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Emmaus Life Sciences, Inc. Receives Notice of Allowance for U.S. Patent for use of L-glutamine in Treatment of Diverticulosis

02.01.2017.

- Related patents previously issued in Japan, China and Australia -
- Patents pending in Europe,  South Korea and other countries - 

TORRANCE, Calif. – February 1, 2017- Emmaus announced today the allowance by the US Patent & Trade Office of patent application number 13/694,592 covering the use of its lead investigative product, pharmaceutical grade L-glutamine (PGLG), for the treatment of diverticulosis. The allowance of this application follows the issuance of corresponding issued patents in Japan, Australia and China. Related patent applications are currently pending in Europe, South Korea, Brazil, Russia, India, Mexico and Indonesia.

The allowed U.S. application reports a significant reduction in the number of intestinal diverticula, the primary indicator of diverticulosis, through therapeutic application of L-glutamine. There are no commercial therapies that claim an ability to reduce intestinal diverticula at the present time. 

The covered invention is directed to a method of treating diverticulosis using L-glutamine.  Diverticulosis refers to a condition where pouches (i.e., diverticula) form along the colon wall. Over time, some people get an infection in the pouches, diverticulitis, which usually requires hospitalization. Epidemiological studies indicate that the prevalence of this disease is increasing worldwide. It is estimated that at least 50% of the population over the age of 60 in the United States, Europe and Australia have diverticulosis. In Japan, a recent study found diverticulosis in 20% of the investigated population (approximate mean age 68 years).

"The US patent further strengthens our broad intellectual property portfolio for PGLG,” said Yutaka Niihara, MD, MPH, Chairman and CEO of Emmaus. “We are very excited about advancing our development program for diverticulosis as we progress through the FDA review of our NDA for sickle cell disease.”

"Diverticulosis and sickle cell disease both represent global unmet needs. We believe that PGLG will have utility in multiple indications as part of our pipeline plan to maximize its utility for people with serious diseases,” added Charles Stark, Pharm.D., Senior Vice President of Research and Development for Emmaus.

In addition to developing PGLG for the treatment of diverticulosis, Emmaus Life Sciences is seeking US Food & Drug Administration (FDA) approval to market the product for the treatment of sickle cell disease in adults and pediatric patients. FDA has set a PDUFA date of July 7, 2017 for a decision on the company’s new drug application for the use of PGLG to treat sickle cell disease.

About Emmaus Life Sciences
Emmaus Life Sciences 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.

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.


For more information, contact:

Media:
Jim Heins
Senior Vice President
ICR Healthcare
203-682-8251
james.heins@icrinc.com 

Investors: 
Charles Butler
Senior Vice President
ICR Healthcare
415-430-2079
charles.butler@icrinc.com