(RTTNews) – Shares of Adamas Pharmaceuticals Inc. (ADMS) have lost more than 9% of their value year to date while the iShares Nasdaq Biotechnology Index (ETF) (IBB) is up more than 14% during the same period.
Adamas is focused on developing new medicines for chronic neurologic conditions like Parkinson’s disease, multiple sclerosis, epilepsy and Alzheimer’s disease.
The Company’s lead program is ADS-5102, a high-dose *Amantadine, taken once-daily at bedtime, in development for levodopa-induced dyskinesia (LID) in people with Parkinson’s disease.
*Amantadine is an antiviral medication used to prevent or treat certain influenza infections and is also prescribed to relieve symptoms of Parkinson’s disease. The drug is also effective in relieving fatigue in multiple sclerosis.
Parkinson’s disease is a degenerative disorder of the central nervous system characterized by tremor, or shaking often in a hand or leg, and stiff muscles. It is estimated that over 1.5 million people in the U.S. have Parkinson’s disease. Levodopa remains the gold standard to treat Parkinson’s symptoms.
A common and severe complication of the Levodopa therapy is dyskinesia, which refers to non-purposeful, fragmented or jerky motions. Approximately 200,000 Parkinson’s disease patients suffer from Levodopa-induced dyskinesia, or LID.
Adamas’ drug candidate for levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease, ADS-5102, is under FDA review – with a decision expected to be announced on August 24, 2017.
In phase III trials, ADS-5102 demonstrated a primary reduction of LID and a secondary reduction in *OFF time in Parkinson’s disease patients, with a manageable safety and tolerability profile. (*OFF time refers to periods of the day when the medication is not working well, causing worsening of the symptoms. (Source: AgingCare.com).)
If approved, ADS-5102 will be the first and only approved medicine for the indication of levodopa-induced dyskinesia in people with Parkinson’s disease.
Another near-term catalyst to watch out for is the top-line data from a phase Ib study of ADS-4101.
ADS-4101 is in development for the treatment of partial onset seizures in patients with epilepsy.
The phase 1b study is evaluating the tolerability and pharmacodynamic profile of three ascending doses of ADS-4101 administered once daily at bedtime compared to ascending doses of twice daily Vimpat tablets.
Vimpat received FDA approval for the treatment of partial onset seizures in adults with epilepsy in October 2008.
The company announced positive results from its phase Ia trial of ADS-4101 for the treatment of partial onset seizures in epilepsy in May of this year. The data demonstrated that ADS-4101 is better tolerated in healthy volunteers than equivalent doses of Vimpat.
The top-line data from phase Ib study of ADS-4101 are expected to be announced in the third quarter of 2017.
The Company reported second quarter 2017 financial results on August 8, 2017.
Net loss for the recent second quarter widened to $20.7 million or $0.93 per share from $16.9 million or $0.78 per share in the year-ago quarter.
Adamas has not generated any commercial product revenue. Till date, revenue has been generated primarily from license, milestone, and development revenue pursuant to the Company’s license agreement with Allergan plc (AGN).
In the second quarter of 2017, revenue was down to $2 thousand from $222 thousand generated in the comparable year-ago quarter.
Adamas ended June 30, 2017 with $144.9 million of cash.
Shares of Adamas touched a 52-week intraday high of $19.50 on January 6, 2017. The stock is down over 21% from the yearly high and trades around $15.25.
Will the stock experience a run up in anticipation of the FDA decision date? Will ADS-5102 score the regulatory agency’s stamp of approval? Stay tuned…
Read more here:
Company Spotlight: Adamas Pharma – Markets Insider
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