Dr. Niihara Feted by Indian Government in Recognition of the Development of Endari®
Celebrity Event Hosted in Mumbai, India
TORRANCE, Calif., Dec. 19, 2022 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQX: EMMA), announced today that Dr. Yutaka Niihara, Chairman and Chief Executive Officer of the company, was feted at an event held on December 16, 2022 at the World Trade Center in Mumbai, India by the Minister of State of India, Arun Halder, in recognition of Dr. Niihara's work in developing Endari® to treat sickle cell disease (SCD). The event was hosted by Dr. Aviti Govatikar, a medical doctor and former Mrs. World.
It is reported in India that over 20 million people in that country suffer from SCD, a genetic disorder affecting individuals of African descent and other ethnic groups. Underprivileged tribal communities in India are disproportionately affected by SCD because of a lack of treatments and resources.
Endari® is approved in the U.S. and several Gulf Cooperation Council countries to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older. Endari® is also available on an early-access basis in the Kingdom of Saudi Arabia and several European Union countries but is not yet available in India.
Dr. Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus, commented "We are grateful and humbled by the recent acknowledgement by the Indian Ministry of State and look forward to discussions with national and local officials in the country to make Endari available to SCD patients there."
George Sekulich, Senior Vice President of Global Commercialization of Emmaus, added "India represents a large, unserved market and we intend to look for possible approaches to reach SCD patients there."
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.
Indication - Endari® is indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
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.
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 potential access to the Indian market for Endari. These forward-looking statements are subject to numerous assumptions, risks and uncertainties which change over time, including the risk of doing business in India and other foreign markets 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.
Emmaus Life Sciences, Inc.
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SOURCE Emmaus Life Sciences, Inc.
Released December 19, 2022