Aspargo Laboratories, Inc. Acquires International Rights to Sildenafil Oral Spray for the Treatment of Erectile Dysfunction
ENGLEWOOD CLIFFS, N.J., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Aspargo Laboratories, Inc. (Aspargo), a privately held, clinical stage, specialty pharmaceutical company, announced today that it has entered into a definitive agreement with Farmalider, S.A. of Madrid, Spain to acquire the exclusive international patent rights related to a proprietary oral spray suspension formulation of sildenafil citrate (Sildenafil Oral Spray) for five million common shares. Aspargo acquired the exclusive U.S. patent rights covering Sildenafil Oral Spray from Farmalider, S.A. in January 2020.
Aspargo’s Sildenafil Oral Spray is an oral liquid suspension of sildenafil citrate administered via a spray pump that dispenses 12.5 mg of sildenafil citrate per push of the pump (referred to as ASP-001) or via an individual single liquid unit dispensing 100 mg per unit (referred to as ASP-002). In May 2020, Aspargo announced the results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA), where the FDA addressed Aspargo's questions and provided guidance on the Company’s Sildenafil Oral Spray for the treatment of erectile dysfunction (ED). The FDA was supportive of a single dose bioequivalent study comparing Aspargo’s Sildenafil Oral Spray, an oral liquid suspension formulation of sildenafil citrate, with VIAGRA® tablets as the basis for approval and deemed the 505(b)(2) regulatory pathway appropriate for the program.
“The acquisition of global rights to Sildenafil Oral Spray represents a significant opportunity for Aspargo”, said Michael Demurjian, Aspargo’s Founder and Chief Executive Officer. “The erectile dysfunction market is one of the most expansive categories in the healthcare industry, as men continue to seek a more efficient and convenient solution to address their condition. Following our recent successful completion of a $7.5 million financing, Aspargo has transformed into a rapidly growing global specialty pharmaceutical company.”
Aspargo’s oral spray suspension formulation of sildenafil citrate (Sildenafil Oral Spray), the active ingredient in VIAGRA®, is a novel and convenient route of administration for this commonly prescribed medication for erectile dysfunction. The oral suspension formulation of sildenafil citrate is approved for sale in 9 European countries in a liquid dosage form and in Spain in the spray dosage form; the spray dosage form is undergoing registration in various jurisdictions worldwide, including 8 European countries and 8 Latin American countries.
Aspargo’s Sildenafil Oral Spray is protected by US Patent No. 10,016,428 B2 (granted: July 10, 2018); European Patent No. EP3072515 (granted: February 28, 2018); and Russian Patent No. RU2016127223A (granted: April 4, 2018) entitled, Pharmaceutical Composition of Sildenafil Citrate in the Form of a Suspension for Oral Use and by trade secrets and manufacturing know-how necessary to manufacture the oral spray formulation and to ensure drug stability. Aspargo is protecting its custom designed spray bottle with US and international patent applications.
About Erectile Dysfunction (ED)
Erectile dysfunction (ED), also known as impotence, is a type of sexual dysfunction characterized by the persistent difficulty achieving and maintaining an erection sufficient to have sexual intercourse. Common causes of ED include: heart disease, clogged blood vessels (atherosclerosis), high cholesterol, high blood pressure, diabetes, obesity, metabolic syndrome, Parkinson’s disease, Multiple Sclerosis, certain prescription medications, tobacco use, Peyronie's disease, alcoholism and other forms of substance abuse, sleep disorders, treatments for prostate cancer or enlarged prostate, surgeries or injuries that affect the pelvic area or spinal cord; and low testosterone. Psychological conditions, such as stress, anxiety or depression, can contribute to erectile dysfunction.
About Aspargo Laboratories, Inc.
Aspargo Laboratories, Inc., located in Englewood Cliffs, New Jersey, is a clinical stage, specialty pharmaceutical company focused on developing an oral spray formulation of sildenafil citrate, the active ingredient in VIAGRA®. Aspargo is the US and international licensee of the patent rights covering Sildenafil Oral Spray from Farmalider, S.A. of Madrid, Spain (www.farmalider.com).
Aspargo’s leadership team has a proven background and a track record in successful drug product development, regulatory approval and commercialization. For additional information, please visit our website at https://aspargolabs.com/.
Forward Looking Statements
This press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events, they give no assurance that such expectations will prove to be correct. Forward-looking statements are subject to a number of risks and uncertainties, but not limited to, our liability to obtain additional capital on acceptable terms, or at all, including additional capital which will be necessary to complete the clinical trials, delays caused by institutional review boards or regulatory agencies, enrollments, shortage of clinical trial supplies, dependence on clinical trial collaborators, loss of any executive officers or key personnel or consultants. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Aspargo disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
|Aspargo Laboratories, Inc.|