Dr. Niihara Meets with Local Indian Governor

Rhea-AI Summary

Emmaus Life Sciences (OTCQX: EMMA) announced a meeting between Dr. Yutaka Niihara, CEO, and Bhagat Singh Koshyari, Governor of Maharashtra, on December 16, 2022, in Mumbai. The discussion focused on the needs of over 20 million individuals suffering from sickle cell disease (SCD) in India and the potential benefits of Endari®, a treatment approved in the U.S. and select regions for patients aged five and older. While Endari is accessible in some areas, it is not yet available in India.

Positive

• Dr. Niihara's engagement with Indian officials highlights the potential for market expansion in India for Endari®.
• Endari® is already approved in the U.S. and several Gulf countries, which supports its credibility and potential growth.

Negative

• Endari® is not yet available in the large Indian market, limiting immediate revenue opportunities.
• Safety concerns exist for Endari® with adverse reactions including constipation and abdominal pain noted in clinical studies.

Cites Large, Unserved Needs of Sickle Cell Disease Patients 

TORRANCE, Calif., Dec. 20, 2022 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQX: EMMA), announced today that Dr. Yutaka Niihara, Chairman and Chief Executive Officer of the company, was hosted in Mumbai, India on December 16, 2022 by Bhagat Singh Koshyari, the Governor of the State of Maharashtra, the industrial, financial and commercial center of India. In remarks on social media, https://t.co/vTrKwVT4if, the Governor cited the more than 20 million people suffering from sickle cell disease (SCD) in his country and spoke of the discovery of Endari® that can help patients with SCD.

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 "I am honored to have been invited by Governor Koshyari to discuss the needs of India's large population of individuals suffering from SCD and grateful to discuss with him how access to Endari may benefit those individuals."

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^® (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.

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

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.

Company Contact:
Emmaus Life Sciences, Inc.
Willis Lee
Chief Operating Officer
(310) 214-0065, Ext. 1130
wlee@emmauslifesciences.com

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SOURCE Emmaus Life Sciences, Inc.

FAQ

What did Emmaus Life Sciences announce on December 20, 2022?

Emmaus Life Sciences announced a meeting between Dr. Yutaka Niihara and Maharashtra Governor Bhagat Singh Koshyari to discuss sickle cell disease and the potential of Endari® in India.

How many people suffer from sickle cell disease in India?

There are over 20 million individuals suffering from sickle cell disease in India.

Is Endari® available in India?

Endari® is not yet available in India, although it is approved in the U.S. and several Gulf Cooperation Council countries.

What is the approval status of Endari®?

Endari® is approved in the U.S. and several Gulf countries but is not yet available in India.

What adverse reactions are associated with Endari®?

Common adverse reactions include constipation, nausea, and abdominal pain, with some cases leading to treatment discontinuation.