Author: aspargolabs20

• Study will compare bioavailability of Sildenafil Oral Suspension and Viagra® tablets under fasted conditions
• Companion study will evaluate the effects of food on the bioavailability of Sildenafil Oral Suspension
• Studies represent pivotal clinical program to support U.S. New Drug Application

ENGLEWOOD CLIFFS, NEW JERSEY – SEPTEMBER 19, 2023 – Aspargo Laboratories, Inc. (“Aspargo” or the “Company”), a privately held specialty pharmaceutical company focused on commercializing innovative formulations of leading tablet medications, announced today that all 47 subjects have received their initial dose in the Company’s comparative bioavailability study comparing Sildenafil Oral Suspension (ASP-001) to Viagra®.

The open label, single center, single dose, two-way crossover comparative bioavailability study in healthy subjects, entitled, “A Phase 1 Pharmacokinetic/Bioequivalence Study of 100 mg of ASP-001 (Oral Liquid Suspension of Sildenafil-Spray) versus 100 mg of Viagra® (Sildenafil) Film-Coated Tablets under Fasted Conditions in Healthy Adult Male Subjects”, is assessing the rate and extent of absorption of ASP-001 (Sildenafil Oral Suspension) compared to Viagra® tablets for the treatment of erectile dysfunction (“ED”). A companion food-effect study will assess the rate and extent of absorption of ASP-001 under fasted versus fed conditions. The companion food-effect study will commence next month.

As recommended by the U.S. Food and Drug Administration (FDA)¹, the bioavailability study is designed to compare ASP-001 with Viagra® tablets in normal healthy subjects between the ages of 18–55 years. Cliantha Research, Aspargo’s designated clinical contract research organization, is conducting the “crossover” study in 47 volunteers. Each subject is receiving ASP-001 and Viagra® in an alternate fashion over two periods separated by a washout period of six days’ duration. The 47 subjects that completed initial dosing were randomly assigned to receive either a single dose of 100 mg of ASP-001 or 100 mg of Viagra®, with approximately the same number of subjects receiving each treatment. Thus, in the 47 subjects that were dosed in period one, one group received a single dose of ASP-001 and will receive a single dose of Viagra® in period two following the washout period, and the second group received a single dose of Viagra® and will receive a single dose of ASP-001 in period two following the washout period.

Among the primary objectives of the comparative bioavailability study is to determine:

• The pharmacokinetics of sildenafil and its active metabolite in plasma following a single dose of 100mg of ASP-001 as compared to a single dose of 100mg of Viagra®, including the rate and extent of absorption of 100mg of ASP-001 compared to the rate and extent of absorption of 100mg of Viagra®.
• Whether the absorption rate of ASP-001 is superior to the absorption rate of Viagra®.

Assuming favorable outcomes and subject to discussions with the FDA, the Company expects these studies to support the regulatory approval of ASP-001 in the United States without the need for additional efficacy studies.

“Completion of initial dosing of all 47 subjects in this important study represents a significant milestone in our late-stage development program of Sildenafil Oral Suspension for the treatment of ED,” said Michael Demurjian, Chief Executive Officer and Chairman of Aspargo. “This milestone paves the way for us to develop a broad pipeline of products designed to leverage the ease, convenience and efficiency of oral suspension formulations that bypass the breakdown step in the stomach and small intestine necessary for tablet dosage forms, leading to potentially faster delivery of the active ingredient into the bloodstream. We look forward to completing this comparative bioavailability study and initiating our companion food-effect study shortly and sharing results from both studies later this year.”

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

ED 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 study conducted by the Sexual Medicine and Andrology Unit at the University of Florence, Italy², showed that ED in younger men is likely to be overlooked and dismissed without a proper medical assessment, indicating a continued unmet medical need, and demand for new and innovative routes of administration of ED therapeutic products.

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 Suspension from Farmalider, S.A. of Madrid, Spain (www.farmalider.com). For additional information, please visit our website at https://aspargolabs.com/.

Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, management gives no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; and the outcome of pending or future litigation or arbitration.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

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

¹Food and Drug Administration (FDA). Guidance for industry: Statistical Procedures for Bioequivalence Studies Using a Standard Two-treatment Crossover Design. U.S Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER). July 1992. Available from: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance

²Rastrelli G, Maggi M. Erectile dysfunction in fit and healthy young men: psychological or pathological? Transl Androl Urol. 2017 Feb;6(1):79-90. doi: 10.21037/tau.2016.09.06. PMID: 28217453; PMCID: PMC5313296

• Company plans to initiate clinical trials in September 2023 to compare Sildenafil Oral Spray to Viagra^® tablets, and effect of dose administration under fasted versus fed conditions
• Represents Aspargo’s first program to receive IND clearance

ENGLEWOOD CLIFFS, NEW JERSEY – September 5, 2023 – Aspargo Laboratories, Inc. (“Aspargo” or the “Company”), a privately held specialty pharmaceutical company focused on commercializing innovative formulations of leading tablet medications, announced today that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate bioequivalence and food-effect clinical studies of ASP-001 (Sildenafil Oral Spray) in comparison to Viagra® for the treatment of erectile dysfunction (“ED”).

“We are thrilled to have received IND clearance from the FDA for Sildenafil Oral Spray for the treatment of ED. This significant milestone brings us one step closer to introducing in the US a disruptive and paradigm-shifting route of administration for this popular medication,” said Michael Demurjian, Chief Executive Officer of Aspargo. “This program marks our first IND clearance as a company and is a testament to Dr. Rober Niecestro, head of regulatory affairs at Aspargo, and the formulation optimization and CMC data provided by our contract manufacturer, Pharmaceutics International Inc. (“Pii”) and regulatory data developed by our regulatory teams at Pii, QARA and Propharma, which support ASP-001 and our IND submission. We look forward to launching our clinical studies designed to compare Sildenafil Oral Spray to Viagra® tablets later this month through our contract research organization, Cliantha Research, at Cliantha’s Mississauga, Ontario clinic.”

Sildenafil Oral Spray is an oral liquid suspension of sildenafil citrate administered via a spray pump that dispenses 12.5mg of sildenafil per push. Aspargo uses a metered-dose container that delivers the precise amount of sildenafil citrate per actuation based on patient need. The discreet and easy-to-carry oral spray allows for physician prescribed customized dosing and avoids splitting or crushing pills, which is common with the traditional tablet medication.

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 study conducted by the Sexual Medicine and Andrology Unit at the University of Florence, Italy¹, showed that ED in younger men is likely to be overlooked and dismissed without a proper medical assessment, indicating a continued unmet medical need, and demand for new and innovative routes of administration of ED therapeutic products.

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 exclusive licensee of the patent rights covering Sildenafil Spray for the US and many international markets from Farmalider, S.A. (www.farmalider.com). For additional information, please visit our website at aspargolabs.com.

Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; and the outcome of pending or future litigation or arbitration.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

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

¹Rastrelli G, Maggi M. Erectile dysfunction in fit and healthy young men: psychological or pathological? Transl Androl Urol. 2017 Feb;6(1):79-90. doi: 10.21037/tau.2016.09.06. PMID: 28217453; PMCID: PMC5313296

• Planned bioequivalence study in healthy adult male subjects will compare the rate and extent of absorption of ASP-001 (Sildenafil Oral Spray) versus Viagra^® tablets
• Companion food-effect study will compare rate and extent of absorption of ASP-001 (Sildenafil Oral Spray) under fasted versus fed conditions

ENGLEWOOD CLIFFS, NEW JERSEY – AUGUST 1, 2023 – Aspargo Laboratories, Inc. (“Aspargo” or the “Company”), a privately held specialty pharmaceutical company focused on commercializing innovative formulations of leading tablet medications, announced today that it has submitted an Investigational New Drug (IND) application, which has been accepted for review, to the U.S. Food and Drug Administration (FDA) for ASP-001 (Sildenafil Oral Spray) in the treatment of erectile dysfunction. Aspargo plans to commence the clinical studies described in the IND in the fourth quarter of 2023, pending the FDA’s acceptance of the Company’s filing.

Aspargo intends to compare ASP-001 to Viagra^® tablets and the effects of ASP-001 administered under fasted and fed conditions in separate but simultaneous single-dose Phase 1 studies in healthy adult male subjects. Among the primary objectives of the studies are to determine:

• The pharmacokinetics of sildenafil and its active metabolite in plasma following a single dose of 100mg of ASP-001 as compared to a single dose of 100mg of Viagra^®, including the rate and extent of absorption of 100mg of ASP-001 compared to the rate and extent of absorption of 100mg of Viagra^®.
• Whether the absorption rate of ASP-001 is superior to the absorption rate of Viagra^®.
• Any food effects on the pharmacokinetics of sildenafil and its active metabolite in plasma following a single dose of 100mg of ASP-001.
• The rate and extent of absorption of 100mg of ASP-001 when administered under fed conditions versus fasted conditions.

“We are committed to disrupting the traditional administration of solid oral dosage forms of popular medications in order to achieve greater convenience and resulting compliance across all patient demographics,” commented Michael Demurjian, Chairman and CEO of Aspargo. “Our initial product candidate, Sildenafil Oral Spray, offers a convenient, discreet option for men with erectile dysfunction. Currently, we market Sildenafil Oral Spray in Spain and are preparing for our commercial launches in Germany, other European countries, the UK, and Central and South America. We intend to leverage our learnings from our international launches to optimize our commercial success in the US market. I would like to acknowledge our regulatory, manufacturing and operations team members who have worked diligently for the past two years to prepare and file our IND and achieve this significant FDA milestone.”

Sildenafil Oral Spray is an oral liquid suspension of sildenafil citrate administered via a spray pump that dispenses 12.5mg of sildenafil per push. Aspargo uses a 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, with physician direction, and avoid pill splitting or crushing common with the traditional tablet medication.

Erectile dysfunction (“ED”) 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 study conducted by the Sexual Medicine and Andrology Unit at the University of Florence, Italy¹, showed that ED in younger men is likely to be overlooked and dismissed without a proper medical assessment, indicating a continued unmet medical need, and demand for new and innovative routes of administration of ED therapeutic products.

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 Spray from Farmalider, S.A. of Madrid, Spain (www.farmalider.com). For additional information, please visit our website at aspargolabs.com

Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; and the outcome of pending or future litigation or arbitration.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

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

¹Rastrelli G, Maggi M. Erectile dysfunction in fit and healthy young men: psychological or pathological? Transl Androl Urol. 2017 Feb;6(1):79-90. doi: 10.21037/tau.2016.09.06. PMID: 28217453; PMCID: PMC5313296

• The aggregate German, Irish and Dutch market for erectile dysfunction (ED) market exceeds $175 million
• Aspargo plans to launch Sildenafil Spray in Germany, Ireland, and the Netherlands under the brand name, “HEZKUE™”
• Aspargo’s Sildenafil Spray offers a convenient, discreet option for men with erectile dysfunction

ENGLEWOOD CLIFFS, NEW JERSEY – JANUARY 24, 2023 – Aspargo Laboratories, Inc. (“Aspargo”), a privately held specialty pharmaceutical company focused on commercializing innovative formulations of leading tablet medications, announced today that the German Federal Institute for Drugs and Medical Devices has authorized the marketability of “Hezkue™ 12.5 mg per actuation, oral suspension“ in Germany effective as of January 12, 2023. The German market – the largest in the EU – represents an important element of Aspargo’s global expansion strategy. Recently, Aspargo received corresponding approvals in Ireland and the Netherlands.

“These product approvals reflect Aspargo’s commitment to quickly expand its global platform to the EU during 2023,” said Michael Demurjian, Aspargo’s Chairman & Chief Executive Officer. “The Marketing Authorizations are an important achievement. They validate Aspargo’s international regulatory strategy and confirm that Aspargo meets the highest standards required to ensure the safe distribution of sildenafil spray.”

Aspargo developed the brand name, HEZKUE™, with assistance from its commercialization consultant, Syneos Health, a global biopharma solutions organization, following focus groups and surveys with physicians, pharmacists, and patients. The criteria used to select the brand name included first impressions, spelling and pronunciation, interpretation, attributes, favorite name and recall. Brand names used to market a drug are subject to approval of the respective health authorities in each country.

Sildenafil 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 a 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.

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 Spray from Farmalider, S.A. of Madrid, Spain (www.farmalider.com). For additional information, please visit our website at aspargolabs.com

Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements. Forward-looking statements reflect management’s current knowledge, assumptions, judgment, and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct, and you should be aware that actual events or results may differ materially from those contained in the forward- looking statements. Words such as “will,” “expect,” “intend,” “plan,” “potential,” “possible,” “goals,” “accelerate,” “continue,” and similar expressions identify forward-looking statements.

Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development, attainment of the requisite regulatory authorizations and approvals and launch of any new pharmaceutical product; the outcome of pending or future litigation or arbitration; and the various risks and uncertainties described in the “Risk Factors” sections of our Confidential Private Placement Memorandum of October 19, 2022.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not rely upon any forward-looking statements as predictions of future events. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof, to reflect new information or the occurrence of unanticipated events, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, in each case, except as required by law.

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

Disrupting Erectile Dysfunction (ED) Market With Oral Spray

• Aspargo Laboratories, Inc. to leverage Laboratorio SIDUS’ ED market position to launch Sildenafil Oral Spray in Argentina via exclusive License and Supply Agreements
• Aspargo’s Sildenafil Oral Spray offers a convenient, discreet option for men with ED

ENGLEWOOD CLIFFS, NEW JERSEY and BUENOS AIRES, ARGENTINA – NOVEMBER 29, 2022 – Aspargo Laboratories, Inc. (“Aspargo”), a privately held specialty pharmaceutical company focused on commercializing innovative formulations of leading tablet medications, announced today that it has entered into an Exclusive License Agreement (the “License”) with Laboratorio SIDUS (“Sidus”), a pharmaceutical group with more than 80 years in the Argentina market and extensive geographic coverage throughout the country. SIDUS currently manufactures and distributes in Argentina the MagnuS® brand of the ED products, Sildenafil and Tadalafil.

“We are focused on revolutionizing how men in Latin America and around the globe treat and manage their ED,” said Michael Demurjian, Aspargo’s Chairman and Chief Executive Officer. “This strategic agreement with Sidus broadens ED treatment options in Argentina with our pocket-sized, oral spray suspension formulation of sildenafil citrate that is both discreet and convenient.”

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 a 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.

Concurrent with the grant of the License, Aspargo, Farmalider, S.A. (Madrid, Spain) (“Farmalider”) and Sidus have agreed to enter into a Supply Agreement for the manufacturing and packaging of Sildenafil Oral Spray for the Argentinian market (the “Supply Agreement” and, together with the License, the “Agreements”). Pursuant to the Agreements, Farmalider will manufacture Sildenafil Oral Spray at its manufacturing facility located in Valencia, Spain, for exclusive sale by SIDUS in Argentina. Aspargo will share in the cash flow from product sales through the Supply Agreement. The transaction leverages Sidus’ marketing position of the MagnuS® brand, which will be expanded to include Sildenafil Oral Spray.

“At Sidus, our passion is to improve people’s health and quality of life through innovative research and development,” said Matias Boscolo, Sidus’ Chief Executive Officer. “Together with Aspargo, we will leverage our ED market commercialization experience to expand our portfolio, offering men of Argentina an alternative Sildenafil Oral Spray option to help treat and manage their ED.”

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 Spray from Farmalider, S.A. of Madrid, Spain ((www.farmalider.com). For additional information, please visit our website at https://aspargolabs.com/.

About Laboratorio SIDUS

Laboratorio SIDUS is a privately held pharmaceutical company headquartered in Buenos Aires, Argentina. The company is dedicated to the development, manufacturing, and commercialization of specialty pharmaceutical products for markets in Argentina and Uruguay. For additional information, please visit our website at https://www.sidus.com.ar.

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

Disrupting Erectile Dysfunction (ED) Market With Oral Spray

• Aspargo Laboratories, Inc. and Taiba Healthcare Group to launch Sildenafil Spray in Middle East region via exclusive license and supply agreements
• Men in Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, Oman, Lebanon, Egypt and Iraq will have a Sildenafil Spray option for erectile dysfunction

ENGLEWOOD CLIFFS, NEW JERSEY, and Dubai, United Arab Emirates – October 4, 2022 – Aspargo Laboratories, Inc. (“Aspargo”), a private specialty pharmaceutical company focused on commercializing an innovative oral spray formulation of sildenafil, the active ingredient in Viagra^®1 (“Sildenafil Spray”) announced today that it has entered into an Exclusive License Agreement (the “License”) with Taiba Healthcare Group (“Taiba”), a leading healthcare marketing, distribution and retail pharmacies group in the Sultanate of Oman, with regional operations and presence. The License grants Taiba the exclusive right and license to market, promote, and distribute Sildenafil Spray in the territory described in the License (the “Territory”), which covers Saudi Arabia, Kuwait, the United Arab Emirates, Qatar, Bahrain, Oman, Lebanon, Egypt, and Iraq. Taiba will assume responsibility for and bear the cost of obtaining regulatory approval to market Sildenafil Spray in each jurisdiction in the Territory.

In consideration of the grant of the rights under the License, Taiba has agreed to enter into a Supply Agreement (the “Supply Agreement”) with Aspargo and Farmalider, S.A. (“Farmalider”) governing the supply of Sildenafil Spray to Taiba for resale in the Territory. The Supply Agreement will include a fixed price per unit agreed upon by Aspargo and Taiba in the License and such other terms as is customary for supply agreements of this nature. Farmalider, the licensor to Aspargo of the rights to Sildenafil Spray and manufacturer of Sildenafil Spray for Aspargo in Spain and Mexico, will manufacture and package Sildenafil Spray for resale in the Territory.

The License and Supply Agreements leverage Taiba’s marketing, logistics, administration, supply chain, and drug distribution services to maximize product sales in the Middle East region.

“Our expansion into the Middle East region validates our effort to bring men an alternative spray option in a market that hasn’t had much disruption in over two decades,” said Michael Demurjian, Aspargo’s Chairman and Chief Executive Officer. “Aspargo’s pocket-sized oral spray empowers men to manage their erectile dysfunction in a discreet way, and we’re proud of this next phase in our global expansion efforts.”

“We are very excited to announce the introduction of Sildenafil Spray in the Middle East region,” said Saif Al Hasani, Taiba’s Chief Executive Officer. “We are continuously expanding our portfolio by introducing new dosage forms that enhance patient care at an affordable cost. Together with Aspargo, we will build on Taiba’s 20 years of experience in this region to successfully market a sildenafil spray option for men with erectile dysfunction.”Sildenafil Spray is an oral suspension formulation of sildenafil citrate administered via a metered-dose spray pump that dispenses 12.5 mg of sildenafil per push. The discreet and easy-to-carry oral spray allows the patient to customize dosing based on his medical need and avoid pill splitting or crushing commonly associated with the traditional tablet medication.

Erectile dysfunction (“ED”) is characterized by the persistent difficulty achieving and maintaining an erection sufficient to have sexual intercourse. Although 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.

Viagra^® is a registered trademark of Viatris Specialty LLC.

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^®. Product sales have commenced in Spain. Aspargo is the exclusive licensee of patent rights covering Sildenafil Spray in the US and various international jurisdictions, granted to Aspargo by Farmalider, S.A. of Madrid, Spain (www.famalider.com). For additional information, please visit our website at https://aspargolabs.com/.

About Taiba Healthcare Group
Taiba is a leading specialty pharmaceutical company in the Sultanate of Oman with operations and presence throughout the Middle East/North Africa (MENA) region. Taiba is focused on providing patient access to innovative health care solutions through a diverse portfolio of niche and rare disease medications addressing unmet patient needs. Taiba partners with pharmaceutical and biotech companies throughout the world to access the latest technology and accelerate the delivery of new medicines in the MENA region. For additional information, please visit Taiba’s website at https://taibahealthcare.com/.

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

• Acquisition significantly boosts Aspargo’s presence as a global biopharmaceutical company in erectile dysfunction
• Company acquires international rights to Sildenafil Oral Spray from Farmalider, S.A. for 5 million shares of Aspargo common stock
• Acquisition follows the Company’s recent completion of a $7.5 million common stock financing

ENGLEWOOD CLIFFS, NEW JERSEY – SEPTEMBER 29, 2020 – 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.

Click here for the full press release.

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