Torrance CA, July 16, 2020 - Emmaus Life Sciences, Inc. (OTCQB: EMMA), a leader in sickle cell disease treatment, is pleased to announce that it has engaged Partner International to lead the out-licensing activity for Emmaus’ prescription grade L-glutamine (PGLG) oral powder for use in the treatment of diverticulosis. This is the same active pharmaceutical ingredient found in Endari®, which is approved by the FDA and the Israeli Ministry of Health to reduce acute complications of sickle cell disease in adult and pediatric patients five years of age and older.
Diverticulosis is an often asymptomatic gastrointestinal (GI) condition affecting a large segment of the adult populations in the U.S. and elsewhere. It can sometimes progress to diverticulitis, a debilitating GI disease that often requires hospitalization and on occasion surgical intervention. Based upon limited clinical results suggesting that Endari® may be effective in slowing and reversing the progression of diverticulosis, in April 2019 Emmaus commenced a Pilot/Phase 1 study of its PGLG oral powder to evaluate the change in the number and size of colonic diverticula and assess safety in 10 to 15 patients at multiple study sites. A preliminary interim evaluation of the first patients in the study indicates consistently positive results. Although the trial is ongoing, based upon the data obtained so far, Emmaus would intend to pursue a Phase III trial under the FDA’s abbreviated 505(b)(2) regulatory pathway.
Yutaka Niihara, M.D., M.P.H., Chairman and Chief Executive Officer of Emmaus, stated, “We are very pleased to work with Partner International to explore licensing and partnering opportunities for PGLG oral powder as a potential treatment for diverticulosis. In my three decades of clinical experience, this is the first time I have observed or heard of any treatment that may reverse the progression of the disease. We value Partner International’s unique experience and connections to prospective pharma industry partners and look forward to engaging with interested parties in one or more mutually beneficial collaborations.”
Joanne Ball-Gautschi, CEO and President of Partner International commented, “Our firm is extremely proud to represent Emmaus in identifying potential partners for its PGLG oral powder as a treatment for diverticulosis. With no current treatment options available, this is a serious unmet medical need with significant market potential worldwide.”
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 Partner International
Partner International is a leading business development group in the life sciences industry, offering a full range of corporate development services, including partnering, licensing, and M&A. Partner International has operations in Switzerland, Canada, United States, and Australia, as well as strategic associates in 26 countries globally. Partner International has a strong track record of successful business development transactions with companies of all sizes and in all therapeutic areas in its 20-year history. For more information about Partner International, please visit www.partner-intl.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 Diverticulosis
Diverticulosis, or the presence of colonic diverticula (i.e., pouches in the colon wall), is very common in industrialized nations, with its prevalence increasing with age. An estimated 40% of 60 year-olds and 70% of 80 year-olds in the U.S. have diverticulosis. Of these patients, 10% to 25% can be expected to develop diverticulitis, the advancement of peridiverticular inflammation and infection, resulting in abdominal pain, nausea, vomiting, constipation, diarrhea, fever and leukocytosis, or abnormally high white blood cell count.
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 organ damage, stroke, pulmonary complications, skin ulceration, infection and a variety of other adverse outcomes. Sickle cell disease is a significant unmet medical need, affecting approximately one hundred thousand patients in the U.S. and millions worldwide, the majority of which are of African descent. An estimated 1-in-365 African American children are born with sickle cell disease.
Forward-looking Statements
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 the possible clinical benefits of PGLG oral powder in treating diverticulosis which have yet to be established and possible out-licensing opportunities. These forward-looking statements are subject to the risks inherent in research and development of human pharmaceuticals and numerous other risks and uncertainties which change over time, including business and financial market risks to Emmaus relating to fallout from the extraordinary governmental response to the COVID-19 pandemic, uncertainties regarding Emmaus’ working capital and ability to carry on its existing operations and to obtain needed financing and other factors previously disclosed in the company’s reports filed with the Securities and Exchange Commission. Actual results may differ, perhaps materially, from those expressed herein. Such forward-looking statements speak only as of the date of this press release, and Emmaus assumes no duty to update them for any new or changed circumstances, except as may be required by law.
Company Contact: Investor Relations Contact:
Emmaus Life Sciences, Inc. LifeSci Advisors
Joseph (Jay) C. Sherwood III Bruce Mackle
Chief Financial Officer (929) 469-3859
(310) 214-0065, Ext. 3005 bmackle@lifesciadvisors.com
jsherwood@emmauslifesciences.com