Thu, Feb 21, 2019 - Page 12 News List

PharmaEssentia gains EU drug approval

By Ted Chen  /  Staff reporter

PharmaEssentia Corp (藥華醫藥) yesterday said that Besremi (Ropeginterferon alfa-2b), its treatment for people with polycythemia vera without symptomatic splenomegaly, has gained marketing approval from the European Medicines Agency.

The company obtained the approval with help from its partner, Austria-based AOP Orphan Pharmaceuticals AG, it said, adding that sales of Besremi in Europe could begin in the first half of this year.

PharmaEssentia has out-licensed to AOP the exclusive rights to market the drug in Europe, the Middle East, the Commonwealth of Independent States and the Baltic Assembly.

PharmaEssentia chief executive officer Lin Ko-chung (林國鐘) in October last year said that the company was preparing to deliver the first batch of 20,000 doses of Besremi to Europe, which would be enough to supply the single market’s estimated 760 patients for a year.

Each dose was expected to retail at US$2,000, Lin said.

However, the company is still finalizing royalty arrangements with AOP before sales can begin in Europe, a company official said yesterday.

Separately, Lotus Pharmaceuticals Co (美時化學製藥) yesterday announced that it has launched a generic equivalent of Suboxone, a sublingual film used to combat opioid addiction in the US.

The treatment, which contains the active ingredients buprenorphine and naloxone administered four times daily under the tongue or inside the cheek, have been made available in four strengths.

The launch took place after the US Supreme Court ruled against UK-based Indivior PLC, Suboxone’s original developer, and opened the way for generics to be sold in the US.

Lotus affiliate Alvogen Group Inc on Jan. 24 obtained final approval from the US Food and Drug Administration for the generic drug and reached an agreement with Indivior on Jan. 31 to lift the restrictions on marketing generics in the US.

Alvogen and Lotus are facing competition from other Suboxone generic makers, Dr Reddy’s Laboratories Ltd of India and Mylan NV registered in the Netherlands.

An estimated 116 Americans die every day from overdoses of prescription painkillers, heroin or synthetic products, such as fentanyl, creating a treatment market estimated at about US$24 billion, the company said last year, citing findings by the US National Center for Health Statistics.

US President Donald Trump has described the issue as an “opioid epidemic” and “health emergency” that requires immediate attention.

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