WASHINGTON, Feb. 8, 2018 /PRNewswire/ -- 60
Degrees Pharmaceuticals (60P) received Priority Review Designation
from the United States Food and Drug Administration (USFDA) for
Tafenoquine (TQ) for prevention of malaria in
adults.
The FDA informed 60P of this designation upon filing of its' New
Drug Application (NDA).
USFDA priority review is granted when a drug is intended to
treat a serious condition and would "provide a significant
improvement in safety or effectiveness"1 over currently
available options. The USFDA goal for completing a priority
review of an NDA is six months. This designation is often used in
combination with other expedited review processes.
In January 2018, 60P received
USFDA Fast Track Designation 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, 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.2
Malaria cases among travelers returning to the U.S. are
trending upwards, with 84% of those infected requiring
hospitalization.3 In 2015, there were 212 million
clinical cases and malaria caused an estimated 429,000
fatalities.4
"We see Priority Review, following our Fast Track Designation,
as a validation of the importance of this therapy. TQ will provide
a significant improvement over currently available therapies. TQ
has the advantage of a convenient weekly dosing regimen which will
help travelers comply and protect themselves from malaria
parasite(s) while in endemic regions of the world" said
Geoffrey Dow, Ph.D., CEO, 60 Degrees
Pharmaceuticals.
Dr. Dow further commented that "receiving priority review
expedites the review of Tafenoquine and indicates that the product
potentially fulfils the statutory requirements for a priority
review voucher (PRV). Receiving a PRV would assist 60P in acquiring
needed resources to launch Tafenoquine."
In 2014, 60P entered into a cooperative research and development
agreement with the U.S. Army Medical Materiel Development Activity
to develop Tafenoquine, which was discovered at the Walter Reed
Army Institute of Research. 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.
An analysis of five clinical trials to assess the safety and
tolerability of Tafenoquine has recently 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. 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 WWARN. 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
4 CDC. 2017. Malaria Facts.
https://www.cdc.gov/malaria/about/facts.html
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Lois Kaufman,
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lkaufman@imsworld.com
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