0001008848-16-000112.txt : 20160701 0001008848-16-000112.hdr.sgml : 20160701 20160701071049 ACCESSION NUMBER: 0001008848-16-000112 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20160701 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160701 DATE AS OF CHANGE: 20160701 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ACORDA THERAPEUTICS INC CENTRAL INDEX KEY: 0001008848 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50513 FILM NUMBER: 161744646 BUSINESS ADDRESS: STREET 1: 420 SAW MILL RIVER ROAD CITY: ARDSLEY STATE: NY ZIP: 10502 BUSINESS PHONE: 914-347-4300 MAIL ADDRESS: STREET 1: 420 SAW MILL RIVER ROAD CITY: ARDSLEY STATE: NY ZIP: 10502 8-K 1 report_cmo-070116.htm 8-K
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):  July 1, 2016
 
Acorda Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
 
 
Delaware
 
000-50513
 
13-3831168
(State or other jurisdiction
 
(Commission
 
(I.R.S. Employer
of incorporation)
 
File Number)
 
Identification No.)
 
 
 
 
 
   
420 Saw Mill River Road,
Ardsley, NY
 
10502
   
(Address of principal executive offices)
 
(Zip Code)
 
 
 
 
 
Registrant's telephone number, including area code:  (914) 347-4300

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))
 
 


Item 8.01 Other Events

On July 1, 2016 Acorda Therapeutics, Inc. (the "Company") issued a press release announcing that Burkhard Blank, M.D. has assumed the role of Chief Medical Officer (CMO) of the Company, effective immediately.  Dr. Blank was appointed as the Company's interim CMO in January 2016, and previously served as CMO for several biopharmaceutical companies, including Boehringer Ingelheim.

Dr. Blank has more than 25 years of industry experience, holding senior leadership positions with responsibility for managing international clinical trial programs, as well as heading regulatory affairs, statistics, drug safety and related departments.  As CMO of Boehringer Ingelheim, Dr. Blank oversaw the submission of five New Drug Applications (NDAs) and had direct responsibility for all aspects of presenting at two U.S. Food and Drug Administration (FDA) Advisory Committee Meetings; subsequently, all five NDAs received FDA approval.

Dr. Blank has also served as a strategic advisor to several biotechnology companies, leading the submission process for multiple Investigational New Drug Applications (INDs), successfully developing protocols for clinical trial programs, and overseeing communications with regulatory agencies.  Dr. Blank received his medical degree from Universitaet Marburg, Germany.

A copy of the press release announcing Dr. Blank's employment as CMO is attached as Exhibit 99.1 to this Current Report on Form 8-K, and incorporated by reference into this Item.


Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.
 
Description
99.1
Press Release dated July 1, 2016


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.
 
 
Acorda Therapeutics, Inc.
     
July 1, 2016
By:
/s/ Michael Rogers
   
Name: Michael Rogers
   
Title: Chief Financial Officer



EXHIBIT INDEX

Exhibit No.
 
Description
99.1
Press Release dated July 1, 2016
 
EX-99.1 2 release_cmo-070116.htm PRESS RELEASE
EXHIBIT 99.1
 
 
 
CONTACT:

Jeff Macdonald
Acorda Therapeutics
(914) 326-5232
jmacdonald@acorda.com

FOR IMMEDIATE RELEASE

Acorda Appoints Burkhard Blank, M.D., as Chief Medical Officer (CMO)

Named to Position After Serving as Interim CMO Since January 2016


ARDSLEY, N.Y. – July 1, 2016 – Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Burkhard Blank, M.D. has assumed the role of Chief Medical Officer (CMO) effective immediately. Dr. Blank was appointed as Acorda's interim CMO in January 2016, and previously served as CMO for several biopharmaceutical companies, including Boehringer Ingelheim.

"I am delighted that Burkhard has joined Acorda as our CMO," said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. "Burkhard brings to Acorda an impressive record of successful drug development and approved NDAs. This will benefit Acorda's entire pipeline, including our late-stage development programs, CVT-301 and tozadenant for Parkinson's disease."

Dr. Blank's primary responsibilities include: setting strategy for and execution of development programs from clinical trials through regulatory filings; oversight of post-marketing studies for approved products; and management of the Company's medical affairs, clinical operations, regulatory affairs, drug safety and biostatistics departments.

"Acorda has a very exciting neurology pipeline with the potential to address significant needs in Parkinson's disease, post-stroke, migraine and multiple sclerosis. With three separate clinical-stage programs that may advance care for people with Parkinson's disease, we are positioned as a leader in PD therapeutic development," said Burkhard Blank, M.D., Chief Medical Officer of Acorda. "My top priorities are to focus on moving our late-stage programs CVT-301 and tozadenant for PD toward regulatory submissions and to advance once-daily dalfampridine into Phase 3 clinical trials in post-stroke walking difficulty."

Dr. Blank has more than 25 years of industry experience, holding senior leadership positions with responsibility for managing international clinical trial programs, as well as heading regulatory affairs, statistics, drug safety and related departments. As CMO of Boehringer Ingelheim, Dr. Blank oversaw the submission of five New Drug Applications (NDAs) and had direct responsibility for all aspects of presenting at two U.S. Food and Drug Administration (FDA) Advisory Committee Meetings; subsequently, all five NDAs received FDA approval.

 
Dr. Blank has also served as a strategic advisor to several biotechnology companies, leading the submission process for multiple Investigational New Drug Applications (INDs), successfully developing protocols for clinical trial programs, and overseeing communications with regulatory agencies. Dr. Blank received his medical degree from Universitaet Marburg, Germany.

Dr. Blank has collaborated with Acorda since 2014, first as consultant to the Company's commercial and business development departments, and then as interim CMO beginning in January 2016.

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, post-stroke walking difficulties, migraine, and multiple sclerosis. Acorda markets three 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
This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: the ability to complete the Biotie transaction on a timely basis; 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.; 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.

These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements.


Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

###
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