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Emmaus Life Sciences announces Bahrain temporary license of Endari

August 18, 2021
government

Emmaus Life Sciences, Inc. (OTC: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, announced that on August 12, 2021, the National Health Regulatory Authority (NHRA) of the Kingdom of Bahrain approved a Temporary License for Importation of Pharmaceutical Product for Endari.® The Pharmaceutical Products Regulation Department of the NHRA is responsible for ensuring the quality, safety, and efficacy of pharmaceutical products in the Kingdom of Bahrain. Endari®, Emmaus’ prescription grade L-glutamine oral powder, is approved by the United States Food and Drug Administration for treating sickle cell disease in adult and pediatric patients five years of age and older.

With a total population of 1.8 million, the incidence of sickle cell disease in the Kingdom of Bahrain is estimated at 2.1%. Emmaus is in the process of applying for marketing authorization for Endari.® In the meantime, the NHRA approval permits the importation of Endari in the Kingdom for up to 12 months to treat sickle cell disease patients on an early access basis to address an unmet medical need. Emmaus estimates that there are approximately 225,000 sickle cell disease patients that are reachable and could potentially be treated with Endari® throughout the Middle East and North Africa (MENA) region.ADVERTISING

“We are pleased that the NHRA has approved Endari on a temporary basis. Along with the submission of our marketing authorization applications to the Saudi Food and Drug Authority and the Kuwait Food and Drug Control earlier this year, the temporary license approval is another important step in our meeting our commitment to serve sickle cell disease patients in the MENA region,” said Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus.

George Sekulich, Senior Vice President of Global Commercialization of Emmaus added, “While we prepare our first shipment of Endari to our distributor in Bahrain, we are working to build our relationships with the hematologists and patient advocacy groups in the Kingdom. In addition, Emmaus continues collaborating with clinicians on providing Endari on a named-patient basis in the Bahrain and the wider MENA region.”

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