Talking of registration paths, ie. OTC versus prescription, here’s something out of left field.
Pharmas are well-known for their so-called “product life cycle management” strategies, which include dodging imminent patent expiries by launching new indications or new formulations of existing products. Another favoured strategy is “switching”, which means switching a product from prescription (RX) to Over the Counter (OTC).
Well, it is suggested that Novartis may be attempting to “switch” Voltaren gel in the US.
Firstly, there are anonymous posters on the Endo board of Cafepharma, a pharma rep website, who are suggesting that this is the case and that Novartis is expecting an FDA response on OTC status for Voltaren gel in the US early next year.(1) The speculation is given some credence by a report released earlier this year, The U.S. Market for Rx to OTC Switches, 6th Edition, which lists Voltaren as a prescription pain product with anticipated OTC approval.(2) Additionally, the Novartis agreement with Endo allows for the possibility of switching
Novartis has the exclusive right, at its sole discretion, to effect a switch of the Licensed Product from a prescription product to an over-the-counter (OTC) product in the United States (referred to as an OTC Switch) by filing an amendment or supplement to the Licensed Product New Drug Application or taking any other action necessary or advisable in connection therewith to effect the OTC Switch, and thereafter to commercialize such OTC product (3)
Novartis’ original agreement with Endo, whereby Endo markets Voltaren gel for Novartis in the US, expired in June, and it’s unclear whether the option to extend the agreement was taken up. The reps think probably not and that Novartis might be planning to go it alone with Voltaren in the US.
Of course, even if Novartis has applied for switch, they still need the FDA to approve it. The FDA will be paying special attention to safety data, but may well be influenced in favour of switch approval by the recent Cochrane Library finding
Topical NSAIDs can provide good levels of pain relief; topical diclofenac solution is equivalent to that of oral NSAIDs in knee and hand osteoarthritis, but there is no evidence for other chronic painful conditions. Formulation can influence efficacy. The incidence of local adverse events is increased with topical NSAIDs, but gastrointestinal adverse events are reduced compared with oral NSAIDs. (4)
A pharmaceutical industry whitepaper on switching suggests that key factors determining the potential success of switching include whether the product is suitable for self medication, whether the product will have first mover advantage, whether the product has a recognizable point of difference and whether strong brand awareness has already been established as an RX product. I think that Voltaren gel would tick all of those boxes. The paper also suggests that typically OTC switch sales are higher than original RX sales levels, despite lower prices, partly because of increased convenience for existing patients and greater accessibility for previous non-users who don’t visit doctors.(5)
Sales of Voltaren gel (RX) by Endo in the US were $142 million in 2011.(6) Global sale growth rates for OTC Voltaren gel continue to be strong and Voltaren has retained its place as the world’s leading OTC topical pain brand. (7)
If the speculation is correct, if the FDA gives switch approval and if Novartis is suitably impressed by the point of difference offered by TPM, this could be a big nearer-term opportunity for POH.
(20min delay)