Highlights:
The Agreement will encompass joint development and expertise, combining LTR Pharma’s pharmaceutical development capabilities with Aptar Pharma’s expertise in nasal spray technology – including Aptar’s VP7 model nasal spray components. The application for SPONTAN Nasal Spray will be filed in the US via the FDA’s 505(b)(2) expedited regulatory pathway, which governs a change in route of administration of an already approved drug, here Levitra® (Vardenafil) tablets.
The Agreement grants LTR Pharma access to Aptar Pharma’s comprehensive range of regulatory, analytical testing, and human factor services, which will considerably strengthen the FDA application process for SPONTAN.
A shared goal will be to focus on imminent market establishment and expansion, targeting commercialisation in the USA, and other key global markets – together with a long-term strategic alliance for ongoing innovation for healthcare solutions.
LTR Pharma Chairman, Lee Rodne, said:
“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 Aptar Pharma, said:
“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 Co- Development– within an efficient timeframe.”
LTP recently completed its clinical trial to compare the pharmacokinetics, safety, and tolerability of Vardenafil following administration of SPONTAN nasal spray and Levitra® tablets in healthy male adults. The trial showed that SPONTAN achieved a rapid absorption and faster onset of action compared to oral PDE5 inhibitors (i.e., vardenafil, sildenafil, tadalafil) and delivered a similar amount of drug (Cmax) at half the dose of the oral PDE5 tablet. Following the success of this clinical trial, medical providers have started prescribing SPONTAN in Australia under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS).
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