1. Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the pricing of its underwritten public offering of 12,500,000 shares of its common stock at a price to the public of $4.40 per share. All of the shares in the offering are being sold by Adamas. The gross proceeds of the offering to Adamas, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $55.0 million, excluding any exercise of the underwriters' option. Adamas has granted the underwriters a 30-day option to purchase up to an additional 1,875,000 shares of its common stock offered in the public…

    Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the pricing of its underwritten public offering of 12,500,000 shares of its common stock at a price to the public of $4.40 per share. All of the shares in the offering are being sold by Adamas. The gross proceeds of the offering to Adamas, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $55.0 million, excluding any exercise of the underwriters' option. Adamas has granted the underwriters a 30-day option to purchase up to an additional 1,875,000 shares of its common stock offered in the public offering. The offering is expected to close on March 1, 2021, subject to customary closing conditions.

    SVB Leerink and William Blair are joint bookrunning managers for the offering. JMP Securities is lead manager for the offering.

    The securities described above are being offered by Adamas pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). The offering is being made only by means of a prospectus supplement and accompanying prospectus, which will be available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808 7525, ext. 6105, or by email at ; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, telephone: 1-800-621-0687, or by email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Adamas Pharmaceuticals, Inc.

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to Adamas' expectations regarding the completion of the public offering. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. Adamas cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, the closing of the offering is subject to the satisfaction of customary closing conditions. Risks and uncertainties relating to Adamas and its business can be found in the "Risk Factors" section of Adamas' Form 10-K for the year ended December 31, 2020, filed with the SEC on February 23, 2021, and in the preliminary prospectus supplement related to the public offering filed with the SEC on February 24, 2021. Adamas undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in Adamas' expectations, except as required by law.

    Source: Adamas Pharmaceuticals, Inc.

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  2. Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that it has commenced an underwritten public offering of its common stock. All shares of common stock to be sold in the offering will be offered by Adamas. Adamas intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the shares of its common stock offered in the public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    SVB Leerink and William Blair…

    Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that it has commenced an underwritten public offering of its common stock. All shares of common stock to be sold in the offering will be offered by Adamas. Adamas intends to grant the underwriters a 30-day option to purchase up to an aggregate of an additional 15% of the shares of its common stock offered in the public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    SVB Leerink and William Blair are acting as joint bookrunning managers for the offering. JMP Securities is acting as lead manager for the offering.

    The securities described above are being offered by Adamas pursuant to a shelf registration statement previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808 7525, ext. 6105, or by email at ; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, telephone: 1-800-621-0687, or by email: .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Adamas

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to Adamas' expectations regarding the proposed public offering. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. Adamas cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to market conditions, and the satisfaction of customary closing conditions related to the proposed public offering. Risks and uncertainties relating to Adamas and its business can be found in the "Risk Factors" section of Adamas' Form 10-K for the year ended December 31, 2020, filed with the SEC on February 23, 2021, and in the preliminary prospectus supplement related to the proposed public offering filed with the SEC on February 24, 2021. Adamas undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in Adamas' expectations, except as required by law.

    Source: Adamas Pharmaceuticals, Inc.

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  3. Fourth Quarter 2020 total revenues of $21.0 million, a 29% increase over fourth quarter 2019

    Full Year 2020 total revenues of $74.5 million, a 36% increase over 2019

    Second indication received February 2021 for GOCOVRI as an adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing OFF episodes

    Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2020, and recent corporate highlights.

    "We are excited with the opportunities ahead of us, including the continued growth of GOCOVRI which is now the…

    Fourth Quarter 2020 total revenues of $21.0 million, a 29% increase over fourth quarter 2019

    Full Year 2020 total revenues of $74.5 million, a 36% increase over 2019

    Second indication received February 2021 for GOCOVRI as an adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing OFF episodes

    Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2020, and recent corporate highlights.

    "We are excited with the opportunities ahead of us, including the continued growth of GOCOVRI which is now the first and only medication approved to treat both OFF and dyskinesia motor complications in Parkinson's disease," said Neil F. McFarlane, Chief Executive Officer. "Bolstered by the launch of a second indication, GOCOVRI is now approved to treat approximately 400,000 to 500,000 Parkinson's patients. The significant progress made across the business in 2020 fueled positive momentum into 2021, and we are leveraging this as we continue to successfully execute our long-term growth strategy."

    Recent portfolio highlights

    • Total revenues were $21.0 million in the fourth quarter of 2020, an increase of 29% as compared to $16.3 million in the fourth quarter of 2019.
    • GOCOVRI® (amantadine) extended release capsules product sales were $19.8 million in the fourth quarter of 2020, an increase of 21% as compared to $16.3 million in the fourth quarter of 2019.
    • Total paid prescriptions (TRx) of GOCOVRI were approximately 8,165 in the fourth quarter of 2020, a 14% increase over approximately 7,160 TRx in the fourth quarter of 2019.
    • Strong patient persistence of 45%-50% at 12 months continued in the fourth quarter of 2020.
    • New paid prescriptions (NRx) of GOCOVRI were approximately 510 in the fourth quarter of 2020, a 19% increase over NRx of approximately 430 in the third quarter of 2020.
    • In February 2021, the U.S. Food and Drug Administration approved a second indication for GOCOVRI as an adjunctive treatment to levodopa/carbidopa in Parkinson's disease patients experiencing OFF episodes.

    Corporate highlights

    • In January 2021, closed the settlement of patent litigation with Osmotica Pharmaceuticals plc. and completed the acquisition of the global rights to OSMOLEX ER® (amantadine) extended release tablets, expanding Adamas' neurology portfolio.
    • Amended certain key terms of the Royalty-Backed Loan agreement with HealthCare Royalty Partners, which became effective with the closing of the acquisition of OSMOLEX ER.
    • In February 2021, announced a settlement agreement with Zydus Worldwide DMCC and Zydus Pharmaceuticals (USA) Inc. ("Zydus") resolving patent litigation between the two parties relating to Zydus' ANDA referencing GOCOVRI. Under the agreement Adamas granted Zydus a non-exclusive license to begin selling a generic version of GOCOVRI as of March 4, 2030, or earlier in certain circumstances.

    Financial results

    Revenue

    Total revenue was $21.0 million for the fourth quarter of 2020, consisting of GOCOVRI product sales of $19.8 million and royalty revenue earned on net sales of NAMZARIC® (memantine hydrochloride extended release and donepezil hydrochloride) capsules of $1.2 million. GOCOVRI product sales were up 21% compared to $16.3 million in the same period in 2019.

    Total revenue was $74.5 million for full year 2020, consisting of GOCOVRI product sales of $71.2 million and royalty revenue earned on net sales of NAMZARIC of $3.3 million. GOCOVRI product sales were up 30% compared to $54.6 million in 2019.

    Research and Development (R&D) expenses

    R&D expenses for the fourth quarter of 2020 were $2.4 million, compared to $5.2 million for the same period in the prior year. R&D expenses in the fourth quarter of 2020 substantially relate to the ongoing open-label study which concluded at the end of 2020. The decrease in R&D expenses from the prior year quarter was primarily due to the completion of the Phase 3 INROADS trial for the treatment of multiple sclerosis patients with walking impairment at the end of 2019.

    R&D expenses for full year 2020 were $9.7 million, compared to $30.0 million in 2019. The decrease in R&D expenses from 2019 was primarily due to the completion of the Phase 3 INROADS trial for the treatment of multiple sclerosis patients with walking impairment at the end of 2019.

    Selling, General and Administrative (SG&A) expenses

    SG&A expenses for the fourth quarter of 2020 were $33.0 million, compared to $30.3 million for the same period in the prior year. SG&A expenses in the fourth quarter of 2020 were primarily attributable to sales force costs and external spend dedicated to GOCOVRI commercialization and the related administrative support. The fourth quarter of 2020 includes approximately $5.0 million related to one-time charges associated with the settlement of patent litigation and acquisition of the global rights to OSMOLEX ER.

    SG&A expenses for 2020 were $106.8 million, compared to $114.4 million for the same period in the prior year. The decrease from 2019 was primarily attributable to certain one-time charges related to personnel transitions incurred in the third quarter of 2019.

    Net loss

    Net loss was $18.3 million, or $0.64 per share, basic and diluted, for the fourth quarter of 2020, compared to a net loss of $23.1 million, or $0.83 per share, basic and diluted, for the fourth quarter of 2019. Net loss for the fourth quarters of 2020 and 2019 included $1.6 million and $2.1 million, respectively, in non-cash stock-based compensation expense.

    Net loss was $57.4 million, or $2.03 per share, basic and diluted, for full year 2020, compared to a net loss of $105.2 million, or $3.80 per share, basic and diluted, for 2019. Net loss for 2020 and 2019 included $6.4 million and $12.9 million, respectively, in non-cash stock-based compensation expense.

    Cash and investments

    As of December 31, 2020, Adamas had $83.4 million of cash, cash equivalents and available-for-sale securities. Subsequent to December 31, 2020, and through February 16, 2021, Adamas raised net proceeds of approximately $7.2 million under an at-the-market offering.

    Full year 2021 expense guidance

    For full year 2021, Adamas estimates R&D, SG&A and stock-based compensation expenses as set forth below:

     

     

    Full Year 2021

    R&D expenses

     

    $5 million -- $10 million1

    SG&A expenses

     

    $110 million -- $120 million2

    Total operating expenses

     

    $115 million -- $130 million3

    1Includes stock-based compensation expense of $1 million.

    2Includes stock-based compensation expense of $8 million.

    3Includes stock-based compensation expense of $9 million.

    Investor conference call and webcast

    Adamas will host a conference call and webcast today, February 23, 2021, at 4:30 p.m. ET (1:30 p.m. PT). The conference call can be accessed by dialing 1-877-407-9716 for participants in the U.S. or Canada and 1-201-493-6779 for international callers. All callers must provide the following Conference ID: 13716505. The webcast can be accessed live via the investor section of the Adamas website at https://ir.adamaspharma.com/events-presentations and will be available for replay for approximately 30 days.

    About GOCOVRI

    GOCOVRI® (amantadine) extended release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About OSMOLEX ER

    OSMOLEX ER® (amantadine) extended release tablets is FDA-approved for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adult patients. OSMOLEX ER is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m2). The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.

    For more information about OSMOLEX ER, including the full Prescribing Information, please visit www.OSMOLEX.com.

    NAMZARIC

    For more information, please visit www.NAMZARIC.com.

    About Adamas

    At Adamas our vision is clear - to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations of its full year 2021 expenses. Such statements are subject to risks and uncertainties, and 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 GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 23, 2021, particularly under the caption "Risk Factors." In addition, the impact that the current COVID-19 pandemic is having and will have on demand for GOCOVRI, and the unknown duration and severity of the COVID-19 pandemic, add additional risk and uncertainty to these forward-looking statements. 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, except as required by law.

    Adamas Pharmaceuticals, Inc.

    Unaudited Condensed Consolidated Statements of Operations

    (in thousands, except per share data)

     

     

    Three Months Ended

    December 31,

     

    Twelve Months Ended

    December 31,

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues:

     

     

     

     

     

     

     

    Product sales

    $

    19,761

     

     

    $

    16,348

     

     

    $

    71,166

     

     

    $

    54,637

     

    Royalty revenue

     

    1,249

     

     

     

     

     

     

    3,295

     

     

     

     

    Total revenues

     

    21,010

     

     

     

    16,348

     

     

     

    74,461

     

     

     

    54,637

     

    Costs and operating expenses:

     

     

     

     

     

     

     

    Cost of product sales

     

    597

     

     

     

    442

     

     

     

    2,038

     

     

     

    2,469

     

    Research and development

     

    2,398

     

     

     

    5,180

     

     

     

    9,746

     

     

     

    30,034

     

    Selling, general and administrative, net

     

    32,992

     

     

     

    30,285

     

     

     

    106,841

     

     

     

    114,369

     

    Total costs and operating expenses

     

    35,987

     

     

     

    35,907

     

     

     

    118,625

     

     

     

    146,872

     

    Loss from operations

     

    (14,977

    )

     

     

    (19,559

    )

     

     

    (44,164

    )

     

     

    (92,235

    )

    Interest and other income, net

     

    94

     

     

     

    124

     

     

     

    748

     

     

     

    2,093

     

    Interest expense

     

    (3,390

    )

     

     

    (3,640

    )

     

     

    (13,987

    )

     

     

    (15,044

    )

    Net loss

    $

    (18,273

    )

     

    $

    (23,075

    )

     

    $

    (57,403

    )

     

    $

    (105,186

    )

    Net loss per share, basic and diluted

    $

    (0.64

    )

     

    $

    (0.83

    )

     

    $

    (2.03

    )

     

    $

    (3.80

    )

    Weighted average shares used in computing net loss per share, basic and diluted

     

    28,617

     

     

     

    27,890

     

     

     

    28,305

     

     

     

    27,677

     

    Adamas Pharmaceuticals, Inc.

    Unaudited Consolidated Balance Sheet Data

    (in thousands)

     

     

    December 31,

    2020

     

    December 31,

    2019

    Cash, cash equivalents, and available-for-sale securities

    $

    83,365

     

     

    $

    132,607

     

    Total assets

     

    120,029

     

     

     

    162,158

     

    Total current liabilities

     

    34,867

     

     

     

    26,948

     

    Long-term debt

     

    126,307

     

     

     

    125,674

     

    Total liabilities

     

    170,005

     

     

     

    163,051

     

    Total stockholders' deficit

     

    (49,976

    )

     

     

    (893

    )

    Source: Adamas Pharmaceuticals, Inc.

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  4. Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, Chief Executive Officer, is scheduled to present at the following investor conferences:

    • 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24 at 1:40 p.m. ET (10:40 a.m. PT)
    • Cowen 41st Annual Healthcare Conference on Tuesday, March 2 at 2:50 p.m. ET (11:50 a.m. PT)
    • H.C. Wainwright Global Life Sciences Conference. Prerecorded presentation available starting on Tuesday, March 9 at 7:30 a.m. ET (4:30 a.m. PT)

    The webcasts will be accessible on the investor relations section of the Adamas website…

    Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, Chief Executive Officer, is scheduled to present at the following investor conferences:

    • 10th Annual SVB Leerink Global Healthcare Conference on Wednesday, February 24 at 1:40 p.m. ET (10:40 a.m. PT)
    • Cowen 41st Annual Healthcare Conference on Tuesday, March 2 at 2:50 p.m. ET (11:50 a.m. PT)
    • H.C. Wainwright Global Life Sciences Conference. Prerecorded presentation available starting on Tuesday, March 9 at 7:30 a.m. ET (4:30 a.m. PT)

    The webcasts will be accessible on the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations and will be available for 30 days.

    About Adamas Pharmaceuticals, Inc.

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Source: Adamas Pharmaceuticals, Inc.

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  5. Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report fourth quarter and year-end 2020 financial results on Tuesday, February 23, 2021, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast

    The conference call can be accessed by dialing 1-877-407-9716 for participants in the U.S. or Canada and 1-201-493-6779 for international callers. All callers must provide the following Conference ID: 13716505. The webcast can be accessed live via the investor section of the Adamas website at https://ir.adamaspharma.com/events-presentations and will…

    Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report fourth quarter and year-end 2020 financial results on Tuesday, February 23, 2021, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast

    The conference call can be accessed by dialing 1-877-407-9716 for participants in the U.S. or Canada and 1-201-493-6779 for international callers. All callers must provide the following Conference ID: 13716505. The webcast can be accessed live via the investor section of the Adamas website at https://ir.adamaspharma.com/events-presentations and will be available for replay for approximately 30 days.

    About Adamas Pharmaceuticals, Inc.

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Source: Adamas Pharmaceuticals, Inc.

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  6. - GOCOVRI is now the first and only medication approved to treat OFF and dyskinesia motor complications -

    - Adamas to host webcast conference call today at 4:30 pm ET/1:30 pm PT -

    Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has received marketing authorization from the U.S. Food and Drug Administration (FDA) for a supplemental New Drug Application for GOCOVRI® (amantadine) extended release capsules, gaining a second indication for the product. GOCOVRI is now approved as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes, in addition…

    - GOCOVRI is now the first and only medication approved to treat OFF and dyskinesia motor complications -

    - Adamas to host webcast conference call today at 4:30 pm ET/1:30 pm PT -

    Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has received marketing authorization from the U.S. Food and Drug Administration (FDA) for a supplemental New Drug Application for GOCOVRI® (amantadine) extended release capsules, gaining a second indication for the product. GOCOVRI is now approved as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes, in addition to its indication for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications.

    "The approval of a second indication for GOCOVRI is a major milestone for patients with Parkinson's who experience motor complications in their daily lives. GOCOVRI is now the first and only medication approved to treat both OFF and dyskinesia motor complications in Parkinson's disease," said Neil F. McFarlane, Chief Executive Officer. "This approval also meaningfully enhances our commercial opportunity by more than doubling the potential number of patients with conditions GOCOVRI is approved to treat. I am very pleased with the performance of our team in executing our growth strategy and look forward to improving access for patients in 2021 and beyond with the expanded label for GOCOVRI."

    Data from two pivotal, placebo-controlled Phase 3 clinical studies showed that treatment with GOCOVRI significantly reduced both OFF time and dyskinesia. This resulted in a clinically meaningful increase in good ON time in patients taking a levodopa-based medication for Parkinson's disease. Additionally, GOCOVRI demonstrated sustained efficacy for at least two years in the Phase 3, open-label EASE LID-2 study.

    "We are delighted in the FDA's responsiveness to our application to include the clinically meaningful reduction in OFF episodes in the indication statement which provides patients and physicians with accurate and complete information to make appropriate treatment decisions," said Adrian Quartel, M.D., Chief Medical Officer. "The extensive clinical trial evidence for GOCOVRI supports its unique ability to reduce OFF episodes and dyskinesia in people with Parkinson's disease who are on levodopa/carbidopa therapy. Many PD medications necessitate a trade-off between reducing OFF time and exacerbating levodopa-induced dyskinesia. GOCOVRI is the first medication approved to reduce both."

    Conference call details

    Adamas will host a conference call and webcast today, February 1, 2021, at 4:30 pm ET/1:30 pm PT to discuss the approval of its sNDA for GOCOVRI. The conference call can be accessed by dialing (877) 407-9716 (toll-free) or 201-493-6779 (toll/international) using the conference ID 13715919. The webcast can be accessed live via the Investors section of the Adamas website at http://ir.adamaspharma.com/events-presentations and will be available for replay for approximately 30 days.

    About Parkinson's Disease, OFF and dyskinesia

    Parkinson's Disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people taking levodopa-based therapy are likely to experience reemergence or sudden return of stiffness, rigidity and tremors, referred to as OFF episodes between medication doses, that may be unpredictable. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement, and OFF lead to considerable impact on patients' lives.

    About GOCOVRI®

    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications, and as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing OFF episodes.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    GOCOVRI® is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2

    WARNINGS AND PRECAUTIONS

    Falling Asleep During Activities of Daily Living and Somnolence: Patients treated with Parkinson's disease medications have reported falling asleep during activities of daily living. If a patient develops daytime sleepiness during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), GOCOVRI should ordinarily be discontinued or the patient should be advised to avoid potentially dangerous activities.

    Suicidality and Depression: Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with GOCOVRI in patients with a history of suicidality or depression.

    Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.

    Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting GOCOVRI or increasing the dose.

    Withdrawal-Emergent Hyperpyrexia and Confusion: Rapid dose reduction or abrupt discontinuation of GOCOVRI, may cause an increase in the symptoms of Parkinson's disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech. Avoid sudden discontinuation of GOCOVRI.

    Impulse Control/Compulsive Behaviors: Patients may experience urges (e.g. gambling, sexual, money spending, binge eating) and the inability to control them. It is important for prescribers to ask patients or their caregivers about the development of new or increased urges. Consider dose reduction or stopping medications.

    ADVERSE REACTIONS

    The most common adverse reactions (>10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and, orthostatic hypotension.

    Please see full Prescribing Information for additional important safety information at https://www.gocovri.com/assets/pdfs/Gocovri_Prescribing_Information.pdf.

    About Adamas

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations regarding the potential number of patients with conditions GOCOVRI is approved to treat. Such statements are subject to risks and uncertainties, and 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 GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 5, 2020, particularly under the caption "Risk Factors." In addition, the impact that the current COVID-19 pandemic is having and will have on demand for GOCOVRI, and the unknown duration and severity of the COVID-19 pandemic, add additional risk and uncertainty to these forward-looking statements. 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, except as required by law.

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  7. - Adamas grants Zydus license for generic version of GOCOVRI® as of March 4, 2030 -

    Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that it has entered into a settlement agreement with Zydus Worldwide DMCC and Zydus Pharmaceuticals (USA) Inc. ("Zydus") resolving its ongoing litigation concerning Zydus's Abbreviated New Drug Application ("ANDA") seeking approval by the U.S. Food and Drug Administration to market a generic version of GOCOVRI® (amantadine) extended-release capsules.

    "I am pleased to announce the swift settlement of this litigation which reaffirms the strength of our…

    - Adamas grants Zydus license for generic version of GOCOVRI® as of March 4, 2030 -

    Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that it has entered into a settlement agreement with Zydus Worldwide DMCC and Zydus Pharmaceuticals (USA) Inc. ("Zydus") resolving its ongoing litigation concerning Zydus's Abbreviated New Drug Application ("ANDA") seeking approval by the U.S. Food and Drug Administration to market a generic version of GOCOVRI® (amantadine) extended-release capsules.

    "I am pleased to announce the swift settlement of this litigation which reaffirms the strength of our intellectual property and gives us confidence in the opportunity to deliver GOCOVRI to the patients who may benefit for years to come," said Neil F. McFarlane, Chief Executive Officer. "We are focused on building on the momentum from our strong 2020 performance and delivering growth for GOCOVRI in 2021."

    Under the settlement agreement, Adamas grants Zydus a non-exclusive license to make, use, sell, offer to sell and import generic versions of GOCOVRI as of March 4, 2030, or earlier in certain circumstances, including a potential for an accelerated license date if the unit sales of GOCOVRI in the 12-month period ending July 31, 2025 or any subsequent 12-month period decline by a specified percentage below the unit sales of GOCOVRI in the year ended December 31, 2019.

    In accordance with the settlement agreement, the parties will submit a joint stipulation and order to the United States District Court for the District of New Jersey, and the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice. Upon entry of the joint stipulation and order, this settlement agreement will conclude all patent litigation brought to date by Adamas against generic pharmaceutical companies that filed an ANDA seeking approval to market generic versions of GOCOVRI prior to the expiration of the patents listed in the Orange Book.

    About GOCOVRI®

    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About Adamas Pharmaceuticals, Inc.

    At Adamas, our purpose is clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company with a growing portfolio of therapies that address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Source: Adamas Pharmaceuticals, Inc.

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  8. -- Total revenues expected to be $20.8 million for fourth quarter 2020 and $74.2 million for full year 2020 --

    -- Product sales of GOCOVRI® expected to be $19.8 million for fourth quarter 2020 and $71.2 million for full year 2020 --

    -- Total prescriptions of GOCOVRI of approximately 8,165 for fourth quarter 2020 and approximately 31,070* for full year 2020 --

    EMERYVILLE, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today provides preliminary unaudited total revenues for the fourth quarter and full year 2020 and key business drivers for 2021.

    "I am proud of our…

    -- Total revenues expected to be $20.8 million for fourth quarter 2020 and $74.2 million for full year 2020 --

    -- Product sales of GOCOVRI® expected to be $19.8 million for fourth quarter 2020 and $71.2 million for full year 2020 --

    -- Total prescriptions of GOCOVRI of approximately 8,165 for fourth quarter 2020 and approximately 31,070* for full year 2020 --

    EMERYVILLE, Calif., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today provides preliminary unaudited total revenues for the fourth quarter and full year 2020 and key business drivers for 2021.

    "I am proud of our team's resilience, ability to adapt, and unwavering execution of our key priority to deliver GOCOVRI® to the Parkinson's community. Through strong performance, GOCOVRI sales are expected to increase 30% for the full year 2020 against the backdrop of a challenging macro environment. Furthermore, we strengthened the foundation of our business for long-term, sustainable growth with key management and board additions," said Neil F. McFarlane, Chief Executive Officer. "In 2021, our goal is to realize the potential of GOCOVRI and integrate OSMOLEX ER®; positioning both to benefit their unique patient populations, and to record a full year of royalties from sales of NAMZARIC®. We appreciate that market dynamics may remain fluid in 2021; however, we are highly encouraged by the strong momentum we established in 2020."

    Preliminary unaudited fourth quarter and full year 2020 selected financial results

    • Full year total revenues are expected to be $74.2 million for 2020, compared to $54.6 million for 2019, a 36% increase. Total revenues for the fourth quarter of 2020 are anticipated to be $20.8 million, a 27% increase over the $16.3 million recorded in the fourth quarter of 2019.
    • Full year 2020 GOCOVRI product sales are anticipated to be $71.2 million compared to $54.6 million for full year 2019, an increase of 30%. Total paid prescriptions (TRx) of GOCOVRI were approximately 31,070* for 2020, a 21% increase over approximately 25,780 TRx for 2019.
    • GOCOVRI product sales for the fourth quarter of 2020 are expected to be $19.8 million, an increase of 21% from $16.3 million in the fourth quarter of 2019. GOCOVRI TRx were approximately 8,165 in the fourth quarter of 2020, a 14% increase over approximately 7,160 TRx in the fourth quarter of 2019.
    • GOCOVRI new paid prescriptions (NRx) were approximately 510 in the fourth quarter of 2020, a 19% increase over NRx of approximately 430 in the third quarter of 2020.
    • Royalty revenue on net sales of NAMZARIC is estimated to be $1.0 million in the fourth quarter of 2020 and $3.0 million for full year 2020. 
    • Cash, cash equivalents, and available-for-sale securities are expected to be $83.4 million as of December 31, 2020.

    These preliminary unaudited results are based on management's analysis of operations for the quarter ended December 31, 2020. Adamas expects to report its final financial results for the fourth quarter and full year 2020 in February 2021.

    *GOCOVRI TRx have been adjusted approximately 1% to 31,070 for the full year 2020 to reflect reconciled 340b dispenses through the specialty distribution channel. TRx by quarter for 2020 is as follows: Q1 2020: 7,205, Q2 2020: 7,915, Q3 2020: 7,785, and Q4 2020: 8,165. There is no impact on current or previously reported NRx, or GOCOVRI product sales.

    Key business drivers for 2021

    • Build on strong 2020 performance by delivering the key strategic priorities for GOCOVRI: raising the urgency to treat both dyskinesia and OFF; communicating its differentiated clinical profile to drive health care provider adoption; and improving access and fulfillment.
      • Anticipated Prescription Drug User Fee Act (PDUFA) action date of February 1, 2021, for supplemental New Drug Application (sNDA) to modify the indication statement for GOCOVRI to include treatment for Parkinson's disease patients receiving levodopa and experiencing OFF episodes.
    • Successfully integrate OSMOLEX ER into commercial operations and position the product for the benefit of patients in its approved indication for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions.
    • Earn a full year of royalty revenue from sales of NAMZARIC.

    About GOCOVRI®

    GOCOVRI® (amantadine) extended release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About OSMOLEX ER®

    OSMOLEX ER® (amantadine) extended release tablets is FDA-approved for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adult patients. OSMOLEX ER is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m2). The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.

    For more information about OSMOLEX ER, including the full Prescribing Information, please visit www.OSMOLEX.com.

    NAMZARIC® 

    For more information, please visit www.NAMZARIC.com.  

    About Adamas

    At Adamas our vision is clear - to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations of its fourth quarter and full year revenue, and expectations for 2021, including as set forth under the caption "Key Business Drivers for 2021". Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. For example, with respect to 2020 preliminary financial results, these results are unaudited and are subject to revision during the audit process. Other risks relating to Adamas may be found in Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 5, 2020, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Media:

    Sarah Mathieson

    Vice President, Corporate Communications

    510-450-3528

    Investors:

    Peter Vozzo

    Managing Director

    Westwicke/ICR

    443-213-0505



    Primary Logo

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  9. EMERYVILLE, Calif., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, Chief Executive Officer, will participate in a fireside chat at the ICR Conference 2021, being held January 11-14, 2021.

    The fireside chat will be webcast live on January 14, 2021 at 11:30 a.m. Eastern Time on the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. The replay will be available for 30 days.

    About Adamas Pharmaceuticals, Inc.
    At Adamas our vision is clear – to deliver innovative medicines that reduce…

    EMERYVILLE, Calif., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, Chief Executive Officer, will participate in a fireside chat at the ICR Conference 2021, being held January 11-14, 2021.

    The fireside chat will be webcast live on January 14, 2021 at 11:30 a.m. Eastern Time on the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. The replay will be available for 30 days.

    About Adamas Pharmaceuticals, Inc.

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Contact

    Media:

    Sarah Mathieson

    Vice President, Corporate Communications

    510-450-3528





    Investors:

    Peter Vozzo

    Managing Director

    Westwicke/ICR

    443-213-0505







    Primary Logo

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  10. EMERYVILLE, Calif., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the closing of the settlement of patent litigation with Osmotica Pharmaceutical US LLC, a subsidiary of Osmotica Pharmaceuticals plc and completes the acquisition of the global rights to OSMOLEX ER®. As previously disclosed, the amended Royalty-Backed Loan Agreement with HealthCare Royalty Partners is now effective with the closing of the acquisition of OSOMOLEX ER.

    Through this acquisition, OSMOLEX ER joins the Adamas portfolio which includes GOCOVRI® (amantadine) extended-release capsules…

    EMERYVILLE, Calif., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the closing of the settlement of patent litigation with Osmotica Pharmaceutical US LLC, a subsidiary of Osmotica Pharmaceuticals plc and completes the acquisition of the global rights to OSMOLEX ER®. As previously disclosed, the amended Royalty-Backed Loan Agreement with HealthCare Royalty Partners is now effective with the closing of the acquisition of OSOMOLEX ER.

    Through this acquisition, OSMOLEX ER joins the Adamas portfolio which includes GOCOVRI® (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications. OSMOLEX ER (amantadine) extended-release tablets is FDA-approved for the treatment for Parkinson's disease and drug-induced extrapyramidal reactions in adult patients. According to their Prescribing Information, neither GOCOVRI nor OSMOLEX ER are interchangeable with other amantadine immediate- or extended-release products for their respective approved indications.

    "We are pleased to begin 2021 by adding OSMOLEX ER to our portfolio, broadening our presence in neurology and our ability to serve more patients," said Neil F. McFarlane, Chief Executive Officer. "Our strategy for OSMOLEX ER is to invest in disciplined, gated execution with the primary objective for the product to become accretive in the near-term. We look forward to leveraging the unique opportunities and benefits of each therapy in our portfolio, with the growth of GOCOVRI remaining our primary focus."

    About GOCOVRI®

    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About OSMOLEX ER®

    OSMOLEX ER®, (amantadine) extended-release tablets, is FDA-approved for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adult patients. OSMOLEX ER is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m2). The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia.

    For more information about OSMOLEX ER, including the full Prescribing Information, please visit www.OSMOLEX.com

    About Adamas

    At Adamas our vision is clear - to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers, and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations regarding the benefits to it from the closing of the transaction with Osmotica. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. Risks relating to Adamas may be found in Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 5, 2020, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Media:

    Sarah Mathieson

    Vice President, Corporate Communications

    510-450-3528

    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505



    Primary Logo

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  11. EMERYVILLE, Calif., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright VIRTUAL BioConnect Conference, being held January 11 – 14, 2021.

    A replay of the pre-recorded fireside chat will be available beginning January 11, 2021 in the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. The replay will be available for 30 days.

    About Adamas Pharmaceuticals, Inc.
    At Adamas our vision is clear – to deliver…

    EMERYVILLE, Calif., Jan. 04, 2021 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, will participate in a fireside chat at the H.C. Wainwright VIRTUAL BioConnect Conference, being held January 11 – 14, 2021.

    A replay of the pre-recorded fireside chat will be available beginning January 11, 2021 in the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. The replay will be available for 30 days.

    About Adamas Pharmaceuticals, Inc.

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Contact

    Media:

    Sarah Mathieson

    Vice President, Corporate Communications

    510-450-3528





    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505





    Primary Logo

    View Full Article Hide Full Article
  12. EMERYVILLE, Calif., Dec. 02, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has entered into an agreement to amend certain key terms of its Royalty-Backed Loan agreement ("Royalty-Backed Loan") with HealthCare Royalty Partners ("HCR"). The key terms amended are summarized as follows:    

    • Revised to provide for repayment from a royalty on OSMOLEX ER® on the same terms as, and in addition to, the royalty for GOCOVRI®. 
    • Eliminated the potential royalty rate step-up to 17.5%, which would have occurred in 2022 if cumulative payments did not reach minimum specified…

    EMERYVILLE, Calif., Dec. 02, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has entered into an agreement to amend certain key terms of its Royalty-Backed Loan agreement ("Royalty-Backed Loan") with HealthCare Royalty Partners ("HCR"). The key terms amended are summarized as follows:    

    • Revised to provide for repayment from a royalty on OSMOLEX ER® on the same terms as, and in addition to, the royalty for GOCOVRI®. 
    • Eliminated the potential royalty rate step-up to 17.5%, which would have occurred in 2022 if cumulative payments did not reach minimum specified levels by December 31, 2021. The 22.5% royalty rate step-up if total cumulative payments have not reached minimum specified levels as measured at December 31, 2022, remains.  
    • Revised prepayment provisions after a change of control provision to provide that the obligation to HCR is fully satisfied by making a prepayment sufficient to bring the cumulative payments to HCR to $175 million, if such prepayment is made on or prior to December 31, 2022, or $195 million if made thereafter. 
    • Extended the maturity date to March 31, 2027, if not earlier repaid.  
    • Added covenant requiring Adamas to maintain a minimum cash and investments balance of $25 million at all times through the term of the Royalty-Backed Loan. 
    • The amendment will come into effect upon closing the acquisition of OSMOLEX ER in early 2021. 

    "We are pleased to announce the amendment to certain key terms of our agreement with HealthCare Royalty Partners.  These revisions allow us to further focus on improving our operational effectiveness to deliver our medicines to patients," said Neil F. McFarlane, Chief Executive Officer. "We appreciate the continued partnership with HCR and believe the amendment will provide added flexibility to facilitate the growth of Adamas in line with our long-term strategy." 

    About GOCOVRI®

    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.   

    ABOUT OSMOLEX ER®

    OSMOLEX ER®, (amantadine) extended-release tablets, is FDA-approved for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adult patients. OSMOLEX ER is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m2). The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia. 

    For more information about OSMOLEX ER, including the full Prescribing Information, please visit www.OSMOLEX.com 

    About Adamas

    At Adamas our vision is clear - to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.  

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations that the amendment to the agreement with HCR will provide added flexibility to facilitate the growth of Adamas in line with its long-term strategy. Such statements are subject to risks and uncertainties, and 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 GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 5, 2020, particularly under the caption "Risk Factors." In addition, the impact that the current COVID-19 pandemic is having and will have on demand for GOCOVRI, and the unknown duration and severity of the COVID-19 pandemic, add additional risk and uncertainty to these forward-looking statements. 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, except as required by law. 

    Contact:

    Media

    Sarah Mathieson

    Vice President of Corporate Communications

    510-450-3528

    Investors

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505



    Primary Logo

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  13. EMERYVILLE, Calif., Dec. 02, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has signed an agreement to settle its ongoing patent litigation with Osmotica Pharmaceutical US LLC, a subsidiary of Osmotica Pharmaceuticals plc. As a result of this agreement, both parties will drop their respective claims relating to the patent litigation, and Adamas will acquire the global rights to OSMOLEX ER® for $7.5 million. The agreement is expected to close early in 2021. 

    Adamas' current portfolio consists of GOCOVRI® (amantadine) extended-release capsules for the treatment of…

    EMERYVILLE, Calif., Dec. 02, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has signed an agreement to settle its ongoing patent litigation with Osmotica Pharmaceutical US LLC, a subsidiary of Osmotica Pharmaceuticals plc. As a result of this agreement, both parties will drop their respective claims relating to the patent litigation, and Adamas will acquire the global rights to OSMOLEX ER® for $7.5 million. The agreement is expected to close early in 2021. 

    Adamas' current portfolio consists of GOCOVRI® (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy. OSMOLEX ER (amantadine) extended-release tablets is FDA-approved for the treatment for Parkinson's disease and drug-induced extrapyramidal reactions in adult patients.

    "This settlement agreement removes any further litigation costs and related distraction for Adamas. The acquisition of OSMOLEX ER also expands our presence in Neurology which is part of our long-term growth strategy," said Neil F. McFarlane, Chief Executive Officer. "The different FDA-approved indications and pharmacokinetic profiles for GOCOVRI and OSMOLEX ER allow for the treatment of distinct patient populations. We intend to leverage our commercial expertise to unlock the full potential of both products and serve more patients in the wider neurology community."

    As part of the acquisition, Adamas will receive existing inventory and all rights to OSMOLEX ER. Parties also entered a supply agreement in which Osmotica will be the sole manufacturer of OSMOLEX ER. Both parties are working together to ensure continuity of product supply to patients.  

    About GOCOVRI® 

    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. 

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension. 

    For more information about GOCOVRI, please visit www.GOCOVRI.com.   

    About OSMOLEX ER® 

    OSMOLEX ER®, (amantadine) extended-release tablets, is FDA-approved for the treatment of Parkinson's disease and drug-induced extrapyramidal reactions in adult patients. OSMOLEX ER is contraindicated in patients with end-stage renal disease (i.e., creatinine clearance below 15 mL/min/1.73 m2). The most common adverse reactions reported in ≥5% of patients at the recommended dosage of immediate-release amantadine were nausea, dizziness/lightheadedness, and insomnia. 

    For more information about OSMOLEX ER, including the full Prescribing Information, please visit www.OSMOLEX.com 

    About Adamas  

    At Adamas our vision is clear - to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.  

    Forward-looking statements  

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations regarding the expected timing of the closing of the transaction with Osmotica. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. For example, the completion of the transaction is subject to closing conditions, which if not met or waived, would cause the transaction not to close.  Other risks relating to Adamas may be found in Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 5, 2020, particularly under the caption "Risk Factors." 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, except as required by law. 

    Contact:

    Media

    Sarah Mathieson

    Vice President of Corporate Communications

    510-450-3528

    Investors

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505



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  14. EMERYVILLE, Calif., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the Evercore ISI 3rd Annual HealthCONx Conference on Tuesday, December 1st at 11:45 am Eastern Time (8:45 am Pacific).

    The presentation will be webcast from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. Archived versions of the webcast will be available via replay for 30 days following the presentation.

    About Adamas Pharmaceuticals, Inc.
    At Adamas…

    EMERYVILLE, Calif., Nov. 24, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the Evercore ISI 3rd Annual HealthCONx Conference on Tuesday, December 1st at 11:45 am Eastern Time (8:45 am Pacific).

    The presentation will be webcast from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. Archived versions of the webcast will be available via replay for 30 days following the presentation.

    About Adamas Pharmaceuticals, Inc.

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Contact

    Media:

    Sarah Mathieson

    Vice President, Corporate Communications

    510-450-3528

    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505



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  15. EMERYVILLE, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the appointment of Spyros Papapetropoulos, MD, PhD, to its Board of Directors. Spyros brings more than 20 years of academic and industry experience with a focus on neurology, and previously held R&D and scientific leadership roles at Acadia, Cavion, Teva, Pfizer, Allergan, and Biogen. Additionally, Adamas announced the retirement of Ivan Lieberburg, MD, PhD from the Adamas board.

    "I would like to sincerely thank Ivan for his dedicated service to Adamas since 2004. He played a critical role through…

    EMERYVILLE, Calif., Nov. 23, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the appointment of Spyros Papapetropoulos, MD, PhD, to its Board of Directors. Spyros brings more than 20 years of academic and industry experience with a focus on neurology, and previously held R&D and scientific leadership roles at Acadia, Cavion, Teva, Pfizer, Allergan, and Biogen. Additionally, Adamas announced the retirement of Ivan Lieberburg, MD, PhD from the Adamas board.

    "I would like to sincerely thank Ivan for his dedicated service to Adamas since 2004. He played a critical role through multiple successful NDA submissions and our evolution into a successful commercial organization. We wish him well," said David L. Mahoney, Chairman, Adamas. "We are pleased to have Spyros join us at this next stage of growth. As a seasoned research and development leader, he will be an outstanding addition to our board."

    "Spyros' extensive experience within neurodegenerative diseases and movement disorders, along with his track record of bringing meaningful therapies to market ideally position him to bring an important perspective to the board. I look forward to his contributions as we continue to deliver on our mission for patients and unlock shareholder value," added Neil F. McFarlane, CEO.

    "I am delighted to join Adamas at this exciting time in the journey towards being a leading neurology company," said Spyros Papapetropoulos. "I very much look forward to being part of the company's future growth and continued success."

    Throughout his career, Spyros has led multiple pharmaceutical development programs resulting in successful regulatory filings and product launches. Spyros is a board-certified Neurologist trained in London, UK, and has authored more than 160 peer-reviewed publications. Additionally, Spyros has served on various U.S. government and non-profit committees on healthcare and biomedical research innovation.

    About Adamas

    At Adamas, our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers, and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Contact:

    Media:

    Sarah Mathieson

    Vice President, Corporate Communications

    510-450-3528

    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505

     



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  16. EMERYVILLE, Calif., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference being held December 1-3, 2020.

    A replay of the pre-recorded fireside chat will be available beginning November 23, 2020 in the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. The replay will be available for 30 days.

    About Adamas Pharmaceuticals, Inc.
    At Adamas our vision is clear…

    EMERYVILLE, Calif., Nov. 18, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference being held December 1-3, 2020.

    A replay of the pre-recorded fireside chat will be available beginning November 23, 2020 in the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. The replay will be available for 30 days.

    About Adamas Pharmaceuticals, Inc.

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Contact

    Media:

    Sarah Mathieson

    Vice President, Corporate Communications

    510-450-3528





    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505







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  17. EMERYVILLE, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report 2020 third quarter financial results on Thursday, November 5, 2020, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast
    The conference call can be accessed by dialing (844) 215-3280 for participants in the U.S. or Canada and (484) 747-6383 for international callers. All callers must provide the following Conference ID: 1578986. The webcast can be accessed live via the investor section of the Adamas website at https://ir.adamaspharma.com/events-presentations

    EMERYVILLE, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report 2020 third quarter financial results on Thursday, November 5, 2020, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast

    The conference call can be accessed by dialing (844) 215-3280 for participants in the U.S. or Canada and (484) 747-6383 for international callers. All callers must provide the following Conference ID: 1578986. The webcast can be accessed live via the investor section of the Adamas website at https://ir.adamaspharma.com/events-presentations and will be available for replay until December 5, 2020.

    About Adamas Pharmaceuticals, Inc.

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Contact

    Media:

    Sarah Mathieson

    Vice President, Corporate Communications

    510-450-3528





    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505





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  18. EMERYVILLE, Calif., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the appointment of Adrian Quartel, MD as Chief Medical Officer. As a member of the executive leadership team, Adrian will provide leadership and direction for all scientific and medical functions.

    "We are delighted to welcome Adrian to our leadership team to further accelerate the progress and execution of our long-term growth strategy," said Neil McFarlane, Chief Executive Officer. "His proven track record in drug development and extensive clinical experience will be especially valuable at this…

    EMERYVILLE, Calif., Oct. 01, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the appointment of Adrian Quartel, MD as Chief Medical Officer. As a member of the executive leadership team, Adrian will provide leadership and direction for all scientific and medical functions.

    "We are delighted to welcome Adrian to our leadership team to further accelerate the progress and execution of our long-term growth strategy," said Neil McFarlane, Chief Executive Officer. "His proven track record in drug development and extensive clinical experience will be especially valuable at this pivotal time as we build our development efforts to expand our reach to more patients."

    "I am excited to join a company which reflects my passion to make an impact on patients with unmet medical needs," said Adrian Quartel, MD. "I look forward to partnering with the Adamas team and applying my broad industry experience to help us maximize the opportunity to address serious neurological diseases."

    Adrian brings over 20 years of global drug development and pharmaceutical experience, both in academia and industry. He was most recently global head of Medical Affairs at BioMarin, where he oversaw the launch of six products. Prior to BioMarin, Adrian held senior positions leading clinical development and as principal investigator for several studies at Chiltern. He also served in pharmacovigilance, clinical development, and medical affairs roles at Paraxel, Icon and, Astellas. Prior to joining the industry, Adrian worked as a clinical research fellow at UCLA Cedar Sinai and as a resident in cardio-thoracic surgery at Erasmus University Medical Center.

    Adrian received his medical degree from Erasmus University Medical School, Rotterdam, in the Netherlands, and his post graduate specialization in pharmaceutical medicine from the Faculty of Pharmaceutical Medicine in London. He is board certified by the General Medical Council (GMC) in pharmaceutical medicine in the United Kingdom.

    About Adamas

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers, and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Contacts:

    Media:

    Sarah Mathieson

    Vice President, Corporate Communications

    510-450-3528



    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505



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  19. EMERYVILLE, Calif., Sept. 11, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, announced today two presentations on GOCOVRI® (amantadine) extended release capsules (ADS-5102) for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy at the Movement Disorder Society (MDS) 2020 Virtual Congress, September 12-16, 2020.

    "These presentations provide further evidence that GOCOVRI may reduce OFF time for people with Parkinson's, with prolonged effects for at least two years," said Jean Hubble MD, Vice President, Medical Affairs at Adamas. "Both dyskinesia…

    EMERYVILLE, Calif., Sept. 11, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, announced today two presentations on GOCOVRI® (amantadine) extended release capsules (ADS-5102) for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy at the Movement Disorder Society (MDS) 2020 Virtual Congress, September 12-16, 2020.

    "These presentations provide further evidence that GOCOVRI may reduce OFF time for people with Parkinson's, with prolonged effects for at least two years," said Jean Hubble MD, Vice President, Medical Affairs at Adamas. "Both dyskinesia and OFF disrupt daily activities for people with PD and treating dyskinesia should not come at the expense of increased OFF, or vice versa. For patients who seek good ON time with long-term reductions in dyskinesia and OFF, providers can consider GOCOVRI as a treatment option shown to provide substantial and sustained benefits."

    The following posters will be available in the MDS 2020 Virtual Poster Hall beginning September 11, 2020:

    Poster #896: Among Parkinson's disease patients with both OFF and dyskinesia, ADS-5102 (amantadine) extended-release reduces disruptive motor episodes and improves function: Analysis of phase 3 trials

    Lead Author: Robert A. Hauser, MD, MBA, USF Parkinson's Disease and Movement Disorders Center, Parkinson Foundation Center of Excellence.

    Poster #955: Long-term effects of ADS-5102 (amantadine) extended release capsules on OFF symptoms in Parkinson's disease patients with levodopa-induced dyskinesia: Analysis of EASE LID 2 trial

    Lead Author: Caroline M. Tanner, MD, PhD, University of California San Francisco.

    About Parkinson's Disease, Dyskinesia, and OFF

    Parkinson's Disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people are likely to experience unpredictable stiffness, rigidity, and tremors, referred to as OFF time. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement, and OFF time lead to considerable impact on patients' lives.

    About GOCOVRI®

    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension. For more information about GOCOVRI, please visit www.GOCOVRI.com.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    GOCOVRI® is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2

    WARNINGS AND PRECAUTIONS

    Falling Asleep During Activities of Daily Living and Somnolence:  Patients treated with Parkinson's disease medications have reported falling asleep during activities of daily living. If a patient develops daytime sleepiness during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), GOCOVRI should ordinarily be discontinued or the patient should be advised to avoid potentially dangerous activities.

    Suicidality and Depression: Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with GOCOVRI in patients with a history of suicidality or depression. 

    Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.

    Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting GOCOVRI or increasing the dose.

    Withdrawal-Emergent Hyperpyrexia and Confusion:  Rapid dose reduction or abrupt discontinuation of GOCOVRI, may cause an increase in the symptoms of Parkinson's disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech.   Avoid sudden discontinuation of GOCOVRI.

    Impulse Control/Compulsive Behaviors: Patients may experience urges (e.g. gambling, sexual, money spending, binge eating) and the inability to control them. It is important for prescribers to ask patients or their caregivers about the development of new or increased urges. Consider dose reduction or stopping medications.

    ADVERSE REACTIONS

    The most common adverse reactions (>10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and, orthostatic hypotension.

    Please see full Prescribing Information for additional important safety information at https://www.gocovri.com/assets/pdfs/Gocovri_Prescribing_Information.pdf.

    About Adamas

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers, and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations of its full year 2020 expenses. Such statements are subject to risks and uncertainties, and 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 GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2020, particularly under the caption "Risk Factors." In addition, the impact that the current COVID-19 pandemic is having and will have on demand for GOCOVRI, and the unknown duration and severity of the COVID-19 pandemic, add additional risk and uncertainty to these forward-looking statements. 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, except as required by law.

    Contact:

    Media:

    Sarah Mathieson

    Vice President of Corporate Communications

    510-450-3528





     
    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505





     

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  20. EMERYVILLE, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15th at 12:30 pm Eastern Time (9:30 am Pacific). 

    The presentation will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the webcast will be available via replay for 30 days following the presentation.

    About Adamas Pharmaceuticals,

    EMERYVILLE, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15th at 12:30 pm Eastern Time (9:30 am Pacific). 

    The presentation will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the webcast will be available via replay for 30 days following the presentation.

    About Adamas Pharmaceuticals, Inc.

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com.

    Contact:

    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505

    Media:

    Sarah Mathieson

    Vice President of Corporate Communications

    510-450-3528

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  21. EMERYVILLE, Calif., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the appointment of Anna Richo, J.D., General Counsel, Chief Compliance Officer, and Corporate Secretary at Cargill, Inc., to its Board of Directors. She will also serve on the Audit Committee. Ms. Richo brings over 30 years of leadership experience managing legal and compliance functions within the biotechnology and pharmaceutical industry, including UCB, Amgen, and Baxter Healthcare as well as prior public-company Board, Audit, and Finance Committee experience at Cytyc Corporation.

    "We are…

    EMERYVILLE, Calif., Sept. 01, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the appointment of Anna Richo, J.D., General Counsel, Chief Compliance Officer, and Corporate Secretary at Cargill, Inc., to its Board of Directors. She will also serve on the Audit Committee. Ms. Richo brings over 30 years of leadership experience managing legal and compliance functions within the biotechnology and pharmaceutical industry, including UCB, Amgen, and Baxter Healthcare as well as prior public-company Board, Audit, and Finance Committee experience at Cytyc Corporation.

    "We are delighted to welcome Anna to our board during this exciting time of growth for us as a commercial organization," said David L. Mahoney, Chairman, Adamas. "Anna brings extensive and relevant operational expertise, and we look forward to her contributions as we continue to advance and evolve Adamas," added Neil F. McFarlane, CEO.

    "I am excited to work with the Adamas Board of Directors and management team given the company's strong patient focus," said Ms. Richo. "I look forward to partnering with the team to help the company reach its long-term goals and deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers, and society."

    Having joined Cargill in 2019, Ms. Richo's successful career path includes leadership roles in biotechnology and pharmaceutical companies as general counsel and leading compliance, intellectual property, and corporate litigation. Ms. Richo has previously been recognized as one of the 'Top 15 Women in Pharma'.  She holds a bachelor's degree in industrial and labor relations from Cornell University and a J.D. degree from DePaul University, College of Law. She is a member of the Board of Trustees for DePaul University.

    About Adamas

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers, and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Contact:

    Media:

    Sarah Mathieson

    Vice President of Corporate Communications

    510-450-3528



    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505

      

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  22. Second quarter 2020 GOCOVRI® product sales of $18.0 million, a 41% increase over second quarter 2019

    Total paid prescriptions grew to 8,150, a 32% increase over second quarter 2019

    EMERYVILLE, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today reported financial results for the second quarter ended June 30, 2020, and recent corporate highlights. 

    "Adamas delivered a strong performance this quarter, reflecting the successful execution of our growth strategy as well as our ability to rapidly adapt to the challenges posed by the ongoing pandemic," said Neil F. McFarlane…

    Second quarter 2020 GOCOVRI® product sales of $18.0 million, a 41% increase over second quarter 2019

    Total paid prescriptions grew to 8,150, a 32% increase over second quarter 2019

    EMERYVILLE, Calif., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today reported financial results for the second quarter ended June 30, 2020, and recent corporate highlights. 

    "Adamas delivered a strong performance this quarter, reflecting the successful execution of our growth strategy as well as our ability to rapidly adapt to the challenges posed by the ongoing pandemic," said Neil F. McFarlane, Chief Executive Officer. "Additionally, we achieved a key milestone during the quarter with the FDA acceptance for review of our sNDA for GOCOVRI as a treatment for OFF episodes in Parkinson's disease patients receiving levodopa-based therapy. As we continue to respond to an uncertain environment, our focus remains on serving the patient community."

    Recent highlights

    • GOCOVRI product sales were $18.0 million in the second quarter of 2020, an increase of 41% as compared to $12.7 million in the second quarter of 2019.
    • Total paid prescriptions (TRx) of GOCOVRI were approximately 8,150 in the second quarter of 2020, a 32% increase over approximately 6,160 TRx in the second quarter of 2019 and an increase of 13% over approximately 7,210 TRx in the first quarter of 2020. Strong patient persistence of 45%-50% at 12 months continued for GOCOVRI in the second quarter of 2020.
    • New paid prescriptions (NRx) of GOCOVRI were approximately 370 in the second quarter of 2020 compared to NRx of approximately 500 in the first quarter of 2020, reflecting a decline in patient visits to clinics due to the pandemic during the second quarter of 2020.
    • The Company began earning royalty revenue on net sales of NAMZARIC® beginning May 18, 2020, recognizing $0.8 million in the second quarter of 2020. Royalties will be earned quarterly through 2024.
    • Supplemental New Drug Application for GOCOVRI as a treatment for OFF episodes in Parkinson's disease (PD) patients receiving levodopa-based therapy was accepted for review by the U.S. Food and Drug Administration. The anticipated Prescription Drug User Fee Act action date is February 1, 2021.
    • The United States Patent and Trademark Office issued a new patent for GOCOVRI that covers a method of reducing OFF time and increasing good ON time in people with PD being treated with levodopa.

    Financial results

    Revenue

    Total revenue was $18.8 million for the second quarter of 2020, consisting of GOCOVRI product sales of $18.0 million and royalty revenue earned on net sales of NAMZARIC of $0.8 million. GOCOVRI product sales were up 41% compared to $12.7 million in the same period in 2019.

    Research and Development (R&D) expenses

    R&D expenses for the second quarter of 2020 were $2.6 million, compared to $8.6 million for the same period in the prior year. R&D expenses in the second quarter of 2020 substantially relate to ongoing clinical development activities, including an open-label study which will conclude by the end of 2020 and completing the assessment of the ADS-5102 program. The decrease in R&D expenses from the prior year quarter was primarily due to the completion of the Phase 3 INROADS trial for the treatment of multiple sclerosis patients with walking impairment at the end of 2019.

    Selling, General and Administrative (SG&A) expenses

    SG&A expenses for the second quarter of 2020 were $23.2 million, compared to $25.2 million for the same period in the prior year.  SG&A expenses in the second quarter of 2020 were primarily attributable to sales force costs and external spend dedicated to GOCOVRI commercialization and the related administrative support. The decrease from prior year quarter was primarily attributable to a combination of cost management activities as well as a reduced cost structure while executing in a virtual environment.  

    Net loss

    Net loss was $10.6 million, or $0.37 per share, basic and diluted, for the second quarter of 2020, compared to a net loss of $24.9 million, or $0.90 per share, basic and diluted, for the second quarter of 2019. Net loss for the second quarters of 2020 and 2019 included $1.7 million and $2.9 million, respectively, in non-cash stock-based compensation expense.

    Cash and investments

    As of June 30, 2020, the Company had $103.4 million of cash, cash equivalents and available-for-sale securities, compared to $132.6 million at December 31, 2019.

    Full year 2020 expense guidance

    The Company is updating its full year 2020 guidance for R&D and stock-based compensation expenses as set forth below:

      Current (as of August 6, 2020) Previous (as of May 7, 2020)
    R&D expenses1 $8 million -- $12 million $10 million -- $15 million
    SG&A expenses2 $105 million -- $115 million $105 million -- $115 million
    Total operating expenses3 $113 million -- $127 million $115 million -- $130 million
         

    1Includes stock-based compensation expense of $1 million.

    2Includes stock-based compensation expense of $7 million.

    3Includes stock-based compensation expense of $8 million. 

    Investor conference call and webcast

    Adamas will host a conference call and webcast today, August 6, 2020, at 4:30 p.m. ET (1:30 p.m. PT). The conference call may be accessed by dialing (833) 350-1318 (U.S./Canada) or (236) 738-2277 (international) using the ID 4795503. The webcast can be accessed live via the investor section of the Adamas website at http://ir.adamaspharma.com/events-presentations and will be available for replay until November 5, 2020.

    About GOCOVRI®

    GOCOVRI® (amantadine) extended release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    NAMZARIC®

    For more information, please visit www.NAMZARIC.com.

    About Adamas

    At Adamas our vision is clear - to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations of its full year 2020 expenses. Such statements are subject to risks and uncertainties, and 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 GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2020, particularly under the caption "Risk Factors." In addition, the impact that the current COVID-19 pandemic is having and will have on demand for GOCOVRI, and the unknown duration and severity of the COVID-19 pandemic, add additional risk and uncertainty to these forward-looking statements. 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, except as required by law.

    Contact:

    Investors:Media:
    Peter VozzoSarah Mathieson
    WestwickeVice President of Corporate Communications
    443-213-0505510-450-3528
      

    — Financial Tables Attached —

    Adamas Pharmaceuticals, Inc.

    Unaudited Condensed Consolidated Statements of Operations

    (in thousands, except per share data)

     Three Months Ended

     June 30,
     Six Months Ended

     June 30,
     2020 2019 2020 2019
    Revenues:       
    Product sales$17,954  $12,691  $32,435  $24,356 
    Royalty revenue840    840   
    Total revenues18,794  12,691  33,275  24,356 
    Costs and operating expenses:       
    Cost of product sales381  685  953  1,098 
    Research and development2,550  8,598  5,015  18,812 
    Selling, general and administrative, net23,177  25,216  47,729  52,904 
    Total costs and operating expenses26,108  34,499  53,697  72,814 
    Loss from operations(7,314) (21,808) (20,422) (48,458)
    Interest and other income, net215  734  299  1,457 
    Interest expense(3,467) (3,797) (7,091) (7,528)
    Net loss$(10,566) $(24,871) $(27,214) $(54,529)
    Net loss per share, basic and diluted$(0.37) $(0.90) $(0.97) $(1.98)
    Weighted average shares used in computing net loss per share, basic and diluted28,194  27,579  28,112  27,516 
                

    Adamas Pharmaceuticals, Inc.

    Unaudited Consolidated Balance Sheet Data

    (in thousands)

     June 30,

    2020
     December 31,

    2019
    Cash, cash equivalents, and available-for-sale securities$103,414  $132,607 
    Total assets133,065  162,158 
    Total current liabilities21,215  26,948 
    Long-term debt126,300  125,674 
    Total liabilities157,474  163,051 
    Total stockholders' deficit(24,409) (893)
          

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  23. EMERYVILLE, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report 2020 second quarter financial results on Thursday, August 6, 2020, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast
    The conference call can be accessed by dialing (833) 350-1318 for participants in the U.S. or Canada and (236) 738-2277 for international callers. All callers must provide the following Conference ID: 4795503.    The webcast can be accessed live via the investor section of the Adamas website at https://ir.adamaspharma.com/events-presentations

    EMERYVILLE, Calif., July 23, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report 2020 second quarter financial results on Thursday, August 6, 2020, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast

    The conference call can be accessed by dialing (833) 350-1318 for participants in the U.S. or Canada and (236) 738-2277 for international callers. All callers must provide the following Conference ID: 4795503.    The webcast can be accessed live via the investor section of the Adamas website at https://ir.adamaspharma.com/events-presentations and will be available for replay until November 5, 2020.

    About Adamas Pharmaceuticals, Inc.

    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com. 

    Contact

    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505

    Media:

    Sarah Mathieson

    Vice President, Corporate Communications

    510-450-3528

    Primary Logo

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  24. EMERYVILLE, Calif., July 15, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced its presentation of a new post-hoc pivotal trial data analysis at the American Academy of Neurology (AAN) Science Highlights Platform showing GOCOVRI decreasing dyskinesia and OFF time for people with Parkinson's Disease (PD) using GOCOVRI® (amantadine) extended release capsules. GOCOVRI is indicated for the treatment of dyskinesia in people with Parkinson's disease receiving levodopa-based therapy. The abstract and poster presentation are available on the 2020 AAN Science Highlights Platform…

    EMERYVILLE, Calif., July 15, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced its presentation of a new post-hoc pivotal trial data analysis at the American Academy of Neurology (AAN) Science Highlights Platform showing GOCOVRI decreasing dyskinesia and OFF time for people with Parkinson's Disease (PD) using GOCOVRI® (amantadine) extended release capsules. GOCOVRI is indicated for the treatment of dyskinesia in people with Parkinson's disease receiving levodopa-based therapy. The abstract and poster presentation are available on the 2020 AAN Science Highlights Platform.

    In this pooled retrospective data analysis, the subset of patients who experienced more than 2.5 hours of OFF time and at least an hour of troublesome dyskinesia a day (101 patients out of total 198 enrolled in clinical trials) were evaluated which showed an improvement of 3.4 hours per day in good ON time on GOCOVRI, compared to placebo. This improvement in good ON time was due to a reduction in the number of hours spent in OFF as well as the hours spent ON with troublesome dyskinesia. In addition to increasing good ON time, patient-reported assessments showed GOCOVRI demonstrated significant improvements in the impact of their symptoms on daily activities and provided more continuous ON time without interruptions from OFF and dyskinesia episodes.

    "This presentation aims to provide additional insights on the effect of GOCOVRI in reducing OFF time for patients with Parkinson's disease," said Robert A. Hauser MD, MBA, Professor of Neurology, Director, USF Parkinson's Disease and Movement Disorders Center Parkinson Foundation Center of Excellence, and lead author of the presentation. "For clinicians seeking to improve management of OFF and dyskinesia for patients without adjusting levodopa doses, these results suggest GOCOVRI could be an important treatment option."

    "It is our hope at Adamas that patients will not have to make the difficult decision between reducing OFF time or troublesome dyskinesia," said Jean Hubble MD, Vice President, Medical Affairs at Adamas. "I am encouraged these results show GOCOVRI can lead to increased good ON time, giving patients the opportunity to spend time with family and friends with fewer disruptions and more sustained good ON time."

    The reduction of OFF was measured as a secondary outcome in the Phase 3 trials for GOCOVRI. Recent OFF trials typically require participants to experience 2-3 hours a day of OFF time at baseline, therefore the subset of patients in this post-hoc study evaluated those who had at least 2.5 hours of OFF time a day.

    Presentation details are as follows:

    Title: GOCOVRI reduces disruptive motor episodes and improves function in Parkinson's disease patients with OFF episodes and dyskinesia: Analysis of phase 3 trial data

    Lead Author: Robert A. Hauser, MD, MBA, Professor of Neurology, Director, USF Parkinson's Disease and Movement Disorders Center, Parkinson Foundation Center of Excellence.

    Poster: 3387

    About Parkinson's Disease, Dyskinesia and OFF

    Parkinson's Disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people are likely to experience unpredictable stiffness, rigidity and tremors, referred to as OFF time. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement and OFF time lead to considerable impact on patients' lives.

    About GOCOVRI®

    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension. For more information about GOCOVRI, please visit www.GOCOVRI.com.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    GOCOVRI® is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2

    WARNINGS AND PRECAUTIONS

    Falling Asleep During Activities of Daily Living and Somnolence:  Patients treated with Parkinson's disease medications have reported falling asleep during activities of daily living. If a patient develops daytime sleepiness during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), GOCOVRI should ordinarily be discontinued or the patient should be advised to avoid potentially dangerous activities.

    Suicidality and Depression: Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with GOCOVRI in patients with a history of suicidality or depression. 

    Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.

    Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting GOCOVRI or increasing the dose.

    Withdrawal-Emergent Hyperpyrexia and Confusion:  Rapid dose reduction or abrupt discontinuation of GOCOVRI, may cause an increase in the symptoms of Parkinson's disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech.   Avoid sudden discontinuation of GOCOVRI.

    Impulse Control/Compulsive Behaviors: Patients may experience urges (e.g. gambling, sexual, money spending, binge eating) and the inability to control them. It is important for prescribers to ask patients or their caregivers about the development of new or increased urges. Consider dose reduction or stopping medications.

    ADVERSE REACTIONS

    The most common adverse reactions (>10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension.

    Please see full Prescribing Information for additional important safety information at https://www.gocovri.com/assets/pdfs/Gocovri_Prescribing_Information.pdf.

    About Adamas

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and 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' commercial activities relating to GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2020, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Media:

    Sarah Mathieson

    Vice President of Corporate Communications

    510-450-3528

               Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505

       

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  25. EMERYVILLE, Calif., July 10, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted three new employees the option to purchase an aggregate of 62,500 shares of the company's common stock, at a per share exercise price of $2.57, the closing trading price on July 8, and restricted stock units to acquire 31,250 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce…

    EMERYVILLE, Calif., July 10, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted three new employees the option to purchase an aggregate of 62,500 shares of the company's common stock, at a per share exercise price of $2.57, the closing trading price on July 8, and restricted stock units to acquire 31,250 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc. 

    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com.

    Contact:

    Investors:

    Peter Vozzo

    Westwicke Partners

    443-213-0505

    Media:

    Sarah Mathieson

    Vice President, Communications & Engagement

    510-450-3528

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  26. EMERYVILLE, Calif., June 17, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the completion of its evaluation of ADS-5102 in multiple sclerosis patients with walking impairment (MSW).

    A comprehensive analysis of the INROADS Phase 3 data validated the top line results announced in December 2019 and informed a revised target product profile reflecting the scale of clinical benefit observed in the study. Additional patient, physician, and payer research based on the revised profile projected a limited commercial opportunity. Further engagement with the U.S. Food and Drug…

    EMERYVILLE, Calif., June 17, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced the completion of its evaluation of ADS-5102 in multiple sclerosis patients with walking impairment (MSW).

    A comprehensive analysis of the INROADS Phase 3 data validated the top line results announced in December 2019 and informed a revised target product profile reflecting the scale of clinical benefit observed in the study. Additional patient, physician, and payer research based on the revised profile projected a limited commercial opportunity. Further engagement with the U.S. Food and Drug Administration (FDA) to fully understand a potential path to submission confirmed the need for an additional pivotal Phase 3 confirmatory study. Based on these findings, Adamas reconfirms it will not initiate further Phase 3 development in MSW.

    "As a patient focused company this was a difficult decision, and I want to thank the patients, healthcare professionals, and employees who contributed to this development program. There remains a significant unmet need for this population and we are committed to completing the open-label study and publishing our data to benefit the MS community," said Neil F. McFarlane, CEO. "We remain focused on maximizing the opportunity for GOCOVRI to benefit Parkinson's disease patients, which includes our recently filed sNDA for a label revision to include OFF episodes. Moving forward we believe we have sufficient capital to execute our near-term strategy and deliver long-term value for shareholders."

    About GOCOVRI®

    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension. For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About ADS-5102

    Adamas evaluated ADS-5102 in the INROADS Phase 3 clinical study for multiple sclerosis patients with walking impairment. ADS-5102 was previously approved by the FDA under the trade name GOCOVRI®. GOCOVRI is not FDA-approved for the treatment of multiple sclerosis patients with walking impairment.

    About INROADS

    The INROADS study was a 12-week, three-arm, multi-center, randomized, double-blind, placebo-controlled study with a 4-week placebo-run in designed to evaluate the efficacy and safety of ADS-5102 for the treatment of walking impairment in multiple sclerosis. The study enrolled 594 patients with walking impairment in the US and Canada and randomized 560 patients in a 1:1:1 fashion to receive 274 mg ADS-5102 (N=185), 137 mg ADS-5102 (N=187), or placebo (N=186). The primary endpoint was the proportion of responders (at least 20% improvement in Timed 25-Foot Walk from baseline) at Week 12.

    Key secondary endpoints include the mean change in the Timed 25-Foot Walk, the Timed Up and Go, and the 2-Minute Walk at 12-week post-treatment at both the 274 mg and 137 mg dose.

    Baseline characteristics were similar across all treatment arms. The mean time since diagnosis of MS was 15.9 years, median Expanded Disability Status Scale at screening was 6.0, and mean timed 25-foot walk at baseline was between 11.5 to 12.4 seconds. Prior dalfampridine use was reported in 52.5% of patients and prior amantadine use was reported in 12.9% of patients.

    Results from the study showed that patients taking 274 mg ADS-5102 had a statistically significant improvement in response rate of 21.1% compared to 11.3% taking placebo (p=0.01). Response was defined as at least a 20% improvement in walking speed from baseline to 12 weeks post-treatment, as measured by the Timed 25 Foot Walk. Additionally, the response rate for patients taking a lower dose of 137 mg ADS-5102 was 17.6% (p=0.08). ADS-5102 did not demonstrate a significant effect on the secondary walking measures at either dose.

    The most common adverse events (occurring in greater than 5% of any ADS-5102 treatment group) were: peripheral edema, dry mouth, fall, constipation, UTI, and insomnia. 20.5% of patients discontinued study drug due to adverse events in the 274 mg group, compared to 6.4% in the 137 mg group, and 3.8% in the placebo group. The reported adverse events associated with ADS-5102 in this study were dose-dependent and consistent with the known safety profile of amantadine.

    About walking impairment in multiple sclerosis

    Multiple sclerosis (MS) is a chronic neurological autoimmune disease that is often disabling with unpredictable symptoms. Among the MS patients in the US, nearly 270,000 have walking impairment, which is present throughout the day. Walking impairment in MS remains an area of high unmet need, as there is only one approved product on the market for this indication.

    About Adamas

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and 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' commercial activities relating to GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2020, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Media:

    Sarah Mathieson

    Vice President of Corporate Communications

    510-450-3528



    Investors:

    Peter Vozzo

    Managing Director, Westwicke

    443-213-0505



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  27. EMERYVILLE, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that its supplemental New Drug Application (sNDA) for GOCOVRI as a treatment for OFF episodes in Parkinson's disease (PD) patients receiving levodopa-based therapy has been accepted for review by the U.S. Food and Drug Administration (FDA). The anticipated Prescription Drug User Fee Act (PDUFA) action date is February 1, 2021. 

    GOCOVRI (amantadine) extended release capsules is approved to treat dyskinesia in PD patients treated with levodopa-based therapy, with or without other dopaminergic medications…

    EMERYVILLE, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced that its supplemental New Drug Application (sNDA) for GOCOVRI as a treatment for OFF episodes in Parkinson's disease (PD) patients receiving levodopa-based therapy has been accepted for review by the U.S. Food and Drug Administration (FDA). The anticipated Prescription Drug User Fee Act (PDUFA) action date is February 1, 2021. 

    GOCOVRI (amantadine) extended release capsules is approved to treat dyskinesia in PD patients treated with levodopa-based therapy, with or without other dopaminergic medications. In the sNDA, Adamas has proposed a revision to the indication statement to include GOCOVRI as an appropriate therapy for the treatment of OFF episodes in PD patients receiving levodopa. The clinical evidence supporting GOCOVRI's effect on OFF time was demonstrated in two large pivotal Phase 3 trials and is currently included in the GOCOVRI prescribing information.

    "We are pleased the FDA has accepted our sNDA for review. If approved, the indication would reflect the full spectrum of GOCOVRI's therapeutic benefit in PD motor complications and better support physicians to identify appropriate treatments for their patients," said Neil F. McFarlane, Chief Executive Officer. "Many PD medications necessitate a trade-off between reducing OFF time and exacerbating levodopa-induced dyskinesia. GOCOVRI is the first medication clinically proven to reduce both."

    About GOCOVRI®
    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.
    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About Parkinson's disease, dyskinesia and OFF
    Parkinson's disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people are likely to experience unpredictable stiffness, rigidity and tremors, referred to as OFF time. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement and OFF time lead to considerable impact on patients' lives.

    About Adamas
    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements
    Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and 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' commercial activities relating to GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2020, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Media
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528
     
    Investors
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505
     

     

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  28. EMERYVILLE, Calif., June 03, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the William Blair Growth Stock Conference on Wednesday, June 10 at 9:20 a.m. Central Time (7:20 a.m. Pacific Time).

    The presentation will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the webcast will be available via replay for 30 days following the presentation.

    About Adamas Pharmaceuticals,

    EMERYVILLE, Calif., June 03, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the William Blair Growth Stock Conference on Wednesday, June 10 at 9:20 a.m. Central Time (7:20 a.m. Pacific Time).

    The presentation will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the webcast will be available via replay for 30 days following the presentation.

    About Adamas Pharmaceuticals, Inc.
    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com

    Contact:
    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528

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  29. EMERYVILLE, Calif., May 13, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has been issued a new patent (no. 10,646,456) by the United States Patent and Trademark Office (USPTO) that covers GOCOVRI® (amantadine) extended release capsules. The new patent covers a method of reducing ‘OFF' time and increasing ‘good ON' time (ON time without troublesome dyskinesia) in people with Parkinson's disease (PD) being treated with levodopa.  GOCOVRI is indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without…

    EMERYVILLE, Calif., May 13, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today announced it has been issued a new patent (no. 10,646,456) by the United States Patent and Trademark Office (USPTO) that covers GOCOVRI® (amantadine) extended release capsules. The new patent covers a method of reducing ‘OFF' time and increasing ‘good ON' time (ON time without troublesome dyskinesia) in people with Parkinson's disease (PD) being treated with levodopa.  GOCOVRI is indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Data from two pivotal, placebo-controlled phase 3 clinical studies showed that GOCOVRI reduced dyskinesia, as well as a secondary benefit in reduction of OFF time, leading to an increase in good ON time.

    This is the second patent to be issued for GOCOVRI that covers reduction in OFF time and will expire in 2034. Adamas' portfolio of patents for GOCOVRI now includes 15 U.S. patents, across three separate patent families that will expire from 2025 to 2034. This latest addition is listed in the U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

    About GOCOVRI®
    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About Parkinson's Disease, Dyskinesia and OFF
    Parkinson's Disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people are likely to experience unpredictable stiffness, rigidity and tremors, referred to as OFF time. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement and OFF time lead to considerable impact on patients' lives.

    About Adamas

    At Adamas our vision is clear – to deliver innovative medicines that reduce the burden of neurological diseases on patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements
    Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and 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' commercial activities relating to GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7 2020, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528


     
    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505


     

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  30. EMERYVILLE, Calif., May 08, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted five new employees the option to purchase an aggregate of 66,000 shares of the company's common stock, at a per share exercise price of $3.46, the closing trading price on May 7, and restricted stock units to acquire 33,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new…

    EMERYVILLE, Calif., May 08, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted five new employees the option to purchase an aggregate of 66,000 shares of the company's common stock, at a per share exercise price of $3.46, the closing trading price on May 7, and restricted stock units to acquire 33,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc. 
    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com.

    Contact:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Communications & Engagement
    510-450-3528

     

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  31. First quarter 2020 GOCOVRI® product sales of $14.5 million, a 24% increase over first quarter 2019

    Total paid prescriptions grew approximately 24% to 7,210 over first quarter 2019

    EMERYVILLE, Calif., May 07, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today reported financial results for the first quarter ended March 31, 2020, as well as recent corporate highlights. 

    "In the first quarter of 2020, we continued to make progress executing on our strategic priorities and treating Parkinson's disease patients with dyskinesia and OFF, as we implemented a number of actions in response…

    First quarter 2020 GOCOVRI® product sales of $14.5 million, a 24% increase over first quarter 2019

    Total paid prescriptions grew approximately 24% to 7,210 over first quarter 2019

    EMERYVILLE, Calif., May 07, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a meaningful difference to people affected by neurological diseases, today reported financial results for the first quarter ended March 31, 2020, as well as recent corporate highlights. 

    "In the first quarter of 2020, we continued to make progress executing on our strategic priorities and treating Parkinson's disease patients with dyskinesia and OFF, as we implemented a number of actions in response to the COVID-19 pandemic," said Neil F. McFarlane, Chief Executive Officer. "While we expect some short-term challenges as we progress through 2020, we continue to optimize the opportunity for GOCOVRI and position Adamas for long-term growth. Our focus remains on the patients who rely on us, while ensuring the health and safety of our employees, their families, and our business partners."

    Recent highlights

    • GOCOVRI product sales were $14.5 million in the first quarter of 2020, an increase of 24% as compared to $11.7 million in the first quarter of 2019.
    • Total paid prescriptions (TRx) of GOCOVRI were approximately 7,210 in the first quarter of 2020, an increase over approximately 5,820 TRx in the first quarter of 2019 and 7,160 TRx in the fourth quarter of 2019. GOCOVRI continued to benefit from strong patient persistence of 45%-50% at 12 months in the first quarter of 2020.
    • New paid prescriptions (NRx) of GOCOVRI were approximately 500 in the first quarter of 2020.
    • Sufficient inventory of GOCOVRI to address patients' needs into late 2021 with recently completed manufacturing campaign.
    • The assessment of ADS-5102 for multiple sclerosis patients with walking impairment, which includes FDA engagement, remains on track to be completed in the second quarter of 2020.

    Financial results

    Product sales

    GOCOVRI product sales were $14.5 million for the first quarter of 2020, up 24% compared to $11.7 million in the same period in 2019. Gross-to-net in both periods reflect annual insurance plan resets, including the Medicare Part D coverage gap.  

    Research and Development (R&D) expenses

    R&D expenses for the first quarter of 2020 were $2.5 million, compared to $10.2 million for the same period in the prior year. R&D expenses in the first quarter of 2020 substantially relate to the continued clinical development and evaluation of the ADS-5102 program. The decrease in R&D expenses from the prior year quarter was primarily due to the completion of the Phase 3 INROADS trial for the treatment of multiple sclerosis patients with walking impairment at the end of 2019.

    Selling, General and Administrative (SG&A) expenses

    SG&A expenses for the first quarter of 2020 were $24.6 million, compared to $27.7 million for the same period in the prior year.  SG&A expenses in the first quarter of 2020 were primarily attributable to sales force costs and external spend dedicated to GOCOVRI commercialization and the related administrative support. The moderate decrease from prior year quarter was primarily attributable to fluctuations in administrative costs.

    Net loss

    Net loss was $16.6 million, or $0.59 per share, basic and diluted, for the first quarter of 2020, compared to a net loss of $29.7 million, or $1.08 per share, basic and diluted, for the first quarter of 2019. Net loss for the first quarters of 2020 and 2019 included $1.5 million and $3.4 million, respectively, in non-cash stock-based compensation expense.

    Cash and investments

    As of March 31, 2020, the Company had $115.3 million of cash, cash equivalents and available-for-sale securities, compared to $132.6 million at December 31, 2019.

    Full year 2020 expense guidance

    The Company is reducing its full year 2020 guidance for SG&A and reaffirming guidance for R&D and stock-based compensation expenses as set forth below:

        Current Full Year 2020   Previous Full Year 2020
    R&D expenses1   $10 million -- $15 million   $10 million -- $15 million
    SG&A expenses2   $105 million -- $115 million   $110 million -- $120 million
    Total operating expenses3   $115 million -- $130 million   $120 million -- $135 million

    1Includes stock-based compensation expense of $1 million.

    2Includes stock-based compensation expense of $9 million.

    3Includes stock-based compensation expense of $10 million. 

    Investor conference call and webcast

    Adamas will host a conference call and webcast today, May 7, 2020, at 5:00 p.m. ET (2:00 p.m. PT). The conference call may be accessed by dialing (844) 215-3280 (U.S./Canada) or (484) 747-6383 (international) using the ID 3483897. The webcast can be accessed live via the investor section of the Adamas website at http://ir.adamaspharma.com/events-presentations and will be available for replay until August 7, 2020.

    About GOCOVRI®

    GOCOVRI® (amantadine) extended release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About Adamas Pharmaceuticals, Inc.

    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations of its full year 2020 expenses, and its expectations to assess the value and potential pathway for ADS-5102 for multiple sclerosis patients with walking impairment and provide a further update by the end of the second quarter of 2020. Such statements are subject to risks and uncertainties, and 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 GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2020, particularly under the caption "Risk Factors." In addition, the impact that the current COVID-19 pandemic is having and will have on demand for GOCOVRI, and the unknown duration and severity of the COVID-19 pandemic, add additional risk and uncertainty to these forward-looking statements. 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, except as required by law.

    Contact:

    Investors: Media:
    Peter Vozzo Sarah Mathieson
    Westwicke Vice President of Corporate Communications
    443-213-0505 510-450-3528

    Adamas Pharmaceuticals, Inc.
    Unaudited Condensed Consolidated Statements of Operations
    (in thousands, except per share data)

      Three Months Ended
     March 31,
      2020   2019
    Revenues:      
    Product sales $ 14,481        $ 11,665     
    Costs and operating expenses:      
    Cost of product sales 572        413     
    Research and development 2,465        10,214     
    Selling, general and administrative, net 24,552        27,688     
    Total costs and operating expenses 27,589        38,315     
    Loss from operations (13,108 )     (26,650 )  
    Interest and other income, net 84        723     
    Interest expense (3,624 )     (3,731 )  
    Net loss  $ (16,648 )     $ (29,658 )  
    Net loss per share, basic and diluted $ (0.59 )     $ (1.08 )  
    Weighted average shares used in computing net loss per share, basic and diluted 28,030        27,453     


    Adamas Pharmaceuticals, Inc.
    Unaudited Consolidated Balance Sheet Data
    (in thousands)

      March 31,
    2020
      December 31,
    2019
    Cash, cash equivalents, and available-for-sale securities $ 115,282        $ 132,607     
    Total assets 144,311        162,158     
    Total current liabilities 23,778        26,948     
    Long-term debt 126,065        125,674     
    Total liabilities 160,164        163,051     
    Total stockholders' deficit (15,853 )     (893 )  

     

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  32. EMERYVILLE, Calif., April 27, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report 2020 first quarter financial results on Thursday, May 7, 2020, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 5:00 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast
    The conference call can be accessed by dialing (844) 215-3280 for participants in the U.S. or Canada and (484) 747-6383 for international callers. All callers must provide the following Conference ID: 3483897. The webcast can be accessed live via the investor section of the Adamas website at ir.adamaspharma.com/events-presentations…

    EMERYVILLE, Calif., April 27, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report 2020 first quarter financial results on Thursday, May 7, 2020, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 5:00 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast
    The conference call can be accessed by dialing (844) 215-3280 for participants in the U.S. or Canada and (484) 747-6383 for international callers. All callers must provide the following Conference ID: 3483897. The webcast can be accessed live via the investor section of the Adamas website at ir.adamaspharma.com/events-presentations and will be available for replay until August 7, 2020.

    About Adamas Pharmaceuticals, Inc.
    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com. 

    Contact

    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Corporate Communications
    510-450-3528

    Primary Logo

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  33. EMERYVILLE, Calif., April 10, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted seven new employees the option to purchase an aggregate of 86,000 shares of the company's common stock, at a per share exercise price of $2.84, the closing trading price on April 7, and restricted stock units to acquire 43,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce…

    EMERYVILLE, Calif., April 10, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted seven new employees the option to purchase an aggregate of 86,000 shares of the company's common stock, at a per share exercise price of $2.84, the closing trading price on April 7, and restricted stock units to acquire 43,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc. 

    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com.

    Contact:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Communications & Engagement
    510-450-3528

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  34. PHILADELPHIA, March 19, 2020 /PRNewswire/ -- Kehoe Law Firm, P.C. is investigating breach of fiduciary duty claims on behalf of shareholders of Adamas Pharmaceuticals, Inc. (NasdaqGM: ADMS) that presently own the common stock of Adamas Pharmaceuticals, Inc.

    On March 16, 2020, a verified shareholder derivative complaint was filed in United States District Court seeking to remedy alleged wrongdoing committed by Adamas Pharmaceuticals' directors and officers from August 8, 2017 through September 30, 2019.

    ADMS investors who currently own shares of Adamas Pharmaceuticals are encouraged to contact either Michael Yarnoff, Esq., (215) 792-6676, Ext. 804, , , or John Kehoe, Esq, (215) 792-6676, Ext. 801, , to discuss the Adamas Pharmaceuticals investigation or potential legal claims.

    Kehoe Law Firm, P.C., with offices in New York and Philadelphia, is a multidisciplinary, plaintiff–side law firm dedicated to protecting investors from securities fraud, breaches of fiduciary duties, and corporate misconduct.  Combined, the partners at Kehoe Law Firm have served as Lead Counsel or Co-Lead Counsel in cases that have recovered more than $10 billion on behalf of institutional and individual investors.   

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/adamas-pharmaceuticals-stock--kehoe-law-firm-pc-investigating-breach-of-fiduciary-duty-claims-on-behalf-of-adms-investors--adms-shareholders-encouraged-to-contact-kehoe-law-firm-pc-301027180.html

    SOURCE Kehoe Law Firm, P.C.

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  35. EMERYVILLE, Calif., March 06, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted six new employees the option to purchase an aggregate of 70,000 shares of the company's common stock, at a per share exercise price of $3.89, the closing trading price on March 6, and restricted stock units to acquire 35,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce…

    EMERYVILLE, Calif., March 06, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted six new employees the option to purchase an aggregate of 70,000 shares of the company's common stock, at a per share exercise price of $3.89, the closing trading price on March 6, and restricted stock units to acquire 35,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc. 

    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com.  

    Contact:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Communications & Engagement
    510-450-3528

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  36. - Full year 2019 GOCOVRI® product sales of $54.6 million, a 60% increase over 2018;
    total paid prescriptions grew approximately 66% to 25,780

    - Fourth quarter 2019 GOCOVRI® product sales of $16.3 million, a 23% increase over fourth quarter 2018;
    total paid prescriptions grew approximately 25% to 7,160 over fourth quarter 2018

    EMERYVILLE, Calif., Feb. 25, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2019, as well as recent corporate highlights. 

    "The progress we made last year treating…

    - Full year 2019 GOCOVRI® product sales of $54.6 million, a 60% increase over 2018;
    total paid prescriptions grew approximately 66% to 25,780

    - Fourth quarter 2019 GOCOVRI® product sales of $16.3 million, a 23% increase over fourth quarter 2018;
    total paid prescriptions grew approximately 25% to 7,160 over fourth quarter 2018

    EMERYVILLE, Calif., Feb. 25, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today reported financial results for the fourth quarter and full year ended December 31, 2019, as well as recent corporate highlights. 

    "The progress we made last year treating Parkinson's disease patients with dyskinesia created a strong foundation to build upon in 2020," said Neil F. McFarlane, Chief Executive Officer of Adamas. "The confidence we have in our growth strategy for GOCOVRI is bolstered by positive physician feedback, our recent patent settlement, strong patient persistence, and newly published open-label data demonstrating patients taking GOCOVRI in a real-world setting experienced reductions in both dyskinesia and OFF time sustained for at least two years."

    Recent highlights

    • GOCOVRI product sales were $16.3 million in the fourth quarter of 2019, compared to $13.9 million in the third quarter of 2019, a 17% increase.

    • GOCOVRI generated approximately 7,160 total paid prescriptions (TRx) in the fourth quarter of 2019, an 8% increase over approximately 6,640 TRx in the third quarter of 2019. The number of new patients starting on GOCOVRI, primarily patients receiving medication through the free trial program, was approximately 750 in the fourth quarter of 2019, compared to 710 in the third quarter of 2019.

    • Continued strong patient persistence of 45%-50% at 12 months for GOCOVRI in fourth quarter 2019.

    • Long term data from the open-label Phase 3 study, EASE LID 2, published in the Journal of Parkinson's Disease shows GOCOVRI may reduce dyskinesia and OFF as far out as 2 years, providing sustained benefits to Parkinson's disease patients with dyskinesia.

    • In January 2020, Adamas announced a settlement agreement with Sandoz Inc. resolving patent litigation between the two parties relating to Sandoz's ANDA referencing GOCOVRI. Under the agreement Adamas granted Sandoz a non-exclusive license to begin selling a generic version of GOCOVRI as of March 4, 2030, or earlier in certain circumstances.

    • During the fourth quarter of 2019, Adamas announced topline results from its INROADS Phase 3 trial of ADS-5102 for multiple sclerosis patients with walking impairment. In the first half of 2020, Adamas plans to assess the value and potential pathway for the program, including additional data analyses from the INROADS trial to fully characterize the profile of ADS-5102.

    Financial results

    Product sales

    GOCOVRI product sales were $16.3 million for the fourth quarter of 2019, up 23% compared to $13.3 million in the same period in 2018. GOCOVRI product sales were $54.6 million for the year ended December 31, 2019, up 60% compared to $34.0 million for the year ended December 31, 2018.

    GOCOVRI received FDA approval in August 2017, becoming the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy. Adamas began commercial promotion of GOCOVRI in January 2018.

    Research and Development (R&D) expenses

    R&D expenses for the fourth quarter of 2019 were $5.2 million, compared to $10.6 million for the same period in the prior year. For the year ended December 31, 2019, R&D expenses were $30.0 million, compared to $39.3 million for the year ended December 31, 2018. The decrease in R&D expenses in both periods was primarily due to the completion of the GOCOVRI development program in the fourth quarter of 2018 and the completion of the Phase 3 INROADS trial at the end of 2019.

    Selling, General and Administrative (SG&A) expenses

    SG&A expenses for the fourth quarter of 2019 were $30.3 million, compared to $27.6 million for the same period in the prior year. For the year ended December 31, 2019, SG&A expenses were $114.4 million, compared to $109.1 million for the year ended December 31, 2018. SG&A expenses in both periods were primarily attributable to sales force costs and external spend related to GOCOVRI commercialization.  

    Net loss

    Net loss was $23.1 million, or $0.83 per share, basic and diluted, for the fourth quarter of 2019, compared to a net loss of $28.9 million, or $1.06 per share, basic and diluted, for the fourth quarter of 2018. Net loss for the fourth quarters of 2019 and 2018 included $2.1 million and $3.8 million, respectively, in non-cash stock-based compensation expense. Net loss for the year ended December 31, 2019, was $105.2 million, or $3.80 per share, basic and diluted, compared with a net loss for the same period in 2018 of $131.0 million, or $4.87 per share, basic and diluted. Net loss for full year 2019 and full year 2018 included $12.9 million and $15.8 million, respectively, in non-cash stock-based compensation expense.

    Cash and investments

    As of December 31, 2019, the Company had $132.6 million of cash, cash equivalents and available-for-sale securities, compared to $210.9 million at December 31, 2018.

    Full year 2020 expense guidance

    For 2020, the Company estimates R&D, SG&A and stock-based compensation expenses as set forth below:

        Full Year 2020
         
    R&D expenses1   $10 million -- $15 million
         
    SG&A expenses2   $110 million -- $120 million
         
    Total operating expenses3   $120 million -- $135 million

    1Includes stock-based compensation expense of $2 million.

    2Includes stock-based compensation expense of $9 million.

    3Includes stock-based compensation expense of $11 million. 

    Investor conference call and webcast

    Adamas will host a conference call and webcast today, February 25, 2020, at 4:30 p.m. ET (1:30 p.m. PT). The conference call may be accessed by dialing (844) 215-3280 (U.S./Canada) or (484) 747-6383 (international) using the ID 4448019. The webcast can be accessed live via the investor section of the Adamas website at http://ir.adamaspharma.com/events-presentations and will be available for replay until May 25, 2020.

    About GOCOVRI®

    GOCOVRI® (amantadine) extended release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About Adamas Pharmaceuticals, Inc.

    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations of its full year 2020 expenses, and its expectations to complete additional analyses of the data from the INROADS trial to fully characterize the profile of ADS-5102 for multiple sclerosis patients with walking impairment and assess the value and potential for the program in the first half of 2020. Such statements are subject to risks and uncertainties, and 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 GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 25, 2020, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Investors: Media:
    Peter Vozzo Sarah Mathieson
    Westwicke Vice President of Corporate Communications
    443-213-0505 510-450-3528

    — Financial Tables Attached —


     
    Adamas Pharmaceuticals, Inc.
    Unaudited Condensed Consolidated Statements of Operations
    (in thousands, except per share data)
     
      Three Months Ended
    December 31,
      Twelve Months Ended
    December 31,
      2019   2018   2019   2018
    Revenues:              
    Product sales $ 16,348       $ 13,315       $ 54,637       $ 34,046    
    Costs and operating expenses:              
    Cost of product sales 442       435       2,469       633    
    Research and development 5,180       10,597       30,034       39,300    
    Selling, general and administrative, net 30,285       27,582       114,369       109,135    
    Total costs and operating expenses 35,907       38,614       146,872       149,068    
    Loss from operations (19,559 )     (25,299 )     (92,235 )     (115,022 )  
    Interest and other income, net 124       184       2,093       3,115    
    Interest expense (3,640 )     (3,768 )     (15,044 )     (19,092 )  
    Net loss $ (23,075 )     $ (28,883 )     $ (105,186 )     $ (130,999 )  
    Net loss per share, basic and diluted $ (0.83 )     $ (1.06 )     $ (3.80 )     $ (4.87 )  
    Weighted average shares used in computing net loss per share, basic and diluted 27,890       27,357       27,677       26,886    


     
    Adamas Pharmaceuticals, Inc.
    Unaudited Consolidated Balance Sheet Data
    (in thousands)
     
      December 31,
    2019
      December 31,
    2018
    Cash, cash equivalents, and available-for-sale securities $ 132,607       $ 210,870  
    Total assets 162,158       234,814  
    Total current liabilities 26,948       24,276  
    Long-term debt 125,674       117,457  
    Total liabilities 163,051       144,929  
    Total stockholders' equity (deficit) (893 )     89,885  

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  37. EMERYVILLE, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the following investor conferences:

    • SVB Leerink Global Healthcare Conference on Thursday, February 27 at 9:00-9:25 a.m. ET
      (6:00 a.m. PT)
    • Cowen Annual Healthcare Conference on Wednesday, March 4 at 9:20 a.m.-9:50 a.m. ET
      (6:20 a.m. PT)

    The presentations will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived…

    EMERYVILLE, Calif., Feb. 20, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the following investor conferences:

    • SVB Leerink Global Healthcare Conference on Thursday, February 27 at 9:00-9:25 a.m. ET
      (6:00 a.m. PT)
    • Cowen Annual Healthcare Conference on Wednesday, March 4 at 9:20 a.m.-9:50 a.m. ET
      (6:20 a.m. PT)

    The presentations will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the webcast will be available via replay for 30 days following the presentations.

    About Adamas Pharmaceuticals, Inc.
    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com.

    Contact:
    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528

    Primary Logo

    View Full Article Hide Full Article
  38. EMERYVILLE, Calif., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report 2019 fourth quarter financial results on Tuesday, February 25, 2020, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast
    The conference call can be accessed by dialing (844) 215-3280 for participants in the U.S. or Canada and  (484) 747-6383 for international callers. The webcast can be accessed live via the investor section of the Adamas website at ir.adamaspharma.com/events-presentations and will be available for replay until May…

    EMERYVILLE, Calif., Feb. 19, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report 2019 fourth quarter financial results on Tuesday, February 25, 2020, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast
    The conference call can be accessed by dialing (844) 215-3280 for participants in the U.S. or Canada and  (484) 747-6383 for international callers. The webcast can be accessed live via the investor section of the Adamas website at ir.adamaspharma.com/events-presentations and will be available for replay until May 25, 2020.

    About Adamas Pharmaceuticals, Inc.
    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com.

    Contact

    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Corporate Communications
    510-450-3528

    Primary Logo

    View Full Article Hide Full Article
  39. EMERYVILLE, Calif., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, announced today two presentations on GOCOVRI® (amantadine) extended release capsules for the treatment of dyskinesia in people with Parkinson's disease (PD) receiving levodopa-based therapy at the 3rd Pan American Parkinson's Disease and Movement Disorders Congress (PAS-MDS), February 14-16, 2020 in Miami, Florida.

    "The data presented at this year's MDS-PAS conference build upon the growing evidence that GOCOVRI can help improve good ON time in patients with PD who experience levodopa-induced dyskinesia…

    EMERYVILLE, Calif., Feb. 13, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, announced today two presentations on GOCOVRI® (amantadine) extended release capsules for the treatment of dyskinesia in people with Parkinson's disease (PD) receiving levodopa-based therapy at the 3rd Pan American Parkinson's Disease and Movement Disorders Congress (PAS-MDS), February 14-16, 2020 in Miami, Florida.

    "The data presented at this year's MDS-PAS conference build upon the growing evidence that GOCOVRI can help improve good ON time in patients with PD who experience levodopa-induced dyskinesia," said Jean Hubble, Vice President, Medical Affairs at Adamas. "We are proud to present clinical results that suggest GOCOVRI may provide additional treatment benefit for people with Parkinson's who have an insufficient response to deep brain stimulation, amantadine immediate release, or both – providing patients with more good ON time, with less troublesome dyskinesia and reduced OFF time." 

    The posters will be presented during the dyskinesia poster session taking place in the Biscayne Ballroom at the InterContinental Miami Hotel on Friday, February 14, from 1:00 pm to 2:30pm Eastern Standard Time. Details of the poster presentations are as follows:

      Poster 54: "Reduced Dyskinesia and OFF time in PD Patients with DBS Following Switch from Amantadine IR to GOCOVRI (Amantadine) Extended Release Capsules: Analysis of 2-Year Open-Label Trial (EASE LID 2)"
    Lead author: Caroline M. Tanner, MD, PhD, University of California San Francisco
       
      Poster 55: "PD Patient Diaries Demonstrated GOCOVRI (Amantadine) Extended Release Capsules Improved ON Time without Dyskinesia: Results from Pooled Phase 3 Clinical Trials"
    Lead author: Robert A. Hauser, MD, University of South Florida

    About Parkinson's Disease, Dyskinesia and OFF
    Parkinson's Disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people are likely to experience unpredictable stiffness, rigidity and tremors, referred to as OFF time. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement and OFF time lead to considerable impact on patients' lives.

    About GOCOVRI®
    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About Adamas Pharmaceuticals, Inc.
    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies to address a range of neurological diseases. For more information, please visit www.adamaspharma.com

    Forward-looking statements
    Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and 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' commercial activities relating to GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2019, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528

    Primary Logo

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  40. -  Final results reported from the longest-running clinical trial of an amantadine product in Parkinson's disease

    - Patients taking GOCOVRI experienced long-term reductions in both dyskinesia and OFF time sustained for at least two years

    EMERYVILLE, Calif., Feb. 11, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a clinically meaningful difference for people affected by neurological diseases, today announced the publication of final results from a two-year open-label study in Parkinson's disease (PD) that demonstrated a sustained improvement in levodopa-induced dyskinesia (LID) among patients using GOCOVRI® (amantadine) extended-release capsules.

    The trial…

    -  Final results reported from the longest-running clinical trial of an amantadine product in Parkinson's disease

    - Patients taking GOCOVRI experienced long-term reductions in both dyskinesia and OFF time sustained for at least two years

    EMERYVILLE, Calif., Feb. 11, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) a company dedicated to developing and delivering medicines that make a clinically meaningful difference for people affected by neurological diseases, today announced the publication of final results from a two-year open-label study in Parkinson's disease (PD) that demonstrated a sustained improvement in levodopa-induced dyskinesia (LID) among patients using GOCOVRI® (amantadine) extended-release capsules.

    The trial enrolled 223 patients, and results demonstrated that the treatment effect of GOCOVRI on motor complications (dyskinesia and OFF), as measured by the Movement Disorder Society‐Unified Parkinson's Disease Rating Scale (MDS‐UPDRS), Part IV, was maintained for at least two years. This effect was seen in all subgroups, including those who continued treatment from prior double-blind trials, from placebo or amantadine immediate release (IR), as well as a subgroup of patients with dyskinesia receiving deep brain stimulation (DBS) treatment.

    Published online in the Journal of Parkinson's Disease, the new paper titled "EASE LID 2: A 2-year open-label trial of GOCOVRI (amantadine) extended release for dyskinesia in Parkinson's disease," shares results from the 223-participant study (mean PD duration, 11.7 years; mean levodopa use, 9.3 years). The EASE LID 2 study was designed to reflect real-world treatment conditions by including patients with DBS implants and those switching from amantadine IR, while also allowing study physicians to adjust patient's other PD medications as needed during the study.

    "As the longest-running amantadine study to date, this open-label trial suggests GOCOVRI may provide sustained improvement in both dyskinesia and OFF to a wide cohort of patients with Parkinson's disease living with motor complications," said Dr. Caroline Tanner, Professor, Dept. of Neurology at University of California, San Francisco. "These results expand not only our knowledge of GOCOVRI efficacy but also of its long-term safety in these patients."

    "These newly published results suggest that GOCOVRI may reduce dyskinesia and OFF as far out as 100 weeks, providing sustained benefits to patients with levodopa-induced dyskinesia. Given the chronic nature of Parkinson's disease, both patients and physicians seek treatments that are effective long-term," said Jean Hubble, MD, Vice President of Medical Affairs for Adamas. "This study further demonstrates that the only FDA-approved medicine for dyskinesia may help people with PD who are struggling to manage these levodopa-related motor complications over this long period of time."

    Overall the median treatment duration for trial participants was 1.9 years. In total, 13.9% discontinued the study because of adverse events considered to be related to GOCOVRI. All patients who received at least one dose of GOCOVRI were included in the safety analyses, which demonstrated findings broadly consistent with the phase III trials and product labeling. Common adverse events were falls, hallucinations, peripheral edemas, constipation and urinary tract infections.

    Reference:
    Full open access study: "EASE LID 2: A 2-Year Open-Label Trial of Gocovri (Amantadine) Extended Release for Dyskinesia in Parkinson's Disease"
    Published in the Journal of Parkinson's Disease, online in pre-press mode ahead of publication of the issue.

    Link: https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd191841

    DOI: 10.3233/JPD-191841

    About Parkinson's Disease, Dyskinesia and OFF
    Parkinson's Disease (PD) is a progressive, neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine and affects approximately one million people in the United States. Dopamine decline in the brain results in a wide range of motor (movement-related) and non-motor symptoms. As the disease progresses, people are likely to experience unpredictable stiffness, rigidity and tremors, referred to as OFF time. The primary treatment for PD is with levodopa; however, over time levodopa may lead to involuntary, uncontrolled movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of dyskinesia, normal movement and OFF time lead to considerable impact on patients' lives.

    About GOCOVRI®
    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day.  Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. 

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    IMPORTANT SAFETY INFORMATION

    CONTRAINDICATIONS

    GOCOVRI® is contraindicated in patients with creatinine clearance below 15 mL/min/1.73 m2

    WARNINGS AND PRECAUTIONS

    Falling Asleep During Activities of Daily Living and Somnolence:  Patients treated with Parkinson's disease medications have reported falling asleep during activities of daily living. If a patient develops daytime sleepiness during activities that require full attention (e.g., driving a motor vehicle, conversations, eating), GOCOVRI should ordinarily be discontinued or the patient should be advised to avoid potentially dangerous activities.

    Suicidality and Depression: Monitor patients for depression, including suicidal ideation or behavior. Prescribers should consider whether the benefits outweigh the risks of treatment with GOCOVRI in patients with a history of suicidality or depression. 

    Hallucinations/Psychotic Behavior: Patients with a major psychotic disorder should ordinarily not be treated with GOCOVRI because of the risk of exacerbating psychosis. Observe patients for the occurrence of hallucinations throughout treatment, especially at initiation and after dose increases.

    Dizziness and Orthostatic Hypotension: Monitor patients for dizziness and orthostatic hypotension, especially after starting GOCOVRI or increasing the dose.

    Withdrawal-Emergent Hyperpyrexia and Confusion:  Rapid dose reduction or abrupt discontinuation of GOCOVRI, may cause an increase in the symptoms of Parkinson's disease or cause delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression, or slurred speech.   Avoid sudden discontinuation of GOCOVRI.

    Impulse Control/Compulsive Behaviors: Patients may experience urges (e.g. gambling, sexual, money spending, binge eating) and the inability to control them. It is important for prescribers to ask patients or their caregivers about the development of new or increased urges. Consider dose reduction or stopping medications.

    ADVERSE REACTIONS

    The most common adverse reactions (>10%) were hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension.

    Please see full Prescribing Information for additional important safety information at https://www.gocovri.com/assets/pdfs/Gocovri_Prescribing_Information.pdf.

    About Adamas Pharmaceuticals, Inc.

    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company focused on growing a portfolio of therapies that address a range of neurological diseases. For more information, please visit www.adamaspharma.com

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future, including the expectations as to the long-term benefits of GOCOVRI, are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and 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' commercial activities relating to GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2019, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528

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  41. EMERYVILLE, Calif., Jan. 10, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted two new employees the option to purchase an aggregate of 12,000 shares of the company's common stock, at a per share exercise price of $5.11, the closing trading price on January 8, and restricted stock units to acquire 6,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce…

    EMERYVILLE, Calif., Jan. 10, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted two new employees the option to purchase an aggregate of 12,000 shares of the company's common stock, at a per share exercise price of $5.11, the closing trading price on January 8, and restricted stock units to acquire 6,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc. 
    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company with a growing portfolio of therapies that address a range of neurological diseases. In 2018, Adamas successfully launched GOCOVRI® (amantadine) extended-release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. GOCOVRI is also the only medicine clinically proven to reduce both dyskinesia and OFF. For more information, please visit www.adamaspharma.com.

    Contact:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Communications & Engagement
    510-450-3528

    Primary Logo

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  42. -- Product sales expected to be approximately $16.3 million for fourth quarter 2019 and approximately $54.6 million for full year 2019 --

    -- Total prescriptions of approximately 7,160 for fourth quarter 2019 and approximately 25,780 for full year 2019 --

    EMERYVILLE, Calif., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today provides preliminary unaudited fourth quarter and full year 2019 product sales for GOCOVRI® (amantadine) extended release capsules and outlines key business priorities for 2020. 

    "We are pleased by our fourth quarter product sales, which reflect…

    -- Product sales expected to be approximately $16.3 million for fourth quarter 2019 and approximately $54.6 million for full year 2019 --

    -- Total prescriptions of approximately 7,160 for fourth quarter 2019 and approximately 25,780 for full year 2019 --

    EMERYVILLE, Calif., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today provides preliminary unaudited fourth quarter and full year 2019 product sales for GOCOVRI® (amantadine) extended release capsules and outlines key business priorities for 2020. 

    "We are pleased by our fourth quarter product sales, which reflect recent operational improvements and the continued advancement of GOCOVRI's commercialization," said Neil F. McFarlane, Chief Executive Officer of Adamas. "In 2020, we intend to further strengthen our operations to benefit Parkinson's disease patients with dyskinesia as well as OFF. Additionally, the recently announced settlement agreement with Sandoz demonstrates the strength of Adamas' intellectual property. We are well-positioned to optimize the opportunity for GOCOVRI and to invest strategically in the growth of Adamas."

    Preliminary Unaudited Fourth Quarter and Full-Year 2019 Product Sales for GOCOVRI

    GOCOVRI product sales for the full year 2019 are anticipated to be approximately $54.6 million compared to $34.0 million for the same period in 2018, an increase of 60%. Product sales for 2019 were based on total prescriptions of approximately 25,780 compared to 15,500 in 2018. Adamas expects GOCOVRI product sales to be approximately $16.3 million for the fourth quarter 2019 compared to $13.9 million for the third quarter 2019, a sequential increase of 17%. Fourth quarter 2019 prescriptions were 7,160 compared to 6,640 prescriptions for the third quarter 2019. New patients started on GOCOVRI in the fourth quarter 2019 was 750 compared to 710 in the preceding quarter. Adamas had approximately $132.6 million of cash, cash equivalents, and available-for-sale securities at December 31, 2019. These preliminary results are based on management's initial analysis of operations for the quarter ended December 31, 2019. Adamas expects to report its full financial results for the fourth quarter and fiscal year 2019 in February 2020.

    Key Priorities for 2020

    GOCOVRI Commercialization

    In 2020, Adamas plans to advance GOCOVRI performance through:

    • Effective differentiation of GOCOVRI by communicating its unique clinical profile to drive health care provider adoption under experienced commercial leadership;
    • Increased demand for GOCOVRI by elevating the urgency to treat dyskinesia and OFF in Parkinson's disease through education about their disruptive impact on patients, both directly and through partnerships with advocacy organizations; and
    • Reducing barriers to access and improving fulfillment to provide an enhanced customer experience, while maintaining strong persistence on GOCOVRI.

    ADS-5102 Multiple Sclerosis Walking Impairment Development

    Adamas expects to engage with the FDA in the first half of 2020 to discuss a potential regulatory pathway for ADS-5102 for multiple sclerosis patients with walking impairment based on data from the INROADS Phase 3 trial.

    Management Update

    Adamas announces today that Jennifer J. Rhodes, General Counsel, Chief Business Officer, Chief Compliance Officer and Corporate Secretary, and Rajiv Patni, M.D., Chief Medical Officer, are leaving the company.

    "I want to thank Jennifer and Rajiv for their many contributions to Adamas over the years," said Mr. McFarlane. "Both have played important roles in helping transform Adamas from a development-stage company to a fully-integrated company delivering a meaningful difference for people affected by neurological diseases. Adamas is positioned for growth and we will maintain management continuity through these transitions, and ensure effective leadership going forward."

    About GOCOVRI® 
    GOCOVRI® (amantadine) extended release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once-daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About Adamas Pharmaceuticals, Inc.

    At Adamas, our purpose and vision are clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company with a growing portfolio of therapies that address a range of neurological diseases. For more information, please visit www.adamaspharma.com

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations of its fourth quarter and full year product sales of GOCOVRI and year end cash, cash equivalents, and available-for-sale securities, and its expectations to advance GOCOVRI and engage with the FDA in the first half of 2020 to discuss a potential regulatory pathway for ADS-5102 for multiple sclerosis patients with walking impairment. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied by such forward-looking statements. For example, with respect to the 2019 preliminary financial results, these results are unaudited and are subject to revision during the audit process. 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 GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2019, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528

    Primary Logo

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  43. EMERYVILLE, Calif., Jan. 02, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that it has entered into a Settlement Agreement with Sandoz Inc. ("Sandoz") resolving its ongoing litigation concerning Sandoz's Abbreviated New Drug Application ("ANDA") seeking approval by the U.S. Food and Drug Administration to market a generic version of GOCOVRI® (amantadine) Extended Release Capsules. 

    "I am pleased to announce this settlement agreement with Sandoz, which demonstrates the strength of Adamas' intellectual property and provides both parties with certainty," said…

    EMERYVILLE, Calif., Jan. 02, 2020 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that it has entered into a Settlement Agreement with Sandoz Inc. ("Sandoz") resolving its ongoing litigation concerning Sandoz's Abbreviated New Drug Application ("ANDA") seeking approval by the U.S. Food and Drug Administration to market a generic version of GOCOVRI® (amantadine) Extended Release Capsules. 

    "I am pleased to announce this settlement agreement with Sandoz, which demonstrates the strength of Adamas' intellectual property and provides both parties with certainty," said Neil F. McFarlane, Chief Executive Officer of Adamas Pharmaceuticals, Inc. "With the launch of GOCOVRI still in its early stages, this agreement facilitates our ability to maximize the number of patients who may benefit from GOCOVRI."

    Under the settlement agreement, Adamas grants Sandoz a non-exclusive license to make, use, sell, offer to sell and import the products that are the subject of Sandoz's ANDA as of March 4, 2030, or earlier in certain circumstances, including a potential for an accelerated license date if the unit sales of GOCOVRI in the 12-month period ending July 31, 2025 or any subsequent 12-month period decline by a specified percentage below the unit sales of GOCOVRI in the year ended December 31, 2019.  The agreed-upon entry date for Sandoz's generic version of GOCOVRI of March 4, 2030 is less than nine months prior to the December 2, 2030 expiration of the last-to-expire patent, on which Sandoz submitted a certification qualifying it for 180-day first filer exclusivity.

    In accordance with the Settlement Agreement, the parties will submit a joint stipulation and order to the United States District Court for the District of New Jersey, and the Settlement Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice. Upon entry of the joint stipulation and order, this Settlement Agreement will conclude all patent litigation brought to date by Adamas against generic pharmaceutical companies that filed an ANDA seeking approval to market generic versions of GOCOVRI prior to the expiration of the patents listed in the Orange Book.

    About GOCOVRI® 
    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once-daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day.  Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies.  The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About Adamas Pharmaceuticals, Inc.
    At Adamas, our purpose is clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society.  We are a fully-integrated company with a growing portfolio of therapies that address a range of neurological diseases.  For more information, please visit www.adamaspharma.com

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties, and 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 GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2019, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Investors:
    Peter Vozzo
    Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528

    Primary Logo

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  44. E-Scape Bio, Inc., a clinical stage, privately held biopharmaceutical company developing novel, precisely-targeted therapeutics for genetically-defined neurodegenerative diseases, today announced the appointment of Tony Rimac as Chief Financial Officer (CFO) and Ann Kapoun, Ph.D., as SVP of R&D.

    "Tony and Ann bring a wealth of experience that will serve us well as we continue to advance our research capabilities and prepare for future financings. With over 30 years of experience building and growing biotech organizations through diligent financial planning and execution, Tony will provide financial and strategic leadership that will be instrumental as we advance E-Scape Bio into its next stage of growth," said Julie Anne Smith, CEO. "Ann

    E-Scape Bio, Inc., a clinical stage, privately held biopharmaceutical company developing novel, precisely-targeted therapeutics for genetically-defined neurodegenerative diseases, today announced the appointment of Tony Rimac as Chief Financial Officer (CFO) and Ann Kapoun, Ph.D., as SVP of R&D.

    "Tony and Ann bring a wealth of experience that will serve us well as we continue to advance our research capabilities and prepare for future financings. With over 30 years of experience building and growing biotech organizations through diligent financial planning and execution, Tony will provide financial and strategic leadership that will be instrumental as we advance E-Scape Bio into its next stage of growth," said Julie Anne Smith, CEO. "Ann is a seasoned leader with a deep understanding of drug development. Her expertise driving programs from discovery through early development will be invaluable as we advance multiple novel, precisely-targeted therapeutics into the clinic."

    Tony brings over 30 years of broad operating and finance experience, including over 20 years of financial leadership within the life sciences industry. Tony joins E-Scape Bio from Chrono Therapeutics Inc., where he served as Chief Financial Officer and Chief Business Officer. Prior to Chrono, he also served as CFO of Aldea Pharmaceuticals, Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a neurology focused company where he led the Initial Public Offering, and Aerovance, Inc., a privately held biopharmaceutical company focused on development and commercialization of clinical-stage products for respiratory and allergic diseases. In his 20 years in the life sciences industry, he has worked in biotech, specialty pharmaceuticals, drug delivery, medical devices and digital therapeutics and has raised in excess of $450M in private and public equity, debt capital and partnership financing.

    Dr. Kapoun comes to E-Scape with more than two decades of leadership and research experience advancing over 10 drug discoveries through early clinical development. She was most recently SVP of Translational Medicine at OncoMed Pharmaceuticals and previously held scientific leadership roles at ALZA and Scios Inc., a biopharma unit of Johnson & Johnson. Dr. Kapoun received her Ph.D. at Howard Hughes Medical Institute, Indiana University and has coauthored more than 50 scientific publications and patents.

    (All bios available at http://www.e-scapebio.com/company/senior-management.php)

    About E-Scape Bio

    E-Scape Bio is a clinical stage, privately held biopharmaceutical company developing novel, precisely-targeted therapeutics for genetically-defined neurodegenerative diseases. E-Scape's pipeline includes small molecules targeting known genetic drivers of CNS disorders including ESB1609 for the treatment of CNS lysosomal storage disorders, a Parkinson's disease program targeting LRRK2 and an Alzheimer's disease program targeting ApoE4. For additional information, please visit www.e-scapebio.com.

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  45. - INROADS study achieved its primary endpoint (proportion of responders with at least a 20% improvement from baseline to Week 12) -

    - Dose-response observed for both efficacy and safety -

    - Safety data consistent with known safety profile of amantadine -

    EMERYVILLE, Calif., Dec. 17, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that INROADS, a 3-arm, randomized, double-blind, placebo-controlled study in 594 multiple sclerosis (MS) patients with walking impairment met its primary endpoint. 

    Results from the study showed that patients taking 274 mg ADS-5102…

    - INROADS study achieved its primary endpoint (proportion of responders with at least a 20% improvement from baseline to Week 12) -

    - Dose-response observed for both efficacy and safety -

    - Safety data consistent with known safety profile of amantadine -

    EMERYVILLE, Calif., Dec. 17, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a company dedicated to developing and delivering medicines that make a clinically meaningful difference to people affected by neurological diseases, today announced that INROADS, a 3-arm, randomized, double-blind, placebo-controlled study in 594 multiple sclerosis (MS) patients with walking impairment met its primary endpoint. 

    Results from the study showed that patients taking 274 mg ADS-5102 had a statistically significant improvement in response rate of 21.1% compared to 11.3% taking placebo (p=0.01). Response was defined as at least a 20% improvement in walking speed from baseline to 12 weeks post-treatment, as measured by the Timed 25 Foot Walk. Additionally, the response rate for patients taking a lower dose of 137 mg ADS-5102 was 17.6% (p=0.08). ADS-5102 did not demonstrate a significant effect on the secondary walking measures at either dose. 

    "We are pleased that ADS-5102 shows a potential benefit for MS patients with walking impairment, for whom there is a significant unmet medical need and limited treatment options," said Neil F. McFarlane, Chief Executive Officer of Adamas Pharmaceuticals, Inc. "However, as we did not see the scale of clinical benefit we had hoped for in this study we will fully assess the potential for ADS-5102 in MS patients before determining the extent of our continued investment in this program."

    The most common adverse events (occurring in greater than 5% of any ADS-5102 treatment group) were: peripheral edema, dry mouth, fall, constipation, UTI, and insomnia.  20.5% of patients discontinued study drug due to adverse events in the 274 mg group, compared to 6.4% in the 137 mg group, and 3.8% in the placebo group. The reported adverse events associated with ADS-5102 in this study were dose-dependent and consistent with the known safety profile of amantadine.

    "We would like to extend our sincere thanks to everyone involved in this study including the patients, investigators, and coordinators," said Rajiv Patni, M.D., Chief Medical Officer of Adamas Pharmaceuticals, Inc. "We will now complete our analyses of these data to fully characterize the efficacy and safety profile of ADS-5102 and the dose response seen in this study.  Given these data, we will not initiate the originally planned replicate second Phase 3 placebo-controlled study.  We are continuing the open-label extension study and will engage with the FDA to discuss a potential regulatory pathway."

    "Walking impairment negatively impacts many aspects of daily life for a large number of patients, and additional treatment options are needed," said INROADS Steering Committee Chair, Jeffrey Cohen, M.D., Director of experimental therapeutics at the Mellen Center for Multiple Sclerosis at Cleveland Clinic and a paid consultant for Adamas. "This trial result is encouraging for the MS patient and physician community and we look forward to reviewing the full data set."

    About ADS-5102

    Adamas is evaluating ADS-5102 in the INROADS Phase 3 clinical study for multiple sclerosis patients with walking impairment. ADS-5102 was previously approved by the FDA under the trade name GOCOVRI® (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy. GOCOVRI is not FDA-approved for the treatment of multiple sclerosis patients with walking impairment.

    About INROADS

    The INROADS study was a 12-week, three-arm, multi-center, randomized, double-blind, placebo-controlled study with a 4-week placebo-run in designed to evaluate the efficacy and safety of ADS-5102 for the treatment of walking impairment in multiple sclerosis. The study enrolled 594 patients with walking impairment in the US and Canada and randomized 560 patients in a 1:1:1 fashion to receive 274 mg ADS-5102 (N=185), 137 mg ADS-5102 (N=187), or placebo (N=186). The primary endpoint was the proportion of responders (at least 20% improvement in Timed 25-Foot Walk from baseline) at Week 12.  
    Key secondary endpoints include the mean change in the Timed 25-Foot Walk, the Timed Up and Go, and the 2-Minute Walk at 12-week post-treatment at both the 274 mg and 137 mg dose.

    Baseline characteristics were similar across all treatment arms. The mean time since diagnosis of MS was 15.9 years, median EDSS at screening was 6.0, and mean timed 25-foot walk at baseline was between 11.5 to 12.4 seconds. Prior dalfampridine use was reported in 52.5% of patients and prior amantadine use was reported in 12.9% of patients. 

    About Walking Impairment in Multiple Sclerosis
    Multiple sclerosis (MS) is a chronic neurological autoimmune disease that is often disabling with unpredictable symptoms. Among the MS patients in the US, nearly 270,000 have walking impairment, which is present throughout the day. Walking impairment in MS remains an area of high unmet need, as there is only one approved product on the market for this indication.

    About Adamas Pharmaceuticals, Inc.

    At Adamas, our purpose is clear: deliver innovative medicines that make a clinically meaningful difference for patients, caregivers and society. We are a fully-integrated company with a growing portfolio of therapies that address a range of neurological diseases. For more information, please visit www.adamaspharma.com

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' development plans for ADS-5102, including its plan to fully assess its program in multiple sclerosis walking impairment and engage with the FDA on a potential regulatory pathway.  Such statements are subject to risks and uncertainties, and 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 GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2019, particularly under the caption "Risk Factors." 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, except as required by law.

    Contact:

    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528

    Primary Logo

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  46. Glancy Prongay & Murray LLP ("GPM") announces an investigation on behalf of Adamas Pharmaceuticals, Inc. ("Adamas" or the "Company") (NASDAQ: ADMS) investors concerning the Company and its officers' possible violations of federal securities laws.

    If you are a shareholder who suffered a loss, click here to participate.

    On March 4, 2019, Adamas revised previous prescription growth estimates for GOCOVRI, the Company's primary product, warned of a continued slowdown in GOCOVRI prescriptions, and refused to predict GOCOVRI's ability to achieve a sizeable market share.

    On this news, Adamas' share price fell $3.99 per share, or more than 32%, to close at $8.16 per share on March 5, 2019, thereby injuring investors.

    Then, on September 30, 2019…

    Glancy Prongay & Murray LLP ("GPM") announces an investigation on behalf of Adamas Pharmaceuticals, Inc. ("Adamas" or the "Company") (NASDAQ: ADMS) investors concerning the Company and its officers' possible violations of federal securities laws.

    If you are a shareholder who suffered a loss, click here to participate.

    On March 4, 2019, Adamas revised previous prescription growth estimates for GOCOVRI, the Company's primary product, warned of a continued slowdown in GOCOVRI prescriptions, and refused to predict GOCOVRI's ability to achieve a sizeable market share.

    On this news, Adamas' share price fell $3.99 per share, or more than 32%, to close at $8.16 per share on March 5, 2019, thereby injuring investors.

    Then, on September 30, 2019, an analyst lowered its rating on Adamas due to "existing overhangs," including lack of "Gocovri coverage: a number of national formularies exclude Gocovri." The analyst "expect[ed] reimbursement hurdles in MSWI space especially with generic Ampyra launch."

    On this news, Adamas' share price fell $3.02 per share, or more than 42%, over several trading sessions to close at $4.03 per share on October 3, 2019, thereby injuring investors further.

    If you purchased Adamas securities, have information, or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Charles H. Linehan, of GPM, 1925 Century Park East, Suite 2100, Los Angeles, CA 90067 at 310-201-9150, Toll-Free at 888-773-9224, or visit our website at www.glancylaw.com. If you inquire by email please include your mailing address, telephone number, and the number of shares purchased.

    This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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  47. Law Offices of Howard G. Smith announces an investigation on behalf of Adamas Pharmaceuticals, Inc. ("Adamas" or the "Company") (NASDAQ: ADMS) investors concerning the Company and its officers' possible violations of federal securities laws.

    On March 4, 2019, Adamas revised previous prescription growth estimates for GOCOVRI, the Company's primary product, warned of a continued slowdown in GOCOVRI prescriptions, and refused to predict GOCOVRI's ability to achieve a sizeable market share.

    On this news, Adamas' share price fell $3.99 per share, or more than 32%, to close at $8.16 per share on March 5, 2019, thereby injuring investors.

    Then, on September 30, 2019, an analyst lowered its rating on Adamas due to "existing overhangs," including…

    Law Offices of Howard G. Smith announces an investigation on behalf of Adamas Pharmaceuticals, Inc. ("Adamas" or the "Company") (NASDAQ: ADMS) investors concerning the Company and its officers' possible violations of federal securities laws.

    On March 4, 2019, Adamas revised previous prescription growth estimates for GOCOVRI, the Company's primary product, warned of a continued slowdown in GOCOVRI prescriptions, and refused to predict GOCOVRI's ability to achieve a sizeable market share.

    On this news, Adamas' share price fell $3.99 per share, or more than 32%, to close at $8.16 per share on March 5, 2019, thereby injuring investors.

    Then, on September 30, 2019, an analyst lowered its rating on Adamas due to "existing overhangs," including lack of "Gocovri coverage: a number of national formularies exclude Gocovri." The analyst "expect[ed] reimbursement hurdles in MSWI space especially with generic Ampyra launch."

    On this news, Adamas' share price fell $3.02 per share, or more than 42%, over several trading sessions to close at $4.03 per share on October 3, 2019, thereby injuring investors further.

    If you purchased Adamas securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to , or visit our website at www.howardsmithlaw.com.

    This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

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  48. EMERYVILLE, Calif., Dec. 09, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted four new employees the option to purchase an aggregate of 89,000 shares of the company's common stock, at a per share exercise price of $6.48, the closing trading price on December 6, and restricted stock units to acquire 44,500 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce…

    EMERYVILLE, Calif., Dec. 09, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted four new employees the option to purchase an aggregate of 89,000 shares of the company's common stock, at a per share exercise price of $6.48, the closing trading price on December 6, and restricted stock units to acquire 44,500 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc.
    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The Company is focused on the commercialization of GOCOVRI® (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company also continues to deliver differentiated investigational programs, including ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com

    Contact:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Communications & Engagement
    510-450-3528

    Primary Logo

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  49. EMERYVILLE, Calif., Nov. 21, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system disorders, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the following investor conferences:

    • Evercore ISI 2nd Annual HealthCONx Conference on Tuesday, December 3 at 9:50 a.m. ET
      (6:50 a.m. PT)
                   
    • Piper Jaffray 31st Annual Healthcare Conference on Wednesday, December 4 at 4:00 p.m. ET
      (1:00 p.m. PT)

    The presentation will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the…

    EMERYVILLE, Calif., Nov. 21, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system disorders, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the following investor conferences:

    • Evercore ISI 2nd Annual HealthCONx Conference on Tuesday, December 3 at 9:50 a.m. ET
      (6:50 a.m. PT)
                   
    • Piper Jaffray 31st Annual Healthcare Conference on Wednesday, December 4 at 4:00 p.m. ET
      (1:00 p.m. PT)

    The presentation will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the webcast will be available via replay for 30 days following the presentations.

    About Adamas Pharmaceuticals, Inc.
    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The Company is focused on the commercialization of GOCOVRI® (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company also continues to deliver differentiated investigational programs, including ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com

    Contact:

    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528

    Primary Logo

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  50. EMERYVILLE, Calif., Nov. 08, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted three new employees the option to purchase an aggregate of 14,500 shares of the company's common stock, at a per share exercise price of $4.70, the closing trading price on November 7, and restricted stock units to acquire 7,250 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce…

    EMERYVILLE, Calif., Nov. 08, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted three new employees the option to purchase an aggregate of 14,500 shares of the company's common stock, at a per share exercise price of $4.70, the closing trading price on November 7, and restricted stock units to acquire 7,250 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc. 
    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The Company is focused on the commercialization of GOCOVRI® (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company also continues to deliver differentiated investigational programs, including ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com

    Contact:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Communications & Engagement
    510-450-3528

    Primary Logo

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  51. - Third quarter GOCOVRI® product sales of $13.9 million; total prescriptions grew to approximately 6,640

    - Topline results from INROADS Phase 3 study of ADS-5102 (GOCOVRI) for walking impairment in patients with multiple sclerosis (MS) expected second half December 2019

    EMERYVILLE, Calif., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system (CNS) disorders, today reported financial results for the third quarter ended September 30, 2019, as well as recent corporate developments. 

    "I'm impressed with the team we have in place and their commitment to develop and commercialize medicines intended to lessen the burden…

    - Third quarter GOCOVRI® product sales of $13.9 million; total prescriptions grew to approximately 6,640

    - Topline results from INROADS Phase 3 study of ADS-5102 (GOCOVRI) for walking impairment in patients with multiple sclerosis (MS) expected second half December 2019

    EMERYVILLE, Calif., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system (CNS) disorders, today reported financial results for the third quarter ended September 30, 2019, as well as recent corporate developments. 

    "I'm impressed with the team we have in place and their commitment to develop and commercialize medicines intended to lessen the burden of chronic neurological diseases on patients, caregivers and society," said Neil F. McFarlane, Chief Executive Officer.  "We continue to identify and execute opportunities to advance GOCOVRI's commercial performance for the benefit of Parkinson's disease patients with dyskinesia and OFF. During the quarter, driven by new patients and  strong persistence, total GOCOVRI prescriptions continued sequential quarter-over-quarter growth."  Mr. McFarlane continued, "In the second half of December, we plan to report topline data from our INROADS Phase 3 study of ADS-5102 for walking impairment in patients with multiple sclerosis.  If successful, this potential second indication for GOCOVRI could be a valuable treatment option for these patients for whom walking impairment remains a significant unmet need."

    Adamas corporate update

    • Neil McFarlane joined Adamas as Chief Executive Officer in September 2019.

    GOCOVRI commercialization updates

    • GOCOVRI product sales were $13.9 million in the third quarter of 2019, compared to $12.7 million in the second quarter of 2019.
    • GOCOVRI generated approximately 6,640 total prescriptions (TRx) in the third quarter of 2019, an 8% sequential increase over approximately 6,160 TRx in the second quarter of 2019. The number of new patients starting on GOCOVRI, primarily patients receiving medication through the free trial program, was approximately 710 in the third quarter, compared to 740 in the second quarter of 2019. 
    • Continued strong patient persistence of 45%-50% at 12 months for GOCOVRI.

    ADS-5102 development update

    • Topline results from the INROADS Phase 3 study of ADS-5102 for walking impairment in patients with multiple sclerosis (MS) are expected in the second half of December 2019.

    Financial results

    Product sales

    GOCOVRI product sales were $13.9 million for the third quarter of 2019, up 31% compared to $10.6 million in the same period in 2018. GOCOVRI product sales were $38.3 million for the nine months ended September 30, 2019, up 85% compared to $20.7 million in the first nine months of 2018.

    GOCOVRI received U.S. Food and Drug Administration (FDA) approval in August 2017, becoming the first and only U.S. FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy. Adamas began commercial promotion of GOCOVRI in January 2018.

    Research and Development (R&D) expenses

    R&D expenses for the third quarter of 2019 were $6.0 million, compared to $11.7 million for the same period a year ago. For the nine months ended September 30, 2019, R&D expenses were $24.9 million, compared to $28.7 million for the nine months ended September 30, 2018. R&D expenses in both periods were primarily attributable to the INROADS Phase 3 study of ADS-5102 for the treatment of walking impairment in patients with MS.

    Selling, General and Administrative (SG&A) expenses

    SG&A expenses for the third quarter of 2019 were $31.2 million, compared to $27.5 million for the same period a year ago. For the nine months ended September 30, 2019, SG&A expenses were $84.1 million, compared to $81.6 million for the nine months ended September 30, 2018. SG&A expenses in both periods were primarily attributable to external and sales force costs related to GOCOVRI commercialization.  

    Net loss

    Net loss was $27.6 million, or $0.99 per share, basic and diluted, for the third quarter of 2019, compared to a net loss of $33.2 million, or $1.22 per share, basic and diluted, for the third quarter of 2018. Net loss for the third quarters of 2019 and 2018 included $4.5 million and $4.1 million, respectively, in non-cash stock-based compensation expense. Net loss for the nine months ended September 30, 2019, was $82.1 million, or $2.97 per share, basic and diluted, compared with a net loss for the same period in 2018 of $102.1 million, or $3.82 per share, basic and diluted. The net loss for the first nine months of 2019 and 2018 included $10.8 million and $12.0 million, respectively, in non-cash stock-based compensation expense.

    Cash and investments

    As of September 30, 2019, Adamas had $150.2 million of cash, cash equivalents and available-for-sale securities, compared to $210.9 million at December 31, 2018.

    Investor conference call and webcast

    Adamas will host a conference call and webcast today, November 7, 2019, at 4:30 p.m. ET (1:30 p.m. PT). The conference call may be accessed by dialing (844) 215-3280 for participants in the U.S. or Canada and (484) 747-6383 for international callers. The webcast can be accessed live via the investor section of the Adamas website at http://ir.adamaspharma.com/events-presentations and will be available for replay until February 7, 2020.

    About GOCOVRI®

    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day.  Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. 

    For more information about GOCOVRI, please visit www.GOCOVRI.com.

    About ADS-5102

    Adamas is currently evaluating ADS-5102 in the INROADS Phase 3 clinical study for walking impairment in patients with multiple sclerosis. ADS-5102 was previously approved by the FDA under the trade name GOCOVRI (amantadine) extended-release capsules for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy. GOCOVRI is not FDA-approved for the treatment of walking impairment in patients with multiple sclerosis.

    About Adamas Pharmaceuticals, Inc.

    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations regarding the performance of GOCOVRI or of topline data from its INROADS Phase 3 study expected in the second half of December 2019. Such statements are subject to risks and uncertainties, and 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 GOCOVRI and ADS-5102, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 7, 2019, particularly under the caption "Risk Factors." 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, except as required by law.


    Contact:

    Investors: Media:
    Peter Vozzo Sarah Mathieson
    Westwicke Vice President of Corporate Communications
    443-213-0505 510-450-3528


    — Financial Tables Attached —


    Adamas Pharmaceuticals, Inc.
    Unaudited Condensed Consolidated Statements of Operations
    (in thousands, except per share data)

      Three Months Ended
     September 30,
      Nine Months Ended
     September 30,
      2019     2018     2019     2018  
    Revenues:              
    Product sales $ 13,933     $ 10,613     $ 38,289     $ 20,731  
    Costs and operating expenses:              
    Cost of product sales 929     100     2,027     198  
    Research and development 6,042     11,709     24,854     28,703  
    Selling, general and administrative, net 31,180     27,491     84,084     81,553  
    Total costs and operating expenses 38,151     39,300     110,965     110,454  
    Loss from operations (24,218 )   (28,687 )   (72,676 )   (89,723 )
    Interest and other income, net 512     921     1,969     2,931  
    Interest expense (3,876 )   (5,386 )   (11,404 )   (15,324 )
    Net loss  $ (27,582 )   $ (33,152 )   $ (82,111 )   $ (102,116 )
    Net loss per share, basic and diluted $ (0.99 )   $ (1.22 )   $ (2.97 )   $ (3.82 )
    Weighted average shares used in computing net loss per share, basic and diluted 27,778     27,266     27,605     26,728  



    Adamas Pharmaceuticals, Inc.
    Unaudited Consolidated Balance Sheet Data
    (in thousands)

      September 30,
    2019
      December 31,
    2018
    Cash, cash equivalents, and available-for-sale securities

     
    $ 150,240   $ 210,870
    Total assets 180,439   234,814
    Total current liabilities 26,358   24,276
    Long-term debt 124,078   117,457
    Total liabilities 160,682   144,929
    Total stockholders' equity 19,757   89,885

     

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  52. EMERYVILLE, Calif., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report 2019 third quarter financial results on Thursday, November 7, 2019, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast
    The conference call can be accessed by dialing (844) 215-3280 for participants in the U.S. or Canada and  (484) 747-6383 for international callers. The webcast can be accessed live via the investor section of the Adamas website at ir.adamaspharma.com/events-presentations and will be available for replay until February…

    EMERYVILLE, Calif., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the company will report 2019 third quarter financial results on Thursday, November 7, 2019, after market close. Subsequently, Adamas' management team will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    Investor Conference Call and Webcast
    The conference call can be accessed by dialing (844) 215-3280 for participants in the U.S. or Canada and  (484) 747-6383 for international callers. The webcast can be accessed live via the investor section of the Adamas website at ir.adamaspharma.com/events-presentations and will be available for replay until February 25, 2019.

    About Adamas Pharmaceuticals, Inc.
    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The Company is focused on the commercialization of GOCOVRI® (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company also continues to deliver differentiated investigational programs, including ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.

    Contact

    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Corporate Communications
    510-450-3528

     

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  53. EMERYVILLE, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted five new employees the option to purchase an aggregate of 44,375 shares of the company's common stock, at a per share exercise price of $4.20 the closing trading price on October 7, and restricted stock units to acquire 22,188 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce…

    EMERYVILLE, Calif., Oct. 08, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted five new employees the option to purchase an aggregate of 44,375 shares of the company's common stock, at a per share exercise price of $4.20 the closing trading price on October 7, and restricted stock units to acquire 22,188 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc.
    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The Company is focused on the commercialization of GOCOVRI® (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company also continues to deliver differentiated investigational programs, including ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com

    Contact:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Communications & Engagement
    510-450-3528

     

    Primary Logo

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  54. EMERYVILLE, Calif., Sept. 27, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system disorders, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the following investor conference:

    • 2019 Cantor Global Healthare Conference on Friday, October 4 at 12:00 p.m. ET (9:00 a.m. PT)

    The presentation will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the webcast will be available via replay for 30 days following the presentations.

    About Adamas Pharmaceuticals, Inc.
    Adamas' goal…

    EMERYVILLE, Calif., Sept. 27, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system disorders, today announced that Neil F. McFarlane, the Company's Chief Executive Officer, is scheduled to present at the following investor conference:

    • 2019 Cantor Global Healthare Conference on Friday, October 4 at 12:00 p.m. ET (9:00 a.m. PT)

    The presentation will be webcast live from the investor relations section of the Adamas website at http://ir.adamaspharma.com/events-presentations. An archived version of the webcast will be available via replay for 30 days following the presentations.

    About Adamas Pharmaceuticals, Inc.
    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The Company is focused on the commercialization of GOCOVRI® (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company also continues to deliver differentiated investigational programs, including ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com

    Contact:

    Investors:
    Peter Vozzo
    Managing Director, Westwicke
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President of Corporate Communications
    510-450-3528

    Primary Logo

    View Full Article Hide Full Article
  55. EMERYVILLE, Calif., Sept. 20, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system (CNS) disorders, announced today the presentation of new data on GOCOVRI® (amantadine) extended release capsules for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy at the Movement Disorder Society (MDS) 2019 International Congress, September 22-26, 2019 in Nice, France. The poster presentations will highlight data derived from the GOCOVRI development program and post-marketing pharmacovigilance surveillance.

    "Adamas' purpose is to significantly improve the lives of people affected by neurological…

    EMERYVILLE, Calif., Sept. 20, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system (CNS) disorders, announced today the presentation of new data on GOCOVRI® (amantadine) extended release capsules for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy at the Movement Disorder Society (MDS) 2019 International Congress, September 22-26, 2019 in Nice, France. The poster presentations will highlight data derived from the GOCOVRI development program and post-marketing pharmacovigilance surveillance.

    "Adamas' purpose is to significantly improve the lives of people affected by neurological diseases, and we remain committed to the presentation of GOCOVRI data to provide further information to support robust clinical discussions," said Rajiv Patni, MD, Chief Medical Officer at Adamas. "Our goal is to ensure that neurologists understand how GOCOVRI may be an option for their Parkinson's disease patients with dyskinesia on dopaminergic therapies by providing them with a treatment that may increase functional ON time by decreasing both dyskinesia and OFF."

    The five posters will be part of the "Clinical Trials, Pharmacology and Treatment" session on Monday, September 23, 2019, from 1:45-3:15pm Central European Time (CET). Details of the poster presentations are as follows:

      Poster 106: "The Effect of GOCOVRI on Motor Aspects of Experiences of Daily Living: Analyses of MDS-UPDRS Part II Data from a Phase 3 Program"
    Lead Author: Dr. Robert Hauser, University of South Florida
       
      Poster 107: "Analysis of the Shape of the GOCOVRI Steady-state PK Profile: Implications for an Extended Release Product"
    Lead Author: Dr. Robert Hauser, University of South Florida
       
      Poster 115: "GOCOVRI Dose Adjustment in Elderly Parkinson's Patients at Risk for Renal Impairment: Implications from an Exposure Simulation Model"
    Lead Author: Dr. Stuart Isaacson, Parkinson's Disease & Movement Disorders Center of Boca Raton
       
      Poster 171: "The Efficacy and Safety of GOCOVRI Based on Age: Special Population Analyses of a Phase 3 Study Program"
    Lead Author: Dr. Rajesh Pahwa, University of Kansas Medical Center
       
      Poster 213: "Safety of GOCOVRI in Clinical Practice: One-Year Post-Launch Pharmacovigilance Data"
    Lead Author: Dr. Caroline Tanner, University of California, San Francisco

    About Parkinson's Disease, OFF and Dyskinesia

    Parkinson's Disease (PD) is a progressive, neurodegenerative disorder caused by a dysregulation of neurotransmitter signaling, afflicting approximately one million people in the United States. The gradual loss of brain cells producing the neurotransmitter dopamine leads to this dysregulation, which results in motor (movement related) and non-motor symptoms. The primary PD treatment approach is with levodopa, a dopamine precursor, that works by entering the brain and being converted to dopamine. While this replacement of dopamine is initially highly effective in relieving motor symptoms, over time, many patients develop a fluctuating, and unpredictable response to levodopa. At low dopamine levels, patients experience stiffness and rigidity, referred to as "OFF" periods, while at high dopamine levels they experience involuntary movements known as dyskinesia. The abrupt and unpredictable transitions between episodes of OFF, dyskinesia and normal movement lead to considerable disruption of patients' lives. At this stage of the disease since the motor symptoms and underlying glutamate hyperactivity are thought to follow a diurnal pattern across the waking day of patients, a therapy that effectively attenuates glutamate hyperactivity using a time-dependent approach, may help improve good motor control throughout the waking day in individuals with dyskinesia and OFF.

    About GOCOVRI
    GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine proven to reduce both dyskinesia and OFF.

    GOCOVRI is thought to work by reducing the amount of glutamate hyperactivity in a region of the brain that controls movement, in patients experiencing dyskinesia and OFF. The NMDA receptor is activated by glutamate and causes post-synaptic nerve signaling in this area of the brain, which is modulated by dopamine.  Levodopa therapy replaces dopamine lost in Parkinson's disease but may result in large fluctuations in synaptic levels of dopamine during waking hours, further exacerbating glutamate hyperactivity. GOCOVRI, developed by Adamas, is novel in that it selectively blocks the NMDA receptor in a time-dependent manner.  Taken at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night and a high concentration from the morning and throughout the waking day. Additionally, the adjunctive use of GOCOVRI does not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension. For more information about GOCOVRI, please see the U.S. Prescribing Information at www.GOCOVRI.com.

    About Adamas Pharmaceuticals, Inc.
    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The Company is focused on the commercialization of GOCOVRI™ (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company also continues to deliver differentiated investigational programs, including ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.

    Important Safety Information

    Before taking GOCOVRI, patients should tell their doctor about all medical conditions, including if they:

    • have kidney problems; unexpected sleepiness; take medicine to help them sleep or that makes them drowsy; have mental problems, such as suicidal thoughts, depression, or hallucinations; unusual urges including gambling, increased sex drive, compulsive eating, or shopping; or if they drink alcoholic beverages.
    • are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. GOCOVRI may harm the unborn baby and can pass into breastmilk.

    Patients should tell their doctor about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements, especially if medicines like sodium bicarbonate are taken.

    What should patients avoid while taking GOCOVRI? Patients should NOT:

    • Take GOCOVRI if they have severe kidney problems.
    • Drive, operate machinery, or do other dangerous activities until they know how GOCOVRI affects them.
    • Drink alcohol while taking GOCOVRI as it can increase their chances of serious side effects.
    • Stop or change the dose of GOCOVRI before talking with their doctor.
    • Take a flu nasal spray vaccine while taking GOCOVRI, but they can receive a flu shot.

    What are the possible side effects of GOCOVRI?

    GOCOVRI may cause serious side effects, including:

    • falling asleep during normal activities, such as driving, talking, or eating, while taking GOCOVRI. Patients may fall asleep without being drowsy or warning. 
    • suicidal thoughts or actions and depression.
    • occurrence or worsening of hallucinations (seeing or hearing things that are not real).
    • feeling dizzy, faint or light headed, especially when standing up too quickly, when first starting GOCOVRI, or if a patient's dose has been increased.
    • unusual urges including gambling, sexual, spending money, binge eating, and the inability to control them.

    If a patient or their family notices that they are developing any new, unusual or sudden changes in behavior or related symptoms, inform the patient's healthcare provider right away.

    The most common side effects of GOCOVRI include dry mouth, swelling of legs and feet, constipation, and falls.

    For additional important safety information, please see GOCOVRI full Prescribing Information at www.gocovri.com.

    Contacts:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505
      

    Media: 
    Sarah Mathieson
    Vice President, Communications and Engagement
    Adamas Pharmaceuticals, Inc.
    510-450-3528

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  56. EMERYVILLE, Calif., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted its new Chief Executive Officer, Neil F. McFarlane, the option to purchase an aggregate of 250,000 shares of the company's common stock, at a per share exercise price of $6.25, the closing trading price on September 16, 2019, and restricted stock units to acquire 125,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq…

    EMERYVILLE, Calif., Sept. 17, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted its new Chief Executive Officer, Neil F. McFarlane, the option to purchase an aggregate of 250,000 shares of the company's common stock, at a per share exercise price of $6.25, the closing trading price on September 16, 2019, and restricted stock units to acquire 125,000 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc. 

    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The Company is focused on the commercialization of GOCOVRI® (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company also continues to deliver differentiated investigational programs, including ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com

    Contact:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505

    Media:
    Sarah Mathieson
    Vice President, Communications & Engagement
    510-450-3528

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  57. - Gregory Went, Ph.D., Founder, transitions to a strategic advisory role

    - David Mahoney, lead independent director, appointed to Chairman of the Board

    EMERYVILLE, Calif., Sept. 13, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system disorders, today announced that Neil McFarlane has been named Chief Executive Officer and appointed to the Adamas Board of Directors, effective September 16th, 2019.  Neil succeeds Gregory Went, Ph.D. who has been Chairman and CEO of Adamas since the company's inception.  Greg will step down from the Board of Directors and transition to a strategic advisory role.     

    Newly appointed Chairman…

    - Gregory Went, Ph.D., Founder, transitions to a strategic advisory role

    - David Mahoney, lead independent director, appointed to Chairman of the Board

    EMERYVILLE, Calif., Sept. 13, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS), a fully-integrated pharmaceutical company pioneering time-dependent medicines for central nervous system disorders, today announced that Neil McFarlane has been named Chief Executive Officer and appointed to the Adamas Board of Directors, effective September 16th, 2019.  Neil succeeds Gregory Went, Ph.D. who has been Chairman and CEO of Adamas since the company's inception.  Greg will step down from the Board of Directors and transition to a strategic advisory role.     

    Newly appointed Chairman of the Board of Adamas, David Mahoney, said: "Neil's appointment as Chief Executive Officer and to the Board is the culmination of a thoughtful succession and transition process undertaken by the Board of Directors.  Neil has a demonstrated track record of accomplishment and brings a broad skill-set incorporating operational, strategic and business development leadership."

    Neil joins Adamas with over 20 years of global biopharmaceutical and life sciences experience delivering value to patients suffering from serious illnesses.  He has delivered growth in both specialty and orphan products in the United States, Europe, Asia and Latin America.  Neil most recently served as Chief Operating Officer of Retrophin, Inc. with principal responsibility for global commercial operations, corporate development, patient services, and program and alliance management.  Previously he held executive and general management positions at leading biopharmaceutical companies, including UCB, Genzyme, and Sangstat Medical Corporation.  Neil served as an officer and enlisted soldier in the United States Army Reserves.  He holds a B.S. and M.S. in Nursing from the University of Florida.

    "I am excited to join Adamas as it navigates a critical stage in the commercialization of GOCOVRI® and prepares for key clinical data in the Phase 3 INROADS trial in Multiple Sclerosis.  The company's focus on delivering significant clinical value to patients with debilitating neurological conditions fits with the passion that has driven me throughout my career in the pharmaceutical industry and is the foundation for long-term success of the business.  I see an opportunity to take Adamas' novel time-dependent approach to a wider group of patients, and I look forward to joining a talented team of professionals who share my belief in the potential of Adamas." said Neil McFarlane. 

    David Mahoney added, "The Adamas Board of Directors extends its profound gratitude to Greg for his contributions as founder and his service as Chairman and CEO.  Under his leadership Adamas grew into a commercial stage public company with an innovative discovery and development platform, which has delivered two approved products. We are grateful for Greg's commitment to patients and his ongoing support of our company.  Combined with other recent changes, we believe Adamas is well positioned to achieve its mission."

    "After leading Adamas for nearly 15 years, now is the right time for this transition," said Greg Went.  "I am thrilled to hand the reins over to Neil.  He has the background and skills to lead the company as we enter the next phase of growth of GOCOVRI and our pipeline.  I am excited about Adamas' future and plan to work with the Board, Neil and the entire leadership team to ensure a smooth transition."

    About Adamas Pharmaceuticals, Inc.

    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com.

    About GOCOVRI

    GOCOVRI (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF.

    GOCOVRI is thought to work by reducing the amount of glutamate hyperactivity in a region of the brain that controls movement, in patients experiencing dyskinesia and OFF. The NMDA receptor is activated by glutamate and causes post-synaptic nerve signaling in this area of the brain, which is modulated by dopamine. Levodopa therapy replaces dopamine lost in Parkinson's disease but may result in large fluctuations in synaptic levels of dopamine during waking hours, further exacerbating glutamate hyperactivity. GOCOVRI, developed by Adamas, is novel in that it selectively blocks the NMDA receptor in a time-dependent manner. Taken at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night and a high concentration from the morning and throughout the waking day. Additionally, the adjunctive use of GOCOVRI does not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall and orthostatic hypotension.

    For more information about GOCOVRI, please see the U.S. Prescribing Information at www.GOCOVRI.com.

    Forward-looking statements

    Statements contained in this press release regarding matters that may occur in the future 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 press release regarding Adamas' expectations regarding the benefits to patients of GOCOVRI. Such statements are subject to risks and uncertainties, and 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 GOCOVRI, and the regulatory and competitive environment and Adamas' business in general, see Adamas' Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2019, particularly under the caption "Risk Factors." 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.

    Contact:

    Investors: Media:
    Peter Vozzo Sarah Mathieson
    Westwicke Vice President of Corporate Communications
    443-213-0505 510-450-3528
     

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  58. EMERYVILLE, Calif., Sept. 10, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted four new employees the option to purchase an aggregate of 17,250 shares of the company's common stock, at a per share exercise price of $5.58, the closing trading price on September 9, 2019, and restricted stock units to acquire 8,625 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants…

    EMERYVILLE, Calif., Sept. 10, 2019 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) today announced that the compensation committee of the company's board of directors granted four new employees the option to purchase an aggregate of 17,250 shares of the company's common stock, at a per share exercise price of $5.58, the closing trading price on September 9, 2019, and restricted stock units to acquire 8,625 shares of the company's common stock. The stock options and restricted stock units vest over four years and were granted pursuant to the Adamas Pharmaceuticals, Inc. 2016 Inducement Plan, which was approved by the company's board of directors in March 2016 under Rule 5653(c)(4) of the Nasdaq Global Market for equity grants to induce new employees to enter into employment with the company.

    About Adamas Pharmaceuticals, Inc. 

    Adamas' goal is to create and commercialize a new generation of medicines intended to lessen the burden of chronic neurologic diseases on patients, caregivers and society using its deep understanding of time-dependent biology. The Company is focused on the commercialization of GOCOVRI® (amantadine) extended release capsules, the first and only FDA-approved medicine for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. The Company also continues to deliver differentiated investigational programs, including ADS-5102 in development for the treatment of walking impairment in patients with multiple sclerosis. For more information about Adamas and its unique approach to developing medicines based on time-dependent biology, please visit www.adamaspharma.com

    Contact:

    Investors:
    Peter Vozzo
    Westwicke Partners
    443-213-0505
     

    Media:
    Sarah Mathieson
    Vice President, Communications & Engagement
    510-450-3528
     

    Primary Logo

    View Full Article Hide Full Article