Link to a press release which should get shareholders excited.
Aptar worked closely with neffy for the approval of their spray (see below extracts). We are very fortunate to have Apatr's vast resources at our disposal. This deal took over two years to complete. With Spontan now in the market, albeit under early access in Aus only, Aptar quickly to partner. They see the upside in partnering with a market disruptor in LTR and selling many millions of units of their delivery system via Spontan. From the release;
1. "Aptar’s dedicated Regulatory Affairs experts and analytical scientists help customers proactively address regulatory needs to help accelerate approval"
2. "The approval of neffy, which uses our Unidose System, and is the first nasally-delivered epinephrine treatment for severe allergic reaction, including anaphylaxis, once again demonstrates Aptar Pharma’s ‘formulation to patient’ focus on helping our customers develop complex, innovative treatments,” stated Gael Touya, President, Aptar Pharma. When we combine our nasal systems’ capabilities with our Aptar Pharma Services offering, we bring added Aptar’s Unidose System for the neffy® 2 mg (epinephrine nasal spray)Image courtesy of ARS Pharmaceuticals value to our customers, and aim to provide further convenience for patients and their caregivers worldwide.”
https://aptar.com/news-events/aptar-nasal-unidose-liquid-system-delivers-fda-approved-neffy-epinephrine-nasal-spray/
LTR Pharma will be meeting with the FDA and TGA in the coming months with Aptar guiding proceedings and seeking an expedited pathway (505b2) to market. They will highlight an unmet need (remember viagra does not work for many and has a high discontinuance rate, so there is a strong argument for unmet) and reduced side effects of a drug (Vardenafil) which is already FDA approved, tried and tested.
IMO, we have not seen any significant upside as yet. Think what will happen to the SP when we get FDA approval. Personally, I don't think that day is too far away! DYOR and not advice.
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