UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
For the month of: May 2014
ALCOBRA LTD.
(Translation of registrant's name into English)
Amot Investment Building
2 Weizman St. 9th Floor
Tel Aviv 6423902 Israel
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F x Form 40-F ¨
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1):_____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7):_____
Indicate by check mark, whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes ¨ No x
If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): ___
Attached hereto and incorporated by reference herein is the registrant's press release issued on May 1, 2014.
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, thereunto duly authorized.
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Alcobra Ltd.
| ||
| Name: Dr. Yaron Daniely | ||
| Chief Executive Officer and President |
Date: May 1, 2014
| U.S. Investor Contacts: | Israel Investor Contact: |
| LifeSci Advisors, LLC | Alcobra Investor Relations |
| Michael Rice | Debbie Kaye |
| 646-597-6979 | +972-72 2204661 |
| mrice@lifesciadvisors.com | debbie@alcobra-pharma.com |
Alcobra Issued New US Patent Covering Metadoxine Use for Cognitive Disorders
TEL AVIV, Israel, May 1, 2014 – Alcobra Ltd. (NasdaqGM: ADHD), an emerging biopharmaceutical company primarily focused on the development and commercialization of its proprietary drug candidate Metadoxine Extended Release (MDX), to treat cognitive dysfunctions, such as ADHD and Fragile X Syndrome, today announced that the United States Patent and Trademark Office (“USPTO”) has issued a new patent covering MDX’s use in the treatment of Cognitive Disorders.
“We are pleased that the USPTO granted us this second important patent,” said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. “As we expand clinical trials and ultimately seek US FDA approval for MDX in the treatment of cognitive disorders, it is important that we protect our intellectual property surrounding MDX.”
Patent #8,710,067 “Method for the treatment, alleviation of symptoms of, relieving, improving and preventing a cognitive disease, disorder or condition,” was filed on July 3, 2012, issued on April 29, 2014, and provides protection until 2032.
This is the second patent to be issued in the U.S. covering MDX. Alcobra’s portfolio of issued patents and patent applications now covers the release formulations and pharmacokinetic profile of Metadoxine, including the special sustained release, combined release and burst release formulations and the associated methods of treatment, as well as the clinical utilization of MDX for cognitive disorders including Alcobra's lead indication, ADHD.
About Alcobra Ltd.
Alcobra Ltd. is an emerging biopharmaceutical company primarily focused on the development and commercialization of a proprietary drug candidate, MDX (Metadoxine Extended Release (MG01CI)), to treat cognitive dysfunctions including Attention Deficit Hyperactivity Disorder (ADHD) and Fragile X Syndrome. MDX has completed Phase II studies to treat Attention Deficit Hyperactivity Disorder. The company was founded in 2008 and is headquartered in Tel Aviv, Israel. For more information please visit the Company’s website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
Forward Looking Statements – This press release may contain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based on Alcobra's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Alcobra could differ materially from those described in or implied by the statements in this press release. For example, forward-looking statements include statements regarding our plan to conduct and expand clinical trials, seeking FDA approval for MDX in treatment of cognitive disorders and the period of time the issued patent reported above would be in force and in effect protect the Company intellectual property assets. In addition, historic results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions or that historic results referred to in this press release would be interpreted differently in light of additional research and clinical and preclinical trials results. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in Alcobra Ltd.'s Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on March 28, 2014, and in subsequent filings with the SEC. Except as otherwise required by law, Alcobra disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.
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