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Biopharmaceuticals FDA

 News Release - November 8, 2021

FDA Grants Profounda Orphan Drug Designation Approval for Treatment of Invasive Candidiasis with Miltefosine

Invasive candidiasis is an infection caused by a yeast (a type of fungus) called Candida. and is a serious infection that can affect the blood, heart, brain, eyes, bones, or other parts of the body

In the United States, candidemia is one of the most common causes of bloodstream infections in hospitalized patients and it often results in long hospital stays and death


ORLANDO, Fla., Nov. 8, 2021 -- (Healthcare Sales & Marketing Network) -- Profounda, Inc. ("Profounda") announced today that it has received the US Food and Drug Administration's Orphan Drug Designation Approval for the use of miltefosine to treat Invasive Candidiasis with Miltefosine. Profounda licensed miltefosine (Impavido®) from Knight Therapeutics (TSX: GUD) Inc in 2013 for Leishmaniasis. Leishmaniasis is a parasitic disease that is found in parts of the tropics, subtropics, and southern Europe. Leishmaniasis is caused by infection with Leishmania parasites, which are spread by the bite of infected sand flies. There are several different forms of leishmaniasis in people. The most common forms are cutaneous leishmaniasis, which causes skin sores, and visceral leishmaniasis, which affects several internal organs (usually spleen, liver, and bone marrow). During 2013–2017, the average incidence for Invasive Candidiasis was approximately 9 per 100,000 people; however, this number varies substantially by geographic location and patient population. CDC estimates that approximately 25,000 cases of candidemia occur nationwide each year.

Though it is the most common form of invasive candidiasis, candidemia does not represent all forms of invasive candidiasis because the infection can occur in the heart, kidney, bones, and other internal organs without being detected in the blood. In fact, the true burden of invasive candidiasis might be twice as high as the estimate for candidemia.

In addition to the approval for the treatment of Leishmanias, Miltefosine has also received orphan drug designation in treating the Free-Living infection Primary Amebic Meningoencephalitis (PAM), the brain infection caused by the water-born amoeba Naegleria fowleri, Granulomatous Amebic Encephalitis (GAE) and also for Acanthamoeba Keratitis, a severe eye infection in which over 200 patients have been treated and is the first Rx product launched in the U.S. by Profounda, Inc. .

In August of 2016, miltefosine played a role in helping a Florida teen survive a brain eating amoeba infection, Primary Amebic Meningoencephalitis (PAM) — Amebic Encephalitis. Since minutes matter, Profounda has offered any hospital in the country a no charge consignment program in which there are now 26 participating hospitals across the country.

Michael MacLaughlan, VP Operations of Profounda, says " An example of invasive Candidiasis is Candida auris which is an emerging multidrug resistant yeast that can cause invasive candidiasis and is associated with high mortality.," and further stated, "Additional treatment options are needed for invasive Candidiasis to allow for a potentially successful treatment".

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. 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 objectives are to bring high quality, innovative options to patients being treated for various conditions, and to improve the lives of those that take our medication. Profounda's first commercial OTC products, Rhinase® Nasal Gel and Rhinase® Nasal Mist & Xynase, help patients with nasal dryness associated with allergies. Profounda is also developing a potential first to file generic product competing in a $150+ million brand market. Profounda also makes Pineapple Peel Daily chemical exfoliator and othe cosmetic products and also manufactures for other companies.

For more information, visit Profounda's website at www.profounda.com.


Source: Profounda

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