WASHINGTON, Jan. 4, 2018 /PRNewswire/ -- 60 Degrees
Pharmaceuticals (60P) has received Fast Track designation from the
United States Food and Drug Administration (USFDA) for the
investigation of Tafenoquine for prevention of malaria in
adults.
A drug is designated as a fast track product "for the treatment
of a serious or life-threatening disease or condition, and it
demonstrates the potential to address unmet medical needs for such
a disease or condition," 1 according to the FDA.
In December, 60P submitted a New Drug Application (NDA) to the
USFDA for the use of Tafenoquine to prevent malaria in adults
traveling to areas where the disease is prevalent.
Malaria, a life-threatening disease transmitted through the bite
of an infected mosquito, caused an estimated 429,000 fatalities and
212 million clinical cases in 2015. 2 It poses a significant
risk to millions of healthy individuals traveling in many parts of
the world, including employees of non-governmental organizations,
casual vacationers, industrial and business workers, and military
forces. 3 Malaria
cases among travelers returning to the U.S. have been trending
upwards, with 84% of those infected requiring hospitalization.
4
"Finding acceptable drugs to safeguard travelers and deployed
military personnel against malaria is a real problem," said
Geoffrey Dow, Ph.D., CEO 60 Degrees
Pharmaceuticals.
We see Fast Track Designation as a next step toward marketing
this product with a convenient weekly dosing regimen in
the United States, and eventually
around the world. It is our continued belief our dossier will
receive priority review, thereby expediting the review of
Tafenoquine. This better positions 60P for a priority review
voucher (PRV) thus assisting 60P to acquire needed resources to
launch Tafenoquine."
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 the top
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 NDA submission 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 the Walter Reed Army
Institute of Research through the current collaboration between 60P
and USAMMDA.
A recent analysis of five clinical trials to assess the safety
and tolerability of Tafenoquine has been published in Travel
Medicine and Infectious Disease, a peer reviewed journal. The
authors concluded that Tafenoquine appeared to be safe and well
tolerated when the anticipated clinical regimen (ACR) was
administered.
In all five studies, the majority of adverse events (AEs) were
mild or considered unrelated to the study drug. For the full
article, "Tafenoquine for malaria prophylaxis in adults: An
integrated safety analysis," by Moreno et al., 2017, please go to:
http://www.travelmedicinejournal.com/article/S1477-8939(17)30079-0/fulltext
About 60P
60P, founded in 2010, focuses on discovering, developing and
distributing new medicines for treatment and prevention of tropical
diseases, including malaria and dengue. 60P's mission is supported
through in-kind funding from the United States Department of
Defense. The company also collaborates with prominent research
organizations in the U.S., Australia and Singapore. In addition, 60P has been funded by
Knight Therapeutics Inc. (TSX:GUD), a Canadian specialty
pharmaceutical company that obtained FDA approval for Impavido, a
product for leishmaniasis, a tropical disease, and monetized a PRV.
60P is headquartered in Washington
DC, with a subsidiary in Australia. Further information is available on
the company's website, www.60degreespharma.com.
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 United States Department of
Defense or Department of the Army.
1 Guidance for Industry, Expedited Programs for Serious
Conditions-Drugs and Biologics, U.S. Department of Health and Human
Services Food and Drug Administration, May
2014,
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf
2 CDC. 2017. Malaria Facts.
https://www.cdc.gov/malaria/about/facts.html
3 WWARN. 2017. Antimalarial Drug Resistance
http://www.wwarn.org/about-us/malaria-drug-resistance
4 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
CONTACT: Lois Kaufman,
President
Integrated Marketing Services
lkaufman@imsworld.com
609-683-9055 x203
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SOURCE 60 Degrees Pharmaceuticals