앨러간, 메디톡스 美진출 방해 의혹 부인…"파트너쉽 변함없어"

Published : Nov 15, 2016 - 14:21 Updated : Nov 15, 2016 - 16:00

[코리아헤럴드(더인베스터)=박한나 기자] 글로벌 1위 보톡스 제조사 앨러간(Allergan)이 시장 독점을 위해 메디톡스의 미국 진출을 의도적으로 지연시키고 있다는 의혹을 전면 부인했다.

지난 2013년 앨러간은 메디톡스의 보톡스 제품 ‘이노톡스’의 미국내 독점판매계약을 맺었는데 지금까지 출시가 미뤄지고 있는 상황이다. 당시 계약금은 4,000억원이었다.

(사진=앨러간 사의 `보톡스`)

앨러간의 자넷 케틀스(Janet Kettles) 언론담당 부사장은 더인베스터에 관련 의혹을 부인하며 “메디톡스의 미국시장 진출은 아직 시간이 필요하다”고 말했다. 그는 또 “제품 개발에서는 성과가 있었다”고 덧붙였다.

메디톡스의 제품 출시가 지연되자 미국에서도 지난해 현지 의사 두 명이 메디톡스와 앨러간이 체결한 라이센싱 계약이 공정거래법과 반독점법에 위배된다며 소송을 제기한 바 있다.

업계 관계자들은 앨러간이 소송에서 패소할 경우 메디톡스와의 계약이 취소될 수도 있다며 우려를 표하고 있다. 이에 대해 케틀스 부사장은 답변을 거부했다.

한편 국내 선두 업체인 메디톡스의 미국 진출이 미뤄지는 동안 후발 주자인 대웅제약과 휴젤은 글로벌 임상실험과 미국 시장 진출에 속도를 올리고 있는 상황이다.

최근 이들 제약사들간의 보톡스 균주 논란 역시 메디톡스가 경쟁사들의 미국 진출에 견제하려는 의도가 있는 것이 아니냐는 의혹이 일면서 진흙탕싸움으로 번지고 있다.

(hnpark@heraldcorp.com)

<원본 영문 기사>

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)