BOTHELL, Wash. and VANCOUVER, British Columbia, Oct. 26, 2017 /PRNewswire/ -- Achieve Life
Sciences, Inc. (NASDAQ: ACHV), a clinical-stage pharmaceutical
company committed to the global development and commercialization
of cytisine for smoking cessation, today announced it has entered
into an exclusive supply agreement with Sopharma AD (BSE: 3JR, WSE:
SPH) for the manufacture of cytisine active pharmaceutical
ingredient (API) and finished tablets.
Under the terms of the agreement, Sopharma agrees to produce
cGMP-grade cytisine for Achieve's use in the development and
commercialization of cytisine. Sopharma has over 20 years of
experience producing cytisine through its commercialization efforts
in Central and Eastern Europe. In
addition, Achieve will have full access to the cytisine supply
chain and Sopharma will manufacture sufficient cytisine to meet
specified forecasted demand of cytisine in the Achieve territories.
The exclusive license agreement provides supply of cytisine to
Achieve for up to 20 years.
"This agreement with Sopharma reinforces our commitment and
ability to bring cytisine forward as a new treatment option to help
the millions of smokers who are battling nicotine and tobacco
addiction," said Rick Stewart,
Chairman and CEO of Achieve. "We look forward to our continued
partnership with Sopharma as we work together to address this
global public health epidemic that claims the lives of more than
six million people annually worldwide."
Achieve recently announced completion of enrollment in a
clinical study evaluating the effect of food on the bioavailability
of 3mg cytisine and commencement of a multi-dose, PK/PD clinical
study. Data from both trials will be used to further inform the
Phase 3 clinical program, which is expected to begin enrollment in
the United States in mid-2018.
About Cytisine
Achieve's focus is to address the
global smoking health epidemic through the development and
commercialization of cytisine. Tobacco use is currently the leading
cause of preventable death and is responsible for nearly six
million deaths annually worldwide1. It is estimated that
28.6% of all cancer deaths in the U.S. are attributable to
cigarette smoking2.
Cytisine is a plant-based alkaloid with a high binding affinity
to the nicotinic acetylcholine receptor. It is an established
smoking cessation treatment that has been approved and marketed in
Central and Eastern Europe for
over 20 years. It is estimated that over 20 million people have
used cytisine to help combat nicotine addiction, including over
2,000 patients in investigator-conducted, Phase 3 clinical trials
in Europe and New Zealand.
Two prior, large-scale Phase 3 clinical studies of cytisine,
with favorable outcomes, have been successfully completed in over
2,000 patients. The TASC trial was a 740 patient, double-blind,
placebo controlled trial conceived by Professor Robert West at University College London and
funded by the U.K. National Prevention Research Initiative. The
CASCAID trial was a 1,310 patient, single-blind, non-inferiority
trial comparing cytisine to nicotine replacement therapy (NRT). The
CASCAID trial was conceived by Dr. Natalie
Walker, National Institute for Health Innovation, University
of Auckland and funded by the
Health Research Council of New
Zealand. Both trials were published in the New England
Journal of Medicine. Learn more at www.achievelifesciences.com
About Sopharma AD
Sopharma is a Bulgarian based EU
pharmaceutical producer with over 80 years tradition in the field.
The company is a strong regional player and a responsible partner
to the Bulgarian government in the health care sector supporting
the entire healthcare system and the hospital sector in particular.
The product portfolio expands to over 200 products in all main
therapeutic areas known in more than 40 markets on 5 continents.
Sopharma has over 30 subsidiaries in the production, distribution
and retail sectors in more than 10 countries. In H1 2017 the Group
reached almost 250 million EUR sales
revenues with EBITDA growth of 37.3% and net profit growth of 14.2%
compared to H1 2016. The Group continues to grow and establish
itself as a preferred partner in the region. Learn more at
www.sopharmagroup.com
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, including, but not limited to, statements regarding the
timing of clinical development of cytisine, the market size for
cytisine and the potential benefits of cytisine. All statements
other than statements of historical fact are statements that could
be deemed forward-looking statements. Achieve may not actually
achieve its plans or product development goals in a timely manner,
if at all, or otherwise carry out its intentions or meet its
expectations or projections disclosed in these forward-looking
statements. These statements are based on management's current
expectations and beliefs and are subject to a number of risks,
uncertainties and assumptions that could cause actual results to
differ materially from those described in the forward-looking
statements, including, among others, the risk that cytisine may not
demonstrate the hypothesized or expected benefits; the risk that
Achieve may not be able to obtain additional financing to fund the
development of cytisine; the risk that cytisine will not receive
regulatory approval or be successfully commercialized; the risk
that new developments in the smoking cessation landscape require
changes in business strategy or clinical development plans; the
risk that Achieve's intellectual property may not be adequately
protected; general business and economic conditions; and the other
factors described in the risk factors set forth in Achieve's
filings with the Securities and Exchange Commission from time to
time, including the final Proxy Statement/Prospectus/Information
Statement filed pursuant to Rule 424(b)(3) in connection with
Achieve's recent merger, and Achieve's Annual Reports on Form 10-K
and Quarterly Reports on Form 10-Q. Achieve undertakes no
obligation to update the forward-looking statements contained
herein or to reflect events or circumstances occurring after the
date hereof, other than as may be required by applicable law.
Achieve Contact
Jason
Wong
jwong@bplifescience.com
(415) 375-3340 ext. 4
1World Health Organization. WHO
Report on the Global Tobacco Epidemic, 2011, Geneva: World Health
Organization, 2011.
|
2Annals of Epidemiology , Volume 25
, Issue 3 , 179 - 182.e1
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SOURCE Achieve Life Sciences, Inc.