Healthcare Industry News:  Knight Therapeutics 

Biopharmaceuticals Ophthalmology FDA

 News Release - December 19, 2016

FDA Orphan Drug Designation Granted to Profounda Inc. for the Treatment of Acanthamoeba Keratitis with Miltefosine

ORLANDO, Fla., Dec. 19, 2016 -- (Healthcare Sales & Marketing Network) -- Profounda, Inc. ("Profounda") announced today that it has received the US Food and Drug Administration's (FDA) Orphan Drug Designation for the treatment of Acanthamoeba Keratitis with miltefosine. Profounda licensed miltefosine (Impavido®) from Knight Therapeutics (USA) in September 2015. View photos

Acanthamoeba Keratitis is a rare but serious infection of the eye that can result in permanent visual impairment or blindness. This infection is caused by a microscopic, free-living amoeba (single-celled living organism) called Acanthamoeba. Acanthamoeba causes Acanthamoeba Keratitis when it infects the transparent outer covering of the eye called the cornea. Acanthamoeba amoebas are very common in nature and can be found in bodies of water (for example, lakes and oceans), soil, and air. Acanthamoeba Keratitis is most common in people who wear contact lenses, but anyone can develop the infection. For people who wear contact lenses, certain practices can increase the risk of getting Acanthamoeba Keratitis.

"We are pleased with the FDA's decision to grant orphan drug designation to miltefosine for the treatment of Acanthamoeba Keratitis," said Todd MacLaughlan, CEO of Profounda Inc., "By creating miltefosine-induced alterations to the membrane architecture of the amoeba, miltefosine allows patients a therapeutic option that has potential advantages over conventional therapy approaches."

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 FDA Orphan Drug Designation

The Orphan Drug Designation program provides orphan status to drugs and biologics, which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the US.

The amoeba species displayed miltefosine-induced alterations of the membrane architecture. [1, 2] The anti-Acanthamoebic activity of miltefosine was confirmed in an Acanthamoeba keratitis hamster model in which topically applied miltefosine [160 µM (65 µg/mL), 28 days] resulted in complete cure of the infection in 85% of the hamsters. [3]
  1. Seifert K, Duchęne M, Wernsdorfer WH, et al. Effects of miltefosine and other alkylphosphocholines on human intestinal parasite Entamoeba histolytica. Antimicrob Agents Chemother 2001;45:1505-10.
  2. Walochnik J, Duchęne M, Seifert K, et al. Cytotoxic activities of alkylphosphocholines against clinical isolates of Acanthamoeba spp. Antimicrob Agents Chemother 2002;46:695-701.
  3. Polat ZA, Obwaller A, Vural A, et al. Efficacy of miltefosine for topical treatment of Acanthamoeba keratitis in Syrian hamsters. Parasitol Res 2012;110:515-20.


Source: Profounda

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