Knight Therapeutics Inc. Announces FDA Approval for Impavido(R) (Miltefosine) for the Treatment of Visceral, Mucosal and

Knight Therapeutics Inc. Announces FDA Approval for Impavido(R) (Miltefosine) 
for the Treatment of Visceral, Mucosal and Cutaneous Leishmaniasis 
NEWS RELEASE TRANSMITTED BY Marketwired 
FOR: Knight Therapeutics Inc. 
TSX VENTURE SYMBOL:  GUD 
MARCH 19, 2014 
Knight Therapeutics Inc. Announces FDA Approval for Impavido(R) (Miltefosine)
for the Treatment of Visceral, Mucosal and Cutaneous Leishmaniasis 
Awarded Priority Review Voucher 
MONTREAL, QUEBEC--(Marketwired - March 19, 2014) - 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 2011. 
About Leishmaniasis: 
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. 
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FOR FURTHER INFORMATION PLEASE CONTACT: 
Knight Therapeutics Inc.
Jeffrey Kadanoff
514-484-4GUD (4483) 
INDUSTRY:  Pharmaceuticals and Biotech - Drugs 
SUBJECT:  PDT 
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-0- Mar/19/2014 22:21 GMT
 
 
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