Source: Taipei Times by Kao Shih-ching

Intech Biopharm Corp (益得生技) has started testing the effects of a metered-dose inhaler generic of Teva Pharmaceutical Industries Ltd’s ProAir, and expects to gain marketing approval by 2023, it said yesterday.

The company, which developed SYN011 to treat acute asthma, received approval from the US Food and Drug Administration in August to study the biochemical and physiological effects of the drug in a phase 3 clinical trial, Intech spokesperson Hugues Hung (洪堯國) told the Taipei Times.

The company has recruited about 200 participants with asthma for the test, dividing them into control and experiment groups to receive a placebo, a brand name drug and SYN011, to determine whether SYN001’s efficacy is comparable to that of a brand name drug, Hung said.

“We have to give participants some food containing allergens that can trigger asthma symptoms. We will see how the inhaler relieves the symptoms,” Hung said.

The study is to finish by the end of next year, and Intech plans to apply to the US agency for marketing approval in the first quarter of 2023, he said.

Intech is optimistic about the metered-dose inhalers market in the US, where the health regulator has become more open to generics amid the COVID-19 pandemic, he said.

Prior to the pandemic, the agency never approved generic versions of metered-dose inhalers, although some applicants had completed trials, Hung said.

As the pressurized metered-dose inhalers could be used to help relieve respiratory symptoms of people with COVID-19, the US regulator last year became more open, granting approvals to India-based Cipla Ltd and Lupin Ltd, which offer generic versions of Merck Sharp & Dohme Ltd’s (MSD) Proventil and Teva’s ProAir respectively, he said.

Last year, Cipla sold about 3 million inhalers and Lupin sold 1 million at lower prices than those of brand names, or at a discount of between 50 and 60 percent, Hung said.

Sales of MSD’s and Teva’s drugs were not affected by the generic versions, and they even raised their prices, suggesting there is a growing demand for the drug in the market, he said.

Intech expects to be the latest supplier of metered-dose inhalers using salbutamol as the main ingredient, which is used to relieve symptoms of asthma, after GlaxoSmithKline PLC, MSD, Teva and the two Indian firms, Hung said.

“With this market position, we will likely gain a market share of 10 to 20 percent,” he said.

More than 64 million metered-dose inhalers using salbutamol were sold in the US last year, Hung said, adding that a larger market share would help boost Intech’s revenue.