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Allergan denies blocking Medytox’s US entry

[THE INVESTOR] Botulinum toxin maker Allergan denied speculations that it has bought rights from South Korea’s Medytox in order to maintain its dominant position in the US market and keep prices for its wrinkle-fighting treatments high. 

Allergan said that the company is seeing a progress in a partnership with Medytox, the country’s largest maker of botulinum toxin, or BTX, to bring latter’s product into the US market. 

“This is a long process, but the companies are making important progress in their development programs,” Janet Kettles, vice president of communications and public relations at the US firm told The Investor via email on Nov. 12. 

In 2013, Allergan signed a US$369 million worth licensing agreement with Medytox to develop neurotoxin product candidates, including a liquid-injectable product. 

Under the agreement, Medytox granted Allergan exclusive rights, worldwide outside Korea, to the new drugs.

In recent months, market rumors have been rampant that Allergan is intentionally delaying the launch of Medytox’s BTX product in the US market, taking more than three years since they signed the deal. 

In fact, two US surgeons filed suits against Allergan in 2015, accusing the US firm of keeping Botox prices artificially high by signing the license deal with its potential competitor Medytox. 

Some industry watchers said the deal between the two companies could be cancelled if Allergan loses the suit. 

“Allergan does not comment on ongoing litigation,” Kettles said. 

While Medytox is making slow progress, its local rivals Daewoong and Hugel are taking bolder steps. 

Daewoong has already concluded Phase 3 clinical trials of its BTX product in the US and plans to file for approval by the FDA early next year.

The companies claim that the  main reason behind the delay is Medytox’s second manufacturing facility in Osong, North Chungcheong Province.

Allergan has been closely engaged with the plant’s regulatory standards as it needs to meet the Current Good Manufacturing Practice, or CGMP, regulations enforced by the US Food and Drug Administration to export products produced in the facility. 

“Allergan and Medytox agreed that it’s better to carry out US clinical trials with the products produced from a plant that follows CGMP to reduce risks during an inspection by the US FDA,” an official at Medytox said. 

The Korean biotech firm also said Allergan has been fully supporting its drug development program by sharing technology and sending researchers to its lab during a press conference held earlier this month. 

Phase 3 clinical trials of Medytox’s next-generation botulinum toxin are likely to begin in the first half of 2017.

By Park Han-na (hnpark@heraldcorp.com)