Bukwang Speeds Lead Asset As It Eyes Danish Operation's Listing
CNS Experts Hired As Contera Built Out
Executive Summary
Helped by a hefty financing earlier this year, Bukwang subsidiary Contera Pharma is poised to speed ongoing multinational Phase II trials with its lead asset for Parkinson’s-associated dyskinesia by hiring CNS experts as new top executives, as the Korean firm looks to take it public in ground-breaking move.
South Korea’s Bukwang Pharmaceutical Co., Ltd. has hired new top management at Danish subsidiary Contera Pharma and continues to make preparations for Contera's listing on the Kosdaq market, in a move to generate new funding and speed up the clinical development of lead asset JM-010 for levodopa-induced dyskinesia in Parkinson's disease.
Copenhagen-based Contera, which focuses on the development of innovative drugs for the treatment of debilitating central nervous system disorders, was acquired by the mid-sized Korean pharma firm back in 2014.
The new executives at Contera, including CEO Thomas Sager, also signal the company is bringing in specialist expertise and weighing the possibility of seeking global licensing partners going forward. The new executives at the operation have big pharma experience in CNS therapy development - Sager previously served as vice-president and head of business development and licensing at Danish major H. Lundbeck A/S.
Anders Brandt Elvang, who was senior director and head of business development strategy at Lundbeck, has been named chief business officer, while Kenneth Vielsted Christensen, a former head of neurology research programs at French group Servier, has been appointed chief science officer.
Bukwang explained to Scrip that, “Global CNS experts were hired to ensure successful development of JM-010 and other pipelines as global products.”
The company sees Contera as having raised sufficient funds through a July financing worth KRW51bn ($46.3m) to prepare for the stock listing in South Korea, progress Phase II studies with JM-010 in Europe and the US, and to hire global CNS expertise. The Danish bioventure also has several programs in its pipeline besides JM-010.
First Korean Listing For European Firm
Contera is accelerating its plan to launch an initial public offering on South Korea’s second-tier Kosdaq market, where most of the country’s bioventures are listed. “If approved by the exchange, Contera will be the first European company to list its shares in Korea. It is also the first time for a Korean pharma to list its European subsidiary on the Korean stock market," Bukwang noted. "We decided to list Contera in Korea as it will be easier to proceed with R&D funding.”
As part of its efforts to prepare for the IPO and progress clinical trials in the country, Contera recently set up a Korean branch office and hired a core workforce in business development and R&D at the operation.
In fact, conditions appear ripe for the float as the Korea Exchange has now added Denmark to the list of countries qualified to list on its bourses. The exchange has generally been easing listing rules for foreign companies in recent years to attract promising foreign firms to Kosdaq.
“Contera is a company with significant competitive and technological advantages. It is currently having an ongoing Phase II study not only in the EU but also in the US. In addition, the preparation for the Contera listing has been very positive and on the right track so far. All of these factors will play an important key role in the success of current financing,” Bukwang said in July.
JM-010 Moving Through Phase II
In February, Bukwang received investigational new drug clearance from the US Food and Drug Administration to proceed with a Phase II study of JM-010, which it has so far described as a synergistic combination of two known drugs in a proprietary formulation. The results from this program and EU Phase II trials will form the basis for determining a safe and effective dosing regimen for the planned Phase III trials.
Dyskinesia emerges in up to 90% of Parkinson's patients following long-term treatment with levodopa, and JM-010 is designed to treat or prevent the involuntary movement disorder without adverse effects.
The company says it has shown "very convincing efficacy" in preclinical and early Phase II proof of concept and should provide a safe and efficacious treatment in the indication.
Progress For Other Pipeline Assets
Elsewhere in the pipeline there is JM-012, a novel formulation of levodopa and carbidopa being developed in collaboration with Solural Pharma ApS and which should be taken at bedtime in Parkinson's patients as an add-on to the normal medications, for morning akinesia.
Bukwang's general R&D strategy is to bring in promising pipeline assets and use a repositioning strategy to reduce clinical trial failures stemming from major adverse effects. The company has been actively investing in both Korean and foreign biotechs and has set up joint ventures as part of this open innovation strategy. (Also see "Bukwang Acquires Acer Stake In Pattern Of Venture Investments" - Scrip, 23 Jul, 2015.)
Other key pipeline projects include MLR-1023, a novel insulin sensitizer undergoing development with Melior Pharmaceuticals, Inc. and now undergoing Phase II studies in the US and South Korea for type 2 diabetes.
Bukwang is also progressing a Korean Phase II clinical program for COVID-19 drug candidate Levovir (clevudine), which is already approved in the country as an antiviral for hepatitis B. The company is scheduled to complete the study by the end of January, although it noted this will largely depend on the pace of patient recruitment.