Knight Therapeutics Inc. Announces FDA Approval for Impavido(R) (Miltefosine)
for the Treatment of Visceral, Mucosal and Cutaneous
Awarded Priority Review Voucher
MONTREAL, QUEBEC -- (Marketwired) -- 03/19/14 -- Knight
Therapeutics Inc. ("Knight") (TSX VENTURE: GUD) today announced that
the U.S. Food and Drug Administration (FDA) has approved Impavido(R)
(Miltefosine) for patients with Visceral, Mucosal and Cutaneous
Leishmaniasis. Also received today was a Priority Review Voucher,
which is designed to be transferable or sold and provides the bearer
with an expedited FDA review for any new drug application.
"We are thrilled to get Impavido approved for patients and to be the
fourth company in the world to receive a Priority Review Voucher,"
said Jonathan Ross Goodman, President and Chief Executive Officer of
Knight, "and we would like to thank the many team members at Paladin
Labs Inc. for all their hard work. Our plan is to commercialize
Impavido in the United States and to monetize the voucher for maximum
value, which may take time to materialize."
About Knight Therapeutics Inc.:
Knight Therapeutics Inc., headquartered in Montreal, Canada, is a
specialty pharmaceutical company focused on acquiring or in-licensing
innovative pharmaceutical products for the Canadian and world
markets. Knight Therapeutics' shares began trading on the TSX-V on
March 3, 2014 under the symbol GUD. For more information about Knight
Therapeutics, please visit the Company's web site at
www.gud-knight.com or at www.sedar.com.
About Impavido(R) (miltefosine):
Impavido(R) (miltefosine) is an oral alkyllysophospholipid analogue
drug with in vitro activity against the promastigote and amastigote
stages of Leishmania species. Miltefosine was included in the WHO
essential medicines list as an anti-leishmaniasis medicine in March
Leishmania organisms are intracellular protozoan parasites that are
transmitted to a mammalian host by the bite of the female
phlebotomine sandfly. The main clinical syndromes are visceral
leishmaniasis, cutaneous leishmaniasis, and mucosal leishmaniasis. In
the United States, leishmaniasis may be seen in returning travelers
following exposure in endemic regions, and in American soldiers
serving in Iraq, Afghanistan or South America.
The WHO estimates that approximately 400,000 new cases of visceral
leishmaniasis occur annually world-wide. Approximately 0.7-1.2
million new cutaneous leishmaniasis cases occur annually world-wide.
About Priority Review Voucher:
Developed by the U.S. FDA in 2007, a Priority Review Voucher ("PRV")
is an incentive for companies to invest in new drugs and vaccines for
neglected tropical diseases. A Priority Review means that the time it
takes the FDA to review a new drug application is reduced. The PRV is
transferable and can be sold and entitles the bearer to a priority
review for any product. To date, only 3 companies have received a PRV
and none have been sold.
This press release may contain forward-looking statements and
predictions. These forward-looking statements, by their nature,
necessarily involve risks and uncertainties that could cause actual
results to differ materially from those contemplated by the
forward-looking statements. The Company considers the assumptions on
which these forward-looking statements are based to be reasonable at
the time they were prepared, but cautions that these assumptions
regarding the future events, many of which are beyond the control of
the Company and its subsidiaries, may ultimately prove to be
incorrect. Factors and risks, which could cause actual results to
differ materially from current expectations, are discussed in the
Company's final application for listing on the TSX Venture Exchange
and can be found on SEDAR at www.sedar.com, which investors should
consult for additional information. The Company disclaims any
intention or obligation to update or revise any forward-looking
statements whether as a result of new information or future events
and except as required by law.
Neither TSX Venture Exchange nor its Regulation Services Provider (as
that term is defined in policies of the TSX Venture Exchange) accepts
responsibility for the adequacy or accuracy of this release.
Knight Therapeutics Inc.
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