Scrip: industry news and insights
26 Nov 2020
Executive appointments at MyoKardia, Scancell Holdings and Sutro Biopharma
In addition to the shortages for ventilators due to the COVID-19 pandemic, health care services company Vizient has found that many medicines needed by ventilator patients are in shortage or may soon be due to the surge in demand.
Vizient reviewed its member purchase data, which includes more than half of US hospitals and health systems, to look at orders from 1-24 March and compare that to a baseline period of 2-25 January. In several key areas, the data show demand has clearly been outstripping supply.
The pandemic impact meant a 51% increase in demand for sedatives and anesthetics in March – including dexmedetomidine, etomidate, ketamine, lorazepam, midazolam and propofol – while the fill rate dropped to 63%. Analgesic purchases – including hydromorphone, fentanyl and morphine – were up 67% with a 73% reduction in fill rate, and there was a 39% increase in demand for neuromuscular blockers – including cisatricurium, rocuronium, succinylcholine chloride and vecuronium – with a 70% fill rate.
“What we are seeing now is some products that are in shortage and others that are in a very tight market. The data show that orders placed are not being completely filled and it is spiraling toward a major shortage of the medications necessary for patients who require a ventilator,” said Dan Kistner, group senior VP of pharmacy solutions for Vizient.
Vizient is calling for the US Food and Drug Administration to approve new lines of manufacturing for these critical drugs, to provide flexibility for compounders to produce any essential medications regardless of their current stocking status, and to work with other government agencies, wholesale distributors and hospitals to develop allocation strategies.
After days of reporting no confirmed home-grown COVID-19 cases, China now adds asymptotic cases to the daily count. As of March 31, China reported 1,367 infected coronavirus cases who are diagnosed but have not shown symptoms. Meanwhile, there are 691 imported cases, which are people who have entered the country and diagnosed with the virus infection, out of them 20 are severe cases. China also reported 169 suspected cases.
There has been suspicion that China is under-reporting its confirmed cases, and to that end, Chinese Premier Li Keqiang has explicitly required local governments to report confirmed cases and asymptotic cases without delay.
Some of the leading US-based big pharma companies announced a medical service volunteer program “to enable employees who are licensed medical professionals to aid in the fight against COVID-19 while maintaining their base pay.”
An announcement on 1 April from Pfizer Inc., Merck & Co. Inc. and Eli Lilly & Co. states that “together, these three major biopharmaceutical companies employ thousands of doctors, nurses, pharmacists, medical laboratory technicians and other medical professionals whose services are in high demand during the COVID-19 pandemic.”
All three companies are allowing licensed medical professionals to volunteer, while Lilly is also using its medical professional employees to open a free drive-through COVID-19 testing facility at its Indianapolis headquarters. “The testing facility serves active front-line health care workers and first responders,” the firm noted. “Lilly scientists are using the company’s specialized research laboratories to analyze the tests, as well as samples taken in Indiana health care facilities, including nursing homes and emergency rooms, in partnership with the Indiana State Department of Health.”
The COVID-19 pandemic is prompting big pharma players to hold their annual shareholder meetings online only, in virtual formats. The latest to announce that approach include Baxter International Inc., Sanofi and Johnson & Johnson.
Baxter and J&J shareholders have been told that although they will not be able to attend the meetings in person, voting on resolutions and the submission of questions will be possible online during the AGM by eligible stakeholders.
Sanofi has told its shareholders it would not be possible for them to ask questions nor to submit draft amendments or new resolutions during their virtual AGM and that they are instead invited to exercise their right to vote prior to the general meeting through the provided internet platform.
Studies of two potential agents against COVID-19 have begun in the UK as the epidemic there grows. Synairgen PLC has started dosing of its inhaled beta-interferon and Gilead Sciences Inc. has started the UK arm of its two Phase III trials of remdesivir.
UK-based Synairgen has begun dosing in its Phase II trial SNG001, a special formulation of interferon beta (IFN-beta) for inhalation. The company announced last month that it would redirect development of the product from COPD for the time being to focus on tackling coronavirus. (Also see "Coronavirus Update: Synairgen Tests First Inhaled Candidate, No New China Cases" - Scrip, 19 Mar, 2020.)
SNG001 has been highlighted as being of interest because of its inhaled route of administration. Synairgen said the addition of exogenous IFN-beta before or during viral infection of lung cells either prevents or greatly diminishes cell damage and viral replication.
The first patient has been dosed at the initial trial site (University Hospital Southampton NHS Foundation Trust) and dosing is expected to start at a further six trial sites in the coming days. 100 patients are planned to be enrolled.
Gilead, meanwhile, has started the UK arm of its two Phase III randomized studies of remdesivir in patients with moderate to severe COVID-19, after they were given urgent public health research status by the Chief Medical Officer. 15 UK centers will be involved initially.
Gilead’s Phase III remdesivir studies for coronavirus have already begun in the US and will take place in 15 counties overall; the company said it was trying to act as quickly as possible to commence the trials in all of these. (Also see "Coronavirus: Gilead Readies For Remdesivir Ramp Up, Questions On Profit Motive" - Scrip, 3 Mar, 2020.)
The open-label, multicenter trials will assess the safety and efficacy of the drug in nearly 1,000 patients. A five-day and 10-day dosing regimen of an intravenous formulation of remdesivir will be tested. (Also see "COVID-19 Study Of Gilead’s Remdesivir Using Ebola-Style Adaptive Platform Trial" - Pink Sheet, 17 Mar, 2020.)
Siu Ping Lam, director of licensing division of the UK’s MHRA, said the UK regulator was keen to expedite promising trials: “The MHRA is ready to prioritize and provide any assistance for clinical trials and other regulatory applications in response to COVID-19, in line with government priorities. We have procedures for rapid scientific advice, reviews and approvals and are ready to support manufacturers, researchers and other regulators. We have dedicated resources to ensure this happens, as we did during the Ebola crisis when we authorized clinical trial applications within a week.”
Faron Pharmaceuticals Oy's acute respiratory distress syndrome therapy Traumakine, which has suffered a number of clinical setbacks, is going to be tested in a major trial evaluating potential treatments for COVID-19.
The Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) program has been running for some years at over 50 sites worldwide but is now recruiting community-acquired pneumonia patients who have the novel coronavirus. The study has several existing treatment domains including antibiotic and hydrocortisone arms but now, in collaboration with Finland-based Faron, a new immune-modulatory arm has been established to include Traumakine (intravenous interferon beta-1a).
The study plans to include 6,800 patients from Asia-Pacific, Europe and Canada and Faron will provide its product to all sites.
The development pathway for Traumakine has not been smooth and in 2018, the drug failed to meet its primary endpoint in the Phase III INTEREST trial which Faron said was due in part to concomitant use of steroids which likely blocked the effect of interferon beta-1. Earlier this month, the company received the backing of the US Food and Drug Administration for a new study of Traumakine that should exclude the use of concomitant glucocorticoids "since they are likely to block the desired therapeutic effect of Traumakine and may have a potentially deleterious impact on patient survival." (Also see "Can Fresh INTEREST Breathe New Life Into Faron's Traumakine? " - Scrip, 6 Dec, 2018.) (Also see "Faron’s Traumakine Flops In Phase III" - Scrip, 8 May, 2018.)
Commenting on the REMAP-CAP study, Faron CEO Markku Jalkanen noted that it would also provide a direct efficacy comparison between Traumakine and hydrocortisone and "further prospective data on the concomitant use of these treatments, following previous observations that the use of overlapping corticosteroids are likely to have a deleterious effect on IFN beta-1.”
Kleo Pharmaceuticals Inc., specialist in bispecific compounds designed to emulate or enhance the activity of biologics, has entered into a research collaboration with South Korea-based Green Cross LabCell to advance testing of the firms' combined technology platforms as a potential therapy for COVID-19. GC LabCell has allogeneic natural killer (NK) cell therapies in late clinical development in immuno-oncology and is an affiliate of South Korean pharma firm GC Pharma.
Earlier this year, Kleo received US approval to proceed with an antibody recruiting molecule (ARM)/NK cell combination therapy in a clinical trial for newly diagnosed, multiple myeloma patients. The US firm says its platform has speed and modularity and the aim is to start trials in the second half. Initial studies will be conducted with the National Institute of Allergy and Infectious Diseases and a team at Korea's Chungbuk National University College of Medicine.
Kleo’s ARM technology platform can rapidly develop fully synthetic bifunctional molecules that redirect a patient’s own antibodies for therapeutic effect. In the context of a COVID-19 therapeutic, the ARM has multiple proposed mechanisms of action: as a neutralizing antibody to block direct binding of the virus to human cells, and enlisting of immune effector cells to eliminate viral particles and/or infected cells. The ARM can also produce a long-term vaccination effect by activating and expanding immune memory cells.
GC Pharma is also developing a subunit vaccine for COVID-19 and exploring therapeutic antibody candidates by separating B-cells from patients’ blood and using genetic recombination technology. Another group affiliate, GC Medical Science, is co-developing an RT-qPCR coronavirus testing kit with GeneCast.
[Editor's note: A new Coronavirus Analytic Solution including comprehensive integrated data on clinical trials, pipeline, market events and insights from across Pharma Intelligence’s suite of products, updated daily, is now available. Contact Duncan Emerton, director of custom intelligence & analytics, for details (separate purchase required).]
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