Aspargo Laboratories, Inc.
Aspargo Laboratories, Inc. owns exclusive rights to obtain FDA approval for and market in the U.S. an oral spray formulation of sildenafil, the active ingredient in Viagra®, Aspargo's oral spray sildenafil is approved in Europe and Latin America.
Aspargo, a Delaware corporation formed in 2019, is a life sciences corporation developing an innovative therapeutic approach to address the large clinical need for drugs that treat erectile dysfunction, one of the most common sex problems that men report to their doctors. Aspargo recently signed an exclusive license agreement for the right to develop, manufacture, sell, sub-license, and otherwise commercialize in the U.S. an oral spray liquid formulation of sildenafil citrate, the active ingredient in Viagra®. Aspargo's rights in its sildenafil oral spray are protected by United States Patent No. US 10,016,428 B2, (Jul. 10, 2018) PHARMACEUTICAL COMPOSITION OF SILDENAFIL CITRATE IN THE FORM OF A SUSPENSION FOR ORAL USE. The granted patent covers a pharmaceutical composition of sildenafil citrate in the form of a suspension for oral administration. Aspargo's sildenafil oral spray was approved in Europe in 2018 and was launched in Spain in 2019. It has not yet been approved by the FDA. Aspargo intends to pursue FDA approval under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which provides that new routes of administration for an approved drug qualify for an expedited form of approval. Benefits include (i) relatively low development/approval risk because of previous drug approval; (ii) lower cost and accelerated development due to fewer clinical studies; and (iii) the opportunity to qualify for three years of FDA market exclusivity in addition to existing patent protection. Aspargo's objective is to obtain FDA approval in late 2021 and launch the drug in early 2022.
Aspargo Laboratories, Inc. owns exclusive rights to obtain FDA approval for and market in the U.S. an oral spray formulation of sildenafil, the active ingredient in Viagra®, Aspargo's oral spray sildenafil is approved in Europe and Latin America. Aspargo, a Delaware corporation formed in 2019, is a life sciences corporation developing an innovative therapeutic approach to address the large clinical need for drugs that treat erectile dysfunction, one of the most common sex problems that men report to their doctors. Aspargo recently signed an exclusive license agreement for the right to develop, manufacture, sell, sub-license, and otherwise commercialize in the U.S. an oral spray liquid formulation of sildenafil citrate, the active ingredient in Viagra®. Aspargo's rights in its sildenafil oral spray are protected by United States Patent No. US 10,016,428 B2, (Jul. 10, 2018) PHARMACEUTICAL COMPOSITION OF SILDENAFIL CITRATE IN THE FORM OF A SUSPENSION FOR ORAL USE. The granted patent covers a pharmaceutical composition of sildenafil citrate in the form of a suspension for oral administration. Aspargo's sildenafil oral spray was approved in Europe in 2018 and was launched in Spain in 2019. It has not yet been approved by the FDA. Aspargo intends to pursue FDA approval under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which provides that new routes of administration for an approved drug qualify for an expedited form of approval. Benefits include (i) relatively low development/approval risk because of previous drug approval; (ii) lower cost and accelerated development due to fewer clinical studies; and (iii) the opportunity to qualify for three years of FDA market exclusivity in addition to existing patent protection. Aspargo's objective is to obtain FDA approval in late 2021 and launch the drug in early 2022.
Products & Services
Aspargo Laboratories, Inc. - Main Product
{'name': 'An oral spray formulation of sildenafil, the active ingredient in Viagra® (subject to FDA approval),', 'description': 'Aspargo\'s spray formulation of sildenafil is dispensed from a metered dose spray pump that delivers exactly 12.5 mg per spray onto or under the tongue. Patients administer two, or four metered sprays when needed, 30 minutes to 1 hour before sexual activity Aspargo\'s sildenafil oral spray formulation has been approved by regulatory authorities in 9 European and 8 Latin American countries. The drug is marketed in Spain under the trade name, “Bandol” and in various Latin American countries under the brand name, "Lysto". The advantages of Aspargo\'s sildenafil oral spray compared to traditional tablets include: (1) suitable for patients who have difficulty swallowing; (2) convenient oral administration without the need for accompanying liquids and attendant utensils or containers; and (3) metered dosing allows for dose titration; (i.e., allows prescribing physicians to adjust the prescribed dose for the maximum patient benefit without adverse side effects).'}
Team
Michael D
CHIEF EXECUTIVE OFFICER
Michael has served as Tyme Inc’s COO, CFO and an executive member of the Board of Directors since Dec. 2013. He retired in April 2019 from Tyme Inc. (...
Robert N
EXECUTIVE VICE PRESIDENT RESEARCH & DEVELOPMENT
Robert is a managing director of Accelapharm, serves as the Head of Regulatory Affairs and Vice President of Axsome Therapeutics and also serves as th...
Michael R
DIRECTOR
Michael is co-founder of LifeSci Advisors, Inc., a leading provider to companies in the life sciences industry with comprehensive solutions to communi...
Peter N
CONSULTING PUBLIC RELATIONS
Peter N......, cohost on CNBC’s Fast Money and a member of the Fast Money 5, is an options trader, market analyst, and co-founder of option MONSTER-so...
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