Cynapsus Therapeutics and MonoSol Rx Announce Global IP Licensing Agreement
(Thomson Reuters ONE) -
- Strengthening Intellectual Property for Sublingual Delivery of Apomorphine to
Treat OFF Episodes in Parkinson's Disease Patients -
TORONTO and WARREN, N.J., April 04, 2016 (GLOBE NEWSWIRE) --Cynapsus
Therapeutics Inc. ("Cynapsus" or the "Company") (NASDAQ:CYNA) (TSX:CTH), and
MonoSol Rx LLC ("MonoSol Rx") today announced that they have signed a global
licensing agreement for certain intellectual property ("IP") including existing
patents, patent applications, and future patents and patent applications
covering all oral films containing apomorphine for the treatment of OFF episodes
in Parkinson's disease ("PD") patients.
Cynapsus, the developer of APL-130277, a "turning ON" medication containing
apomorphine in a fast-acting, easy-to-use, sublingual thin film for all types of
OFF episodes associated with PD, holds global commercialization rights for APL-
130277. Cynapsus also has a substantial patent portfolio, including issued and
pending patent applications in the United States and certain other
jurisdictions, covering APL-130277 and its use in the treatment of PD. MonoSol
Rx has key issued industry-leading patents and pending patent applications as
well as significant expertise and know-how in film technology which together
with the Cynapsus' IP, creates a significant patent portfolio further
strengthening APL-130277 commercial protection.
Under the license agreement, MonoSol Rx will receive up front and contingent
milestone payments and single-digit royalty payments on net sales of APL-130277.
"We are delighted to have signed the agreement with MonoSol Rx for their
intellectual property portfolio covering pharmaceutical films which will broaden
our IP protection for APL-130277 as we move closer to commercialization.
Cynapsus aims to provide patients suffering with PD a patient-friendly way to
treat their often debilitating OFF episodes," said Anthony Giovinazzo, President
and CEO of Cynapsus. "We continue to focus on completing our Phase 3 clinical
trials and filing our NDA with the FDA near the end of 2016 or in early 2017."
Keith J. Kendall, CEO of MonoSol Rx, commented, "MonoSol Rx has the world's
leading portfolio of intellectual property and knowhow relating to film
applications in the pharmaceutical industry. We are very pleased to license our
technology to Cynapsus. For MonoSol Rx this is recognition for the value of the
capabilities and differentiation that PharmFilm® represents for patients and
partners. Entering into this licensing agreement with Cynapsus benefits both
parties and we are happy to be aligned with Cynapsus in providing PD patients
with more convenient and effective therapies."
About Cynapsus
Cynapsus is a specialty central nervous system pharmaceutical company developing
and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film
for the on-demand management of debilitating OFF episodes associated with PD.
The Company has successfully completed a Phase 2 clinical trial for its product
candidate, APL-130277, a sublingual formulation of apomorphine hydrochloride, or
apomorphine. Apomorphine is the only molecule approved for acute, intermittent
treatment of OFF episodes for advanced PD patients, but is currently only
approved as a subcutaneous injection in the United States. APL-130277 is a
"turning ON" medication designed to rapidly, safely and reliably convert a PD
patient from the OFF to the ON state while avoiding many of the issues
associated with subcutaneous delivery of apomorphine. It is designed to convert
all types of OFF episodes, including morning OFF episodes, often considered the
most difficult to treat. Cynapsus has initiated its Phase 3 clinical program for
APL-130277, relying on the abbreviated Section 505(b)(2) regulatory pathway in
the United States, and the Company intends to submit an NDA near the end of
2016 or in early 2017. For additional company information, please visit our
website www.cynapsus.ca.
About MonoSol Rx
MonoSol Rx is a specialty pharmaceutical company leveraging its proprietary
PharmFilm® drug delivery technology to develop products that improve patient
outcomes and address unmet needs. These pharmaceutical and over-the-counter
products are developed independently and with partners. PharmFilm can provide a
benefit to patients by improving the efficacy, safety, and convenience of
currently marketed pharmaceutical products, new molecular entities, and
combination products. MonoSol Rx's leadership in film drug delivery is supported
by strong IP protection, a robust pipeline of prescription drug formulations,
and two FDA-approved products - Suboxone® (buprenorphine and naloxone)
sublingual film and Zuplenz® (ondansetron) oral soluble film. For press releases
and other company information, visit www.monosolrx.com. More information about
PharmFilm can be found at www.pharmfilm.com.
Cynapsus Forward-Looking Statements
This announcement contains "forward-looking statements" within the meaning of
applicable securities laws, including, without limitation, the Company's
expectation for filing an NDA near the end of 2016 or in early 2017;
expectations regarding the Company's clinical and regulatory activities,
including without limitation, the anticipated timing and completion of clinical
studies; and beliefs regarding the Company's IP protection for APL-130277. These
forward-looking statements include information about possible or assumed future
results of the Company's business, financial condition, results of operations,
liquidity, plans and objectives. In some cases, you can identify forward-looking
statements by terminology such as "believe," "may," "estimate," "continue,"
"anticipate," "intend," "should," "plan," "expect," "predict," "potential," or
the negative of these terms or other similar expressions. These forward-looking
statements are based on the Company's current expectations and beliefs and
inherently involve significant risks and uncertainties. Actual results and the
timing of events could differ from those anticipated in such forward-looking
statements as a result of risks and uncertainties, and include, but are not
limited to, those factors identified under the caption "Risk Factors" in the
Company's Form 10-K filed with the United States Securities and Exchange
Commission (the "SEC") on March 9, 2016, as amended by Amendment No. 1 to Form
10-K/A filed with the SEC on March 18, 2016, and its other filings and reports
in the United States with the SEC available on the SEC's web site
at www.sec.gov, and in Canada with the various Canadian securities regulators,
which are available online at www.sedar.com. Furthermore, unless otherwise
stated, the forward-looking statements contained in this press release are made
as of the date of this press release, and the Company has no intention and
undertakes no obligation to update or revise any forward-looking statements,
whether as a result of new information, future events, changes or otherwise,
except as required by law.
Neither the NASDAQ nor the TSX has approved or disapproved of the contents of
this press release.
Contact Information
Cynapsus
Kristen Galfetti
Vice President Investor Relations
(416) 703-2449 x246
kgalfetti(at)cynapsus.ca
Media Contact:
Matt Middleman
Russo Partners LLC
(212) 845-4272
matt.middleman(at)russopartnersllc.com
MonoSol Rx
Investor Contact:
Lee Roth
The Ruth Group
Vice President
(646) 536-7000
lroth(at)theruthgroup.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Cynapsus Therapeutics Inc. via GlobeNewswire
[HUG#2000026]
Unternehmensinformation / Kurzprofil:
Datum: 04.04.2016 - 12:00 Uhr
Sprache: Deutsch
News-ID 461627
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contact information:
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