Korean drugmakers are preparing to release modified and generic drugs of Azilect (ingredient: rasagiline mesylate), Lundbeck’s popular treatment for Parkinson’s disease.
Winning local license in 2014, Azilect enjoyed rapid growth in prescription sales which surged to 14.3 billion won ($13.2 million) in 2017 from 7.1 billion won in 2015.
Pharmaceutical sources said three mid-sized pharmaceutical firms – Kyongbo Pharm, Myung In Pharm, and YuYu Pharma – have obtained approval for clinical trials and bioequivalence tests to develop incrementally-modified drugs (IMD) and generics.
Kyongbo Pharm won the green light from the Ministry of Food and Drug Safety for a phase-1 trial on “KB_RASA Tab” (ingredient: rasagiline tartrate) to make it an IMD of Azilect. The treatment changed the base of Azilect’s main ingredient rasagiline mesylate to rasagiline tartrate.
The change of the base could boost the drug’s safety and body absorption. If it works, the treatment can be recognized as an IMD.
Myung In Pharm and YuYu Pharma are working on Azilect-targeting generic drugs. The two firms received approval for bioequivalence tests on their investigational drugs, quickly tapping the Parkinson’s disease generic treatment market.
The Parkinson’s disease drug market has long been led by Novartis’ Stalevo, Boehringer Ingelheim’s Mirapex, and GSK’s Liquip. The three strongest players in the market began to lose power as the drugs’ effectiveness weakened when taken over a long time even in increased dosage.
Azilect as a latecomer successfully avoided the weakening of the efficacy and gained more popularity.
According to U-BIST data, Mirapex sold 9.2 billion won in 2017, Stalevo, 9.1 billion won, Azilect, 8.5 billion won, and Liquip, 5.9 billion won.
Except for Azilect, the other drugs suffered sales declines last year. Whereas Azilect’s sales surged 26.4 percent year-on-year, that of Mirapex fell 13.2 percent. Stalevo’s sales plunged 19 percent, and those of Liquip also went down 3.9 percent.
Analysts said if Azilect keeps the current growth momentum, it could win the No.1 place in the Parkinson’s treatment market within this year.
Whether Azilect will be able to block aggressive moves by IMDs and generic drugs and top the market remains to be seen, they added.
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