WASHINGTON, Dec. 18, 2017 /PRNewswire/ -- 60 Degrees
Pharmaceuticals (60P) announced it has submitted a New Drug
Application (NDA) to the United States Food and Drug Administration
for the use of Tafenoquine to prevent malaria in adults traveling
to areas where malaria is prevalent.
Malaria, a life-threatening disease caused by Plasmodium
parasites that are transmitted to people through the bite of an
infected mosquito, caused an estimated 429,000 fatalities and 212
million clinical cases in 2015.1 It poses a significant
risk to millions of healthy individuals traveling in many parts of
the world, including employees of non-governmental organizations
(NGOs), casual vacationers, industrial and business workers, and
military forces.2 Malaria cases among returning
travelers in the U.S. have been trending upwards, with 84% of those
infected requiring hospitalization.3
"There are real problems with the few anti-malarial drugs we
currently have, including both resistance and safety issues. In
particular, there can be a problem finding acceptable drugs to
safeguard travelers and deployed military personnel," said Dr.
Stephen Toovey, Pegasus Research.
"Tafenoquine should prove a useful alternative in combating
malaria."
"60P is proud of this significant milestone, a first for our
organization," stated Geoffrey Dow,
Ph.D., CEO 60 Degrees Pharmaceuticals. "The work that has been done
to date, including significant legacy research at the Walter Reed
Army Institute of Research (WRAIR), establishes that Tafenoquine
targets all types of malaria including the most common parasites
(P. vivax and P. falciparum). We hope to market this
product with a convenient weekly dosing regimen in the United States and eventually around the
world," Dr. Dow continued. "It is our belief our dossier will
receive priority review, expediting the review of Tafenoquine, and
60P may qualify for a priority review voucher (PRV). This will help
us acquire needed resources to provide this product to travelers
who wish to be protected against deadly malaria parasites."
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. As 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 Walter Reed Army
Institute of Research (WRAIR) through the current collaboration
between 60P and USAMMDA.
Researched for more than 30 years for both the prevention and
treatment of malaria, Tafenoquine works against the major malaria
parasites and all stages of the parasite's lifecycle. Tafenoquine
has been studied in more than 30 clinical trials involving more
than 4,000 study participants.
A recent analysis of five clinical trials to assess the safety
and tolerability of an investigational antimalarial agent,
Tafenoquine, has been published in Travel Medicine and
Infectious Disease, a peer-reviewed journal. The authors of the
analysis conclude that the antimalarial agent 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.
1CDC. 2017. Malaria Facts.
https://www.cdc.gov/malaria/about/facts.html
2WWARN. 2017. Antimalarial Drug
Resistance http://www.wwarn.org/about-us/malaria-drug-resistance
3Cullen 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, LLC