3rd Feb 2014 09:20
LONDON (Alliance News) - Plethora Solutions PLC Monday said it is considering reducing the size of the doses of its premature ejaculation treatment that it eventually brings to market, potentially increasing the profits it can make, as it also said it had a positive initial meeting with US regulators over the product and was advancing talks with potential partners and a manufacturer.
The company got marketing approval for its premature ejaculation treatment from the European Commission last November. It said that after consulting with its external lawyers, it has been advised it has data exclusivity rights until November 2021 and market exclusivity until November 2023. The exclusive rights prevent any other companies from relying on Plethora's regulatory dossier if they seek regulatory approval for their own products.
Plethora had previously said it was in talks with several parties, including major pharmaceutical companies, about bringing the product to market. Monday, it said those talks had reached a more advanced stage, but it can't yet be sure of when a deal will be secured. It added that it is in detailed discussions with a preferred manufacturing partner.
It had previously predicted that the product, known as PSD502 will hit the market in mid- to late-2014.
The company said it is considering reducing the dosage per canister used for the product, moving to a six dose canister from the current 20 dose canister that was used in obtaining EMA approval. That follows the talks with potential licensing and manufacturing partners and after it got feedback from a US consultancy about potential US pricing for the product.
It said the US feedback suggested that PSD502 should be priced at a similar level to other erectile dysfunction treatments, at about USD100 per six dose can, or about USD16 a dose. It said it expects more varied pricing across EU countries.
"By way of benchmark, at equivalent pricing, we understand that the leading erectile dysfunction products have generated revenues in excess of GBP2 billion per annum," it said.
The EU approval was a key step in Plethora's long-lasting efforts to commercialize the treatment, and it's now seeking the same approval from the US regulator.
Plethora met the US Food and Drug Administration with its advisers earlier this month and said it had been a positive meeting. It said it now expects to make an approval submission for the product in the US in the first quarter of 2015. It is hoping that it will get approval in the first quarter of 2016, launching the product in the US shortly afterwards.
"This submission will be based on the EU dossier prepared historically by the company but incorporating a new can size (six doses, three sprays per dose). Based on the recent market sensitivity analysis and interactions with potential licensing partners, Plethora believes that incorporation of this new can size in the dossier will dramatically increase the commercial value of the product to an extent equivalent to that achieved by the leading drugs for erectile dysfunction," it said in a statement.
Plethora Solutions shares were flat at 11.75 pence Monday morning.
By Steve McGrath; [email protected]; @SteveMcGrath1
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