- 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))
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.
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.
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SOURCE Profounda, Inc.