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Hanmi pushes for Champix follow-on despite hardships

By Lee, Tak-Sun | translator Alice Kang

21.09.10 06:18:48

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Struggles through patent challenge failure, license revocation, to CMO product impurity issue

Reapplied for approval with a salt-modified drug¡¦is recieving attention for its 3rd varenicline attempt


One pharmaceutical company is determined to develop a follow-on of the smoking cessation drug, ¡®Champix¡¯ (Pfizer, varenicline tartrate), and it is Hanmi Pharmaceuticals.

Hanmi Pharmaceuticals had succeeded in the early release of its drug as a salt-modified drug, but had lost the patent challenge failed to enter the market.

After the original's patent expiry, the company had attempted to set foot in the market again with a CMO product but faced hardships due to an impurity issue. On the 7th, the company voluntarily recalled its products due to an excess amount of N-nitroso-varenicline (NNV) impurities.

With perseverance, Hanmi Pharmaceuticals attempted once more with a se

Lee, Tak-Sun(hooggasi2@dailypharm.com)
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