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.
Photo: CNA
“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.
DIVIDED VIEWS: Although the Fed agreed on holding rates steady, some officials see no rate cuts for this year, while 10 policymakers foresee two or more cuts There are a lot of unknowns about the outlook for the economy and interest rates, but US Federal Reserve Chair Jerome Powell signaled at least one thing seems certain: Higher prices are coming. Fed policymakers voted unanimously to hold interest rates steady at a range of 4.25 percent to 4.50 percent for a fourth straight meeting on Wednesday, as they await clarity on whether tariffs would leave a one-time or more lasting mark on inflation. Powell said it is still unclear how much of the bill would fall on the shoulders of consumers, but he expects to learn more about tariffs
Meta Platforms Inc offered US$100 million bonuses to OpenAI employees in an unsuccessful bid to poach the ChatGPT maker’s talent and strengthen its own generative artificial intelligence (AI) teams, OpenAI CEO Sam Altman has said. Facebook’s parent company — a competitor of OpenAI — also offered “giant” annual salaries exceeding US$100 million to OpenAI staffers, Altman said in an interview on the Uncapped with Jack Altman podcast released on Tuesday. “It is crazy,” Sam Altman told his brother Jack in the interview. “I’m really happy that at least so far none of our best people have decided to take them
PLANS: MSI is also planning to upgrade its service center in the Netherlands Micro-Star International Co (MSI, 微星) yesterday said it plans to set up a server assembly line at its Poland service center this year at the earliest. The computer and peripherals manufacturer expects that the new server assembly line would shorten transportation times in shipments to European countries, a company spokesperson told the Taipei Times by telephone. MSI manufactures motherboards, graphics cards, notebook computers, servers, optical storage devices and communication devices. The company operates plants in Taiwan and China, and runs a global network of service centers. The company is also considering upgrading its service center in the Netherlands into a
NOT JUSTIFIED: The bank’s governor said there would only be a rate cut if inflation falls below 1.5% and economic conditions deteriorate, which have not been detected The central bank yesterday kept its key interest rates unchanged for a fifth consecutive quarter, aligning with market expectations, while slightly lowering its inflation outlook amid signs of cooling price pressures. The move came after the US Federal Reserve held rates steady overnight, despite pressure from US President Donald Trump to cut borrowing costs. Central bank board members unanimously voted to maintain the discount rate at 2 percent, the secured loan rate at 2.375 percent and the overnight lending rate at 4.25 percent. “We consider the policy decision appropriate, although it suggests tightening leaning after factoring in slackening inflation and stable GDP growth,”
RSS