TORRANCE, Calif., Nov. 10, 2020 /PRNewswire/ -- Emmaus Life Sciences (Formerly Known As Emmaus Medical, Inc.), Inc. (OTC: EMMA), a leader in the treatment of sickle cell disease, announced today that it has submitted a temporary license application for Endari® to the National Health Regulatory Authority in the Kingdom of Bahrain. Approval of the temporary application takes one to two months and is a prerequisite for Marketing Authorization Approval (MAA). Upon approval of the temporary license application, Emmaus will apply for MAA, which typically takes twelve months. The temporary license will allow Endari® to be prescribed in Bahrain pending MAA.
"This submission of a temporary license application for Endari is another important step in 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.
It is estimated that approximately 1% of the total population of 1.7 million in the Kingdom of Bahrain has sickle cell disease. Throughout the MENA (Middle East North Africa) region, Emmaus estimates that there are approximately 225,000 sickle cell disease patients that could potentially be treated with Endari®.
Endari®, Emmaus' prescription grade L-glutamine oral powder, was approved by the FDA in July 2017 for treating sickle cell disease in adult and pediatric patients five years of age and older. Sales of Endari® began in the United States in 2018.
George Sekulich, Senior Vice President of Global Commercialization of Emmaus added, "We look forward to continue enhancing Emmaus' partnership with the hematologists and patient advocacy groups in the Kingdom of Bahrain to provide sickle cell disease patients with Endari and a better quality of life."
About Emmaus Life Sciences
Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company engaged in the discovery, development, marketing and sale of innovative treatments and therapies, including those in the rare and orphan disease categories. For more information, please visit www.emmausmedical.com.
About Endari® (prescription grade L-glutamine oral powder)
Indication - Endari is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Important Safety Information
The most common adverse reactions (incidence >10 percent) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremities, back pain, and chest pain.
Adverse reactions leading to treatment discontinuation included one case each of hypersplenism, abdominal pain, dyspepsia, burning sensation, and hot flash.
The safety and efficacy of Endari in pediatric patients with sickle cell disease younger than five years of age has not been established.
For more information, please see full Prescribing Information of Endari at: www.ENDARIrx.co/PI.
About Sickle Cell Disease
Sickle cell disease is an inherited blood disorder characterized by the production of an altered form of hemoglobin which polymerizes and becomes fibrous, causing red blood cells to become rigid and change form so that they appear sickle shaped instead of soft and rounded. Patients with sickle cell disease suffer from debilitating episodes of sickle cell crises, which occur when the rigid, adhesive and inflexible red blood cells occlude blood vessels. Sickle cell crises cause excruciating pain as a result of insufficient oxygen being delivered to tissue, referred to as tissue ischemia, and inflammation. These events may lead to organ damage, stroke, pulmonary complications, skin ulceration, infection and a variety of other adverse outcomes. Sickle cell disease is a significant unmet medical need, affecting approximately one hundred thousand patients in the U.S. and millions worldwide, the majority of which are of African descent. An estimated 1-in-365 African American children are born with sickle cell disease.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding the prospective marketing approval of Endari® in the Kingdom of Bahrain. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including uncertainties related to the future sales of Endari® in the Kingdom of Bahrain and the MENA region, Emmaus' working capital and ability to carry on its existing operations and obtain needed financing and up-listing of Emmaus' common stock and other factors previously disclosed in the company's reports filed with the Securities and Exchange Commission, and actual results may differ materially. Such forward-looking statements speak only as of the date they are made, and Emmaus assumes no duty to update them, except as may be required by law.
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SOURCE Emmaus Life Sciences, Inc.