Lotus Pharmaceuticals Co (美時化學製藥), one of the nation’s leading specialty generic drug developers, yesterday gave a positive outlook for this year, setting its sights on the US market for opioid use disorder (OUD) treatments.
The company, which is vying to launch a generic version of buprenorphine and naloxone, a leading agonist treatment for opioid dependence, said that toward the second half of this year, a US court is expected to give its ruling on patent lawsuits initiated by UK-based Indivior PLC, which is marketing the original drug as Suboxone.
The plaintiff’s patent claims are not solid and a favorable ruling is expected, Lotus Pharmaceuticals chairman Andrew Lin (林群) told an investors’ conference, adding that the company is prepared to initiate an “at-risk” launch for the generic treatment despite ongoing lawsuits.
In particular, the company is developing a film version of the OUD treatment that is placed under the tongue or inside the cheek, he said.
As the US Food and Drug Administration approved Sublocade, Indivior’s monthly subcutaneous injection OUD treatment, the British company slowed its litigation against companies making generic versions of Suboxone, Lin said.
The company is also expecting to launch a generic version of Budesonide ER, a corticosteroid indicated for patients with mild to moderate ulcerative colitis, in the final quarter of this year, after gaining a non-infringement ruling against Valeant Pharmaceuticals International Inc and Cosmo Pharmaceuticals NV, which are marketing the original drug as Uceris, he said.
The drug is expected to launch after Valeant’s 180-day exclusivity period ends, allowing the company to tap into a US$190 million market in the US, he said.
Meanwhile, the company has overhauled its goodwill and intangible assets portfolio as it continues to book impairment charges in an effort to reduce risks ahead, Lotus Pharmaceutical executive assistant Nadiya Chen (陳萩雅) said.
The amount of the impairment charges has been cut from NT$500 million (US$17.12 million) in 2016 to about NT$140 million last year, Chen said.
The company reaped gains from cross-region commercial synergies with affiliates of US-based Alvogen and its Asia-based affiliates, which helped lower its operating-to-expense ratio to a record 40 percent, it said.
Efforts to refinance debt have also cut annual interest expenses, Chen said.
As the global generic drug market has undergone significant changes since 2016, with many industry giants such as Teva Pharmaceuticals Industries Ltd and Perrigo Co experiencing precipitous declines, the company is to continue its strategy of specializing in the segment of complex, high-barrier and small-volume products that have high average selling prices, Chen said.
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