Form 8-K ACORDA THERAPEUTICS INC For: Nov 20

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of Earliest Event Reported):  November 20, 2017

 

Acorda Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Not Applicable

Former name or former address, if changed since last report

 

 Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

---

 

Item 8.01Other Events

 

On November 20, 2017, Acorda Therapeutics, Inc. (the “Company”) issued a press release announcing that it is discontinuing its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease, including immediately discontinuing dosing of all participants currently enrolled in its tozadenant studies. The Company made this decision based on new information obtained from the Phase 3 program related to previously disclosed agranulocytosis and associated serious adverse events. After analyzing this additional information, the Company concluded that it could not be confident that weekly white blood cell count screening would sufficiently ensure patient safety. The Company has informed regulatory authorities and trial investigators regarding the orderly closure of ongoing studies. Over 90% of the participants in the placebo-controlled Phase 3 efficacy and safety study, CL-05, have completed the study. The Company expects data from these participants in the first quarter of 2018 and to present these at appropriate medical/scientific venues. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item.

 

Item 9.01Financial Statements and Exhibits

 

(d) Exhibits

 

---

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

EXHIBIT 99.1

 

CONTACT:

[email protected]

 

FOR IMMEDIATE RELEASE

 

Acorda Discontinues Tozadenant Development Program

 

ARDSLEY, NY – November 20, 2017 – Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it is discontinuing its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease, including immediately discontinuing dosing of all participants currently enrolled in its tozadenant studies. The Company made this decision based on new information obtained from the Phase 3 program related to previously disclosed agranulocytosis and associated serious adverse events. After analyzing this additional information, the Company concluded that it could not be confident that weekly white blood cell count screening would sufficiently ensure patient safety. Acorda has informed regulatory authorities and trial investigators regarding the orderly closure of ongoing studies.

 

“Patient safety is our top priority,” said Ron Cohen, M.D., Acorda’s President and CEO. “While we are deeply disappointed by this outcome, we remain committed to the Parkinson’s community, which is in great need of new therapeutic options. We are grateful to the patients who volunteered for the tozadenant studies and to their care partners, clinical investigators, and the internal and external study teams.”

 

Over 90% of the participants in the placebo-controlled Phase 3 efficacy and safety study, CL-05, have completed the study. The Company expects data from these participants in the first quarter of 2018 and to present these at appropriate medical/scientific venues.

 

About Acorda Therapeutics

 

Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with neurological disorders. Acorda has an industry-leading pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease, migraine and multiple sclerosis. Acorda markets two FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.

 

For more information, please visit the Company’s website at: www.acorda.com.

 

Forward-Looking Statement

 

These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: the ability to realize the benefits anticipated from the Biotie and Civitas transactions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; the ability to successfully integrate Biotie’s operations and Civitas’ operations, respectively, into our operations; we may need to raise additional funds to finance our expanded operations and may not be able to do so on acceptable terms; our ability to successfully market and sell Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S., which will likely be materially adversely affected by the recently announced court decision in our litigation against filers of

 

---

 

Abbreviated New Drug Applications (each, an “ANDA”) to market generic versions of Ampyra in the U.S.; third party payers (including governmental agencies) may not reimburse for the use of Ampyra or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of Ampyra or from our other research and development programs, including CVT-301 or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market CVT-301, any other products under development, or the products that we will acquire when we complete the Biotie transaction; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain and maintain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaborator Biogen in connection therewith; competition; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

 

###

 

---

Serious News for Serious Traders! Try StreetInsider.com Premium Free!

---

You May Also Be Interested In

• COMPASS MINERALS INTERNATIONAL, INC. (NYSE: CMP) INVESTOR ALERT: Bernstein Liebhard LLP Announces that a Securities Class Action Lawsuit Has Been Filed Against Compass Minerals International, Inc.
• Cooler Master Announces New High-Performance PC Case – the MasterBox 600
• Federal Home Loan Bank of Atlanta Announces First Quarter 2024 Operating Highlights