First European sales of generic Tiotropium bromide 18 µg DPI, developed by Phargentis

(November 10, 2021) Tiotropium bromide 18 µg Dry Powder Inhaler developed by Phargentis has been launched in Europe. It is the first generic product approved in the EU with precisely the same strength and same delivered dose as Spiriva®Handihaler®, the global first-line treatment for COPD. This generic equivalent has been delivered to the UK, Norway, Spain and the Netherlands, with formal pricing and substitution agreements agreed within those markets. Global turnover for Spiriva®Handihaler® in 2020 exceeded 2.5 bUSD (IQVIA).

In May 2021 the generic Tiotropium bromide 18µg DPI, developed by Phargentis, an agile, small-scale pharmaceutical company headquartered in Lugano, Switzerland, was launched for the first time in Europe - starting with UK and then followed by other markets such as the Netherlands, Norway and Spain. Other markets will follow soon. The generic product has been launched ahead of schedule. With reimbursement agreed in launched countries and ongoing discussions for formal substitution, the generic can be prescribed to COPD patients by healthcare providers as fully substitutable for Spiriva®Handihaler®.

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. Developed by Phargentis it has now been approved in 28 European Countries.

Phargentis CEO Andrea Tam announced: “Our Early Market Entry strategy is a defining strategy for us. Generic drugs offer powerful benefits to society and patients, maintaining lives and outcomes whilst reducing healthcare and social costs. Being able to deliver them at volume is all about achieving market access first. We’re pleased to move ahead in these important markets.”

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

For further information please contact:

Andrea Tam, CEO

E-mail: andrea.tam@phargentis.ch

Phone: +41 796 34 4075

About Phargentis SA

Phargentis, founded in 2015 and headquartered in Lugano Switzerland, develops Generic and Hybrid Generic products for the respiratory market with a strong focus on COPD and Asthma. Phargentis is an agile company that leverages robust global partnerships to execute a unique Early Market Entry strategy for Generics and global out-licensing for its diverse, competitive portfolio. Phargentis is co-owned by Chemholding (Switzerland), Helm AG (Hamburg) and Pharmaxis (Dubai). Its flagship product is generic Tiotropium bromide DPI, the fully interchangeable generic version of the world’s first-line COPD treatment, achieved European sales ahead of schedule and is being planned to launch in other key markets. Phargentis’ current respiratory portfolio addresses a combined market value exceeding 3.5b USD.

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