Generic Tiotropium bromide 18 µg DPI, developed by Phargentis, receives approval in 28 European countries


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Phargentis, an agile, small-scale pharmaceutical company headquartered in Switzerland, has earned the approval of the main markets across Europe, including high-value giants such as the UK, France and Germany for its generic version of blockbuster COPD Treatment Spiriva®Handihaler®.

Fully interchangeable generic version

This is the first generic product approved in EU with the same strength (18 µg/capsule) and the same delivered dose (10 µg/capsule) of Spiriva® capsules, plus a device with comparable appearance, handling and performance as the Handihaler® device. Gaining market approval for generic versions of inhaled treatments and their inhaler devices is notoriously challenging, with many regions only approving inhaled generic drugs as fully substitutable (and therefore reimbursable), if their inhaler device  is also fully interchangeable. The active ingredient in Spiriva® (Tiotropium bromide), is notoriously difficult to formulate and its inhaler specifications are complex.  

Phargentis CEO Andrea Tam announced: “This is a great vindication of our agility and our market intelligence-, not technology-based, business model. We’re a small team - but we constantly  leverage our relationships with owners and partners like Chemholding, Helm AG, Pharmaxis and others to carry out highly innovative work without being held back by any single technology – giving us key capabilities from formulation of APIs through to devices, supply and distribution.”

Early Market Entry

Also Key to the success is Phargentis’ Early Market Entry development strategy, which analyzes in detail the existing patent protection of targeted originator products, to identify opportunities to launch a generic product prior to the patent expiry (or ‘theoretical date’) of the originator product.

Phargentis CEO Andrea Tam stated: “Our Early Market Entry strategy is at the heart of our business – it’s a defining strategy for us. Generic drugs offer powerful benefits to society and patients –maintaining lives and outcomes whilst reducing healthcare and social costs but being able to deliver them at volume is all about achieving market access first. We’re delighted to move ahead so swiftly in these crucial markets. Annual sales generated by Spiriva in the EU in 2020 were approx. 700m Euro according to IQVIA. An approved early-entry generic version can expect to achieve at least 10% of that. Worldwide generic Tiotropium DPI developed by Phargentis addresses a 2.5b USD market.”

Phargentis has a portfolio of three Active Development Programs (including Tiotropium bromide DPI) that together address a market value exceeding 3.5 bUSD. Phargentis is currently planning for market access for generic Tiotropium DPI in other key international markets.