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Author: Aspargo Labs

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Aspargo Labs Appoints General Managers in Spain and Germany to Drive International Expansion

NEW YORK, December 20, 2024 – Aspargo Labs, Inc. (“Aspargo Labs” or the “Company”), a specialty pharmacy and MedTech company focused on reformulating the world’s most meaningful Rx and OTC medications into its novel oral suspension technology, announced the recent appointment of two highly experienced General Managers to accelerate Aspargo Labs’ global expansion: Álvaro Fernández in Spain and Dr. Marc van Unen in Germany.

“It is my pleasure to welcome Álvaro and Marc to the Aspargo Labs leadership team,” said Michael Demurjian, Chief Executive Officer. “What we’re building here is quite unique, and these are exactly the type of seasoned leaders we need to drive our international expansion. Álvaro’s expertise in pharmaceutical marketing and sales leadership will be instrumental in developing our presence in Spain, while Marc will leverage his experience launching innovative healthcare products to spearhead our German initiatives. Both represent strategic additions to our team and bring a high level of operational acumen and industry experience that will help us to scale our operations efficiently while prioritizing innovation. Their track records of building successful teams and driving revenue growth align with our mission as we become a global player in medication delivery technology.”  

Álvaro Fernández, the General Manager of Spain at Aspargo Labs, is a pharmaceutical industry veteran with 23 years of experience, leading companies including Lilly, Orion Pharma, Biowise Pharmaceuticals, Angelini, Merck KGaA, and Ferring. His expertise spans across Marketing and Sales leadership roles, where he has demonstrated success in managing multidisciplinary teams and executing high-impact projects. He holds a BA in Biology and Biotechnology from the University of Madrid, an Executive MBA from IE Business School, and completed the Management Development Program at IESE Business School. His leadership approach emphasizes innovation, collaboration, and excellence, consistently driving organizational growth and success.

Dr. Marc van Unen, the General Manager of Germany at Aspargo Labs, has extensive experience in the pharmaceutical industry across a range of products and therapeutic indications. Previously, Dr. van Unen worked at Bristol Myers Squibb, where he led the cardiovascular business unit. He is the former VP of Regional Marketing in Asia for Bayer’s General Medicine portfolio. Through positions at Bristol Myers Squibb and Bayer, Dr. van Unen gained extensive international experience in the US and England, accumulating over 25 years of experience across various therapeutic areas including cardiovascular & central nervous system medicine, urology, hormone, and antibiotic treatments. Dr. van Unen is a visiting lecturer at the Vienna University of Economics and Business and has authored “Product Launch Playbook – introducing new products in the innovative healthcare industry”. He is also an active member of the European International Business Academy. He received his degree in economics from Erasmus University in Rotterdam and his doctorate in International Business Administration from the Bradford School of Management in England.

About Aspargo Labs, Inc.
Aspargo Labs, Inc., is a commercial stage, specialty pharmaceutical and MedTech company focused on advancing administration of medications through innovative oral spray technology and developing a smart delivery system integrated with a mobile platform to connect patients and caregivers. Aspargo Labs’ technology platform has the potential to transform a wide range of medications across various therapeutic areas, with an initial focus on bringing an oral spray formulation of sildenafil to market. By converting solid dose medications into convenient, easy-to-administer oral suspensions, Aspargo Labs’ technology offers several key advantages, including enhanced drug delivery, patient-centricity, dosing flexibility and more personalized medicine. Aspargo Labs 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 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.

For more information:

Aspargo Labs, Inc.
(646) 503-1260
info@aspargolabs.com

Investor & media contacts:

Russo Partners
Nic Johnson or Liz Phillips
(347) 956-7697
AspargoIR@russopr.com

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Aspargo Labs Appoints Chief Marketing Officer

Life sciences marketing executive Andrew Chamlin will drive Aspargo Labs’ global growth in revolutionizing the way medications are delivered.


New York, November 19, 2024 – Aspargo Labs, Inc. (“Aspargo Labs” or the “Company”), a specialty pharmacy and MedTech company focused on reformulating the world’s most meaningful Rx and OTC medications into its revolutionary oral suspension technology, has appointed Andrew Chamlin, a veteran of the life sciences industry, to the role of Chief Marketing Officer. Chamlin has joined the executive team to drive Aspargo Labs’ aggressive global expansion and to advance the company’s technology pipeline and drug applications.

Chamlin will spearhead the development and implementation of commercial strategies for Aspargo’s groundbreaking oral spray suspension platform and innovative delivery device. He will oversee the company’s global branding initiatives, lead international marketing teams and drive the commercialization of Aspargo’s expanding product portfolio.

“Joining Aspargo Labs presents an extraordinary opportunity to be at the forefront of transforming healthcare,” Chamlin said. “Applying Aspargo Labs’ cutting-edge suspension technology to important medications means we’re not just improving patient experiences, but we’re fundamentally reshaping the future of drug administration. We have a bold vision here at Aspargo, to optimize the healthcare ecosystem, bringing patients, physicians and caregivers closer together to make lives healthier. I look forward to collaborating with the entire Aspargo Labs team and our partners to turn this transformative vision into reality.”

Aspargo Labs is transforming medication administration through its patented oral spray suspension technology. The company’s lead product, HEZKUE®, is an oral spray sildenafil, the active ingredient in Viagra®, for erectile dysfunction that is currently available in Spain and Germany, with anticipated launches in additional European markets. Aspargo Labs is actively pursuing FDA approval in the United States under the regulatory name ASP-001. Beyond HEZKUE®, the company is also reformulating other compounds that will represent significant advancements in the delivery of care for both emergent and chronic conditions.

As part of the next phase of Aspargo Labs’ technology pipeline, the company is developing a next generation, user-friendly oral medicine delivery device with mobile connectivity software. The device will enable precise dosing and encourage adherence while providing real time patient data to healthcare professionals and caregivers.

Chamlin is a global health and wellness executive whose experience spans pharmaceuticals, consumer products and health technology. He has spent the past 12 years serving as Chief Marketing Officer at IPG Health, the industry’s largest and most creatively awarded agency network. Previously, he held senior positions at Pfizer, Johnson & Johnson and Ironwood Pharmaceuticals in areas that include marketing, market research and operations, as well as executive positions at WebMD and Revolution Health Ventures. He earned a B.A. from the University of Wisconsin and an MBA from Columbia Business School.

“Expanding our leadership team with Andrew marks a key milestone for Aspargo Labs, as we accelerate our mission to revolutionize medication delivery and enhance patient care worldwide,” said Michael Demurjian, CEO of Aspargo Labs. “His expertise and leadership will be instrumental as we advance our drug applications, expand our global footprint and bring our transformative oral spray suspension technology to millions of patients.”

About Aspargo Labs, Inc.
Aspargo Laboratories, Inc., is a commercial stage, specialty pharmaceutical and MedTech company focused on advancing how medications are delivered through innovative oral spray suspension technology. Aspargo Labs’ technology platform has the potential to transform a wide range of medications across various therapeutic areas, with an initial focus on bringing an oral spray formulation of sildenafil to market. By converting solid dose medications into convenient, easy-to-administer oral sprays, Aspargo Labs’ technology offers several key advantages, including enhanced drug delivery, patient-centricity, dosing flexibility and more personalized medicine. Aspargo Labs 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.

For more information:

Aspargo Labs, Inc.
(646) 503-1260
info@aspargolabs.com

Investor & media contacts:

Russo Partners
Nic Johnson or Liz Phillips
(347) 956-7697

nic.johnson@russopartnersllc.com
elizabeth.phillips@russopartnersllc.com  

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Aspargo Labs Announces Data on First Oral Spray for Erectile Dysfunction, ASP-001, Showing Two Times Faster Absorption Compared to Viagra® Tablets

Phase 1 study published in International Journal of Science and Research shows absorption of ASP-001 within 5 minutes, which is markedly faster than Viagra tablets

ASP-001 is the first investigational product based on Aspargo Lab’s innovative oral spray formulation technology

Aspargo Labs plans to pursue a new drug application (NDA) in the U.S. with the potential to become the first FDA-approved oral spray formulation for ED

NEW YORK – JULY 30, 2024 – Aspargo Laboratories, Inc. (“Aspargo” or the “Company”), a specialty pharmaceutical and MedTech company focused on transforming drug delivery with innovative oral sprays, today announced the release of a Phase 1 study demonstrating that ASP-001, an investigative sildenafil oral spray in development for erectile dysfunction (ED), achieves absorption starting within five minutes, twice as fast as traditional sildenafil tablets. The study results were published in the International Journal of Science and Research (IJSR). ASP-001 utilizes sildenafil, the active ingredient found in Viagra®, and has already received regulatory approval in various countries such as Spain, Germany, the Netherlands, Ireland, Mexico and the United Kingdom. Aspargo Labs now seeks to obtain its first U.S. Food and Drug Administration (FDA) approval for ASP-001, while also pursuing oral suspensions and solutions for other prescription and over-the-counter medications currently only available in tablet form.

“The rapid and enhanced absorption profile demonstrated by ASP-001 in this Phase 1 study highlight its potential to address key unmet needs in the treatment of erectile dysfunction”

Aspargo Labs’ groundbreaking oral spray formulation of sildenafil presents an alternative to the commonly used tablet form, providing patients with increased discretion and spontaneity. Using its oral suspension technology, the Company aims to tackle key obstacles associated with traditional pills, such as slower absorption rates and the need for fasting or food consumption before administration. Additionally, its convenient application method eliminates the need for accompanying liquids. By enhancing convenience and flexibility, Aspargo Labs’s technology represents a patient-centric approach towards improving the efficacy, adherence and safety of medication usage.

“Our innovative oral spray technology has been carefully developed to provide a novel approach for administering medication, simplifying the process of drug consumption,” said Michael Demurjian, CEO of Aspargo Labs. “The study data provides evidence for the safety and pharmacokinetic profile of our oral spray technology. Our research has demonstrated that ASP-001 exhibits rapid absorption, surpassing the absorption rate of Viagra® tablets in the initial minutes after administration. We look forward to collaborating with the FDA to file an NDA for ASP-001 for the treatment of ED under the 505(b)2 regulatory pathway and are enthusiastic about the opportunity to make this drug available to patients in the US.”

The recently published IJSR study was authored by Dr. Steven Kaplan, Chief Medical Officer at Aspargo Labs, Director of the Men’s Wellness Program at the Mount Sinai Health System and Professor at the Icahn School of Medicine at Mount Sinai.

“The rapid and enhanced absorption profile demonstrated by ASP-001 in this Phase 1 study highlight its potential to address key unmet needs in the treatment of erectile dysfunction,” said Dr. Kaplan. “Many patients struggle with the inconvenience and lack of spontaneity associated with planning ahead to take a tablet and the requirement to fast or time their dosing. An oral spray formulation that achieves therapeutic levels quickly could represent a significant advancement in patient-centric therapy. If approved, ASP-001 would be a welcome addition to the treatment landscape, offering patients and their partners a novel and practical option to enhance their sexual health and overall quality of life.”

The open-label, single center, two-way crossover study examined the pharmacokinetics of 4 ml of ASP-001 versus 100 mg Viagra® in 53 healthy, fasted male volunteers. Additional endpoints include rate and extent of absorption, safety, and tolerability. Patients were selected following a 28-day screening period, then were randomized and checked-in at a Phase 1 clinical trial unit the evening before day-one dosing to ensure at least a 10-hour fasting period. A total of 24 plasma blood samples were collected over 24 hours.

Key results from the study include:

  • Initial absorption was observed within 5 minutes of administration, showing a higher average amount in the bloodstream (0.615 ng/mL) compared to Viagra® tablets (0 ng/mL), suggesting that ASP-001 is absorbed more quickly
  • Average levels of the medication in the bloodstream via mean plasma concentrations were shown to be higher for ASP-001 as compared to Viagra® tablets during the first 30 minutes after administration by mouth

The company is advancing additional regulatory submissions to support approvals in key global markets, including Japan and several countries in the Middle East and South America.

Viagra® is a registered trademark of Viatris Inc.

About Aspargo Laboratories, Inc.
Aspargo Laboratories, Inc., is a commercial stage, specialty pharmaceutical company focused on advancing how drugs are delivered with innovative oral sprays. Aspargo Lab’s innovative oral suspension technology platform has the potential to transform a wide range of medications across various therapeutic areas, with an initial focus on bringing an oral spray formulation of sildenafil to market. By converting solid dose medications into convenient, easy-to-administer oral sprays, Aspargo Lab’s platform offers several key advantages, including enhanced drug delivery, patient-centricity, dosing flexibility and more personalized medicine. 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.

Contacts

Media 

Aspargo Labs, Inc.
(201) 408-4831
media@aspargolabs.com

Alexis Feinberg
ICR Westwicke
203-939-2225
Alexis.feinberg@westwicke.com

Investors

Mike Cavanaugh
ICR Westwicke
617-877-9641
Mike.cavanaugh@westwicke.com

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Aspargo Announces Completion of Dosing of All Subjects in Sildenafil Oral Suspension Bioavailability Study and Initiation of Dosing in Companion Food-Effect Study

  • Dosing complete for 53 subjects in Sildenafil Oral Suspension Bioavailability Study
  • Initiated dosing in 38 subjects in Sildenafil Oral Suspension Food-Effect Study
  • Top-line data from both studies expected in February 2024

ENGLEWOOD CLIFFS, NEW JERSEY – DECEMBER 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 the completion of dosing of all 53 subjects in two cohorts 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”).

In addition, today the Company announced the initiation of dosing of 38 subjects in two cohorts in the Company’s food effect study, comparing the amount of active drug in plasma after administration of a single oral dose of Sildenafil Oral Suspension (ASP-001) under fasting and fed (following a meal) conditions. The open label, single center, single dose, two-way crossover study in healthy subjects, entitled, “A Phase 1 Food-Effect Study of 100 mg of ASP-001 (Oral Liquid Suspension of Sildenafil-Spray) Under Fed Versus 100 mg of ASP-001 (Oral Liquid Suspension of Sildenafil-Spray) Under Fasted Conditions in Healthy Adult Male Subjects”, is assessing any food effects and the rate and extent of absorption of Sildenafil Oral Suspension when administered under fed and fasted conditions.

“We are thrilled about the progress we have made in our clinical trials for Sildenafil Oral Suspension,” said Michael Demurjian, CEO and Chairman of Aspargo Laboratories Inc. “Our goal is to provide patients suffering from ED with a paradigm shifting dosing technique to facilitate positive therapeutic outcomes, and these milestones bring us one step closer to achieving that goal. We look forward to providing top-line data from both studies in early 2024.”

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, 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 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

 

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

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Aspargo Laboratories Inc. Announces Initial Dosing of All Subjects in Bioavailability Study for Sildenafil Oral Suspension

  • 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

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Aspargo Laboratories Announces IND Clearance by U.S. FDA, Enabling Launch of Bioequivalence and Food-Effect Studies for Sildenafil Oral Spray

  • 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

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Aspargo Laboratories, Inc. Announces Filing of Its Investigational New Drug Application For Sildenafil Oral Spray

  • 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

Categories
Press Release

Aspargo Receives Regulatory Approval to Market Sildenafil Spray in Germany, Ireland, and The Netherlands

  • 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

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Press Release

Aspargo Extends Latin America Reach From Mexico To Argentina

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

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Aspargo’s Footprint Grows With Middle East Expansion

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