Capital Investment Management Corp (群益投顧) gave a neutral outlook on TaiMed Biologics Inc (中裕新藥) even as the company begins to book sales from its new HIV/AIDS drug, Ibalizumab, formerly known as TMB-355.
Following more than a decade of development, Ibalizumab is expected to commence sales in North American markets by the end of the year, and in Europe in 2019 at the latest, with the help of its exclusive distribution partner, Montreal-based Theratechnologies Inc.
Despite maximum sales projections of US$360 million in North America and US$230 million in Europe, the company might not post a profit until the end of next year, Capital analysts said in a report last month.
The drug might have a small potential market due to its annual cost of US$60,000 per patient, one of the highest among HIV/AIDS drugs treatments, the report said, adding that prices would be lower in Europe.
Capital analysts expect the drug would only be prescribed to drug-resistant patients that have exhausted other treatment options and require medication adjustments, as the virus cannot be effectively controlled after 48 weeks of treatment in such patients.
Sales would also be hindered by inconvenience as it is administered by intravenous injection, the report said.
Unlike the US Food and Drug Administration’s orphan drug designation, the European Medicines Agency does not have fast-track designations for breakthrough therapies, which might result in a longer time-to-market period for the drug, the report said.
TaiMed has plans to submit a marketing authorization application to European regulators with the aim of securing a trial waiver for the drug, which will not be announced until the fourth quarter this year, the report said.
If a waiver is granted the drug could hit the market by the end of next year, the report said, but if the waiver is not granted, TaiMed will bear the costs of conducting another clinical trial and other requirements.
Meanwhile, TaiMed on Monday last week said that it has inked a worldwide exclusive licensing agreement with the Aaron Diamond AIDS Research Center for bispecific monoclonal antibody technology.
The patents would help TaiMed develop its third-generation HIV/AIDS treatments, and a clinical trial would begin in the US before the end of this year, the company said.
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