"Our team has received positive feedback from HCPs across the territory who are excited to have L-glutamine as a valuable therapeutic option for the treatment of sickle cell disease patients," said Dr. Saif Al-Hasani, Chief Executive Officer of taiba. Dr. Saif Al-Hasani added, "We expect within the first quarter of 2020 to have received requests for early access programs from the Gulf Cooperation Countries as the start of providing access to this valuable treatment for a significant number of sickle cell disease patients in our region."
"In a relatively short period of time, taiba has become a valuable partner in bringing patients in the Middle East this much needed drug. Through this partnership, we have already identified 40 patients and look forward to working with taiba to expand and increase access to patients in the entire MENA region," said George Sekulich, Senior Vice President of Global Commercialization for Emmaus Life Sciences.
Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus added, "We are grateful to have taiba as our partner in the very important MENA region and greatly appreciate their support and commitment in helping us improve the lives of sickle cell disease patients by providing early access to our efficacious and safe treatment."
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.emmauslifesciences.com.
About Endari® (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.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 market potential for Endari and timing of future Endari sales. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the possibility that we may experience delays in the roll-out of early access programs in the MENA region and uncertainties related to the company's 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 the company assumes no duty to update them.
Emmaus Life Sciences, Inc.
Joseph (Jay) C. Sherwood III
Chief Financial Officer
(310) 214-0065, Ext. 3005
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