Press release, JM-010CS01, Phase IIa/cPoC study

  • Wednesday, September 7, 2016

  • Bukwang Pharma and its fully owned subsidiary Contera Pharma are pleased to announce that the investigational medical product, JM-010 has successfully been dosed to cohorts of patients with Parkinson’s disease suffering from moderate to severe levodopa-induced dyskinesia in a Phase IIa/Proof-of-Concept study. The primary study objectives concerning efficacy and safety were fulfilled. The aim is now to continue the development of JM-010 and initiate a Phase IIb Dose Range Finding study in first half of 2017.

  • Hee-Won Yoo, President and co-CEO of Bukwang Pharma stated: The reach of this significant and important outcome is a significant milestone for Bukwang Pharma and underlines a successful acquisition of Contera Pharma.

  • The co-founder and inventor of Contera Pharma and the JM-010 product, Mikael Thomsen, CSO stated: The positive result and outcome of this comprehensive clinical Proof-of-Concept study is really encouraging for all the patients suffering from levodopa-induced dyskinesia as there is no current approved treatment and JM-010 could be the first new approved effective and safe treatment paradigm.

  • About Bukwang
  • Bukwang Pharm. Co. (www.bukwang.co.kr), Ltd. is a leading Korean pharmaceutical company listed on the Korean Stock Exchange [KRX:003000]. The company has been in business for over 50 years, and achieved US$140 million in sales in 2015. Sales are primarily derived from products licensed from Europe, the United States, and Japan. The company is currently investing significant resources in R&D to create a robust pipeline of preclinical and clinical agents for the treatment of antiviral diseases, gastrointestinal disorders, CNS disorders and metabolic disease. For more information contact: bizcontact@bukwang.co.kr.

  • About Contera Pharma
  • Contera Pharma (www.conterapharma.com) is a Danish clinical stage biotech company focusing on discovery and development of new innovative drugs for treatment of movement disorders for which there is a high unmet medical need.

    Contera Pharma was founded in 2010 is now fully owned subsidiary of Bukwang Pharm. Co., Ltd acquired in November 2014.

    For more information contact John Bondo Hansen, CEO (jbha@conterapharma.com) or Mikael Thomsen, CSO (mst@conterapharma.com).


  • About JM-010
  • JM-010 holds a novel mechanism-of-action as a fixed dose combination of two safe marketed products in a proprietary formulation for treatment of L-DOPA induced dyskinesia (LID) in Parkinson’s disease (PD). The novel mechanism-of-action combines effects of different serotonergic receptor agonists. The combination exploits the mechanism of actions and the synergistic effects of the two drugs, neither of which is approved for treatment of PD or LID. Strong preclinical data in a validated model of LID is supported by experimental clinical studies.

  • Press release (PDF)

    US patent covering JM-010 for treatment of movement disorders has been granted

  • Friday, November 6, 2015

  • Bukwang Pharm and its fully owned subsidiary Contera Pharma are pleased to announce that the United State patent covering the investigational medical product, JM-010 and analogues thereof has been granted. Dr. Hee-Won Yoo, President and co-CEO of Bukwang Pharm stated: “The US patent is a significant milestone for Bukwang Pharm and supports the further development of JM-010”. John Bondo Hansen, CEO of Contera Pharma stated: “JM-010 and its analogues have been covered by several strong patent applications. It is important news that we now have received information that a US patent covering JM-010 has been granted. This is in support of our strategy to build our intellectual property rights to support our exclusivity to these products”.

  • About Bukwang
  • Bukwang Pharm. Co., Ltd. is a leading Korean pharmaceutical company listed on the Korean Stock Exchange [KRX:003000]. The company has been in business for over 50 years, and achieved US$140 million in sales in 2014. Sales are primarily derived from products licensed from Europe, the United States, and Japan. The company is currently investing significant resources in R&D to create a robust pipeline of preclinical and clinical agents for the treatment of gastrointestinal disorders, CNS disorders and metabolic disease.

  • About Contera Pharma
  • Contera Pharma (www.conterapharma.com) is a Danish clinical stage biotech company focusing on discovery and development of new innovative drugs for treatment of movement disorders for which there is a high unmet medical need. Contera Pharma was founded in 2010 is now fully owned subsidiary of Bukwang Pharm. Co., Ltd acquired in November 2014. For more information contact John Bondo Hansen, CEO (jbha@conterapharma.com) or Mikael Thomsen, CSO (mst@conterapharma.com).

  • About JM-010
  • JM-010 holds a novel mechanism-of-action as a fixed dose combination of two safe marketed products in a proprietary formulation for treatment of L-DOPA induced dyskinesia (LID) in Parkinson’s disease (PD). The novel mechanism-of-action combines effects of different serotonergic receptor agonists. The combination exploits the mechanism of actions and the synergistic effects of the two drugs, neither of which is approved for treatment of PD or LID. Strong preclinical data in a validated model of LID is supported by experimental clinical studies. JM-010 is currently under investigated in a Phase IIa/Proof-of-Concept study, which will assess the efficacy, safety/tolerability and pharmacokinetics of the product. It is planned to complete the dosing of at least 25 patients by first quarter 2016 followed by reporting later in H1 2016.

  • Press release (PDF)

    Press release, JM-010CS01, Phase IIa/cPoC study

  • Monday, June 15, 2015

  • Bukwang Pharma and its fully owned subsidiary Contera Pharma are pleased to announce that the investigational medical product, JM-010 has been dosed to the first patients with Parkinson’s disease suffering from moderate to severe levodopa-induced dyskinesia. The Phase IIa/Proof-of-Concept study is a randomized, double-blind, placebo-controlled, 2-way crossover study, which will assess the efficacy, safety/tolerability and pharmacokinetics of JM-010. It is planned to complete the dosing of at least 25 patients by first quarter 2016 followed by reporting later in H1 2016.

  • Hee-Won Yoo, President and co-CEO of Bukwang Pharma stated: The start of this important study is a significant milestone for Bukwang Pharma and underlines a successful acquisition of Contera Pharma.

  • The co-founder and inventor of Contera Pharma and the JM-010 product, Mikael Thomsen, CSO stated: The start of this study is a significant milestone for all the patients suffering from levodopa-induced dyskinesia as there is no approved treatment and JM-010 could be the first new approved effective and safe treatment paradigm.

  • About Bukwang
  • Bukwang Pharm. Co., Ltd. is a leading Korean pharmaceutical company listed on the Korean Stock Exchange [KRX:003000]. The company has been in business for over 50 years, and achieved US$140 million in sales in 2014. Sales are primarily derived from products licensed from Europe, the United States, and Japan. The company is currently investing significant resources in R&D to create a robust pipeline of preclinical and clinical agents for the treatment of antiviral diseases, gastrointestinal disorders, CNS disorders and metabolic disease.

  • About Contera Pharma
  • Contera Pharma (www.conterapharma.com) is a Danish clinical stage biotech company focusing on discovery and development of new innovative drugs for treatment of movement disorders for which there is a high unmet medical need.
    Contera Pharma was founded in 2010 is now fully owned subsidiary of Bukwang Pharm. Co., Ltd acquired in November 2014.
    For more information contact John Bondo Hansen, CEO (jbha@conterapharma.com) or Mikael Thomsen, CSO (mst@conterapharma.com).

  • About JM-010
  • JM-010 holds a novel mechanism-of-action as a fixed dose combination of two safe marketed products in a proprietary formulation for treatment of L-DOPA induced dyskinesia (LID) in Parkinson’s disease (PD). The novel mechanism-of-action combines effects of different serotonergic receptor agonists. The combination exploits the mechanism of actions and the synergistic effects of the two drugs, neither of which is approved for treatment of PD or LID. Strong preclinical data in a validated model of LID is supported by experimental clinical studies.

  • Press release (PDF)

    Solural Pharma and Contera Pharma initiate Eurostar sponsored project in Parkinson’s disease

  • Friday, May 1, 2015

  • Solural Pharma and Contera Pharma have in collaboration with Ernst Moritz Arndt University Greifswald, Germany and Erweka GmbH, Germany been awarded a Eurostar grant to support a project to develop new treatments of morning akinesia associated with Parkinson’s disease (PD).

  • Parkinson’s disease, which affects 1 in 100 people over the age of 60, is primarily characterized by a degeneration of dopaminergic motor neurons in the substantia nigra leading to a lack of dopamine on post-synaptic receptors. In order to replace the lost dopamine, PD is currently treated with levodopa. Levodopa very efficacious reduces motor symptoms of Parkinson’s disease but unfortunately will lose its effect after prolonged use.

  • Morning akinesia due to delayed onset of the first daily levodopa dose may occur in up to 50 % of patients receiving levodopa after several years. Morning akinesia can significantly affect quality of life in PD patients, consequently impairing the ability to perform daily activities, such as arising from bed, dressing, bathing, toileting, and preparing breakfast and getting on with the day’s work.

  • John Bondo Hansen, CEO of Contera Pharma states: “It is a great pleasure that we in collaboration with our partners in Denmark and Germany will be able to pursue this project. This will add to our portfolio of projects focusing on new treatments of severe debilitating movement disorders. Helping patients and their families to better daily lives with their diseases is our focus.”

  • Peter G. Nielsen, CEO of Solural Pharma states: “The Eurostar project creates a unique opportunity for us to work together with a leading expert in the field, professor Dr. Sandra Klein from the University of Greifswald, and by using new advanced technology from Erweka GmbH, to develop new innovative medication for patients in need.

  • About Solural Pharma
  • Solural Pharma (www.soluralpharma.com) uses its formulation technology platform to develop new innovative oral drug products that meet the need by the patients, the doctors and the society for the treatment of important medical conditions.

  • About Contera Pharma
  • Contera Pharma (www.conterapharma.com) is a clinical stage biotech company focusing on discovery and development of new innovative drugs for treatment of movement disorders for which there is a high unmet medical need. The lead product is JM-010, which is in development for treatment of dyskinesia associated with L-DOPA treatment of Parkinson’s disease. Contera Pharma is fully owned subsidiary of Bukwang Pharm. Co., Ltd. Bukwang Pharm. Co., Ltd. is a leading Korean pharmaceutical company listed on the Korean Stock Exchange. For more information contact John Bondo Hansen, CEO (jbha@conterapharma.com).

  • Press release (PDF)