Hanmi pushes for Champix follow-on despite hardships

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 self-developed salt-modified drug.

 

This is the company’s third attempt at a varenicline product.

 

According to industry sources on the 9th, Hanmi Pharmaceuticals had recently applied for the approval of its smoking cessation treatment, ‘varenicline oxalate hydrate,’ to the Ministry of Food and Drug Safety.

 

Industry experts observed that the product was prepared to replace the ‘Nokotine S tablet' that was partially recalled due to excess NNV detection.

 

▲ Smoking cessation treatment being sold by Hanmi Pharmaceuticals,

Nokotine S is a Varenicline salicylate substance that is being produced on consignment by CTC Bio.

 

The drug was released by Hanmi Pharmaceuticals after the original Champix’s substance patent was expired in July last year.

 

Hanmi Pharmaceuticals had released a varenicline product before Nokotine S called ‘Nokotine,’ a varenicline oxalate hydrate that was originally developed by Hanmi Pharmaceuticals.

 

However, the item was withdrawn after the company lost the patent challenge.

 

Hanmi Pharmaceuticals had released Nokotine in November 2018 before the original's substance patent expiry, using the logic that the extended substance patent duration does not apply to salt-modified drugs.

 

The claim, which was accepted by the Intellectual Property Trial and Appeal Board, was then rejected at the Patent Court.

 

Due to the ruling, the product was taken off the market.

 

To make matters worse, the Ministry of Food and Drug Safety revoked the license of ‘Nokotine’ with the reason of its sale before patent expiry.

 

This was why the company had released the CMO product ‘Nokotine S,’ as an alternative.

 

But the impurity issue put a hold on Hanmi’s path.

 

Excess amounts of N-nitroso-varenicline were detected in products produced by Hanmi’s CMO, CTC Bio.

 

The company recalled 16 lots of Nokotine S that was produced by CTC Bio.

 

The fact that Hanmi Pharmaceuticals, whose credibility had suffered due to the impurity issue, was preparing a new product was found last month.

 

The company filed an application to revive the canceled license for the varenicline oxalate hydrate product.

 

In fact, many pharmaceutical companies have been wrapping up their Champix’s follow-on business due to the downtrend of the smoking cessation treatment market.

 

Based on IQVIA, Champix sold ₩8.8 billion and NoKotine sold ₩715 million in the second half of last year.

 

However still, Hanmi Pharmaceuticals is still intent on making it in the market.

 

The company had entered the smoking cessation treatment market with ‘Nicopion,’ which was rare using bupropion products., and also lead the patent challenge against Champix after the development of its salt-modified drug.

 

The company had filed for an invalidation trial of a patent after its appeal had failed.

 

The company also runs a smoking cessation program involving all of its employees every time it launched a new product.

 

Will the company be able to reap the rewards for its sincere efforts some day?

 

Whether Hanmi Pharmaceuticals’ new smoking cessation treatment market will be able to break the sole lead held by Pfizer is gaining attention.