Nabriva Therapeutics plc (NASDAQ:NBRV) has reported financial results for the quarter ended September 30, 2020, and also offered a business update.
Nabriva enhances sales team for XENLETA and SIVEXTRO
Ted Schroeder, Nabriva’s CEO, said that the company commenced the quarter with a business development deal with Merck & Co for promotion and distribution of SIVEXTRO in the US. The transaction was among the several components of the company’s plan towards establishing community-focused sales effort alongside the continued expansion of the managed care coverage and deployment of the Amplity sales team. Schroeder confirmed that since late September the company had 15 Amplity sales representatives in the field promoting XENLETA and SIVEXTRO.
Already there has been encouraging indications for SIVEXTRO because of its brand recognition with enhanced access to physicians. Schroeder confirmed that Nabriva leveraged Amplity’s experience during the pandemic to target the most accessible healthcare provider. Because of the favourable experience so far, another 45 professional representatives will be placed in select locations this month. The company estimates that the expanded Amplity team will call around 8,000 health care providers to reach around 60% of the historical SIVEXTRO prescribers and around 57% of projected SENLETA prescribers. Since almost half of the physicians are potential subscribers of the brands, Nabriva will be in a better position to establish a right-sized organization to boost demand for the products.
CONTEPO NDA among affected reviews due to COVID-19
In late October 30, 2020, the company had a Type A meeting with the FDA for new information regarding the pending FDA conduct of reviews of foreign manufacturers over delays in product reviews due to the pandemic. The company’ New Drug Application for CONTEPO is among the affected reviews. The FDA indicated that it has not determined how to carry international inspections because of the pandemic. Therefore the company will finalize the next steps and specific timing for resubmission of CONTEPO NDA after the FDA has given guidance. However, the FDA hasn’t requested any new non-clinical or clinical data, and there were no concerns regarding CONTEPO’s efficacy and safety.