienced any and does not currently expect to experience significant supply issues or any changes in customer demand.”

• Eli Lilly partners with the Indiana State Department of Health (ISDH) in a US Food and Drug Administration-supported scheme to accelerate testing in Indiana for coronavirus. Lilly will use its laboratories to analyse samples taken in Indiana healthcare facilities, including nursing homes and emergency rooms.

• In a letter to customers, CDMO Bora Pharmaceuticals says “to manage the risk to production and supplies, we are continuing to monitor our supply chains to assess stock levels.” It adds that although the situation is currently under control, “we will maintain certain stocks and ensure the stability of our supply chain remains intact.”

• Catalent says it has established a senior, multi-disciplinary coronavirus response team to monitor the global situation and execute mitigation activities. The CDMO says it has not identified any significant risk that threatens delivery of products or clinical trial supplies and it has “adopted specific procedures to minimize and manage any future disruption to our ongoing operations.” These include expanded safety stocks of raw materials and personal protective equipment, as well as ongoing monitoring of suppliers’ stock levels to assure future deliveries.

17 March:

• AbbVie and Allergan’s USD63 billion merger could be delayed after the US Department of Justice's antitrust division warned it may struggle to complete merger reviews in time due to COVID-19.

• In an update, Sanofi says its global network of manufacturing plants is operational and the diversity of its global sourcing is helping ensure business continuity across all product lines. “At this time, Sanofi does not anticipate shortages for patients resulting from the COVID-19 situation,” the French pharma firm says.

• The World Health Organization says South-East Asian countries need to urgently scale-up aggressive measures to combat COVID-19, as confirmed cases cross 480. “The situation is evolving rapidly. We need to immediately scale up all efforts to prevent the virus from infecting more people,” says Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region.

• Medicines for Europe says blocks at Italy’s borders with Austria and Switzerland are delaying trucks carrying supplies for medicines production and finished medicines that, if unsolved, puts Europe at risk. “These blockages are caused by different rules being applied by Interior Ministries and Transport ministries in the same country!” the generics industry body says.

• Novartis announces measures to support the global response to COVID-19, including the creation of a global fund to support communities impacted by the pandemic as well as its decision to join two cross-industry R&D initiatives.

The Novartis COVID-19 Response Fund will provide USD 20 million in grants to support public health initiatives designed to help communities manage challenges posed by the pandemic. An accelerated global review process will approve individual grants of up to USD 1 million.

Novartis says it has joined the COVID-19 Therapeutics Accelerator, coordinated by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard, as well as a COVID-19 directed partnership organized by the Innovative Medicines Initiative (IMI).

• Pfizer and BioNTech sign letter of intent to co-develop and distribute the latter’s potential COVID-19 vaccine, BNT162, globally (excluding China). The collaboration aims to accelerate development of the vaccine programme, which should enter clinical testing by the end of April.

16 March:

• Merck KGaA postpones its Annual General Meeting scheduled for April 24 in Frankfurt am Main, Germany, to a later date due to the coronavirus pandemic.

• Johnson & Johnson says there is lack of evidence to suggest its HIV drug darunavir (DRV) can effectively treat COVID-19, citing “anecdotal, unsubstantiated reports” to the contrary.

• Biotech firm Moderna says the first patient has been dosed in a Phase I clinical trial of its mRNA vaccine against coronavirus at the US National Institutes of Health.

• Sanofi and Regeneron announce they are ready to start a multi-centre, double-blind, Phase 2/3 trial of their novel interleukin (IL)-6 receptor inhibitor Kevzara in patients hospitalised with severe COVID-19. The first part will recruit patients with severe COVID-19 infection across around 16 US sites and will evaluate the impact of Kevzara on fever and patients' need for supplemental oxygen. The second, larger part of the trial will evaluate the improvement in longer-term outcomes including preventing death and reducing the need for ventilation, supplemental oxygen and/or hospitalization.

• Armas Pharmaceuticals says it does not expect any COVID-19-related product disruptions. The generics firm says it is closely monitoring stock levels at its logistics provider and is in contact with supply chain partners, group purchasing organizations, wholesalers and distributors to oversee where it can assist in ensuring supply of its products.

• BioNTech says it has partnered with Fosun Pharma to develop the former’s potential COVID-19 vaccine BNT162 in China. Fosun Pharma will commercialize the vaccine in China upon regulatory approval, with BioNTech retaining full rights to develop and commercialize the vaccine in the rest of the world.

15 March:

• Biopharma firm Amarin says it has suspended all of its sales force's face-to-face activities for its lead product, Vascepa, until 30 March to help reduce the spread of COVID-19.

• The US Centers for Disease Control and Prevention recommends that for the next 8 weeks, organizers of mass gatherings of 50 people or more cancel or postpone them.

14 March:

• Medicines for Europe calls for “maximum, pan-European collaboration and coordination to succeed and limit the pandemic” and warns that the crisis “cannot hinge on national protectionism which could block the circulation of essential medicines.”

The generics industry association highlights three urgent actions to ensure Europe-wide supply of medicines:

1) All available Europe pharmaceutical manufacturing should be open and running at all times, avoidance of export restrictions on manufacturers of medicines or APIS and the creation of green lanes for the flow of medicines and ingredients across national borders.

2) Clear regulatory guidance to counter the stress on global supply chain made by production and logistics problems.

3) Analysis of the scenarios of the possible future spread of coronavirus to plan for possible future surges in demand.

13 March:

• Thermo Fisher Scientific says the US Food and Drug Administration has issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by CLIA high-complexity laboratories in the US to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.

• Novartis requests all employees in Europe, the US and Canada to work from home for the next three weeks effective Monday, 16 March, except for those working in laboratories, manufacturing sites and in the field.

• Pfizer promises to make available its manufacturing capabilities for approved therapies or vaccines for COVID-19 that need to be rapidly scaled and deployed. “As one of the largest manufacturers of vaccines and therapeutics, Pfizer is committed to using any excess manufacturing capacity and to potentially shifting production to support others in rapidly getting these life-saving breakthroughs into the hands of patients as quickly as possible,” the pharma company says.

• Describing its medicines supply chain as “robust,” AstraZeneca says it has implemented temporary measures to help reduce the risk of COVID-19 infection. “These include leveraging digital technology to support working-from-home, as well as restricting business travel, off-site meetings and external visitors to AstraZeneca sites,” it says.

On the research side, AstraZeneca says it has rapidly mobilised research efforts to discovering novel coronavirus-neutralising antibodies as a treatment to prevent COVID-19: “Our teams are now focused on identifying monoclonal antibodies to progress into clinical trial evaluation.”

• The US Food and Drug Administration says it has granted an Emergency Use Authorization (EUA) for Roche’s cobas SARS-CoV-2 Test within 24 hours of receiving the application. The EUA is the third granted for a diagnostic test during the COVID-19 outbreak.

12 March:

• AbCellera and Eli Lilly agree to co-develop antibody products derived from blood samples from one of the first US patients who recovered from COVID-19, for the treatment and prevention of the disease.

• CDMO Catalent says it has not identified any significant COVID-19-related risk to its supply chain that may have a substantial effect on delivery of any product or clinical trial supplies. It says all sites are fully operational and it has established a dedicated senior leadership team and specific procedures “to assure that we minimize and manage any future disruption to our ongoing operations for the continued supply of clinical and commercial materials, products, and services.”

• Indian pharmaceutical supply chain disruption could be far greater than the China environmental regulation-induced shortfall of 2017 If the COVID-19 outbreak is not contained within the next three months, says credit ratings agency India Ratings and Research.

• The COVID-19 death toll in Italy surpasses 1,000, with 189 new fatalities in just over two weeks, the Italian government announces.

• Informa announces CPhI North America 2020, originally scheduled on 5-7 May, has been postponed to 9-11 September. The exhibition will still take place at the Pennsylvania Convention Center in Philadelphia.

• The Asian Development Bank says it will make available USD 200 million through its supply chain finance program for companies manufacturing and distributing medicines and other items to combat COVID-19.

• Bristol Myers Squibb says it is strongly encouraging its global workforce, including employees, contingent workers and contractors, to work remotely if they can, effective 13 March. The pharma company has also expanded restrictions on visitors to its sites and in-person meetings.

• Vir Biotechnology and Biogen sign a letter of intent for the development and manufacturing of human monoclonal antibodies for the potential treatment of COVID-19. Because of the urgency of the situation, the companies say they have begun work while a definitive agreement is being negotiated. Biogen would continue cell line development, process development, and clinical manufacturing activities in order to advance the development of Vir’s proprietary antibodies.

• Genentech says two people who were at its South San Francisco campus on 2 March have since tested positive for COVID-19. The biotech firm says it is encouraging employees to work from home where possible, restricting global and domestic company air travel and cancelling or postponing large meetings.

• India’s Ministry of Environment, Forests and Climate Change says to ensure drug availability to reduce the impact of the COVID-19 outbreak, it will expedite environmental clearances for bulk drug projects -- including API and intermediate production -- within the country.

11 March:

• In a COVID-19 update, GE Healthcare Life Sciences says it is experiencing “limited disruptions from suppliers and transport is becoming increasingly challenging.” The CDMO says it is holding daily cross-functional call with its logistics, customer service and sales & operations planning to review shipments. It says it is moving materials to regional warehouses 10-14 days earlier than normal to mitigate potential delays caused by flight cancellations. “At this time, we are not experiencing delays or impact to our manufacturing capabilities,” it says.

• CDMO WuXi AppTec says its Wuhan site has resumed operations, in compliance with local regulations and global COVID-19 health and safety guidelines. Operations at the facility, which provides discovery chemistry services, will ramp up over the coming days and weeks.

• US President Donald Trump announces travel restrictions from Europe to the US on foreign nationals who have travelled to any of the 26 European countries in the Schengen Area in the past 14 days before coming to the US, effective midnight 13 March.

• Italy’s prime minister Giuseppe Conte announces a closure of all ‘non-essential’ shops except supermarkets and pharmacies as reported cases of COVID-19 in the country top 12,000.

• Lilly confirms that an employee in Indianapolis has tested positive for COVID-19.

• Declaring COVID-19 a pandemic, the World Health Organisation is “deeply concerned both by the alarming levels of spread and severity, and by the alarming levels of inaction,” says director-general Dr Tedros Ghebreyesus.

• Biotech firm Tiziana Life Sciences says it is expediting development of its anti-interleukin-6-receptor mAb, TZLS-501, for treatment of patients infected with COVID-19. An excessive production of IL-6 is regarded as a key driver of chronic inflammation and is believed to be associated with severe lung damage observed with COVID-19 infections and acute respiratory illness, it says.

• Novartis is the latest pharma company to say it does not anticipate supply chain disruption at the present time. “Where required, we have enacted mitigation plans to ensure ongoing drug supply to depots for our clinical studies, and we are working closely with the authorities on dispensing to trial participants,” it says.

The Swiss firm says that as well as evaluating existing products to see if any could be repurposed, it will make available from its libraries a set of compounds that it considers suitable for in vitro antiviral testing, in response to the European Federation of Pharmaceutical Industries and Association’s urgent call for R&D on coronavirus.

• The number of reported COVID-19 cases in the US rises to 1,312, with 38 deaths.

10 March:

• Several bodies representing Italy’s pharmaceutical supply chain, including industry associations Farmindustria and Federfarma say “the seriousness of the [COVID-19] situation requires us to guarantee, as always, our maximum commitment in the production and distribution of medicines to the nation.”

• The US Food and Drug Administration postpones “most foreign inspections” through April in response to the COVID-19 outbreak. Inspections outside the US deemed mission-critical will be considered on a case-by-case basis, it says. The regulator had already suspended on-the-ground inspections in China, the source of the outbreak, but the new restrictions will include India, a key supplier of active pharmaceutical ingredients (APIs) and generic medicines.

• Generics firm Teva says it is taking measures to ensure the reliability of its global supply chain and identifying opportunities for its pharma and API businesses to address potential shortages in affected markets. It says the only impact so far on its API network is the closure of one small API site in China, with preparations for restart progressing.

• Roche asks all of its 1,200 Spanish employees to work remotely as of Wednesday amid the COVID-19 outbreak. “The company will maintain its normal activity and will guarantee, as until now, the supply of medicines to hospitals,” the Swiss firm says. The number of reported cases in Spain has risen to 1,646 as of Tuesday, with 28 deaths.

• The European Medicines Agency says it is closely monitoring the potential impact of the COVID-19 outbreak on pharmaceutical supply chains into the EU. While no shortages or supply disruptions of medicines marketed in the EU due to COVID-19 have been reported, it says that as the public health emergency develops, shortages or disruptions “cannot be excluded.”

Along with the European Commission and member state national competent authorities, the EMA has organised the first meeting of the EU Executive Steering Group on medicine shortages caused by major events to discuss measures aimed at addressing the impact of COVID-19 on EU medicines supply.

The group will identify and coordinate EU-wide actions when medicines are at risk of supply shortage due to a temporary lockdown of manufacturing sites in areas affected by COVID-19 or travel restrictions impacting shipment.

The EMA also highlights “the responsibility of pharmaceutical companies to ensure the continuity of supply of their medicines,” with manufacturers expected to put in place appropriate resilience measures such as the increase of stocks or dual sourcing of products and materials.

• The Indian Pharmaceutical Alliance and the Indian Drug Manufacturers’ Association write to the Indian government, asking it to reverse restrictions on API exports, claiming they have surplus stock to deal with any shortages.

9 March:

• As Italy’s reported cases of COVID-19 top 10,000 and the death toll rises from 366 to 463 Monday, the government extends emergency measures – including travel restrictions and bans on public gatherings – to the entire country.

• Vertex Pharmaceuticals says the coronavirus outbreak has not had any impact on its supply chain. “We are well-prepared from a business continuity perspective, with ample supply to meet commercial needs well into the future,” says CEO Jeffrey Leiden.

• The Bill & Melinda Gates Foundation and charities Wellcome Trust and Mastercard Impact fund pledge up to USD 125 million on an initiative to help development of treatments for coronavirus. The COVID-19 Therapeutics Accelerator will first focus on testing antiviral drugs that have already gone through preclinical development.

• In an internal memo, Lilly asks US employees to work from home if possible, to reduce the risk of transmission to workers using specialised equipment in manufacturing facilities and R&D labs who do not have the option of working from home.

•Swedish CDMO Recipharm says it expects some of its facilities in the restricted zone of northern Italy to operate at a lower capacity than normal over the coming days but stresses that currently, they continue to “receive materials, manufacture and deliver routinely.”

• Innovation Pharmaceuticals says its defensin mimetic candidate, Brilacidin, has been shipped to one of the US’s regional biocontainment labs for testing against coronavirus.

7 March:

• As the global number of confirmed COVID-19 cases surpasses 100,000, the WHO says the spread of the virus can be significantly slowed or even reversed through the implementation of robust containment and control activities such as identifying sick people, bringing them to care following up on contacts, preparing hospitals to manage a surge in patients, and training health workers.

6 March:

• The South Korean Ministry of Food and Drug Safety approves phase II clinical trial of Gilead’s remdesivir on 100 hospitalised COVID-19 patients.

• Biogen says all attendees of a recent employee meeting in Boston have been directed to work from home for two weeks after three of them tested positive for COVID-19. The biotech firm said it is also restricting business travel through the end of March.

• Amgen says it has suspended international business travel and attendance at medical congresses, conferences and other large events until 17 April. Based on current inventory levels, the firm says it does not anticipate a shortage of its medicines.

• South Korean CDMO Samsung Biologics confirms that to date, no employees at its Songdo facility have been diagnosed with COVID-19. It says it is conducting daily assessments of the potential impact on its supply chain and business activities.

5 March:

• India’s Minister of Chemicals and Fertilizers, DV Sadananda Gowda says API stocks are sufficient for another three months of manufacturing. Minister of State for Chemicals and Fertilizers, Mansukh Mandaviya is leading a task force to look at increasing Indian API production.

• Mairead McGuinness, first vice-president of the European Parliament says MEPs will debate the potential shortage of medicines in Europe on 11 March, given the increasing strain on global public health services and pharmaceutical supply chains due to the spread of coronavirus.

• Quest Diagnostics says it will be in a position to receive specimens and start conducting a test for coronavirus for US patients by next Monday (9 March), pending review by the FDA under emergency use authorization.

• Merck KGaA says it is difficult to determine the potential impact of coronavirus on general economic developments and its own business and it has developed various scenarios. “According to the scenario being applied right now, the epidemic will reach its high point in the first quarter and subside in the course of the second quarter,” before normalizing in H2, the company says, adding that based on these assumptions, it would expect a negative effect of -1% on 2020 net sales. “Should the crisis grow or trigger a global recession, the company would adapt its business forecast,” Merck KGaA concludes.

4 March:

• Xinhua News, China’s official state-run news agency, posts an article saying that if China bans exports of pharmaceutical products to the US, the US will be “plunged into the mighty sea of coronavirus.”

• Dr. Julie Gerberding, executive vice president at Merck & Co. and former director of the US Centers for Disease Control and Prevention cautions people “not to overpromise on the timeline of the vaccine availability” citing longer clinical development and more difficult manufacturing.

• Vir Biotechnology and Alnylam Pharmaceuticals expand their existing collaboration to include the development and commercialisation of RNAi (RNA interference) therapeutics targeting SARS-COV-2, the virus that causes COVID-19.

• China’s National Health Commission updates treatments guidelines saying Roche’s rheumatoid arthritis drug, Actemra (tocilizumab) can be used to treat some coronavirus patients with serious lung damage from uncontrolled immune response.

• Japan’s Takeda Pharma says it is developing a plasma-derived hyperimmune globulin therapy (TAK-888) to treat high-risk patients with COVID-19 and will share its plans with US Congress members. It is also exploring whether its currently marketed and pipeline products could be viable candidates for the treatment of COVID-19.

• Total reported cases of COVID-19: 92,943 and 3,160 deaths: WHO.

3 March:

• Inovio Pharmaceuticals announces an accelerated timeline for developing its DNA vaccine INO-4800 to address COVID-19. The company plans to begin human clinical trials in the US in April and then in China and South Korea. It plans to deliver one million doses by year-end based on existing resources and capacity.

• Amid concern about the impact of coronavirus, major drug maker Lilly says it does not anticipate shortages for any of its products, including all forms of insulin. It says it does not source APIs for any of its approved medicines from China, while its insulin manufacturing sites in the US and Europe have not been affected by coronavirus.

• India restricts exports of 26 APIs including antibiotics, vitamins and hormones with immediate effect, according to a Directorate General of Foreign Trade notification. The move is understood to ensure no shortages of drugs as a result of China’s current lockdown.

2 March:

• World Health Organisation director-general Dr Tedros Ghebreyesus says containment of COVID-19 is “feasible and must remain the top priority for all countries.”

• China reports 206 cases of COVID-19 over the last 24 hours, the lowest since 22 January, according to the WHO.

• Outside China, 8,739 cases reported from 61 countries, with 127 deaths: WHO.

• US President Donald Trump meets with pharmaceutical executives at the White House, wanting to hear about progress on therapies and vaccines for COVID-19. According to latest estimates, a vaccine is 12-18 months away, while a therapeutic treatment could be developed within months.

• Sun Pharma says there is a shortage of APIs for its generic hypertension drug, pindolol, brand name Visken, in the US but that it was not due to the Chinese situation.

• Bristol Myers Squibb says it has restricted employee business travel globally and is monitoring manufacturing and supply facilities across the globe. “At this time we do not anticipate disruptions to the supply of our medicines for patients due to COVID-19,” it says.

28 Feb:

• China reports 329 cases in last 24 hours – the lowest in more than a month, according to the WHO.

• China reported cases: 78,959 cases and 2,791 deaths: WHO.

• Outside China, 4,351 cases in 49 countries, and 67 deaths: WHO.

27 Feb:

• The US Food and Drug Administration reports the first case of a pharmaceutical drug shortage directly related to the global coronavirus (COVID-19) outbreak. In a supply chain update, the agency’s commissioner of food and drugs, Stephen Hahn says a manufacturer has alerted the FDA to an unnamed human drug that has recently been added to the drugs shortages list due to an API shortage caused by a site affected by coronavirus.

• In an earnings call, Mylan president Rajiv Malik says the firm has alternative arrangements for API supply and does not see any immediate coronavirus impact, unless the situation persists for another few months.

26 Feb:

• Sandoz commits to keep prices stable of certain essential medicines it markets that may help in the treatment of COVID-19 cases “despite current uncertainties about how the supply situation will evolve.” Novartis’ generics subsidiary singles out antivirals to reduce the impact of coronavirus and antibiotics to combat pneumonia.

• In an SEC filing, Merck & Co warns that “the outbreak of the virus has caused material disruptions to the Chinese economy, including its health care system, which will have a negative effect on the company’s first quarter 2020 results which, at this time, is not expected to be material." Merck adds that the outbreak of COVID-19 has so far had a limited effect on its supply chain of drugs into and raw materials out of China.


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