Author: aspargolabs20

Disrupting Erectile Dysfunction (ED) Market with Oral Spray

• Aspargo Laboratories, Inc. and Laboratorios Vanquish, S.A. to jointly launch Sildenafil Oral Spray in Mexico via exclusive License and Distribution Agreements
• Mexico, Brazil, Argentina, and Columbia represent combined annual ED market in excess of $1 billion
• Aspargo’s Sildenafil Oral Spray offers a convenient, discreet option for men with ED

ENGLEWOOD CLIFFS, NEW JERSEY and MEXICO CITY, MEXICO – JUNE 21, 2022 – Aspargo Laboratories, Inc. (“Aspargo”), a private specialty pharmaceutical company focused on commercializing innovative formulations of leading tablet medications, announced today that it has entered into an Exclusive Patent License Agreement (the “License”) with LABORATORIOS VANQUISH, S.A. (“Vanquish”), a leading Mexican pharmaceutical company, to commercialize Sildenafil Oral Spray in Mexico. Concurrent with the grant of the License, Aspargo and Vanquish have agreed to enter into a Distribution, Collaboration, and Profit-Sharing Agreement for the joint marketing and promotion of Sildenafil Oral Spray in Mexico (the “Distribution Agreement” and, together with the License, the “Agreements”). The Agreements allow Aspargo to expand its international marketing of Sildenafil Oral Spray for the treatment of erectile dysfunction to the Latin American market.

Sildenafil Oral Spray is an oral liquid suspension of sildenafil citrate administered via a spray pump that dispenses 12.5 mg of sildenafil per push. Aspargo uses an FDA-approved, metered-dose container that delivers the precise amount of sildenafil citrate per push based on patient need. The discreet and easy-to-carry oral spray allows the user to customize dosing and avoid pill splitting or crushing attendant with the traditional tablet medication.

“The expansion of our product launch to Mexico positions Aspargo to access the lucrative LATAM markets of Mexico, Brazil, Argentina, and Columbia, which represent combined annual sales in excess of $1 billion,” said Michael Demurjian, Aspargo’s Chairman and Chief Executive Officer. “This pocket-sized oral spray suspension formulation of sildenafil citrate will now give men in Mexico a convenient and precise delivery system of a proven ED medication to manage their erectile dysfunction.”

Pursuant to the Agreements, Aspargo and Vanquish will jointly market Sildenafil Oral Spray in Mexico and share in the net profit and cash flow from product sales. Farmalider, S.A. (Madrid, Spain), licensor to Aspargo of the patent rights to Sildenafil Oral Spray, will supply the commercial product for the Spanish market pursuant to a multi-year Supply Agreement. The joint venture leverages Aspargo’s proprietary patents, know-how, and sales expertise and Vanquish’s logistics, administration, supply chain, and drug distribution services in the Mexican market to maximize product sales.

“At Vanquish, we are dedicated to making safe and reliable prescription drugs accessible to members of our local communities,” said Aristides Torres, Vanquish’s CEO. “Together with Aspargo, we will commercialize an oral spray of the proven drug sildenafil, providing men suffering from erectile dysfunction and their partners with an alternative, discreet option. I’m honored to be on the forefront of bringing this drug to Mexico.”

Erectile dysfunction is characterized by the persistent difficulty achieving and maintaining an erection sufficient to have sexual intercourse. While the prevalence of ED has been shown to increase with age, a recent study conducted by the Sexual Medicine and Andrology Unit of the University of Florence, Italy, showed that ED in younger men is likely to be overlooked and dismissed without a proper medical assessment.

About Aspargo Laboratories, Inc.
Aspargo Laboratories, Inc., located in Englewood Cliffs, New Jersey, is a commercial stage, specialty pharmaceutical company. Aspargo’s current focus is to commercialize 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). For additional information, please visit our website at https://aspargolabs.com/.

About Laboratorios Vanquish
Laboratorios Vanquish is a privately held pharmaceutical company headquartered in Mexico City, Mexico. The company is dedicated to the development, manufacturing, and commercialization of drugs and medical devices, mainly for the institutional market. For additional information, please visit our website at https://www.grupovanquish.com/.

Contact:                     
Aspargo Laboratories, Inc.
(201) 408-4831
info@aspargolabs.com

Immediate Revenue And Expansion Of Global Footprint

• Acquisition transforms Aspargo into a revenue producing company
• European market entry positions Aspargo for commercialization of Sildenafil Oral Spray world-wide

ENGLEWOOD CLIFFS, NEW JERSEY and BARCELONA, SPAIN – MAY 3, 2022 – Aspargo Laboratories, Inc., a privately held specialty pharmaceutical company focused on commercializing innovative formulations of leading medications, today announced the acquisition of the prescription brand BANDOL^® (sildenafil oral suspension) from Laboratorios Rubio S.A., a specialty pharmaceutical company headquartered in Barcelona, Spain. BANDOL^® is indicated for the treatment of erectile dysfunction (ED). Concurrent with the acquisition, Aspargo entered into a distribution agreement with Rubio for the continued marketing and promotion of BANDOL^® in Spain and a license and supply agreement with Farmalider, S.A. (Madrid, Spain) for the supply of BANDOL^® to the Spanish market.

“The acquisition of BANDOL^® is part of our strategic global growth plan that positions Aspargo to be first to market with an innovative oral spray solution for erectile dysfunction,” said Michael Demurjian, Aspargo’s Chairman and Chief Executive Officer. “Utilizing BANDOL^® as our initial venture in Europe, we plan to accelerate the commercialization of Sildenafil Oral Spray in other European countries and globally, subject to regulatory compliance in each country.”

BANDOL^®, offered in a convenient and discreet metered dose container that delivers the equivalent of 12.5 mg per actuation, is manufactured in Spain and is prescribed predominantly by primary care physicians and urologists. Originally licensed by Rubio from Farmalider—a pharmaceutical company dedicated to the research, development, and manufacture of pharmaceutical products, and launched by Rubio in 2020—BANDOL^® is the only sildenafil oral spray currently on the market world-wide. The Spanish market for VIAGRA^®, CIALIS^®, and their generic equivalents was valued at approximately $80 million in 2021 (IQVIA analytics 2021).

“We are pleased to have entered this commercial distribution agreement with Aspargo and look forward to working on additional opportunities together”, said Pelayo Rubio, Rubio’s Chief Executive Officer.

Erectile dysfunction is characterized by the persistent difficulty achieving and maintaining an erection sufficient to have sexual intercourse. While the prevalence of ED has been shown to increase with age, a recent study conducted by the Sexual Medicine and Andrology Unit of the University of Florence, Italy, showed that ED in younger men is likely to be overlooked and dismissed without a proper medical assessment.

About Aspargo Laboratories, Inc.
Aspargo Laboratories, Inc., located in Englewood Cliffs, New Jersey, is a commercial stage, specialty pharmaceutical company. Aspargo’s current focus is to commercialize 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). For additional information, please visit our website at https://aspargolabs.com/.

About Laboratorios Rubio
Laboratorios Rubio is a privately held pharmaceutical company, headquartered in Spain. The company engages in the development, manufacturing, marketing & distribution of established products while introducing new products each year that arise both from proprietary formulations and strategic commercial partnerships. For additional information, please visit our website at https://www.laboratoriosrubio.com/.

Contact:
Aspargo Laboratories, Inc.
(201) 408-4831
info@aspargolabs.com

Aspargo Laboratories, Inc. Announces Successful Completion of Pre-IND Meeting with FDA on Sildenafil Oral Spray for the Treatment of Erectile Dysfunction

• Alignment with FDA to pursue 505(b)(2) regulatory pathway
• On-track for IND filing in Q3 2020

ENGLEWOOD CLIFFS, NJ. MAY 4, 2020 – Aspargo Laboratories, Inc. (Aspargo), a privately held, clinical stage pharmaceutical company, today 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).

A pre-IND meeting provides an opportunity for an open communication between the sponsor and the FDA to discuss the IND development plan and to obtain the Agency’s guidance for clinical studies for the sponsor’s new drug candidate. 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 and deemed the 505(b)(2) regulatory pathway appropriate for the program.

“We are encouraged by the outcome of the pre-IND meeting with the FDA and based on their feedback are advancing towards an IND submission for Sildenafil Oral Spray in the third quarter of 2020,” said Michael Demurjian, Chief Executive Officer of Aspargo. “Importantly, the FDA deemed the 505(b)(2) regulatory pathway appropriate for our clinical program and pending results from our planned single-dose bioequivalent study, we do not foresee the need to conduct any additional long-term safety, toxicology or phase 3 efficacy studies. We look forward to advancing Sildenafil Oral Spray in the U.S. market to provide men who suffer from erectile dysfunction a differentiated dosing formulation that provides convenient administration, flexible dosing and access for ED patients who have difficulty swallowing oral tablets.”

In its written response, the FDA supported Aspargo’s plan to conduct a single dose bioequivalent study to evaluate the pharmacokinetics, bioequivalency, tolerability and safety of the Company’s Sildenafil Oral Spray drug candidate, administered via a metered dose pump or individual single liquid unit, when compared to Viagra^® tablets. The randomized, single center, unblinded, three-way crossover study will seek to enroll a total of 72 healthy volunteers who will receive a single dose of Sildenafil Oral Spray administered via a dose metered pump, a single dose of Sildenafil Oral Spray administered via an individual single liquid unit or a single dose of Viagra® oral tablet. Thirty-six subjects will be treated under fed conditions and thirty-six subjects will be treated under fasting conditions.

The FDA did not object to the planned study design and patient populations, as well as plans for manufacturing and product testing, and did not recommend any additional studies in preparation for an IND submission and initiation of clinical trials.

Aspargo is collaborating with Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization located in Hunt Valley, MD (www.pharm-int.com) to develop and manufacture Sildenafil Oral Spray for clinical trials. Pii is also laying the groundwork for the future commercial manufacturing requirements of Sildenafil Oral Spray in the U.S.

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’s Sildenafil Oral Spray
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 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). The oral spray liquid suspension is currently approved for sale in Spain, Portugal, Italy, Poland, The Czech Republic, Slovakia, Hungary, Romania, Bulgaria and Greece. Regulatory approval is pending in Brazil, China, France, Germany, Israel, Mexico, Ukraine and the United Kingdom.

About Aspargo Laboratories, Inc.
Aspargo Laboratories, Inc., located in Englewood Cliffs, New Jersey, is a clinical stage pharmaceutical company focused on developing an oral spray formulation of sildenafil, the active ingredient in Viagra®, in the United States. Aspargo is the exclusive U.S. licensee of the U.S. 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 www.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.

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