MONTREAL, QC--(Marketwired - March 22, 2016) - Knight Therapeutics Inc. (TSX: GUD), through one of its wholly-owned subsidiaries ("Knight"), announced today that its U.S. commercialization partner, Profounda Inc. ("Profounda"), has launched Impavido® (miltefosine) 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").
Knight entered into an exclusive distribution agreement with Profounda in September 2015 to commercialize Impavido® (miltefosine), an oral treatment for visceral, mucosal and cutaneous leishmaniasis in the United States.
Clinicians can find out more about how to order Impavido® for their patients or how to have the ability to hold 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 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 Ross Goodman, Director of Knight.
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 Centers for Disease Control.
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 regions such as Asia and the Middle East. Impavido® is approved for marketing in Germany, India, Israel and the United States.
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.
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. Profounda's 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.
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.