Arakoda™ (Tafenoquine) Tablets, First Prescription Drug Approved for Malaria Prevention by US FDA in Over 18 Years, Now Available in US
WASHINGTON, Nov. 21, 2019 /PRNewswire/ -- 60 Degrees Pharmaceuticals (60P) has initiated distribution of Arakoda™ (tafenoquine) into the US healthcare marketplace. This significant milestone complements the regulatory approval of Arakoda™ by the United States Food and Drug Administration (FDA). Arakoda (tafenoquine) is approved for the prevention of malaria in adults and was the first anti-malarial product approved for prevention in over 18 years. Arakoda has the potential to protect thousands of U.S. travelers and military personnel from the devastating and life-threatening effects of malaria. 60P's first significant shipment of Arakoda occurred in September, 2019, to the U.S. Army. The product is now commercially available via select retail pharmacy outlets and pharmaceutical wholesalers. 60P continues to work closely with distribution networks and third-party insurance companies to provide extensive access to the product. "Malaria is one of the most malicious diseases, on the rise in both U.S. and other parts of the world," said Geoffrey Dow, chief executive officer of 60P Pharmaceuticals. "It poses a significant risk to millions of healthy individuals traveling to areas where malaria is endemic, including those traveling for leisure, employees of non-governmental organizations, industrial and business workers, and military forces." Arakoda™ (tafenoquine) Patent Issued to 60P by USPTO Earlier this year the U.S. Patent and Trademark Office (USPTO) issued a patent covering the use of Arakoda (tafenoquine) tablets for the prevention of symptomatic Plasmodium falciparum malaria in human subjects. P. falciparum is present everywhere where prophylactic malaria drugs are prescribed for travelers and is the cause of most of the deaths from malaria among travelers returning from malaria hot zones (to the US). The patent summary is now listed in the US FDA The Orange Book (https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=001&Appl_No=210607&Appl_type=N). The marketing approval of Arakoda was the culmination of years of scientific discovery and research by experts in the field of Malariology and Infectious Disease. Tafenoquine was discovered by scientists at the Walter Reed Army Institute of Research (WRAIR). The approval was based on a concerted effort by the U.S. Army and 60P, involving over 25 clinical trials and over 3,000 trial subjects, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria. The patent's term will extend to 2035 and will provide 60P and its commercial partner, the US Army, with protection for a product which has been under development for a long time and for which significant financial resources have been invested. Corresponding patent applications are in prosecution in Europe, Canada, Australia and elsewhere. ARAKODA is supplied in 100 mg tablets for oral use only. After an initial loading dose prior to traveling, ARAKODA is intended to be taken once a week. For Full Prescribing Information go to: https://arakoda.com For ordering information call 202-327-5422 or e-mail: inquiries@60-p.com If you should have medical or technical questions regarding ARAKODA (tafenoquine), please don't hesitate to call 1-888-834-0225. Important Safety Information Contraindications
Warnings and Precautions
Adverse Reactions Drug Interactions Use in Specific Populations To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1-888-834-0225 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch About malaria Millions of healthy individuals travel to areas where malaria is endemic, including those traveling for leisure, employees of non-governmental organizations, industrial and business workers, and military forces. ARAKODA™ has the potential to protect thousands of U.S. travelers from the devastating and life-threatening effects of malaria. About ARAKODA™ 60P entered into a cooperative research and development agreement with the U.S. Army Medical Materiel Development Activity (USAMMDA) in 2014 to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria. Since malaria is a significant infectious disease threat to U.S. military service members overseas, the military maintains a robust anti-malarial drug development effort through internal research and commercial partnerships. The FDA approval is a culmination of over 30 years of research and development with the U.S. Army Medical Research and Materiel Command, from the discovery of tafenoquine at WRAIR through the current collaboration between 60P and USAMMDA. About 60P The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements. The statements expressed herein are those of 60P and do not necessarily represent those of the U.S. Department of Defense or Department of the Army. Contact: Doug Loock 1 Cullen KA, Mace KE, Arguin PM. Malaria Surveillance-United States, 2013 MMWR Surveillance Summary 2016:65 (No.SS-2);1-22 DOI: http://dx.doi.org/10.15585/mmwr.SS6502a1 -#- View original content to download multimedia:http://www.prnewswire.com/news-releases/arakoda-tafenoquine-tablets-first-prescription-drug-approved-for-malaria-prevention-by-us-fda-in-over-18-years-now-available-in-us-300962690.html SOURCE 60 Degrees Pharmaceuticals (60P) |