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  • CEO Cho Jeong Woo “Cenobamate U.S. release is all ready"
  • by Lee, Tak-Sun | translator Byun Kyung A | Mar 13, 2020 06:30am
Personally persuaded Chairman Chey Tae-won to independently develop new drug
Shooting for approval in Europe this year, and to join Asian market including Korea
Anticipates mutual growth with other Korean companies targeting global markets
 ▲ CEO Cho Jeong Woo of SK Biopharmaceuticals

A new anti-epileptic drug from SK Biopharmaceuticals, cenobamate (U.S. brand name Xcopri), has set a new milestone in the Korean history of pharmaceutical industry history as it independently won an approval by the U.S. Food and Drug Administration (FDA).

To this date, a new drug developed in Korea has been licensed out to foreign pharmaceutical sales companies before receiving approval from the U.S. or EU health authorities. So the Korean drug developers had no experience in processing overseas approvals by themselves.

Moreover, SK Biopharmaceuticals plans to independently market the drug in the U.S. market. During a recent interview with Daily Pharm, President and CEO of SK Biopharmaceuticals Cho Jeong Woo said, “In the second quarter, 120 specialists in sales would release the product in the U.S. market. We have already established a sales network that could cover all regions in the U.S. at the same time.”

Cenobamate also completed the last administrative procedure for the launch as the U.S. Drug Enforcement Administration (DEA) has designated the drug as a Schedule V medicine.

DEA reviews FDA-approved central nervous system (CNS) medicine based on medical indication, and risk of abuse and dependency to categorize them into five levels (from Schedule I to V). And cenobamate received Schedule V for lowest risk of abuse. Accordingly, the level of pharmaceutical management on the drug would not be as stringent.

Solely owned by SK Holdings, SK Biopharmaceuticals has fully emerged as Korea’s top new drug developing company after FDA granted approvals on solriamfetol, a new drug for sleep disorder licensed out to Jazz Pharmaceutical, and new anti-epileptic drug cenobamate.

Daily Pharm asked CEO Cho Jeong Woo of what has been SK Biopharmaceuticals’ driving force to win two FDA approvals in a year and to independently launch a drug in the U.S. market.

Following is CEO Cho’s answer to Daily Pharm’s questions.

Q. Cenobamate has received the FDA approval in last November, and was nominated for the 21st Korea New Drug Award. Please tell us about the development process of cenobamate.

In 2001, the company explored candidate medicines with high potential for anti-epileptic drug and discovered cenobamate. Since then, the company took step-by-step process, including nonclinical study, Phase 1 to 3 clinical trials, preparation for new drug marketing approval application and post-review procedure. And last year, the U.S. FDA has approved the drug to treat partial-onset seizure for adults.

The commitment to develop a new drug targeting the U.S. market was made from strategic call expecting that receiving the strict FDA approval and releasing it in the world’s largest pharmaceutical market would put us on an advantageous side. Now that we have the FDA approval, we plan to move forward to accommodate cenobamate to various countries’ approval regulation.

Q. Please tell us in detail about the process of selecting candidate medicine, initiating clinical trial and applying for approval.

Over 2,000 candidate medicines were explored from 2001, and cenobamate was selected as an investigational candidate. The drug’s clinical protocols for testing efficacy in anxiety and epilepsy were approved by FDA in 2005 and 2007, respectively. Studies were conducted to develop an innovative and new anti-epileptic drug. With over 1,900 patients, Phase 2, randomized, double-blinded, placebo-controlled trial (completed 2013 and 2015) and Phase 3, large-scale, multicenter, open-label trial (completed 2018) were conducted.

On Nov. 21 of 2018, cenobamate submitted a New Drug Application (NDA) to FDA and acquired the agency’s approval on Nov. 21 of 2019 after a year-long review. In 2020, FDA also reviewed and cleared current good manufacturing practice (cGMP) on SK Biopharmaceuticals and SK Biotek that produces active pharmaceutical ingredient (API) of cenobamate. As a result, SK is now a full-fledged new drug developing company capable of researching, conducting clinical trial, manufacturing and sales.

Q. The company is the first in Korea to independently handle candidate medicine exploration, clinical development, sales and regulatory approval process. What has driven the company to cruise on with the standalone development, despite the high-cost of global clinical trials and R&D?

The biggest driving forces have been the ‘solid sense of purpose’ and ‘daring mind’ taking the road not taken. The R&D capacity was built on years of research, but also on the sense of purpose to develop a breakthrough anti-epileptic drug. And in the process, the company gained experience in developing global-scale new drug and confidence of new drug development by collaborating with global pharmaceutical companies on a different drug.

To acquire global drug development capacity, SK also collaborated with multinational company on post-Phase1 development of Sunosi, which provided rich experience like the approval application procedure. From then on, we were confident enough to plan for a transnational clinical trial and took the ‘standalone development route,’ unprecedented at the time in Korea, by personally persuading Chairman Chey Tae-won.

Q. Sources say the U.S. subsidiary SK Life Science is planning to release the drug in the second quarter. Could you elaborate on the commercialization plan in the U.S.?

Cenobamate is aiming for the U.S market release in the second quarter. The company has finished planning for marketing strategies, hiring salespeople and setting direct sales network covering the whole U.S. market.

Commercialization of the anti-epileptic drug would be executed through intricately designed marketing strategy as the existing options are mainly prescribed by neurologists.

While there are approximately 13,000 working neurologists the U.S., some 120 neurology sales specialists, on par with the scale of sales force for other anti-epileptic drug, would promote the Korean-made drug everywhere in the U.S.

Q. Is there any news about the drug in development for other parts of the world besides the U.S.? Is Korea one of them?

To commercialize cenobamate in the European market, the company has signed USD 530 million worth license-out deal with Arvelle Therapeutics last year. We are planning to submit application for European market authorization approval by the end of June.

Although we are solely taking care of commercialization in the world’s largest market in the U.S., we are marketing the drug in Europe based on strategic partnership with local companies to accommodate their diverse regulatory and marketing landscapes. As for Korean, Chinese and Japanese markets taking up over 90 percent of overall sales in Asian anti-epileptic market, the company is preparing clinical trial and other approval review procedure required for respective countries.

Q. Aside from solriamfetol and cenobamate, is there any other highly potential candidate drug?

SK Biopharmaceuticals have been focusing on CNS disease for last 27 years, and solidified distinctive pipeline in the industry.

Another Phase 3 clinical trial is ongoing for cenobamate to expand indication to treat patients with generalized tonic-clonic seizure. Carisbamate, a Lennox-Gastaut syndrome (LGS) treatment, is currently in development but also received Orphan Drug Designation from FDA in 2017.

A new candidate anti-epileptic medicine, SKL24741, is to start Phase I trial from this year as FDA cleared its IND in March last year.
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