0001193125-11-355986.txt : 20111230 0001193125-11-355986.hdr.sgml : 20111230 20111230082749 ACCESSION NUMBER: 0001193125-11-355986 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20111230 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20111230 DATE AS OF CHANGE: 20111230 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ARCA biopharma, Inc. CENTRAL INDEX KEY: 0000907654 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 363855489 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-22873 FILM NUMBER: 111287946 BUSINESS ADDRESS: STREET 1: 8001 ARISTA PLACE STREET 2: SUITE 200 CITY: BROOMFIELD STATE: CO ZIP: 80021 BUSINESS PHONE: 720-940-2200 MAIL ADDRESS: STREET 1: 8001 ARISTA PLACE STREET 2: SUITE 200 CITY: BROOMFIELD STATE: CO ZIP: 80021 FORMER COMPANY: FORMER CONFORMED NAME: NUVELO INC DATE OF NAME CHANGE: 20030203 FORMER COMPANY: FORMER CONFORMED NAME: HYSEQ INC DATE OF NAME CHANGE: 19970610 8-K 1 d275627d8k.htm FORM 8-K Form 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): December 30, 2011 (December 30, 2011)

 

 

ARCA biopharma, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

 

Delaware   000-22873   36-3855489

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

8001 Arista Place, Suite 430, Broomfield, CO 80021

(Address of Principal Executive Offices) (Zip Code)

(720) 940-2200

(Registrant’s telephone number, including area code)

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 (see General Instruction A.2. below):

 

¨ 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))

 

 

 


Section 8 — Other Events

Item 8.01 Other Events.

On December 30, 2011, ARCA issued a press release announcing that the U.S. Patent and Trademark Office has issued a patent on methods for treating patients with bucindolol based on genetic targeting. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

Section 9 — Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit Number

  

Description

99.1    Press Release titled “ARCA biopharma Announces Additional Patent Issued for Methods for Treatment with Bucindolol Based on Genetic Targeting,” dated December 30, 2011.


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.

Dated: December 30, 2011

 

ARCA biopharma, Inc.

(Registrant)

By:  

/s/ Michael R. Bristow

  Name: Michael R. Bristow
  Title:   President and Chief Executive Officer


INDEX TO EXHIBITS

 

Exhibit Number

  

Description

99.1    Press Release titled “ARCA biopharma Announces Additional Patent Issued for Methods for Treatment with Bucindolol Based on Genetic Targeting,” dated December 30, 2011.
EX-99.1 2 d275627dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

Contact:

Derek Cole

Vice President, Investor Relations & Corporate Communications

720.940.2163

derek.cole@arcabiopharma.com

ARCA BIOPHARMA ANNOUNCES ADDITIONAL PATENT ISSUED FOR METHODS

FOR TREATMENT WITH BUCINDOLOL BASED ON GENETIC TARGETING

------------------------------------------------------------------------

Prospective Knowledge of Alpha-2C Genotype May Allow for Prediction of

Degree of Norepinephrine Lowering by Bucindolol in Individual Patients

Broomfield, CO, December 30, 2011 – ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a patent on methods for treating patients with bucindolol based on genetic targeting and focused on a specific genotype – homozygous wildtype for Deletion 322-325 in the alpha-2C adrenergic receptor. The patent (USP# 8,080,578) entitled “Methods for Treatment with Bucindolol Based on Genetic Targeting,” provides protection in the United States for this novel approach to treating patients with bucindolol.

“We are obviously pleased with the USPTO’s issuance of this patent, which we believe extends our pharmacogenetic intellectual property protection around bucindolol” said Michael R. Bristow, President and Chief Executive Officer of ARCA. “Chronic cardiovascular diseases continue to be a major health care problem, and among the challenges to improving care is the uncertainty of patient responses to drug treatment. We believe new therapies that include a simple test to identify a substantial subpopulation of patients more likely to benefit have the potential to alleviate some of the problems encountered with the current standard of pharmacotherapy, where all members of a disease cohort, including those who will not respond, are treated. A unique pharmacologic property of bucindolol is norepinephrine lowering, and bucindolol’s heart failure clinical responses demonstrated in a large Phase 3 clinical trial (BEST) were modulated by this important effect. The degree of norepinephrine lowering by bucindolol is under genetic control by alpha-2C 322-325 Insertion/Deletion adrenergic receptor polymorphisms (Circulation Heart Failure: 3:21-28 2010). Accordingly, we believe prospective knowledge of the alpha-2C 322-325 genotype allows for prediction of the degree of norepinephrine lowering by bucindolol in an individual patient.”

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company’s lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict


individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA is collaborating with Laboratory Corporation of America to develop the companion genetic test for Gencaro. For more information please visit www.arcabiopharma.com.

Safe Harbor Statement

This press release contains “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the issuance of, and protection provided by, U.S. Patent 8,080,578 entitled “Methods for Treatment with Bucindolol Based on Genetic Targeting” and statements regarding the potential for knowledge of the alpha-2C genotype to predict individual patient response to Gencaro; the ability of genetic variations to predict individual patient response to Gencaro; the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention treatment; and the Company’s ability to fund future operations. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company’s financial resources and whether they will be sufficient to meet the Company’s business objectives and operational requirements; the protection and market exclusivity provided by the Company’s intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA’s filings with the SEC, including without limitation the Company’s annual report on Form 10-K for the year ended December 31, 2010 and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

###

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