Wednesday, September 28, 2022
Emmaus Life Sciences, Inc., a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced a collaboration with the Steve Harvey Morning Show cast member Kier (Junior) Spates to share Mr. Spate’s personal experience with the use of Endari®, Emmaus’ prescription L-glutamine oral powder, to treat his sickle cell disease, or SCD.
SCD is endemic in the African American community yet remains a significant unmet healthcare need — despite the advent of Endari — for many possible reasons, including a historical lack of treatment options and inadequate access to primary care. As a result, many SCD sufferers are reluctant or unsure how to seek a doctor’s assistance in managing their disease, leaving untreated the debilitating pain, anemia and other symptoms of the disease which lead to premature death among SCD patients as compared to the general population.
“Our collaboration with Mr. Spates will help destigmatize SCD and inform 9 million weekly listeners to Mr. Harvey’s popular show, including those who with SCD, about Endari,” said Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus. “We admire and appreciate Mr. Spates’ courage in living with this disease and publicly sharing his experiences and would like to extend our public thanks to Mr. Harvey and the show’s producers for their cooperation”
“I’ve been taking Endari since April and found it to be beneficial in my treatment regime for sickle cell disease,” said Mr. Spates. “Since adding Endari to my treatment protocol I have had fewer crises. After many conversations with Emmaus, I decided to become a consultant to the company because I understand firsthand how this disease devastates the Black community. I support and understand Emmaus commitment to take a holistic approach to the treatment of sickle cell disease.”
George Sekulich, Senior Vice President of Global Commercialization at Emmaus, added, “This new collaboration, like our recently announced telehealth services, is intended to reach Americans nationwide who lack information regarding available SCD treatment options such as Endari. We believe that Mr. Spates’ experience will resonate with his and Mr. Harvey’s audience.”
About Endari® (prescription grade L-glutamine oral powder)
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.
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
There are approximately 100,000 people living with sickle cell disease (SCD) in the United States and millions more globally. The sickle gene is found in every ethnic group, not just among those of African descent; and in the United States an estimated 1-in-365 African Americans and 1-in-16,300 Hispanic Americans are born with SCD.1 The genetic mutation responsible for SCD causes an individual’s red blood cells to distort into a “C” or a sickle shape, reducing their ability to transport oxygen throughout the body. These sickled red blood cells break down rapidly, become very sticky, and develop a propensity to clump together, which causes them to become stuck and cause damage within blood vessels. The result is reduced blood flow to distal organs, which leads to physical symptoms of incapacitating pain, tissue and organ damage, and early death.2
1Source: Data & Statistics on Sickle Cell Disease – National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, December 2020.
2Source: Committee on Addressing Sickle Cell Disease – A Strategic Plan and Blueprint for Action — National Academy of Sciences Press, 2020.
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 possible increased awareness of Endari among listeners of popular radio programming. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including risks inherent in the regulatory approval process and other factors previously disclosed in the company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 31, 2022 and our Quarterly Reports on Form 10-Q, 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.