Artemis is now qualified to receive significant benefits throughout its orphan drug development program including more frequent FDA interactions, protocol assistance, and tax credits for clinical research costs.
NEW YORK, Nov. 6, 2017 /PRNewswire/ -- Artemis Therapeutics (OTCQB: ATMS), (“Artemis” or the “Company”), a pharmaceutical company developing new therapies for the treatment of life-threatening infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for Artemisone, the Company’s lead product candidate, for the treatment of malaria.
“We are delighted Artemisone has received orphan drug designation from the FDA for the treatment of malaria,” stated Brian M. Culley, Chief Executive Officer of Artemis. “With approximately half of the world’s population at risk, malaria presents an unmet global challenge with enormous economic implications. In recent years, artemisinin-resistant malaria has become increasingly common. Our product candidate, Artemisone, is a potent and fast-acting member of the artemisinin class and we believe it may offer a more attractive safety and efficacy profile compared to currently-available artemisinins. We are excited to be moving Artemisone toward additional clinical trials.”
The FDA Orphan Drug designation program provides incentives to sponsors that are developing therapies for rare diseases which affect fewer than 200,000 people in the United States. Artemis is now qualified to receive significant benefits throughout its orphan drug development program including more frequent FDA interactions, protocol assistance, and tax credits for clinical research costs. Also included is a waiver of certain fees and a seven-year term of market exclusivity upon FDA approval of the orphan drug. In 2015, malaria caused 212 million clinical episodes and 429,000 deaths, according to the World Health Organization.
About Artemis Therapeutics
Artemis Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of new therapies for the treatment and prevention of severe and life-threatening infectious diseases. The Company’s lead product candidate, Artemisone, is a unique, synthetic artemisinin derivative with potent anti-viral and anti-parasitic properties. The Company currently is evaluating Artemisone for the treatment of p. falciparum malaria and human cytomegalovirus (CMV) infections, including stem cell transplant CMV and congenital CMV. Artemis also plans to evaluate Artemisone for the treatment of additional viral and parasitic diseases. More information is available on the Company’s website: www.artemis-therapeutics.com and Twitter: @ArtemisThera.
Forward Looking Statements:
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
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Contact:
Investor Relations
(ir@artemis-therapeutics.com)
SOURCE Artemis Therapeutics, Inc.
