NEW YORK--Emmaus Life Sciences, Inc. (Emmaus), after making significant inroads into the sickle cell patient population with the launch of Endari™ (L-glutamine oral powder), indicated to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older, is participating in the upcoming Seventh Annual Sickle Cell Disease Conference in New York City on September 13th. Darrel W. Harrington, M.D. MACP, Emmaus’ Chief Medical Officer will discuss the considerable toll this devastating disease takes on the thousands of patients suffering from this chronic condition in the United States1 and how Endari has been shown to reduce painful crises and reduce hospitalizations.
“Not only are these patients experiencing painful sickle cell crises, but this condition also poses life threatening risks such as acute chest syndrome. Endari, approved by the FDA last year, is a treatment option for certain of these suffering patients, many of whom lead a life of crippling pain and frequent hospitalizations,” said Dr. Harrington.
Emmaus’ CEO and founder Dr. Yutaka Niihara stated: “As a company that worked with the FDA for over two decades to bring a disease-modifying treatment to US sickle cell patients, we look forward to participating in the conference which we believe will draw attention to this patient population who have been suffering so much. We strive to bring hope to children, as well as adults who are affected by sickle cell disease.”
The 7th Annual Sickle Cell Disease (SCD) Therapeutics Conference will be held on Thursday, September 13, 2018, at the Park Central Hotel in New York. Taking place during National SCD Awareness Month, the Conference highlights the latest medical advances and future trends in the treatment of patients with SCD. The program will feature panel discussions and presentations from leading physicians, patient advocates and healthcare policymakers on a range of issues and topics including the clinical consequences of SCD beyond vaso-occlusive crises (VOCs), the impact of SCD on quality of life, and innovative programs to improve patient access to care. The Conference will also feature updates from the Sickle Cell Disease Association of America (SCDAA), as well as corporate presentations from industry leaders.
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.
Notes
1. https://www.cdc.gov/ncbddd/sicklecell/data.html
2. Niihara, Y. et al. A Phase 3 Trial of L-Glutamine in Sickle Cell Disease. N Engl J Med, 2018; 379:226-235 DOI: 10.1056/NEJMoa1715971
Contacts
LaVoie Health Science
Katie Gallagher, 617-374-8800 x109
kgallagher@lavoiehealthscience.com