Insmed recently implemented a number of corporate initiatives in response to the novel coronavirus (SARS-CoV-2) global pandemic which manifests as COVID-19. These include a remote working policy for all employees in order to aid the global containment effort and allow infectious disease specialists and pulmonologists to focus exclusively on treating patients and containing the virus. This policy was implemented with the protection of the Company’s employees and patients in mind as its patients are particularly vulnerable to infection with potentially serious life-threatening consequences. The policy includes all of the field-based therapeutic specialists and other “customer-facing” employees who support ARIKAYCE (amikacin liposome inhalation suspension) prescribers. Insmed’s Arikares Trainers will now offer remote training for patients who initiate treatment with ARIKAYCE rather than conducting in-person onboarding.
Importantly, Insmed has observed no disruptions to date in its supply chain for the production of ARIKAYCE. The Company believes it has adequate supply of finished product on hand to support its commercial efforts for at least the next 7 months, with production continuing, and sufficient active pharmaceutical ingredient used in ARIKAYCE to meet anticipated global requirements, including commercial, clinical, and compassionate use, through the end of 2022.
While Insmed has no current supply issues and continues to see use of ARIKAYCE, including new patient adds and continued prescription renewals, the general uncertainty regarding the impact of COVID-19 on the ARIKAYCE patient population and their physicians has led the Company to suspend its previously stated 2020 revenue guidance.
“Patients suffering from refractory NTM lung disease are typically older individuals with underlying lung conditions, and are often treated by pulmonologists and infectious disease specialists. These treating physicians are on the front lines in addressing this global pandemic and must now, understandably, focus their attention on COVID-19. We are active participants in the social distancing policy and recommend its adoption by others to try to help slow the spread of this virus and alleviate the demands on the US hospital system,” said Mr Lewis. “We are committed to the NTM community, and will continue to support them through these trying circumstances.”
The company also announced that it has submitted a New Drug Application in Japan for ARIKAYCE for the treatment of patients with NTM Lung Disease Caused by MAC; and that AstraZeneca has exercised an exclusive option to develop INS1007 in COPD and asthma.
Link to Press Release.