Sydney, Australia – 13 August 2024 | LTR Pharma Limited (ASX: LTP) ("LTR Pharma" or "the Company") is pleased to announce that it has entered into a significant Co-Development Agreement (the “Agreement”) with Aptar Pharma, a global leader in drug delivery systems. This Agreement to collaborate is aimed at accelerating the commercialisation of LTR Pharma’s innovative nasal spray treatment for Erectile Dysfunction (“ED”), SPONTAN®, across the USA and other global markets.
Highlights:
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The Strategic Partnership: LTR Pharma and Aptar Pharma will collaborate to advance SPONTAN® towards regulatory approval and introduction to the market. LTR Pharma brings its pharmaceutical development capabilities, while Aptar Pharma provides its leading nasal spray technology, including their VP7 model nasal spray components.
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Regulatory Pathway: The application for SPONTAN® Nasal Spray will be filed under the US Food and Drug Administration’s (FDA) 505(b)(2) expedited regulatory pathway. This pathway is specifically designed for changes in the route of administration of an already approved drug. In this case, the approved drug is Levitra® (Vardenafil).
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Enhanced Support: The Agreement grants LTR Pharma access to Aptar Pharma’s comprehensive regulatory, analytical testing, and human factor services, which will significantly strengthen the FDA application process for SPONTAN®, as well a future launch to the market.
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Global Market: The primary goal of this partnership is to achieve commercialisation in the USA, with plans to expand into other global markets. The Agreement also lays the foundation for a long-term strategic alliance.
Lee Rodne, Chairman of LTR Pharma, stated: “We are delighted to enter into a Co-Development Agreement with Aptar Pharma – a respected and experienced partner in our imminent goal to obtain regulatory approval for SPONTAN and to expand its global market reach and impact. As part of this, we will gain access to Aptar’s expertise in the VP7 nasal spray system and related specialised services to support our FDA application process. This vastly de-risks the FDA application process and elevates the profile of LTR Pharma as a long-term partner of a global market innovator, which we anticipate may create opportunities for other products with alternative indications in future.”
Guillaume Brouet, Vice President Analytical Regulatory and Scientific Affairs at Aptar Pharma, commented: “We look forward to working closely alongside the LTR Pharma team to support its SPONTAN Nasal Spray application. We have purpose-designed facilities and experienced personnel to ensure a successful partnership throughout this CoDevelopment– within an efficient timeframe.”
Clinical Success:
LTR Pharma recently completed a clinical trial comparing the pharmacokinetics, safety, and tolerability of Vardenafil administered via SPONTAN® nasal spray and Levitra® tablets. The trial demonstrated that SPONTAN® achieved rapid absorption and a faster onset of action compared to traditional oral PDE5 inhibitors, delivering a similar amount of the drug at half the dose. Following this successful trial, medical providers in Australia have started prescribing SPONTAN® under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS).
For further information, please contact:
Haley Chartres
Media Relations
[email protected]
Peter McLennan
Investor Relations
[email protected]
About us:
About LTR Pharma:
LTR Pharma is focused on improving men’s health, physically and mentally, through the commercialisation of an innovative nasal spray treatment for Erectile Dysfunction. ED is a pressing health issue for millions of men that can negatively impact self-esteem and relationships, across multiple age brackets. LTR Pharma’s lead product SPONTAN® is set apart from existing ED therapies by its mechanism of action – intranasal delivery technology of a PDE5 inhibitor. The nasal cavity is a highly vascular part of the body supporting even and rapid absorption of the drug, empowering it to work within 10 minutes or less. LTR Pharma is proudly aiming to restore greater control over the timing, spontaneity, and enjoyment of sexual experiences.
Contact details:
Jane Morgan
Jane Morgan Management
Investor & Media Relations
[email protected]