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Healthcare

Drug Manufacturers

Adamas Pharmaceuticals Inc.

Executive Summary&nbsp;
Sales of GOCOVRI™ Ramping Up
Adamas Pharmaceuticals (<a name="_Hlk527053154">Nasdaq:</a>ADMS) is a commercial stage specialty pharmaceutical company, founded in 2000 and headquartered in Emeryville, California. Company is developing novel therapeutics for chronic neurological disease by modifying the pharmacokinetic profiles of commercially available drugs. Adamas&#8217; lead product is GOCOVRI™ (amantadine, ADS-5102), which received FDA approval in August of 2017. GOCOVRI™ was approved for the treatment of dyskinesia in patients with Parkinson&#8217;s disease (PD) treated with levodopa. Dyskinesia manifests in Parkinson&#8217;s patients through uncontrolled involuntary movements, which can affect one part of the body, such as the head, an arm or leg, but could extend to the entire patient&#8217;s body.
Levodopa is the most effective oral agent for motor-symptom control in PD. However, dyskinesia remains a dose-limiting factor, hindering the effectiveness of levodopa treatment. Before the introduction of GOCOVRI™, dyskinesia in these patients was treated by adjusting the dosing of levodopa and/or adjunctive drugs, such as off-label Amantadine&nbsp;(Symmetrel, by&nbsp;Endo Pharmaceuticals) a non-competitive N-methyl-D-aspartate&nbsp;receptor antagonist (Ki = 10?M). 
GOCOVRI is the extended-release capsules of amantadine, that provides pharmacokinetic (PK) advantage. It is used by dosing at bedtime to sustain high plasma amantadine concentrations upon waking and throughout the day, hence the lower concentrations amantadine in the evening helps overcoming the insomnia side effect of the medication. GOCOVRI™ is administered to patients at bedtime, resulting in much lower drug concentrations during the night, but higher plasma amantadine concentrations upon waking and throughout the day. Hence, lower evening drug levels significantly reduces incidence of insomnia, a true clinical benefit for treated PD patients.
Adamas started a full-scale U.S. launch in January 2018. The launch is off to a solid start. Adamas reported current demand to be 3,430 paid prescriptions from 970 distinct prescribers, which translated into $7.6 million in net product sales in Q2 2018 (200% increase compared to Q1 2018). In order to boost GOCOVRI™ sales, the company is conducting programs to educate patients and physicians, raising awareness on the potential of the medicine for the treatment of dyskinesia. On the Q2 2018 earnings call, management explained that a number of physicians are currently in a trial phase, some of which could become prescribers after GOCOVRI™&#8217;s clinical benefit is proven in the clinics. Adamas&#8217; sales force consists of 50-60 sales personnel marketing GOCOVRI™. The drug costs around $2,488 for a supply of 60 oral capsules (68.5 mg and 137 mg).&nbsp; 
GOCOVRIâ™ Clinical Benefit in Patients Suffering from Dyskinesia &#8211; (41% total score reduction, meeting primary efficacy end-point in two Phase III clinical trials)
Adamas completed two Phase III human clinical trials on the use of GOCOVRI™ (ADS-5102) for the treatment of dyskinesia in PD patients. These trials were randomized, double-blind, placebo-controlled efficacy studies, which enrolled 121/75 patients for 25/13 weeks, respectively. The primary efficacy endpoint of the trials was improvement in &#8220;Unified Dyskinesia Rating Scale&#8221;? (UDysRS), which is designed to assess involuntary movements in Parkinson&#8217;s patients. 
 
ON-OFF Phenomenon&nbsp;&#8211; When a PD patient is treated with levodopa, the period of time when a patient is responding to treatment is known as &#8220;ON&#8221;? time, whereas the period of time when the drug wears off and symptoms return is known as &#8220;OFF&#8221;? time. During &#8220;ON&#8221; time, a PD patient feels much better, energetic and moves freely. In contrast, a patient&#8217;s symptoms worsen significantly during the &#8220;OFF&#8221; time. As the disease progresses, the duration of the ON time period gets reduced, while OFF time increases. Furthermore, a PD patient could experience dyskinesia even during the ON time, which emphasizes the need for a more effective drug therapy.
 
Secondary Efficacy Endpoints &#8211;&nbsp;Few key efficacy endpoints measurements used include; 1) OFF time, 2) ON time without troublesome dyskinesia (the sum of ON time with no dyskinesia and ON time with non-troublesome dyskinesia), 3) UDysRS historical (Parts I and II) and 4) objective (Parts III and IV) scores, MDS-UPDRS, and 5) CGI-C. All measurements compared patient score at baseline to score after twelve weeks of treatment.
Data from pooled analysis of two Phase III clinical trials demonstrated significant benefit in patients treated with GOCOVRI™. In a combined analysis from the two studies, patients treated with ADS-5102 showed a significant improvement in UDysRS score, <a name="_Hlk527041073">resulting in a 41% reduction in total score (-17.7 score) compared to only 14% reduction in patients treated with placebo (-7.6 score) </a>(Figure 1). The relative treatment difference between the patient group treated with GOCOVRI™ and placebo group was 27.3%, which was a statistically significant result (p&gt;0.0001).
 
 Figure 1. The treatment of GOCOVRI reduced dyskinesia by 41% at week 12 compared to week 2, the response was maintained through week 24 <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/F1.jpg" style="width: 647px;height: 273px" /> 
Source: Company Presentations 2018
 
Patients treated with ADS-5102 also showed a significant decrease in OFF time (36% reduction, -0.6 with ADS-5102 vs. +0.4 placebo) as shown in Figure 2, and statistical improvements in ON time without troublesome dyskinesia (+3.8 with ADS-5102 vs. +1.4 placebo), and in ON time with troublesome dyskinesia (-3.3 with ADS-5102 vs. -1.9 placebo) between baseline and Week 12 (Figure 3). Overall, GOCOVRI™ demonstrated 4 hours a day improvement in functional time. Functional time is defined as the hours of ON time without troublesome dyskinesia during the waking day.
 
 Figure 2. GOCOVRI treatment also showed 36% improvement in reduced OFF time
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/F2.jpg" style="width: 633px;height: 283px" /> 

 Figure 3. GOCOVRI treatment also improved ON time without troublesome dyskinesia and in ON time with troublesome dyskinesia between baseline and Week 12 
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/F3.jpg" style="width: 652px;height: 288px" />&nbsp;
Source: Elmer et al. CNS Drugs (2018) 32:387â€“398
In the trials, the most common adverse events were hallucinations (21% vs. 3.1%), dizziness (16% vs. 1%), dry mouth (16% vs. 1%), peripheral edema (16% vs. 1%) in ADS-5102 vs. placebo, respectively.
Recent Presentation of Results at PD Conference &#8211; Company presented data at the 2nd&nbsp;Annual Pan American Parkinson&#8217;s&nbsp;Diseases and Movement Disorders Congress in Q2/2018. The results showed functional time (ON time without troublesome dyskinesia) of eight hours in treated patients, with 4 distinct episodes disrupted by dyskinesia or OFF state. Recent data showed 17% of patients treated with GOCOVRI™ to have continuous functional time without dyskinesia. Continuous functional time also increased to 7.3 hours for GOCOVRI™ treated patients compared to only 2.1 hours for placebo arm. 
Adamas emphasized the importance of bedtime dosing with GOCOVRI™ to achieve slowly rising high concentrations (1,500 ng/ml) of amantadine prior to awakening, in line with the drug&#8217;s pharmacokinetic profile.
Expanding ADS-5102 in Treatment for Multiple Sclerosis Patients with Walking Impairment
Adamas is also assessing ADS-5102 for the treatment of walking impairment, a common manifestation of multiple sclerosis (MS). As the disease progresses, walking impairment worsens in MS patients. The company is currently evaluating ADS-5102 in a Phase III clinical trial. The first patient on this trial, named INROADS3, was dosed in Q2 2018. 
Management&#8217;s decision to advance the ADS-1502 program was based on the analysis of results from a previously completed Phase II clinical trial. In this study, the company evaluated the safety and tolerability of ADS-5102 (340 mg dose) in 56 MS patients. In the trial, ADS-5102 demonstrated a 25% change from baseline compared to 7.5% in the placebo group; placebo-adjusted improvement of 17% (p &lt; 0.05) in the &#8220;Timed 25-Foot Walk Test&#8221; (T25FW), is a quantitative mobility and leg function performance test. 
The results also showed a 3 second placebo-adjusted improvement in the &#8220;Timed Up and Go (TUG) test.&#8221; In this test, a patient is instructed to stand up off a chair, walk distance, and sit back on the chair. 
 Figure 4. The treatment of ADS-5102 improved walking speed and time up and go 90% compared to 30% placebo control <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/F4.png" style="width: 645px;height: 169px" /> 
Source: Company Presentations 2018
Management also stated its plans to evaluate ADS-1502 in additional indications, which will likely be announced in Q1 2019.
ADS-4102 for the Treatment of Partial Onset Seizures 
Additional pipeline candidates in clinical development include ADS-4101 (lacosamide) for the treatment of patients with partial onset seizures. In Phase 1b trials, ADS-4101 demonstrated a clinical benefit, which was discussed with FDA. Management plans to advance the product further in clinical development. Company anticipates commencement of ADS-4101 Phase III clinical trials in 2019. 
Company&#8217;s pipeline is shown in Figure 5.
 Figure 5. Company Pipeline <img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/F5.jpg" style="width: 647px;height: 284px" />&nbsp; Source: Company Presentations 2018
&nbsp;Key Catalysts
Company plans to:
<ul>
<li>Select additional indications for clinical development of ADS-5102 in Q1 2019 </li>
<li>Complete enrollment (570 subjects) in Phase III trial (INROADS3) MS walking impairment study in H2 2019 </li>
<li>Start patient enrollment in Phase III clinical trial on the use of ADS-4101 for the treatment of partial onset seizures in 2019-20 timeframe </li>
<li>Commence clinical development of two additional products in 2020</li>
</ul>
 
Stock Information
<img decoding="async" src="https://www.noblelinx.com/x/research/images/reports/F6.jpg" style="width: 644px;height: 364px" /> 

Source: Capital IQ

Adamas Pharmaceuticals Inc. (ADMS)

Off to A Good Start, Ramping Up Sales and Growing Development Pipeline

Off to A Good Start, Ramping Up Sales and Growing Development Pipeline (ADMS)

Gocovri Launch Still on Ramp, Stock Recovers from Drop (ADMS)

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