Emmaus is monitoring the Coronavirus (COVID-19) pandemic daily to ensure its patients have an uninterrupted supply of Endari® (L-glutamine oral powder). The company has not experienced any supply chain issues regarding its prescription grade L-glutamine and has sufficient finished goods inventory of Endari® to support current and projected needs.
Emmaus wishes to assure the SCD community, patients, caregivers and clinicians that it has the infrastructure and systems in place to maintain the ability of its patients to stay on therapy. George Sekulich, Senior Vice President of Global Commercialization of Emmaus, stated, "Our patients are our first priority and we have invested heavily in our distribution network. We are confident the mail order and home delivery systems we have instituted with our specialty pharmacy network and GPO in-house dispensing clinics will continue to give our patients the highest level of service."
As many other pharmaceutical and life sciences companies are reviewing their existing therapies and technologies, Emmaus is also exploring whether its prescription grade L-glutamine may be potentially beneficial to those patients with Coronavirus (COVID-19). Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus, commented, "We are looking into the possibility of providing our prescription grade L-glutamine as part of the oral rehydration therapy (ORT) that some patients might need to mitigate the impact of the coronavirus and assist them in their recovery. A study regarding ORT has suggested that an oral hydration solution containing glutamine and glucose might be superior to conventional glucose ORT in viral enteritis, but further study is warranted to confirm that hypothesis."
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® (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 patient access to Endari®. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including 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.
|Company Contact:||Investor Relations Contact:|
|Emmaus Life Sciences, Inc.||LifeSci Advisors|
|Joseph (Jay) C. Sherwood III||Bruce Mackle|
|Chief Financial Officer||(929) 469-3859|
|(310) 214-0065, Ext. email@example.com|
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