February 9, 2018
Emmaus Medical, Inc. Selects AmerisourceBergen to Support the Launch of Endari (L-glutamine oral powder)
Frisco, Texas – AmerisourceBergen, a global healthcare solutions leader, today announced
that US Bioservices, an independent specialty pharmacy, has been selected by Emmaus
Medical, Inc. as the specialty pharmacy for EndariTM (L-glutamine
oral powder), for the treatment of patients with sickle cell disease.
The U.S. Food and Drug Administration approved Endari on July 7, 2017 for adult and pediatric patients 5 years of age and older to reduce the acute complications of sickle cell disease. Endari is the first approved treatment for sickle cell disease in pediatric patients and the first new treatment available in nearly 20 years for adults.
As part of this partnership, Emmaus will leverage the breadth of AmerisourceBergen’s integrated commercialization solutions to support adherence and realize the best possible outcomes for patients. In addition to utilizing the comprehensive clinical services of US Bioservices, Emmaus will also collaborate with AmerisourceBergen’s ASD Healthcare and ICS. ASD Healthcare will serve as the specialty distributor for Endari and ICS will develop and execute personalized third-party logistics services for the product. The collaboration and integration of these core processes benefits both the manufacturer and the patient.
“We aim to improve the lives of people through the discovery, development and commercialization of innovative treatments and therapies for rare and orphan diseases,” said Yutaka Niihara, MD, CEO of Emmaus Medical, Inc. “The launch of Endari is an example of our mission in action, and we are extremely grateful to bring the first treatment for patients with sickle cell disease in two decades to market.”
AmerisourceBergen is committed to ensuring treatment reaches those who need it most. AmerisourceBergen’s commercialization experts have deep industry knowledge and years of experience supporting partners through launch and throughout the product lifecycle. The company’s commercialization experts partner with manufacturers to design an integrated solution around individual products and the unique needs of patients, providing end-to-end support for each step of the product and patient journey.
“We know that bringing rare and orphan products to market is a remarkable responsibility, and supporting a patient population that requires high-touch adherence services requires superior planning, collaboration and execution,” said Peyton Howell, President and EVP of Health Systems & Specialty Care Solutions at AmerisourceBergen. “Businesses like US Bioservices, ASD Healthcare and ICS offer unmatched history and experience in the rare and orphan space. We remain strongly committed to supporting patients, providers and manufacturers as these promising therapies come to market.”
With the addition of Endari, US Bioservices strengthens its already robust offerings for patients facing rare and orphan diseases. US Bioservices has years of experience helping small patient populations maximize engagement and the benefits of therapies. The specialty pharmacy also helps manufacturers navigate the unique commercialization challenges for rare and orphan products and develop high-touch solutions that improve patient access, adherence and outcomes. US Bioservices provides clinical care that is specific to patient needs, conditions and therapies.
As an independent specialty pharmacy, US Bioservices is committed to being a premier partner on programs that support small and underserved patient populations. The specialty pharmacy’s multidisciplinary teams are organized to develop long-standing, collaborative relationships with physicians and specialists, resulting in more integrated care for patients and caregivers.
Endari is only available from US Bioservices, in-office dispensing practices, and hospitals. Physicians may submit prescriptions to US Bioservices via phone (833-831-1166), fax (844-773-1423), ePrescribe or the MyPathpoint Prescriber Portal.
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%) in clinical studies were constipation, nausea, headache, abdominal pain, cough, pain in extremity, back pain, and chest pain.
Adverse reactions leading to treatment discontinuation included 1 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 5 years of age has not been established.
For more information, please see full Prescribing Information of Endari at www.ENDARIrx.com/Repository/Prescribing information.pdf
About Emmaus Medical, Inc.
Emmaus Medical, Inc., a subsidiary of Emmaus Life Sciences, Inc., is engaged in the discovery, development and commercialization of innovative treatments and therapies for rare diseases. The company's research on sickle cell disease was initiated by Yutaka Niihara, MD, MPH, Chairman and CEO of Emmaus, at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center. For more information, please visit www.emmauslifesciences.com.
AmerisourceBergen provides pharmaceutical products, value-driving services and business solutions that improve access to care. Tens of thousands of healthcare providers, veterinary practices and livestock producers trust us as their partner in the pharmaceutical supply chain. Global manufacturers depend on us for services that drive commercial success for their products. Through our daily work—and powered by our 21,000 associates—we are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #11 on the Fortune 500, with more than $150 billion in annual revenue. The company is headquartered in Valley Forge, Pa. and has a presence in 50+ countries. Learn more at amerisourcebergen.com.
About US Bioservices
US Bioservices, a part of AmerisourceBergen, delivers nationwide specialty pharmacy and nursing services that meet the unique needs of patients, physicians, payers, and manufacturers. US Bioservices’ approach combines superior patient-centric customer service, clinical expertise, and robust data analytics. Their partner solutions, such as the MyPathpoint Portal, provide unmatched transparency and increased clinical collaboration that improves patient outcomes. For more information, visit www.usbioservices.com.
About ASD Healthcare
As one of AmerisourceBergen’s specialty distributors, ASD Healthcare provides health systems, specialty pharmacies, hemophilia centers, dialysis centers, as well as home healthcare companies and retail pharmacies, exceptional service along with a robust selection of specialty pharmaceutical products. ASD Healthcare is the largest distributor of blood derivatives and nephrology products in the United States. With over 40,000 active accounts, including 95 percent of hospitals in the United States, and partnership with all major GPOs, ASD Healthcare commands sizeable market share in oncology and specialty care products. For more information, see www.asdhealthcare.com.
ICS, a part of AmerisourceBergen, partners with pharmaceutical manufacturers to deliver third-party logistics services that improve the quality and efficiency of their supply chains. As the pioneer in the specialty logistics market, ICS has helped bring hundreds of specialty pharmaceutical products to market and served as an integral component in their growth. ICS was founded in 1997 and since then, has organically grown to become the industry leader in outsourced logistics and distribution services for pharmaceutical manufacturers. From strategic program design to enhanced 3PL and performance analytics, ICS goes the extra mile to ensure increased supply chain efficiency, maximum return on investment and enhanced patient care. ICS is the model of excellence in global healthcare logistics.