Swiss pharmaceutical giant Novartis has told EU regulators it will have to stop producing the active ingredient indacaterol at its Ringaskiddy plant unless it is allowed to continue using a banned toxic chemical.
Sales of indacaterol from the Ringaskiddy plant ranged from 20 million to 65 million Swiss francs (€18 million-€59 million) per year over the 2012-14 period. Indacaterol is used in medicinal products for the treatment of chronic obstructive pulmonary disease in 110 countries.
Novartis uses diglyme, which will be banned for use in the EU on August 22nd, 2017, in the early stage of the manufacturing process for indacaterol. The company has applied to the EU for authorisation to continue using diglyme in Ringaskiddy for another seven years while it puts an alternative manufacturing process in place and obtains the necessary approvals from health authorities around the world.
Human reproduction
The net benefit of the seven-year authorisation would be €45 million-€75 million, Novartis told the
European Chemicals Agency
.
Diglyme is toxic for human reproduction. A maximum of 24-40 workers are potentially exposed to diglyme for a few weeks each year at the Ringaskiddy plant, Novartis said. Exposure is minimised through use of contained systems and is within the safe limit, Novartis said.
As a solvent, diglyme does not end up in the final product that consumers use. All waste streams and filters are incinerated so “environmental impacts can be considered as negligible”, the firm said.
Authorisation
The European Chemicals Agency will advise the
European Commission
on whether the authorisation should be granted. Member states will vote on the Commission’s proposal.
More than 1.5 million patients have been treated for chronic obstructive pulmonary disease using indacaterol-based products. Interruption of supply would result in patients not having access to their medication. The firm argues that the resulting loss of confidence “cannot be quantified but is expected to have far-reaching consequences for all Novartis products”.
“Currently, chronic obstructive pulmonary disease is the fifth leading cause of death worldwide and is expected to become the third by 2020,” the company said.
“Novartis is known as an innovative market leader in this field. [It is] nevertheless facing a very competitive market situation as many new original and generic compounds enter the market.”
