Biophytis and Innovation Solutions Pharma sign a partnership agreement to accelerate market access for Sarconeos (BIO101) in Brazil
Biophytis announces the signature of a partnership with Innovation Solutions Pharma, a company specializing in support for clinical development and drug registration operations in South America, with a view to accelerate market access for Sarconeos (BIO101) in Brazil.
As part of this partnership, Innovative Solutions Pharma will represent Biophytis in front of the Brazilian agency ANVISA to lift the suspension of the Early Access Program (EAP) authorized at the beginning of 2022. This program will enable a maximum of 80 patients suffering from critical forms of COVID-19 to be treated for 28 days under mechanical ventilation in the intensive care units of Brazilian hospitals. The aim is to offer a therapeutic alternative to prevent death of these patients.
While the number of patients hospitalized with COVID-19 is currently rising sharply in Brazil and around the world, there are still very few options available for treating severe forms of the disease.
ANVISA’s approval of an EAP is based primarily on the following criteria:
- The product is intended for patients suffering from a serious disabling and/or life-threatening disease.
- There is no satisfactory therapeutic alternative in the treatments already registered in Brazil.
- Authorization to use the product is granted on request, and only under the responsibility of the prescribing practitioner, as it is likely to be of significant benefit to the patient.
Stanislas Veillet, Chief Executive Officer of Biophytis, stated: “Making Sarconeos (BIO101) available to Brazilian patients hospitalized in intensive care due to Covid-19 represents a key step towards bringing our treatment to market. This program will enable us to treat critical patients and generate important new information on the safety and efficacy of our treatment in real-life conditions. Biophytis aims to start this early access program in Brazil in the first quarter of 2024, and to continue expanding our early access program in France and in other countries.”