Our team took a look at the most recent pharmaceutical developments from the week, including where we are with treatment options and how manufacturers are racing to find an effective treatment for COVID-19.
COVID-19 has had significant effects across the healthcare system
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TAKEAWAYS: |
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PATIENTS / PHYSICIANS
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Treating COVID-19 patients is a top priority, but it will also remain important to treat other chronic conditions |
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PAYERS
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Manufactures can expect P&T review cycle to remain as is, but should consider bringing the most critical business issues into meetings |
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SUPPLIERS / LOGISTICAL
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Manufacturers will need to find new ways to navigate supply chain issues and generic ingredient sourcing and may need to increase resources dedicated toward generics |
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MEDICARE / MEDICAID
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Medicare reimbursement will not change as a result of COVID-19 and Medicare patients will maintain access to doctor visits and critical medications |
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PHARMA / BIOTECH
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It will remain important to prioritize innovative therapies as well as treatments and vaccines for COVID-19 |
There are several vaccines and drug candidates in development which could help prevent or treat COVID-19
VACCINES*
| INO-4800 (Inovio) | Inovio said its Phase 1 U.S. clinical test for INO-4800 is fully enrolled with all 40 healthy volunteers receiving their first dose, with interim immune responses and safety results expected in late June |
| Ad5-nCoV (CanSino) | Genetically engineered vaccine building off the platform used to develop an Ebola vaccine; this vaccine recently entered Phase 2 clinical trials |
| mRNA-1273 (Moderna) | The phase 2 study is expected to begin in the second quarter. That will evaluate the safety and any adverse reactions and immune responses of two mRNA-1273 vaccinations given 28 days apart |
| Pfizer & BioNTech (BNT-162) | Pfizer announced a joint venture with BioNtech to develop and distribute BioNTech’s mRNA based COVID-19 vaccine candidate BNT-162 |
| Dynavax | Working with the University of Queensland to develop a vaccine for COVID-19. It would make its vaccine adjuvant technology available to other companies working on a vaccine through CEPI |
| Curevac | Curevac has begun work on its COVID-19 vaccine and plans to enter clinical trials with its lead vaccine candidate in June 2020 |
TREATMENTS
| Remdesivir (Gilead) | Data from the open-label SIMPLE trial, show that remdesivir may accelerate recovery rates among patients with advanced Covid-19 |
| Chloroquine (Rising Pharmaceuticals) | Donated Hydroxychloroquine tablets in support of a Phase 2 trial exploring hydroxychloroquine as preventive treatment for COVID-19 in patients with cancer who are receiving radiation therapy |
| Actemra (Roche) | FDA approved a Phase 3 trial of Actemra (tocilizumab) in COVID-19 patients with pneumonia |
| Kaletra/Aluvia (AbbVie) | An HIV medication that showed promise but failed to meet endpoints in an early study; however, it is possible that this drug could be more effective if administered sooner after disease onset |
| Kevzara (Sanofi/Regeneron) | Kevzara delivered disappointing results in their clinical studies, which would have helped ease the immune system’s overreaction to the virus |
| TAKE-888 (Takeda) | A blood plasma derived therapy in development; this treatment depends on the company’s ability to obtain enough blood plasma of recovered patients |
| Vir (VIR-7831 & VIR-7832) | The pair’s (GSK has invested $250 million) immediate focus will be VIR-7831 and VIR-7832 in which they plan to move the candidates into a phase 2 clinical trial in the next three to five months |
| Eli Lilly & AbCellera | Lilly is working with biotechnology company AbCellera, to develop a treatment based on antibodies present in the blood of patients who’ve recovered from Covid-19, trials to start end of May |
| Emergent BioSolutions | Begun the development of two candidate hyperimmune products against the disease. It will aim to leverage the immune response in order to combat COVID-19 and are derived from antibodies |
| Novartis (canakinumab) | Novartis announced plans to initiate a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. Treat a type of immune overreaction in people with COVID-19 pneumonia |
| Novavax Inc (NVX-CoV2373) | The company has now identified its lead vaccine candidate, NVX-CoV2373 and will initiate a first-in-human trial |
| Incyte (Jakafi) | Plan to test Jakafi in a second phase 3 trial for COVID-19 patients with acute respiratory distress syndrome. Jakafi’s safety and efficacy over standard of care in ARDS patients who need ventilators |
*Non-exhaustive list. As of May 17, there were a total of 82 active Phase II trials; J&J/Janssen and Sanofi Pasteur are also developing vaccines.
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