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):
November 19, 2015
LIGHTLAKE THERAPEUTICS INC.
(Exact name of registrant as specified in
its charter)
Nevada |
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000-55330 |
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N/A |
(State or other jurisdiction of
incorporation) |
|
(Commission File Number) |
|
(I.R.S. Employer Identification No.) |
445 Park
Avenue, 9th Floor, New York, NY 10022
(Address of principal
executive offices) (Zip Code)
Registrant’s telephone number, including
area code: (212) 829-5546
N/A
(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)) |
On November 19, 2015, Lightlake
Therapeutics Inc. (“Lightlake”) issued a press release announcing that the U.S. Food and Drug Administration has
approved NARCAN® (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose,
to be marketed by Adapt Pharma Limited, Lightlake’s partner. In December 2014, Lightlake announced a licensing deal
with a subsidiary of Adapt. As per the terms of the deal, in exchange for licensing its opioid overdose reversal treatment,
Lightlake could receive potential development and sales milestone payments of more than $55 million, plus up to double-digit
royalties.
A copy of the press release is filed as
Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 |
Financial Statements and Exhibits |
(d) Exhibits
Exhibit No. |
|
Description |
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|
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99.1 |
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Lightlake Therapeutics Inc. Announces NARCAN(R) (Naloxone Hydrochloride) Nasal Spray Approved by U.S. Food and Drug Administration, dated November 19, 2015. |
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: November 20, 2015
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LIGHTLAKE THERAPEUTICS INC. |
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By: |
/s/ Dr. Roger Crystal |
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Dr. Roger Crystal |
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Chief Executive Officer and President |
Exhibit 99.1
News Release
Corporate Contact:
Lightlake Therapeutics Inc.
445 Park Avenue, 9th Floor
New York, NY 10022
Dr. Roger Crystal, CEO
(212) 829-5546
investor.relations@lightlaketherapeutics.com
NARCAN® (NALOXONE HYDROCHLORIDE)
NASAL SPRAY APPROVED BY U.S. FOOD AND DRUG ADMINISTRATION
NEW YORK – (November 19, 2015) –
Lightlake Therapeutics Inc. (“Lightlake”) (OTCQB: LLTP), a specialty pharmaceutical company developing pharmacological
treatments for substance use, addictive, and eating disorders announced today that the U.S. Food and Drug Administration (FDA)
has approved NARCAN® (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose,
to be marketed by Adapt Pharma Limited (“Adapt”), Lightlake’s partner.
For more than 40 years naloxone has been
trusted by healthcare providers for reversing the effects of opioid overdose, but until yesterday it was FDA approved only as an
injection. NARCAN® Nasal Spray, to be marketed by Adapt, can be administered in an emergency by family members, caregivers,
or others to reverse the effects of opioid overdose until help arrives. An opioid overdose may cause brain damage or death, so
NARCAN® Nasal Spray should be administered as quickly as possible if a patient is unresponsive and an opioid overdose is suspected,
even when in doubt. In the United States, opioid overdose related deaths are growing and claimed almost 24,500 lives in 2013, or
an average of one life every 21 minutes.1 The majority of those deaths involved prescription opioids2 and
happened in people’s homes.3
In response, momentum to increase access
to naloxone is building. In October, President Obama, included a call to make naloxone more readily available as part of a major
initiative to address the nation’s opioid epidemic.4 Major medical groups, including the American Medical Association
and American Academy of Family Physicians, have also called for increased access to naloxone.5
“This is a very important day for
physicians, patients, first responders, and caregivers,” commented Dr. Roger Crystal, M.D., CEO of Lightlake. “This
product has the potential to save thousands of lives each year. It has been a privilege to develop this drug in partnership with
NIDA, and we’re very pleased that our partner Adapt will be launching NARCAN® Nasal Spray very soon.”
Lightlake plans to now focus on developing
products for substance abuse, addictions, and eating disorders. Over the next year, Lightlake plans to bring the next generation
of products into clinical trials.
In
December 2014, Lightlake announced a licensing deal with a subsidiary of Adapt. As per the terms of the deal, in exchange
for licensing its opioid overdose reversal treatment, Lightlake could receive potential development and sales milestone payments
of more than $55 million, plus up to double-digit royalties.
Relevant Links
The National Institute on Drug Abuse (NIDA):
http://www.drugabuse.gov/news-events/news-releases/2015/11/fda-approves-naloxone-nasal-spray-to-reverse-opioid-overdose
Adapt Pharma Limited: http://www.adaptpharma.com/press-releases/
Indications and Important Safety Information:
http://www.NarcanNasalSpray.com
About Lightlake Therapeutics Inc.
Lightlake Therapeutics Inc. is a specialty
pharmaceutical company developing pharmacological treatments for substance use, addictive, and eating disorders. Lightlake has
entered into a licensing deal with a subsidiary of Adapt Pharma Limited with respect to a treatment to reverse opioid overdoses,
which have reached epidemic proportions in the United States. Lightlake also has collaborated on clinical trials with the National
Institute on Drug Abuse, part of the National Institutes of Health, with respect to this treatment. In addition, Lightlake has
completed a Phase II clinical trial to treat Binge Eating Disorder. For more information please visit: www.lightlaketherapeutics.com.
Forward-Looking Statements
This press release contains forward-looking
statements. These statements relate to future events or our future financial performance and involve known and unknown risks, uncertainties
and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to
be materially different from any future results, levels of activity, performance or achievements expressed, implied or inferred
by these forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may,”
“will,” “should,” “could,” “would,” “expects,” “plans,”
“intends,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,”
“potential,” or “continue” or the negative of such terms and other comparable terminology. These statements
are only predictions based on our current expectations and projections about future events. You should not place undue reliance
on these statements. Actual events or results may differ materially. In evaluating these statements, you should specifically consider
various factors. These and other factors may cause our actual results to differ materially from any forward-looking statement.
We undertake no obligation to update any of the forward-looking statements after the date of this press release to conform those
statements to reflect the occurrence of unanticipated events, except as required by applicable law.
# # #
1 Centers for Disease
Control and Prevention: NCHS Data Brief Number 190, March 2015 http://www.cdc.gov/nchs/data/databriefs/db190.htm#ref2
2 Ibid
3 CDC Wonder Database
Multiple Cause of Death MCD - ICD-10 Codes: T40.1 (Heroin), T40.2 (Other opioids), T40.3 (Methadone), T40.4 (Other synthetic narcotics)
2013
4 The White House Office
of the Press Secretary. FACT SHEET: Obama Administration Announces Public and Private Sector Efforts to Address Prescription Drug
Abuse and Heroin Use. 2015. Available at: https://www.whitehouse.gov/the-press-office/2015/10/21/fact-sheet-obama-administration-announces-public-and-private-sector
5 American Medical Association.
The American Medical Association Task Force to Reduce Prescription Opioid Abuse. 2015. Available at: http://www.ama-assn.org/ama/pub/advocacy/topics/preventing-opioid-abuse/opioid-abuse-task-force.page
Corporate
Contact:
Lightlake
Therapeutics Inc.
445
Park Avenue, 9th Floor
New
York, NY 10022
Dr.
Roger Crystal, CEO
(212)
829-5546
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