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.
Poland is betting on a flood of investments and technology transfers from Taiwanese companies to reengineer its US$1 trillion economy. Polish Prime Minister Donald Tusk said yesterday that Poland will no longer be “just an assembly hub” as it pursues further investments from the likes of Foxconn Technology Group (富士康). The firm, whose full name is Hon Hai Precision Industry Co (鴻海精密), last month agreed to build electric vehicles (EVs) in the European Union nation and now could be a partner in a semiconductor venture, he said. The government’s aim is to boost manufacturing and the country’s high-tech chops in an era
RESTRICTION BREACH: ASML said that it denies ‘unfounded rumors regarding non-compliance with export controls concerning China,’ and enforces controls strictly US Secretary of Commerce Howard Lutnick in a series of recent meetings outlined concerns to Dutch chip-equipment giant ASML Holding NV’s senior leaders that one of its top-of-the-line machines might have made its way into China, in violation of US-led export restrictions. In the meetings, Lutnick expressed concern to ASML executives over the company’s extreme ultraviolet lithography (EUV) machines, people familiar with the talks said. EUV systems are used by firms such as Taiwan Semiconductor Manufacturing Co (台積電) to manufacture processors for the likes of Nvidia Corp and Apple Inc. ASML has never been allowed to ship them to China because of curbs
Google DeepMind vice president John Jumper, who won the 2024 Nobel Prize in chemistry for his work on artificial intelligence (AI), is leaving the company to join Anthropic PBC. Jumper has been a key member of Google’s AI coding development team and his departure strains the tech giant’s efforts to beat Anthropic, OpenAI and SpaceX in the race to build the most powerful AI models. Google has struggled to sell AI coding tools to businesses, according to former employees. Employees and executives at DeepMind have raised concerns in the past few months that the company does not have a clear solution for
BAD FAITH LITIGATION? The two companies, owned by a California-based private equity firm, could be seeking licensing fees or a settlement payout with the suit Taiwan Intellectual Property Office (TIPO) Director-General Liao Cheng-wei (廖承威) said yesterday he suspected that two firms suing contract chipmaker Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) for patent infringement are “patent trolls.” A patent troll refers to a company that buys patents not for manufacturing products, but to sue other companies for compensation, accusing them of using its patents. Patent trolls, formally called Non-Practicing Entities or Patent Assertion Entities, were responsible for more than 50 percent of lawsuits in the US last year, costing targeted businesses tens of billions of US dollars a year, according to the US-based LegalCharity Web site. Asked whether
RSS