Emmaus Life Sciences Receives Endari® Marketing Authorization from the Israeli Ministry of Health
TORRANCE, Calif., June 29, 2020 (GLOBE NEWSWIRE) -- Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, announced today that it was issued a license from the Israeli Ministry of Health on June 17, 2020 granting marketing authorization for the commercial distribution and sale of Endari® in Israel.
Endari® is approved in Israel as in the U.S. as an amino acid indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus, commented, “We are very pleased that the Israeli Ministry of Health has issued this license to Emmaus. It represents another important step in providing increased access to Endari in the Middle East and North Africa region with its large and underserved sickle cell disease patient population.”
George Sekulich, Senior Vice President of Global Commercialization of Emmaus, added, “The approval from the Israeli Ministry of Health is an important and gratifying validation of the safety and efficacy of Endari. It is also a significant development in our strategy of expanding the global availability of Endari. We look forward to working with our partner, Megapharm Ltd., to make Endari available to the Israeli sickle cell disease patient population.”
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 (U.S.) - Endari® is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age andolder.
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.com/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 license received from the Israeli Ministry of Health. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the risk that the license does not result in significant sales of Endari® in Israel and uncertainties related to Emmaus’ working capital and ability to carry on its existing operations and obtain needed financing 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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