Medytox’s American dream falters with returned botox rights

Rights to a new botulinum toxin substance that was exported to Allergan (now Abbvie) through a technology transfer contract was returned to Medytox.

Received Phase 3 clinical trail data from ABBvie…is internally reviewing whether to enter the U.S. business

Medytox’s plans to overcome the license revocation in Korea by entering the US market, have come to a halt with AbbVie, which had been conducting global trials for the new botulinum toxin candidate 'MT10109L,’ returning its rights to Medytox.

 

◆A technology export agreement worth up to ₩400 billion was returned in 8 years On the 8th, Medytox announced that AbbVie has returned the rights concerning MT10109L, an improved botulinum toxin candidate, to its company.

 

The right was returned in 8 years since the technology export.

 

Medytox had signed a licensing-out agreement for its botulinum toxin candidate in 2013 to Allergan (now AbbVie) and handed over the global development and sales right of its product in all countries around the world than Korea and Japan.

 

The agreement including the signing fee and milestone was worth $362 million (₩390 billion) The returned rights by themselves are not bad news to Medytox, as the company has no obligations to return the $100 million (₩120 billion) that it received during the term of the contract.

 

The company had received $65 million upon signing the agreement, and an additional $35 million milestone.

 

company However, the returned rights could be a serious blow considering Medytox’s current circumstances.

 

Medotx’s 6 botulinum toxin products are all on the verge of license revocations.

 

The Ministry of Food and Drug Safety had ordered the disposition to suspend sales and cancel licenses of Medytoxin 50·100·150·200, as well as Coretox, and Innotox.

 

The court accepted Medytox’s request to suspend the execution of the administrative order, however, the MFDS’s disposition served as a major negative factor on Medytox.

 

Medytox earned ₩140.8 billion last year, which was a 32% decrease from the previous year.

 

To Medytox, MT10109L was the key substance that could save the company from the looming crisis.

 

The plan was for MT10109L to enter the US market through AbbVie to overcome the crisis of license revocation in Korea.

 

In addition, the company had planned to use the FDA approval as momentum to receive authorization for MT10109L as a new product.

 

Until earlier this year, the plan seemed to be in smooth progress.

 

AbbVie had started 4 global Phase III trials on a total of 1,308 subjects in December 2018.

 

The trials were completed in March this year.

 

The industry had expected AbbVie to submit a Biologics License Application (BLA) to the US FDA within this year.

 

However, contrary to industry belief, AbbVie suddenly returned its rights to Medytox., putting a stop to Medytox’s plans to enter the US market.

 

◆Why did AbbVie return the rights after completing Phase III trials? The industry has been speculating on two reasons as to why the company had returned the rights to MT10109L after completing Phase III trials.

 

One is the possibility of trial failure.

 

The results of the Phase III trial may not have been satisfactory, which led to the return of rights of MT10109L to Medytox.

 

The other is the poor relationship it has with Daewoong Pharmaceuticals.

 

In May, Daewoong Pharmaceuticals had submitted an investigation request into MT10109L claiming that its data has been manipulated.

 

Its argument was that MT10109L is the same product as the Innotox that was revoked in Korea, and that Innotox’s data was found to be manipulated during the MFDS investigation.

 

On this, Medytox had refuted the claim, saying that MT10109L is a new botulinum toxin formulation and a clearly different product from Innotox.

 

Innotox is a domestically sold pharmaceutical that complies with the MFDS regulations, however, MT10109L is a product designed for approval in the US and Europe, and is manufactured and produced in compliance with the regulations in those countries.

 

An industry official said, “AbbVie may have determined MT10109L the same substance as Innotox.

 

And even if the company decided the two were not the same, the FDA’s move to launch an investigation into the drug may have been a burden.” Medytox plans to soon decide whether to apply for authorization of the retrieved MT10109L in the US.

 

A company official explained that although the rights were returned from AbbVie, the possibility of applying for approval remains as the development of the product has not been aborted.

 

An official from Medytox said, “We have received the full clinical data from Abbvie.

 

We will be reviewing entry into the global market while conducting data analysis.

 

We have not decided whether to directly apply for approval or seek a new partner.

 

It’s all being reviewed internally.”