Emmaus Life Sciences, a Leader in Sickle Cell Disease Treatment, to Sponsor the 12th Annual Sickle Cell Disease and Thalassaemia (ASCAT) Conference in London
TORRANCE, Calif.--(BUSINESS WIRE)-- Emmaus Life Sciences, Inc. (Emmaus) is a proud sponsor of the upcoming 12th Annual Sickle Cell Disease and Thalassaemia (ASCAT) Conference to be held in London on October 22-24. A poster highlighting aspects of Emmaus’ phase 3 study of Endari™ will also be presented at the conference.
Emmaus’ recently approved treatment for sickle cell disease in the United States, Endari, will be featured in a poster session highlighting the results of a phase 3 trial that showed statistically significant improvements on a number of clinical outcomes among patients on Endari as compared to placebo. In particular, the abstract to be presented at ASCAT supports those findings indicating that improvements occurred in patients that used Endari alone or in combination with hydroxyurea.
More specifically, the strength and clarity of the claims that Emmaus’ phase 3 trial was able to make regarding the improved outcomes in both the Endari-alone patients, and the Endari-plus-hydroxyurea patients, may have been undermined by the lack of compliance among those patients that were on hydroxyurea. It is well understood that in practice, hydroxyurea patients are not very compliant. The University of Illinois research team analyzed mean corpuscular volume (MCV) data from the Emmaus phase 3 study and determined that patients on hydroxyurea therapy were indeed compliant with their therapy during the trial period. This was true for patients assigned to Endari and those that were assigned to placebo. Therefore, the beneficial effects of Endari among patients on it alone and in those taking hydroxyurea concomitantly, were robust and not confounded by unequal hydroxyurea compliance between study assignments.
Dr. Yutaka Niihara, CEO of Emmaus, and discoverer of this disease-modifying treatment stated, “We are pleased that the Illinois group was able to add further support to the findings of our phase 3 trial. Also, we are delighted to sponsor this important conference, one that provides an opportunity for physicians, nurses, scientists and other care-givers to learn about the latest advances in diagnoses, treatments and new developments in haemoglobinopathies. Moreover, we look forward to exposing evermore patients to our Endari product – a new therapy that has already improved the lives of so many suffering from this disease in the United States.”
      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 a variety of other
      adverse outcomes such as acute chest syndrome that requires
      hospitalization. Sickle cell disease is an orphan disease, affecting
      approximately 100,000 patients in the U.S. and millions worldwide with
      significant unmet medical needs.
    
      About Endari™
      (L-glutamine oral powder)
Indication
Endari
      is indicated to reduce the acute complications of sickle cell disease in
      adult and pediatric patients 5 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 Emmaus Life Sciences, Inc.
Emmaus Life Sciences, Inc.
      is a biopharmaceutical company engaged in the discovery, development and
      commercialization of innovative treatments and therapies primarily for
      rare and orphan disease. Its lead product, Endari, demonstrated positive
      clinical results in the completed Phase 3 clinical trial for sickle cell
      anemia and sickle ß0-thalassemia and has received U.S. FDA approval.
      Visit: http://www.emmausmedical.com.
    
      Forward-Looking Statements
This press release contains
      forward-looking statements as that term is defined in the Private
      Securities Litigation Reform Act of 1995, regarding the research,
      development and potential commercialization of pharmaceutical products.
      Such forward-looking statements are based on current expectations and
      involve inherent risks and uncertainties, including factors that could
      delay, divert or change any of them, and could cause actual outcomes and
      results to differ materially from current expectations. Additional risks
      and uncertainties are described in reports filed by Emmaus Life
      Sciences, Inc. with the U.S. Securities and Exchange Commission,
      including its Annual Report on Form 10-K and Quarterly Reports on Form
      10-Q. Emmaus is providing this information as of the date of this press
      release and does not undertake any obligation to update any
      forward-looking statements as a result of new information, future events
      or otherwise.
    
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      LaVoie Health Science
Katie Gallagher, 617-374-8800 x109
kgallagher@lavoiehealthscience.com
    
Source: Emmaus Life Sciences, Inc.
Released October 22, 2018