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: February 2017
Commission file number: 001-35932
ALCOBRA LTD.
(Translation of registrant’s name into English)
Azrieli Triangle Building
132 Derech Menachem Begin 39th Floor
Tel Aviv 6701101 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):_____
Attached hereto and incorporated by reference herein is the Registrant’s press release issued on February 6, 2017, regarding a productive FDA meeting for a new lead product candidate for ADHD.
The first paragraph and the paragraphs titled “About ADAIR” and “Forward Looking Statements” of the press release attached to this Form 6-K of the Registrant are incorporated by reference into the Registration Statements on Form F-3 (File No. 333-209960) and Form S-8 (File No. 333-194875, 333-202394 and 333-209947) of the Registrant, filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit No.
| 99.1 | The press release issued by Alcobra Ltd. on February 6, 2017, regarding a productive FDA meeting for a new lead product candidate for ADHD. |
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.
|
Alcobra Ltd.
By /s/ Dr. Tomer Berkovitz | |
| Name: Dr. Tomer Berkovitz | |
| Chief Financial Officer and Chief Operating Officer |
Date: February 6, 2017
Exhibit 99.1
Alcobra Reports on Productive FDA Meeting for New Lead Product Candidate for ADHD
| · | Pre-IND meeting held on Alcobra’s proprietary Abuse-Deterrent, Amphetamine Immediate Release (ADAIR) product candidate. |
| · | Meeting defined a 505(b)(2) development path, to be funded with existing cash balance, and targeting a 2H 2018 NDA submission |
| · | Investor call to be held on February 7, 2017 at 8:30 AM EST |
TEL AVIV, Israel, February 6, 2017 -- Alcobra Ltd. (Nasdaq: ADHD) announced today that it has reached a regulatory milestone in the development of ADAIR (Abuse-Deterrent, Amphetamine Immediate-Release), a novel product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). Alcobra has been working on this proprietary product and its unique formulation with Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions. Alcobra recently held a pre-IND meeting with the U.S. Food and Drug Administration (FDA) to discuss the details of the proposed 505(b)(2) development program. The FDA provided guidance on the necessary steps towards an NDA, which is expected to be submitted before the end of 2018. Alcobra expects its existing financial resources to support the development program of ADAIR to NDA filing. There are currently no such FDA-approved abuse-deterrent stimulants.
“For more than a year, we have collaborated with Capsugel to leverage our combined expertise towards the development of a novel treatment option for ADHD. We believe this proprietary, investigational product, if approved, has the potential to be the first abuse-deterrent, immediate-release stimulant, offering additional protection and peace of mind for patients, parents and physicians,” said Dr. Yaron Daniely, President & CEO of Alcobra. “Our work on ADAIR recently culminated in a productive pre-IND meeting with the FDA, which confirmed a potentially rapid development path towards a 2018 NDA submission for ADHD.”
In 2015, nearly 25 million prescriptions were filled in the U.S. for immediate-release (IR) stimulants, which represent the fastest growing class of ADHD drugs in both the pediatric and adult ADHD segments. While effective in the treatment of ADHD, CNS stimulants have been shown to have high potential for abuse and addiction and are scheduled as Class II controlled substances by the U.S. Drug Enforcement Agency (DEA) and other similar agencies outside the U.S. The risks of stimulants are not limited to those who are prescribed the medications. Published studies report that between 25-60% of teenagers and college students with ADHD report being approached to give away or sell their ADHD stimulants. Other published studies report that 40% or more of the people who misuse stimulants, particularly immediate release stimulants, do so by snorting or injecting them.
Alcobra will hold an investor conference call and webcast on Tuesday, February 7, 2017 at 8:30 AM EST. Members of Alcobra’s senior management team, including Dr. Daniely, Dr. Tomer Berkovitz, CFO & Chief Operating Officer, and Mr. David Baker, Chief Commercial Officer, will provide additional insights into plans for the development and market opportunity of ADAIR. Details are provided below.
Conference Call & Webcast
Tuesday, February 7, 2017 @ 8:30 AM Eastern Time
| Domestic: | 855-469-0611 |
| International: | 484-756-4341 |
| Passcode: | 63955279 |
| Webcast: | http://edge.media-server.com/m/p/p33hr67d |
| Replays available through March 1, 2017 | |
| Domestic: | 855-859-2056 |
| International: | 404-537-3406 |
| Passcode: | 63955279 |
About ADAIR
Alcobra’s Abuse-Deterrent
Amphetamine Immediate-Release
(ADAIR) product candidate is a proprietary, abuse-deterrent oral formulation of immediate-release (short-acting) dextroamphetamine
that is currently under development for the treatment of ADHD. ADAIR is being specifically designed to limit abuse by snorting
or injecting. The U.S. Department of Health and Human Services reports that nearly two million people misuse or abuse prescription
stimulants annually with studies reporting that 40 percent or more do so by snorting or injecting these products. The ADAIR formulation
was developed in close collaboration with Capsugel, a global leader in delivering high-quality, innovative dosage forms and solutions.
About Alcobra
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of medications to
treat CNS and cognitive disorders. 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 contains 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 the timing of filing
an NDA for ADAIR, if filed at all, the proposed development path to approve ADAIR, the sufficiency of Alcobra’s financial
resources for its future plans and the potential benefits of ADAIR. In addition, historic results of scientific research do not
guarantee that the conclusions of future research would suggest similar conclusions or that historic results referred to in this
press release would be interpreted similarly in light of additional research or otherwise. 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's Annual Report on Form 20-F for the fiscal year ended December 31, 2015, filed with the Securities and
Exchange Commission (SEC) 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 they were made, whether as a
result of new information, future events or circumstances or otherwise.
Investor Contact:
Alcobra Investor Relations
Debbie Kaye
US: 212-3908964, Intl: +972-3-7299871
IR@alcobra-pharma.com
Media Inquiries:
Sam Brown, Inc.
Mike Beyer
312-961-2502
mikebeyer@sambrown.com