Emmaus Life Sciences Inc (EMMA)

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https://www.otcmarkets.com/stock/EMMA/news/Emmaus-Life-Sciences-Announces-Submission-of-Marketing-Authorization-Application-to-Swissmedic-Ideogen-AG-to-Manage-Earl?id=307395

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Emmaus Life Sciences Announces Submission of Marketing Authorization Application to Swissmedic Ideogen, A.G. to Manage Early Access Program
Press Release | 06/15/2021
Emmaus Life Sciences Announces Submission of Marketing Authorization Application to Swissmedic Ideogen, A.G. to Manage Early Access Program

PR Newswire

TORRANCE, Calif., June 15, 2021

TORRANCE, Calif., June 15, 2021 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTC: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, announced today it has received confirmation from the Swiss Agency for Therapeutic Products (Swissmedic) of Emmaus' application for Marketing Authorization (MA) for Endari® in Switzerland. Swissmedic is responsible for the authorization and supervision of therapeutic products in Switzerland. In November 2020, Swissmedic granted Endari® orphan drug status.

(PRNewsfoto/Emmaus Life Sciences, Inc.)

Swissmedic's MA review and approval process typically takes 16 to 18 months. Endari® will be available to sickle cell disease patients on an early-access basis during the review and approval process. According to the University of Zurich, there were an estimated 220 people with sickle cell disease in Switzerland in 2017 and that number is expected to increase. Endari®, Emmaus' prescription grade L-glutamine oral powder, is approved by the United States FDA and the Israeli Ministry of Health to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.

"We are looking forward to Swissmedic's review of our MA application for Endari®, which represents another important step in our progress and commitment to reach and improve the lives of sickle cell disease patients internationally," said Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus. "We will present for Swissmedic's review our study data that led to FDA approval of Endari® along with additional data and patient experience acquired since the approval."

George Sekulich, Senior Vice President of Global Commercialization of Emmaus, added, "With the Swissmedic marketing authorization approval process underway, we continue building and enhancing Emmaus' relationships with hematologists and patient advocacy groups in Switzerland to afford sickle cell disease patients access to Endari® in the most expeditious and efficient manner possible."

Murat Goker, Head of Europe of Ideogen A.G., further commented, "Sickle cell disease is an orphan disease and chronic illness with debilitating symptoms affecting the lives of 250 to 300 patients in Switzerland. The limited approved treatment options in Switzerland classify sickle cell disease as an essential unmet medical need. Ideogen has partnered up with Emmaus to initiate a managed access program and register the drug Endari to improve access to an essential therapeutic option for physicians and patients alike."

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 Ideogen A.G.
Ideogen A.G. is a Swiss pharmaceutical group with a primary focus on specialty medicines for unmet medical needs. Ideogen strives to improve patients' quality of life and physicians' access to therapeutic options via managed access programs and approved marketing authorizations in the European continent. For more information, please visit www.ideogen.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.“