- 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, Feb. 06, 2017 (GLOBE NEWSWIRE) -- 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: 212-390-8964, Intl: +972-3-7299871 IR@alcobra-pharma.com Media Inquiries: Sam Brown, Inc. Mike Beyer 312-961-2502 mikebeyer@sambrown.com