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KDDF-201110-14 YKP3089, an Innovative Drug for the Treatment of Epilepsy: Late-Phase Global Clinical Development(CNS Diseases, Chemical) [01.04.2013]

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Development and Market Objectives

Our goal is to complete multinational Phase 2a and Phase 2b trials to evaluate efficacy and safety of YKP3089 to treat epilepsy. We are seeking to commercialize it globally and/or co-develop by region through partners. Furthermore, with the NDA approval in epilepsy we plan to conduct clinical trials to expand YKP3089’s indication to include neuropathic pain and bipolar disorder. Ultimately, we anticipate that YKP3089 will have multiple therapeutic uses in the burgeoning area of central nervous system (CNS) diseases.

Unmet Medical Need & Target Patients

● Target patients

Epilepsy is categorized into two major types: partial onset seizures and generalized seizures. Partial onset seizures are the more common type of seizures, representing 53 percent among all epilepsy patients. Approximately 30 to 40 percent of patients still have refractory seizures on their current drug regimens. We will confirm the efficacy of YKP3089 in the treatment of refractory partial-onset seizures in patients whose medical needs are urgent and unmet. Later we will expand the research in other types of seizures including generalized seizures.

 

● Unmet medical need

Epilepsy is the most common neurological disorder and the various types of seizures are difficult to control with a single drug. Despite the availability of many antiepileptic drugs acting by a variety of molecular mechanisms, there are huge medical unmet needs for approximately 30 – 40 percent of refractory seizure patients. In addition, the use of many of the currently-available drugs is compromised by their inconvenient dosage regimens or deleterious side effects, such as sedation, cognitive deficits, weight gain, and behavioral changes.

Status

A multinational Phase 2a study in US, Korea, Poland and India and a multinational Phase 2b study in 16 countries was completed. Several drug-drug interaction studies and MOA studies are on progress.

Intellectual Property

Composition of Matter Patent:

• US : issued as US 7,598,279 (parent case filed April 2005)

• Pending : Canada, Mexico, Brazil, Chile, Argentina, Europe, South Africa, Russia, India, Indonesia, Malaysia, Thailand, Taiwan, China, Korea, Japan, Australia

• Process patent (A) : filed June 2009

• Pending : WorldwideProcess patent (B) (EZ process): filed October 2009

• Pending: Worldwide

Competitive Advantages

Broad spectrum in efficacy across seizure types:

YKP3089 shows very potent efficacy in many preclinical epilepsy models, in particular those that reflect refractory seizure types.

 

Facilitates uncomplicated combination therapy:

YKP3089 exhibits no or minimal interaction with existing drugs (oral contraceptives, other antiepileptic drugs such as divalproex sodium or carbamazepine) in clinical studies. Its novel mechanism of action can be expected to complement the effects of currently-available therapeutic agents without augmenting any of their current side effects.

 

Convenient once-a-day dosing:

Numerous studies have identified patient compliance as a significant issue in the treatment of epileptic disorders. The ability to take YKP3089 on a once-a-day dosing schedule is expected to increase patient compliance and outcomes and improve social benefits (less frequent hospitalizations and societal costs).

Indication

CNS Disease (Epilepsy)

Research Period

Feb. 23, 2012 - Apr. 30, 2016

Company

SK Biopharmaceuticals

Developmental Stage

Phase 2b

Additional Information

Contact Information

Contact
Address Company Name: SK Biopharmaceuticals
WebSite Homepage: http://www.skbp.com Contact Person: Hae In Shin
E-mail: haein.shin@sk.com Contact: +82-31-8093-0140

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