ADS-4101 is an investigational high-dose lacosamide, to be taken once-daily at bedtime. Lacosamide is an anti-epilepsy active ingredient previously approved by the U.S. Food and Drug Administration (FDA) and currently marketed by UCB as VIMPAT® (lacosamide).

Epilepsy affects an estimated 2.2 million Americans, of which 60% have partial onset seizures. Monotherapy treatment of partial seizures is effective in approximately 60% of patients, leaving the remainder of patients to require adjunctive treatment with one or more additional anticonvulsant therapies. There are limited data on the temporal distribution of seizures over the 24-hour day. However, data from published studies and from a study conducted by Adamas suggest that seizures occur in a diurnal pattern, characterized by a peak between 8 AM and 4 PM, and lowest between midnight and 8 AM. Thus, by matching the timing pattern of seizures to the concentration of the anti-epileptic drug, with a higher drug concentration during the day and lower drug concentration during the night, may enable improved seizure control.

Clinical studies of lacosamide have demonstrated dose limitations due to dizziness immediately following administration. We hypothesized the dizziness associated with higher doses might be in part attributed to the rapid initial rate-of-rise in drug concentration. Adamas scientists confirmed this time-dependent effect through in vivo modelling and pre-clinical experiments, showing that tolerability was dependent on rate -of-rise of drug concentration and not on maximum concentrations (Cmax).

We designed ADS-4101 to have an [attenuated/ tempered] initial rate-of-rise in lacosamide concentrations, to potentially improve the adverse event profile. This slow initial rise, enables a higher once-daily nighttime dose, resulting in a higher daytime concentration that may be more effective for patients then VIMPAT.

The data from a Phase 1 study of 24 healthy volunteers showed that a single 400 mg dose of ADS-4101 have improved tolerability compared to the equivalent dose of VIMPAT (lacosamide) immediate-release (IR) tablets. The data also demonstrated that ADS-4101 exhibited the desired pharmacokinetic properties, namely a reduced initial rate-of-rise and prolonged time to maximum drug concentration (Tmax) appropriate for nighttime dosing.

We are currently conducting a multi-dose Phase 1b study designed to evaluate the tolerability and pharmacokinetic profile of three ascending doses of ADS-4101 (up to 600 mg/day) taken once-daily at bedtime compared to ascending doses of twice daily VIMPAT tablets in 24 healthy volunteers. Topline data from the study is expected in the third quarter of 2017.

Counsel / Senior Counsel, Healthcare Law

The Counsel / Senior Counsel, Healthcare Law, will support legal matters related to the strategy and execution of commercial, medical, and clinical activities. This position reports to the Assistant General Counsel and is expected to work closely with other members of the legal and compliance group, as well as executive, commercial, medical, regulatory, and clinical teams.  This position is based in Emeryville, CA.

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Desktop Engineer, Information Technology

The Desktop Engineer is responsible for developing, deploying, and managing end user’s systems security, automation, software deployment, software patch remediation and device management in addition to providing escalated helpdesk support to internal users. This position will be tasked with creating functional deliverables, such as; testing plans/scripts, creating training plans and on-boarding manuals, identifying gaps, and providing solutions to IT related matters. This position reports to the Senior Manager, IT Operations and is located in Emeryville, California.

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Director, Channel and Patient Services Strategy and Operations

The Director of Channel and Patient Services Strategy and Operations will be responsible for the management of the commercial organization’s specialty distribution and dispensing channel strategy and patient services strategy, including the development and evaluation of performance-based metrics related to the deployment of such strategies in collaboration with channel intermediaries and service providers. This position will support the commercialization and channel strategies of Adamas’ first commercial product, Gocovri™ through the relationship and oversight of Gocovri™ Onboard, exclusive specialty pharmacy provider (SPP) relationship, and specialty distributor relationships. As a member of the commercial team, this position will work across the organization and commercial functions to ensure patient access support is in alignment with brand team deliverables that support the execution of commercial launch and growth plans. This position reports to the SVP of Market Access, Distribution, and Commercial Operations and may be based in Emeryville, CA or remotely, based on approval from Adamas™ Executive Leadership.

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Director, Commercial Operations

The Director, Commercial Operations partners with the Commercial Organization to drive and measure performance by providing subject matter expertise, leadership and insights with a primary focus on Reporting, Incentive Compensation, and CRM/DW/MDM. This position reports to the Vice President, Commercial Operations and is based in Emeryville, CA.

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Director, Quality Assurance

The Director, Quality Assurance is responsible for all aspects quality assurance and GxP compliance. The Director, Quality Assurance will establish quality plans and policies and report to Quality Management on a regular basis on compliance activities and findings. This position will design, implement and maintain QA and compliance programs and infrastructure including a SOP system, training program, and perform internal and external audits. The Director, Quality Assurance will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. This position will serve as an in-house advisor on GxP compliance and report to the Vice President, Quality Assurance and is based in Emeryville, CA.

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Manager / Senior Manager, Commercial Finance (Financial Planning and Analysis)

The Manager/ Senior Manager, Commercial Finance (FP&A) is primarily responsible for providing strategic and financial leadership to the organization’s Commercial function. The role will focus on the analytics that support strategic financial planning, budgets, forecasting, monthly close support, and project management. The role will be a hands-on resource to senior management, project/brand leads, and department heads. This position reports to the Sr. Director, FP&A and is based in Emeryville, CA.

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Manager / Senior Manager, Pharmaceutical Development

The Manager / Senior Manager, Pharmaceutical Development contributes to the drug product development process by developing formulations for preclinical and clinical evaluation.  It involves working collaboratively within a multidisciplinary framework within the organization and with external contract manufacturing organizations. This position reports to the Vice President, Pharmaceutical Development and is based in Emeryville, CA.

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Medical Director/ Senior Medical Director

The Medical Director / Senior Medical Director will be integrally involved in all aspects of clinical trial design and execution, including authoring of protocols, site initiation, and medical monitoring, as well as data interpretation and reporting. Position reports to Senior Vice President, Clinical Research and is based in Emeryville, CA.

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Medical Science Liaison (Southeast)

The Medical Science Liaison (MSL) is responsible for conducting medical/scientific interactions and for supporting internal activities related to medical communications, medical information and clinical research. This position reports to the Director, MSL Team and is a field based position with a corporate headquarters in Emeryville, California.

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Payroll Administrator

The Payroll Administrator is responsible for all aspects of payroll processing, the daily activities of stock plan administration, and provides back-up support for the Accounts Payable team. The Payroll Administrator will ensure accurate and timely processing of semi-monthly and off-cycle payroll in Workday for approximately 200 multi-state employees, generate payroll accounting entries, ensure accurate tax calculation of employee stock option exercises and RSU vesting, process grants, and ensure timely and accurate payroll tax and stock government filings.  Additionally, this individual will routinely partner with others across multiple functions ensuring proper alignment with policies, controls and compliance with US GAAP. This position reports to the Senior Manager, Accounting and is based in Emeryville, CA.

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Senior Accountant

The Senior Accountant will have a critical role in maintaining accounting principles, practices, and procedures to ensure the timely/accurate preparation of financial statements. The Senior Accountant is responsible for preparation of journal entries and financial statement analysis to support key monthly deliverables. Areas of responsibility include but are not limited to analyzing, recording, and reconciling accounting transactions to support internal and external financial reporting. Additionally, this individual will routinely partner with others across multiple functions ensuring proper alignment with policies, controls and compliance with US GAAP. This position reports to the Senior Manager, Accounting and is based in Emeryville, CA.

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Sr. Project Manager / Associate Director, Product Planning

The Senior Project Manager/Associate Director Project Manager (PM) will drive critical execution objectives for compounds in all stages of development (early, late and commercial). This position requires excellent communication and leadership skills, in addition to a strong technical understanding of the inter-disciplinary nature of drug development. The individual will collaborate closely with the Project Team Leader (PTL) and team members. This position will report into the Vice President, Product Planning and is based in Emeryville, CA.

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Vice President, Business Development / Licensing

The Vice President, Business Development / Licensing will be responsible for business development, partnering and alliance management activities, including supporting operations, as required, and conducting product/market evaluations outside of the United States. The ideal candidate will be a business-minded strategic and operational leader who will bring strong corporate transaction, alliance management, analytical, and general operations expertise to Adamas. This individual will lead our internal and external business development and partnering activities, and collaborate with key functions to achieve Adamas’ objectives.  This position will report to the Chief Operating Officer.

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Vice President, Statistical Science

The Vice President, Statistical Science, will build and oversee data management, biostatistics, and statistical programming for the clinical research, medical affairs, and research teams. This position will be the Company representative both internally and externally on all matters related to biometrics. This position will report to the Senior Vice President, Clinical Research and is based in Emeryville, CA.

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