Announcing FDA Approval of GOCOVRI TM

Similar documents
It s time. for a new approach to treat chronic neurological diseases Adamas Pharmaceuticals, Inc. All Rights Reserved.

It s time. for a new approach to treat chronic neurologic disease Adamas Pharmaceuticals, Inc. All Rights Reserved.

Prior Authorization with Quantity Limit Program Summary

Amantadine Extended-Release. Gocovri, Osmolex ER. Description

DYSKINESIA SYMPTOM TRACKER

DOCTOR DISCUSSION GUIDE

Acorda Acquisition of Civitas Therapeutics. September 24, 2014

ACADIA Pharmaceuticals Issues Statement Reaffirming Benefit/Risk Profile of NUPLAZID

ASTELLAS AND MEDIVATION INITIATE PHASE III TRIAL OF ENZALUTAMIDE IN PATIENTS WITH TRIPLE-NEGATIVE BREAST CANCER

Dorset Medicines Advisory Group SHARED CARE GUIDELINES FOR PRESCRIBING ENTACAPONE (INCLUDING IN COMBINATION) OR OPICAPONE IN PARKINSON S DISEASE

35 th Annual J.P. Morgan Healthcare Conference

Tonix Pharmaceuticals Reports Top Line Results From Phase 2b BESTFIT Trial of TNX-102 SL in Patients With Fibromyalgia

BioMarin Pharmaceutical Inc. Conference Call to Discuss Approval of

Synergy Pharmaceuticals TRULANCE (Plecanatide) Receives U.S. FDA Approval for the Treatment of Adults with Chronic Idiopathic Constipation

Determined to realize a future in which people with cancer live longer and better than ever before Q Conference Call

U.S. FDA Approves New Indication for the Use of XTANDI (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate Cancer

Pimavanserin Top-Line Results Phase III Parkinson s Disease Psychosis Trial (-020 Study) Creating the Next Generation of CNS Drugs

DOSAGE FORMS AND STRENGTHS Extended release capsules: 68.5 mg and 137 mg (3)

Zogenix Announces Positive Top-line Results from Pivotal Phase 3 Clinical Trial of ZX008 in Dravet Syndrome

Faculty. Joseph Friedman, MD

Broad and clinically important benefits beyond the initial registrational endpoints are now reported.

Medications used to treat Parkinson s disease

LIVING. WITH PD. DAVID RYTARY patient since Fighting his symptoms. Embracing his life.

Introductory Clinical Pharmacology Chapter 32 Antiparkinsonism Drugs

Tamsulosin Hydrochloride 0.4 mg Capsule

Phase 2b/3 Topline Trial Results

ADAPTIMMUNE INVESTOR PRESENTATION. August 2016

Nitrazepam. Nitrazepam Tablets TAJ GROUP PHARMACEUTICAL B U S I N E S S. Generics. Active Ingredients: Each tablet contains 10 mg Nitrazepam

ASK IF NAMZARIC MAY BE RIGHT FOR THEM.

Novartis announces Phase III STRIVE data published in NEJM demonstrating significant and sustained efficacy of erenumab in migraine prevention

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C FORM 8-K

STUDY 1 PHASE 3 TOP-LINE RESULTS. September 2017

parts of the gastrointenstinal tract. At the end of April 2008, it was temporarily withdrawn from the US Market because of problems related to

SIFROL â. Contraindications Hypersensitivity to pramipexole or any other component of the product.

AVENUE THERAPEUTICS, INC. NASDAQ: ATXI JANUARY 2018

Media Contacts: Kelley Dougherty Investor Contact: Graeme Bell (215) (908)

Supernus Pharmaceuticals

IRONWOOD AND FOREST ANNOUNCE POSITIVE LINACLOTIDE RESULTS FROM PHASE 3 TRIAL IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION

37 th Annual J.P. Morgan Healthcare Conference. January 9, 2019

Patients with Parkinson s disease treated with Neupro (rotigotine) showed low rates of dyskinesias with long term treatment

Supernus Pharmaceuticals

Investor Presentation March 2015

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS

Savient's Pegloticase Data in Treatment-Failure Gout Patients Presented at 72nd Annual Meeting of the American College of Rheumatology Conference

ADDITIONAL DOSAGE STRENGTHS OF OTREXUP (METHOTREXATE) INJECTION APPROVED BY FDA

New data show sustained 5-year benefit of Neupro (Rotigotine Transdermal System) for symptoms of Restless Legs Syndrome

Cowen Investor Conference March confidently live life with ease

Motor Fluctuations Stephen Grill, MD, PHD Parkinson s and Movement Disorders Center of Maryland and Johns Hopkins University

NY-ESO SPEAR T-cells in Synovial Sarcoma

CHMP recommends Approval of Xadago TM (safinamide) to treat Parkinson s disease in the EU

Fact Sheet. Zohydro ER (hydrocodone bitartrate) Extended-Release Capsules, CII

Anticholinergics. COMT* Inhibitors. Dopaminergic Agents. Dopamine Agonists. Combination Product

Avenue Therapeutics, Inc. September 2016

August 7, Q Financial Results

Memory Pharmaceuticals Establishes Plans for Clinical Program for MEM 3454 in Schizophrenia. -Broadens Roche Nicotinic Alpha-7 Alliance-

Advancing Innovative Therapies for Neurological Diseases

Cowen Healthcare Conference March 12, 2018

February 23, Q4 and Year-End 2016 Financial Results

USPSTF Draft Recommendations Investor Call. October 6, 2015

Annual Stockholder Meeting May 30, confidently live life with ease

LEERINK GLOBAL HEALTHCARE CONFERENCE. Marino Garcia EVP, Chief Strategy Officer February 15, 2017

What s new for diagnosing and treating Parkinson s Disease?

PATENCY-1 Top-Line Results

8 of 21 (38.1%) Achieved RECIST v1.1 Durable Complete Response (CR) in Predicted Anti-PD-1 Non-Responder Melanoma Patients at 24 Weeks

Phase 3c Topline Results. Page 1

November 2, Q Financial Results

Corporate Presentation August 6, 2015

OTEZLA (Apremilast) Showed Meaningful Improvements in Clinical and Quality of Life Measures of Psoriasis Beyond Those Captured by Assessing Skin Alone

Committed to Transforming the Treatment Paradigm for Migraine Prevention

American Society for Experimental Neurotherapeutics - ASENT 2019 Annual Meeting. Walter E Kaufmann, MD CMO Nasdaq: AVXL March 2019

- The safety and efficacy of oral, once-daily VRAYLAR was established in a clinical trial program involving more than 2,700 patients

Swiss Summary of the Risk Management Plan (RMP) for Ongentys (opicapone) 50 mg hard capsules

M (SAPPHIRE-II)

10th Medicine Review Course st July Prakash Kumar

Committed to Transforming the Treatment Paradigm for Migraine Prevention

Avenue Therapeutics, Inc. May 2017

INVESTOR PRESENTATION

ALMIRALL AND IRONWOOD ANNOUNCE POSITIVE RESULTS FROM A PHASE 3 TRIAL WITH LINACLOTIDE IN PATIENTS WITH IRRITABLE BOWEL SYNDROME WITH CONSTIPATION

PROMISE 1 Top-Line Data Results. June 27, 2017

- Amendment accelerates anticipated PROSPER top-line results by two years -

NASDAQ: ZGNX. Company Presentation. October 2017

XP23829 PHASE 2 PSORIASIS TRIAL PRELIMINARY TOPLINE DATA PRESENTATION SEPTEMBER 15, 2015 COPYRIGHT 2015 XENOPORT, INC. ALL RIGHTS RESERVED.

Developing a Sublingual Formulation of Apomorphine to Rapidly Convert Parkinson s Patients from OFF to ON State

XARACOLL Phase 3 Results Webcast. MATRIX 1 and MATRIX 2 Clinical Trials May 25, 2016

Parkinson s Disease Current Treatment Options

Rotigotine provided sustained efficacy and tolerability in long term studies of early and late stage idiopathic Parkinson s disease

ARE YOUR LEVODOPA PILLS WORKING LIKE THEY USED TO?

Optimizing Clinical Communication in Parkinson s Disease:

Building a Stroke Portfolio. June 28, 2018

LIVING. WITH PD. DAVID RYTARY patient since Fighting his symptoms. Embracing his life.

Opicapone is a peripheral, selective and reversible catechol-o-methyltransferase (COMT) inhibitor 1.

MARINE Study Results

Investor Presentation

Northera (droxidopa) Preliminary Findings From Study 301 in Symptomatic Neurogenic Orthostatic Hypotension. September 2010

Postpartum depression is the most common medical complication of childbirth, estimated to affect approximately 400,000 women annually in the U.S.

Press Release

4Q and Full Year 2017 Financial Results Call February 7, 2018

Drugs used in Parkinsonism

Advanced Therapies for Motor Symptoms in PD. Matthew Boyce MD

CONTINUOUS THERAPY BECAUSE LIFE GOESON

Transcription:

Announcing FDA Approval of GOCOVRI TM August 24, 2017 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 1

Forward-looking Statements Statements contained in this presentation regarding expected future events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to, statements contained in this presentation regarding the expected benefits of GOCOVRI, physician and patient access in fourth quarter 2017 and launch of GOCOVRI (amantadine) extended release capsules (previously ADS-5102) in January 2018 for the treatment of dyskinesia in patients with Parkinson s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and Adamas plans to offer a number of programs providing patient access support throughout the course of treatment, along with commercial copay assistance and financial assistance for patients who are uninsured or underinsured. Words such as potentially, expected, will, plans and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas research, clinical, development, and commercial activities relating to ADS-5102 and ADS- 4101, and the regulatory and competitive environment and Adamas business in general, see the Section captioned Risk Factors in Adamas Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2017. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release. 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 2

Announcing FDA Approval of GOCOVRI TM August 24, 2017 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 3

Dyskinesia in People with Parkinson s Disease Involuntary, non-rhythmic movements that are purposeless and unpredictable Struggle to balance dyskinesia and with OFF time Frustration, embarrassment, isolation Poor quality of life, increased care burden Risk of injury, social withdrawal, depression Affecting 150,000 200,000 people in the United States 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 4

First and only FDA-approved medicine for treatment of dyskinesia in patients with Parkinson s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medicines 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 5

GOCOVRI Clinical Program Overview 8-week Dose Ranging (EASED) Study 1 (EASE LID) Study 2 (EASE LID 3) Randomized, 4-arm, placebo-controlled trial 80 in mitt, 8-wks duration Randomized, 2-arm, placebo-controlled trial 121 in mitt, 25-wks duration Randomized, 2-arm, placebo-controlled trial 75 in mitt, 13-wks duration Primary outcome measure: UDysRS Key secondary outcome measures: - ON time without troublesome dyskinesia (functional time) - OFF time Open Label (EASE LID 2) Open-label safety study 223 subjects (Ongoing), Up to 2-yrs duration 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 6

Change in UDysRS Total Score (LS Mean ± SE) GOCOVRI Delivered Statistically Significant Reductions in Dyskinesia Study 1, GOCOVRI provided a 37% reduction in Unified Dyskinesia Rating Scale (UDysRS) total score vs. 12% for placebo at Week 12 Reduction in dyskinesia was evident at the first post-baseline assessment Week Week Week Week Baseline 2 4 6 8 10 12 0 Percent Improvement at 12 weeks -5-10 -8.0 12% 37% -15-20 -15.9 P=0.0009-25 Placebo (n=58) GOCOVRI (n=63) 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 7

Change in UDysRS Total Score (LS Mean ± SE) Significant Reductions in Dyskinesia Confirmed in Second Pivotal Study Study 2, GOCOVRI-treated patients demonstrated a 46% reduction in UDysRS total score vs. 16% for placebo at Week 12 Week Week Week Week Baseline 2 4 6 8 10 12 0 Percent Improvement at 12 weeks -5-6.3 16% -10 46% -15-20 -20.7-25 Placebo (n=38) GOCOVRI (n=37) P<0.0001 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 8

LS Mean Change from Baseline (hrs) LS Mean Change from Baseline (hrs) GOCOVRI-Treated Patients Gained 3.6 Hours of Functional Time Daily* Study 1, increased functional time due in part to a placebo-adjusted 1-hr decrease in OFF time and reductions in ON time with troublesome dyskinesia ON time w/o troublesome dyskinesia OFF time 4 3 3.6 4 3 2 2 1 0-1 Baseline 2 4 6 8 10 12 Week Placebo (n=58) GOCOVRI (n=63) 0.8 P<0.0001 1 0 P=0.0171 0.3-0.6-1 Baseline 2 4 6 8 10 12 Week Placebo (n=58) GOCOVRI (n=63) LS = Lease Squares. *As defined by ON time without troublesome dyskinesia. Results derived from PD Home Diary Data. 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 9

LS Mean Change from Baseline (hrs) LS Mean Change from Baseline (hrs) Increased Functional Time* Confirmed in a Second Pivotal Study Study 2, GOCOVRI provided a placebo-adjusted 1.1 hour decrease in OFF time daily ON time w/o troublesome dyskinesia OFF time 5 5 4 3 4.0 4 3 2 1 0-1 Baseline 2 4 6 8 10 12 Week Placebo (n=38) GOCOVRI (n=37) 2.1 P=0.0168 2 1 P=0.0199 0.6 0-0.5-1 Baseline 2 4 6 8 10 12 Week Placebo (n=58) GOCOVRI (n=63) LS = Lease Squares. *As defined by ON time without troublesome dyskinesia. Results derived from PD Home Diary Data. 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 10

Warnings/Precautions and Adverse Reactions Warnings / Precautions Falling asleep during activities of daily living and somnolence Suicidality and depression Hallucinations / psychotic behavior Dizziness and orthostatic hypotension Withdrawal emergent hyperpyrexia and confusion Impulse control / compulsive behaviors Common Adverse Reactions (>10%) vs. placebo Hallucination (21% v. 3%) Dizziness (16% v. 1%) Dry mouth (16% v. 1%) Peripheral edema (16% v. 1%) Constipation (13% v. 3%) Falls (13% v. 7%) Orthostatic hypotension (13% v. 1%) Please see full prescribing information at www.gocovri.com 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 11

Dosage and Administration GOCOVRI is a high-dose 274 mg amantadine taken once-daily at bedtime that delivers consistently high levels of amantadine in the morning and throughout the day when dyskinesia occurs Administer orally once-daily at bedtime The initial daily dosage is 137 mg; after 1 week, increase to the recommended daily dosage of 274 mg Swallow whole; may sprinkle contents on soft food May be taken with or without food; avoid use with alcohol A lower dosage is recommended for patients with moderate or severe renal impairment GOCOVRI is contraindicated in patients with End Stage Renal Disease Please see full prescribing information at www.gocovri.com 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 12

Phase 3 Study Publications 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 13

First and only approved medicine for treatment of dyskinesia in patients with Parkinson s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medicines 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 14

GOCOVRI is Well Received by Physicians Physicians report intent to use in 54% of dyskinetic Parkinson s patients Share of dyskinesia patients to GOCOVRI (by source) Instead of addition of another Product 23 47 ~150-200K Parkinson s disease patients in U.S. suffer with dyskinesia HCPs indicated that 54% of dyskinesia patients would be prescribed GOCOVRI Instead of C/L fractionation / dosage adjustment 10 16 Share would come from: Untreated dyskinesia patients 24% For untreated dyskinesia patients taking C/L 13 37 Instead of C/L fractionation or dose adjustment 6% Prescribe GOCOVRI 54 Instead of other therapies (AMT IR, dopamine agonist, COMT inhibitor, MAO-B Inhibitor) 24% 0 20 40 60 Payers appreciate value proposition After GOCOVRI Before GOCOVRI C/L = Carbidopa / Levodopa Quantitative Research among 138 HCP s treating Parkinson's Disease (MDS and Neurologist), Fielded Q1 2017 Question asked: Assuming the FDA-approval of Product X, how would you anticipate your overall treatment of ALL levodopa-induced dyskinesia patients to change in the next 12 months? 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 15

GOCOVRI Launch Preparations Launch Medical Information Hotline GOCOVRI Available GOCOVRI Launch Announce Price of GOCOVRI Launch Patient Access Support (GOCOVRI Onboard) Speaker Training September October November December January Key Account Managers Deployed Medical Science Liaisons Deployed Training, Appointment Scheduling 6 Regional Business Directors Start 59 Neurology Account Specialists Start 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 16

First and only approved medicine for treatment of dyskinesia in patients with Parkinson s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medicines 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 17

Adamas Portfolio Disease Program Phase 1 Phase 2 Phase 3 Commercial Commercial Lead Dyskinesia in Parkinson s Disease Multiple Sclerosis Walking Parkinson s disease Additional Indication GOCOVRI (amantadine) ADS-5102 (amantadine) ADS-5102 (amantadine) Epilepsy Partial Onset Seizures ADS-4101 (lacosamide) Alzheimer s Dementia NAMENDA XR (memantine HCl) NAMZARIC (memantine HCl & donepezil HCl) (US) NAMENDA XR and NAMZARIC are trademarks of Merz Pharma GmbH & Co. KGaA. 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 18

First and only approved medicine for treatment of dyskinesia in patients with Parkinson s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medicines 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 19

Questions? 2017 Adamas Pharmaceuticals, Inc. All Rights Reserved. 20