SK Bio To Go All The Way With Novel Epilepsy Drug

SK Biopharmaceuticals, the new drug development subsidiary of South Korean conglomerate SK Group, is to seek approval of epilepsy drug YKP3089 without conducting a Phase III efficacy trial and aims to launch the drug globally in 2018, becoming the first domestic pharma to develop, commercialize and market a new product single handedly.

SEOUL - SK Biopharmaceuticals Co. Ltd. has received confirmation that the US FDA will allow it to skip a Phase III efficacy trial for its novel epilepsy drug candidate YKP3089, which recently completed a four-year Phase II program in multiple sites including in the US, Europe and Asia.

YKP3089 is a novel compound with broad-spectrum anticonvulsant activity, and the company conducted Phase II studies as a once-daily therapy for partial onset seizures. It also has potential as a versatile CNS drug with multiple therapeutic uses.

Thanks to its superior efficacy and safety versus existing drugs during the Phase II trials, the FDA allowed the subsidiary of South Korea’s conglomerate SK Group to skip an efficacy study at the Phase III stage, and to only conduct a safety trial, said SK Biopharmaceuticals.

"During the Phase IIb trial, patients that didn't respond to existing drugs showed a 55% reduction in seizure frequency, which is about twice as efficacious as existing drugs," said an official at SK Biopharmaceuticals. According to the company, YKP3089 also marked the highest rate of patients whose seizures completely disappeared.

The firm plans to apply for marketing authorization to the FDA in 2017 and for launches in global markets in 2018. SK Biotek, a subsidiary of SK Group, will manufacture the epilepsy drug. SK Biopharmaceuticals received funding from the state-run Korea Drug Development Fund for the Phase IIb trials in the US, South Korea, Poland and India.

Go It Alone Strategy

SK Biopharmaceuticals plans to proceed with further development, commercialization and marketing of the in-house developed molecule wholly by itself, the first such move by a South Korean pharma firm.

"What differentiates SK Biopharm from other domestic pharmas is that it plans to complete clinical trials of YKP3089 by itself without licensing it out to a multinational pharma," said Hana Financial Investment.

The move underlines the company's confidence in its pipeline as well as its ample cash on the back of the strong funding ability of its parent. By maximizing the value of its pipeline and commercialization experience, SK Biopharmaceuticals has the potential to grow into a specialty pharma along the lines of Jazz Pharmaceuticals PLC, UCB Group, Ironwood Pharmaceuticals Inc. and Shire PLC, the brokerage firm said.

The firm has particular R&D strength in the CNS sector, which has relatively good growth prospects as it is a niche market where competition is less fierce. There are still substantial unmet needs and prescriptions in the field are rising. If successful with YKP3089, the company could grow into a global pharma focused on specialty drugs, and is likely to expand its business via mergers and acquisitions, Hana Financial predicted.

SK Biopharmaceuticals has received approvals from the US FDA to proceed with clinical trials of 15 new drug candidates, the highest number at a South Korean company. It is conducting Phase III global clinical trials with sleep disorder therapy SKL-N05 with US partner Jazz (Also see "SK’s Narcolepsy Therapy Ready For U.S. Phase III Trial" - Scrip, 3 Jun, 2015.).

A US NDA for the acute repetitive seizure therapy Plumiaz (intranasal formulation of diazepam) has also been submitted.

Growing Epilepsy Market

Using patient-based methodology, Datamonitor Healthcare forecasts that sales of drugs for epilepsy across the US, Japan, and five major EU markets (France, Germany, Italy, Spain, and the UK) will rise to $5.4bn by 2022, from $4.5bn in 2013.

Uptake of new or recently launched drugs, both organic and through label expansions, will drive the market to a peak of $6.3bn in 2021, although a wave of patent expiries will cause a sharp decline in 2022.

The US is the largest market on account of its large diagnosed patient population and the high prices that manufacturers can command for branded products. Datamonitor estimates that sales of anticonvulsants for epilepsy totaled $2.7bn in the US in 2013, over five times the value of the next largest market, Japan.

UCB is set to continue its dominance of the epilepsy market with Vimpat (lacosamide; UCB/Daiichi Sankyo Co. Ltd.), with 2013 sales of $515m. Owing to its historical growth, additional epilepsy indications, and expansion to Japan, Vimpat is expected to have overtaken Keppra (levetiracetam; UCB/Otsuka Pharmaceutical Co. Ltd.) in 2014 to become the highest selling brand in the epilepsy market.

Vimpat’s epilepsy sales are forecast to peak at $1.4bn in 2021, declining thereafter due to its loss of exclusivity.

Based on its drug development ability in the CNS sector and entry into new disease areas such as oncology, SK Biopharmaceuticals itself is aiming to grow into a global biopharma with a corporate value of KRW10tn ($8.4bn) in 2020. The SK Group is planning to nurture the biopharma business, with SK Biopharmaceuticals at the center, as a main pillar of the group.