Champix patent expires soon, follow-ons eager to launch

Extended patent term to expire next July, heated competition to start then

MFDS approves Yuhan’s follow-on IND Phase 1 clinical trial

Despite a joint sales deal with Pfizer Korea on a quit-smoking medication Champix (varenicline tartrate), Yuhan Corporation is currently developing a follow-on medicine of the original.

 

Seemingly, Yuhan is preparing for the Pfizer’s Champix’s patent to expire in next July.

 

On Nov.

 

11, Ministry of Food and Drug Safety (MFDS) approved an investigational new drug application for Phase 1 clinical trial on Yuhan’s candidate medicine, ‘YHP190’.

 

The study protocol states it aims to compare and evaluate pharmacokinetics of healthy adult subject arms taking 1mg of YHP1903 and 1mg of Champix tablet, respectively.

 

The commercial clinical trial is to be initiated for the regulators to approve Champix’s follow-on medicine.

 

Yuhan’s development of Champix’s follow-on drug and its clinical trial has gotten the industry’s attention as the company is currently co-promoting the original Champix with Pfizer Korea.

 

In September last year, Yuhan signed a joint sales deal with Pfizer Korea.

 

It was a co-promotion strategy to defend Champix’s market share from incrementally modified drug (IMD) launching in November same year.

 

The IMD with a change in saline substance of Champix was able to enter the Korean market as it evaded extended term of the original’s substance patent.

 

The Intellectual Property Trial and Appeal Board ruled the IMD does not infringe the original’s patent with extended term.

 

However, the table turned in last January, as the Supreme Court on other case ruled that an IMD with changed saline substance does not evade extended patent.

 

The Champix’s IMD released in November last year stopped most of its manufacturing after January.

 

Korean court is expected to hand down the ruling on Champix’s IMD on coming Dec.

 

20.

 

On the other hand, MFDS has already approved of 72 IMDs related to Champix.

 

But initially Yuhan did not submit a follow-on drug approval application, due to its joint sales deal.

 

Although the sales of IMDs are blocked at the moment, it would resume from July next year when the extended patent term expires on July 19, 2020.

 

There are saline substance and composition variant patents expiring on Jan.

 

31, 2023, but most of Korean companies are evading the patent as they are using different substances.

 

At last, July next year would be the long-awaited start of the heated smoking-cessation medication market competition.

 

While many companies are eager to launch items in same class, the pharmaceutical industry is keeping a close eye on Yuhan with co-promotion deal over the original, to see if it would also join the follow-on drug market competition.

 

Meanwhile, IQVIA reported Champix sales in the first half of the year plummeted by 51.1 percent, compared to same time last year, and that the drug only generated 11.5 billion won.

 

The sudden drop of sales was affected by the original’s price reduction due to release of IMDs and decreased number of participants applying for government-supported quit-smoking program.