Saudi Pharmaceutical Industries and Medical Appliances Co. (SPIMACO) signed, on Nov. 27, a non-binding memorandum of understanding (MoU) with German biopharmaceutical firm, CureVac, to provide COVID-19 vaccine in the Kingdom.
The MoU stipulates that SPIMACO will apply for the necessary approvals from the Ministry of Health (MoH) and the Food and Drug Authority (FDA) for all regulatory requirements related to the registration, supply and distribution of the vaccine, and then may agree on the final agreement on the commercial terms.
The MoU includes the possibility of extending the supply and distribution rights later, to include the UAE, Kuwait, Bahrain, and Oman, the company said in a bourse statement.
The vaccine is characterized by its routine storage conditions (2-8) degrees Celsius, which facilitates the transportation and storage process.
CureVac conducted a successful Phase I dose finding clinical trials, and with very promising results, is proceeding to Phase IIb/III clinical trial, aiming to start rolling submission to the European Medicines Agency (EMA) during the first quarter of 2021 according to the plan set by the company.
The financial impact will be determined later after obtaining the necessary approvals from MoH and FDA, and upon signing the final commercial agreement.
The MoU comes within the framework of the efforts exerted by the Custodian of the Two Holy Mosques and the Crown Prince to confront COVID-19 pandemic, and to continue achieving the company's strategy to maintain drug security in Saudi Arabia.
Since the beginning of the pandemic, SPIMACO worked towards preserving and maintaining drug production capacity to cover the increasing demand in the local market, and through the efforts of the employees to produce more than 1.3 billion treatment units during the first nine months of 2020.
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