- Launch follows September 25,
2015 Licensing Agreement with a wholly-owned subsidiary of
Knight Therapeutics Inc. (TSX:GUD) ("Knight").
ORLANDO, Fla. and MONTREAL, March 22, 2016 /PRNewswire/ --
Profounda, Inc. ("Profounda") announced today that
Impavido® (miltefosine) is now available in
the United States. Impavido is the
first and only oral treatment for visceral, mucosal and cutaneous
leishmaniasis approved by the U.S. Food and Drug Administration
("FDA") and the first Rx product launched in the U.S. by
Profounda.
The skin sores of cutaneous leishmaniasis ("CL") usually heal on
their own, even without treatment. However, this can take months or
even years, and the sores can leave ugly scars. In 1-10% of
patients with New World CL.1 Leishmania
disseminates from the skin to the nasooropharyngeal mucosa,
resulting in mucosal leishmaniasis ("ML") and destruction of nasal
and pharyngeal structures. Death may occur due to complicating
aspiration pneumonia. Mucosal leishmaniasis might not be noticed
until years after the original sores healed. The best way to
prevent mucosal leishmaniasis is to ensure adequate treatment of
the cutaneous infection. Visceral leishmaniasis ("VL") is the
result of systemic infection. Clinical manifestations include
fever, hepatomegaly, splenomegaly, and bone marrow involvement with
pancytopenia. VL is fatal if untreated. There are no other current
FDA approved drugs for the treatment of CL or ML other than
Impavido.
Clinicians can find out more about how to order Impavido for
their patients or how to have the ability to have Impavido on
consignment by visiting www.impavido.com.
"Making such an important treatment option for leishmaniasis
available in the United States
will help those very few patients who need this important therapy,"
said Todd MacLaughlan, CEO of
Profounda. "With the launch of Impavido, we look forward to working
with the infectious disease community to create awareness about the
disease and this newly available treatment option."
"Impavido is approved for sale in Germany, India, Israel, and the
United States and has been helping patients suffering from
leishmaniasis since 2002. We are pleased that Profounda has taken
the initiative to make this medically important medicine available
to Americans. Impavido will touch the lives of U.S. patients to our
immense delight," said Jonathan
Goodman, President and CEO of Knight.
1. (Bratisl Lek Listy 2015; 116 (3))
About Leishmaniasis
Leishmania organisms are intracellular protozoan parasites that
are transmitted to a mammalian host by the bite of the female
phlebotomine sandfly. The genus is divided into two subgenera,
Leishmania and Viannia. Leishmania subgenus includes L. donovani,
L. chagasi/infantum, L. tropica, L. major, L. aethiopica, L.
mexicana and L. amazonensis. The subgenus Viannia includes L.
braziliensis, L. peruviana, L. guyanensis and L. panamensis.
Traditionally, Leishmania infections that occur in Asia, Africa,
Europe and the Middle East are designated 'Old World', while
infections that occur in the Americas are designated 'New
World'.
The main clinical syndromes are visceral leishmaniasis,
cutaneous leishmaniasis, and mucosal leishmaniasis. Visit
http://www.cdc.gov/parasites/leishmaniasis for more information
from the Center for Disease Control ("CDC").
About Impavido® (miltefosine)
Impavido® (miltefosine) is an FDA-approved, oral
treatment for visceral, mucosal and cutaneous leishmaniasis in
patients 12 years of age and older. Please see Full
Prescribing Information on www.impavido.com for complete
information. In the United States,
leishmaniasis may be seen in returning travelers following exposure
in endemic regions, and in American soldiers serving in
Asia and the Middle East. Impavido is approved for
marketing in Germany, India, Israel, and the
United States.
Miltefosine is an 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 Profounda, Inc.
Profounda is a product-oriented, privately backed pharmaceutical
company that aims to license or develop high quality specialty
niche pharmaceutical products in both the branded and generic
pharmaceutical markets. Our objective is to focus on bringing high
quality innovative options to patients being treated for various
conditions in order to improve the lives of those that take our
medication. Profounda's first commercial OTC
products, Rhinase® Nasal Gel and Rhinase® Nasal Mist,
will help patients with nasal dryness associated with
allergies. Profounda is also developing a potential first to
file generic product competing in a $100+ million brand market. For
more information, visit Profounda's website
at www.profounda.com.
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 select
international markets. Knight Therapeutics Inc.'s shares trade on
TSX under the symbol GUD. For more information about Knight
Therapeutics Inc., please visit the company's web site at
www.gud-knight.com or www.sedar.com.
Forward-Looking Statement
This document contains forward-looking statements for Knight
Therapeutics Inc. and its subsidiaries. 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. Knight
Therapeutics Inc. considers the assumptions on which these
forward-looking statements are based to be reasonable at the time
they were prepared, but cautions the reader that these assumptions
regarding future events, many of which are beyond the control of
Knight Therapeutics Inc. 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 Knight Therapeutics Inc.'s Annual Report and in Knight
Therapeutics Inc.'s Annual Information Form for the year ended
December 31, 2014. Knight
Therapeutics Inc. disclaims any intention or obligation to update
or revise any forward-looking statements whether as a result of new
information or future events, except as required by law.
Contacts:
Knight Therapeutics Inc.
Jeffrey Kadanoff, P.Eng., MBA
Chief Financial Officer
514-484-GUD1 (4831)
514-481-4116 (FAX)
info@gud-knight.com
www.gud-knight.com
For further information please contact:
Profounda, Inc.
Todd MacLaughlan
Chief Executive Officer
Tel: 407-270-7792
Fax: 514-481-4116
Email: todd@profounda.com
Website: www.profounda.com // www.Impavido.com
Logo - http://photos.prnewswire.com/prnh/20160321/346134LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/profounda-inc-launches-impavido-miltefosine-the-first-and-only-oral-rx-treatment-for-visceral-mucosal-and-cutaneous-leishmaniasis-in-the-united-states-300238867.html
SOURCE Profounda, Inc.